Clinical trial register · European Union · CTIS

Clinical Trials in Germany, 2026

The most recently authorised trials on the EU Clinical Trials Information System (CTIS), the single register for every trial run under the EU Clinical Trials Regulation (536/2014). CTIS holds a far larger historical archive than any one list can usefully show — this register states both numbers rather than picking one.

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Source: EMA Clinical Trials Information System (CTIS). Showing the 2556 most recently authorised of 12766 total CTIS records — a stated recency window, not the full historical archive. Synced 04 Nov 2026, 03:17 UTC

2556

Shown in this register

most recently authorised

12,766

Total on CTIS

full historical archive

788

Phase III

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Top member states

Spain 1071 France 936 Germany 897 Italy 779 Poland 622 Netherlands 547

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Trials with a site in Germany

Phase

Study

Lead sponsor

Area

Member states

Decision

Phase I/II

C6461020 - An Interventional Open-Label Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of PF-08634404 in combination with Different Anticancer Agents in Participants with Advanced Solid Tumors

2025-523526-40-00Advanced Solid Tumors

Pfizer Inc.

Neoplasms

Italy, Spain, France, Germany

09/04/2026

Phase I/II

C6461013 - An Interventional Open-label Phase 1b/2 Study to Evaluate Safety, Pharmacokinetics, and Preliminary Efficacy of PF-08634404 as Monotherapy and Combination Therapy in Adult Participants With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma

2025-523525-17-00Unresectable Locally Advanced or Metastatic Hepatocellular …

DrugsPF-08634404·Ipilimumab

Pfizer Inc.

Neoplasms

Spain, Italy, Germany, France

09/04/2026

Phase I

Study of diclofenac skin reservoir formation and emptying after Voltaren Emulgel 2.32% application in healthy participants

2025-524764-38-00For the local, symptomatic treatment of pain in acute bruis…

Haleon CH SARL

Therapeutics

Germany

09/04/2026

Phase III

C6461004 - A GLOBAL PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH EXTENSIVE-STAGE SMALL CELL LUNG CANCER

2025-523522-41-00Extensive-Stage Small Cell Lung Cancer

DrugsPF-08634404·Etoposide·Atezolizumab·Carboplatin

Pfizer Inc.

Neoplasms

France, Italy, Germany, Spain

07/04/2026

Phase III

A multicenter, randomized, double-blind, parallel group, placebo-controlled study of the efficacy and safety of early depemokimab initiation as add-on treatment in COPD patients with type 2 inflammation.

2025-521108-23-00Chronic Obstructive Pulmonary Disease

Glaxosmithkline Research & Development Limited

Respiratory Tract Diseases

Germany, Belgium, Netherlands, Denmark, Spain, Greece, Poland, Hungary, France, Italy, Bulgaria, Romania

07/04/2026

Phase III

A Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept (2 mg) in Participants with Diabetic Macular Edema (DME) (EYP-1901-303)

2025-523937-25-00Diabetic Macular Edema (DME)

Eyepoint Inc.

Eye Diseases

Germany, Poland, Slovakia

07/04/2026

Phase III

Multicenter, open-label study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of filgotinib in children and adolescents from 8 years to less than 18 years of age with polyarticular-course juvenile idiopathic arthritis

2024-511593-70-00Polyarticular-course juvenile idiopathic arthritis

Alfasigma S.p.A.

Musculoskeletal Diseases

Spain, Bulgaria, France, Belgium, Germany, Greece, Italy, Poland, Hungary, Czechia

07/04/2026

Phase II

Open-label, safety, tolerability and proof of concept study to evaluate the use of ANXV (recombinant human Annexin A5 protein) in the treatment of patients with either Diabetic Retinopathy or recent onset Retinal Vein Occlusion

2026-525349-65-00Diabetic Retinopathy, Retinal Vein Occlusion

Annexin Pharmaceuticals AB (publ)

Eye Diseases

Germany

02/04/2026

Phase I

A research study looking into how cagrilintide influences food intake and appetite in people with overweight or obesity

2025-524206-15-00Obesity

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Germany

02/04/2026

Phase I

Study in healthy male participants to compare the blood levels after epoetin alfa (Blau EPO) and Erypo, administered as multiple intravenous injections as well as safety, tolerability and the effects on certain blood values.

2025-522246-43-00Treatment of symptomatic anemia associated with chronic ren…

Blau Farmaceutica S.A.

Hemic and Lymphatic Diseases

Germany

02/04/2026

Phase III

EVALUATING THE EFFICACY AND SAFETY OF MET097, A FULLY- BIASED ULTRA LONG-ACTING GLP-1RA IN PEOPLE WITH OVERWEIGHT OR OBESITY: A PHASE 3, MULTI-CENTER RANDOMIZED, CONTROLLED TRIAL (VESPER-4)

2025-523974-18-00Obesity

DrugBerobenatide

Metsera Inc.

Nutritional and Metabolic Diseases

Germany, Hungary, Slovakia, Poland, Spain, Czechia, Romania, Bulgaria

02/04/2026

Phase II

L-Thyroxine for the treatment of acute unilateral vestibulopathy (AUVP): a monocentric, double-blind, placebo-controlled trial (T4U)

2024-519515-34-00Patients with acute unilateral vestibulopathy (AUVP)

Klinikum der Universitaet Muenchen AöR

Nervous System Diseases

Germany

02/04/2026

Phase III

J3R-MC-YDAN - A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants with Osteoarthritis Knee Pain, and Obesity or Overweight (ENLIGHTEN-4) J3R-MC-YOA1: Intervention-Specific Appendix 1 (ISA1) for Eloralintide in Participants with Osteoarthritis Knee Pain J3R-MC-YOA2: Intervention-Specific Appendix 2 (ISA2) for Eloralintide in Participants with Osteoarthritis Knee Pain

2025-523768-19-00Osteoarthritis, Overweight or Obesity

Eli Lilly & Co.

Nutritional and Metabolic Diseases

Denmark, Belgium, Germany, Czechia

02/04/2026

Phase II

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety of surlorian (ARM210, S48168) in Adults with Autosomal Dominant RYR1-Related Myopathy

2025-522343-18-00Autosomal Dominant RYR1-Related Myopathy

Rycarma Therapeutics Inc.

Musculoskeletal Diseases

Netherlands, Spain, France, Germany

02/04/2026

Phase III

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Zasocitinib in Pediatric Participants Aged 4 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

2025-522567-15-00Plaque Psoriasis

Takeda Development Center Americas Inc.

Skin and Connective Tissue Diseases

Spain, Poland, Germany, Italy

01/04/2026

Phase III

Open Label Extension (OLE), multiple dose study to evaluate pharmacokinetics, safety, tolerability and efficacy of filgotinib in children and adolescents from 8 years to less than 18 years of age with juvenile idiopathic arthritis (JIA).

2025-523239-21-00Juvenile idiopathic arthritis

Alfasigma S.p.A.

Immune System Diseases

France, Germany, Poland, Belgium, Hungary, Spain, Czechia, Greece, Italy

01/04/2026

Phase II

A Phase 2, randomized, placebo-controlled, double-blind clinical study to evaluate efficacy and safety of LAD328 in adult subjects with moderate to severe hidradenitis suppurativa

2025-521865-29-00moderate-to-severe hidradenitis suppurativa

Almirall S.A.

Skin and Connective Tissue Diseases

Bulgaria, Spain, France, Poland, Germany

01/04/2026

Phase II

A Phase 2, Dose Ranging, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of BFB759 in Patients with Moderate to Severe Hidradenitis Suppurativa (COMPASS 2 - HS)

2025-522440-41-00Hidradenitis Suppurativa

Bluefin Biomedicine Inc.

Immune System Diseases

Spain, Germany, Czechia, Poland, Bulgaria

31/03/2026

Phase I/II

A Phase Ib/II Open-Label, Multicentre Platform Study Evaluating Novel Combinations in Participants with Advanced or Metastatic Non-Small Cell Lung Cancer (ALTAIR)

2024-519786-22-01metastatic non-small cell lung cancer (NSCLC)

DrugsRamucirumab·Rilvegostomig

AstraZeneca AB

Neoplasms

Germany, Spain, France, Poland, Belgium, Netherlands, Italy

30/03/2026

Phase III

2025-523938-10-00Diabetic Macular Edema (DME)

Eyepoint Inc.

Eye Diseases

Hungary, Czechia, Germany

30/03/2026

Phase III

A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of Azetukalner in Major Depressive Disorder

2025-523618-10-00Major Depressive Disorder

Xenon Pharmaceuticals Inc.

Mental Disorders

Finland, Poland, Romania, Slovakia, Spain, Germany

30/03/2026

Phase III

Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with overweight or obesity, and obstructive sleep apnoea not treated with positive airway pressure (AMAZE 3)

2024-520442-36-00Overweight or obesity, and obstructive sleep apnoea not tre…

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Denmark, Poland, Spain, Germany

30/03/2026

Phase I

A multiCenter phase I study of aUtologous CD19 CAR T cElls for therapy refractory chronic GvHD (CURE-cGvHD)

2025-524468-40-00chronic Graft-versus-Host-Disease (cGvHD)

Universitaetsklinikum Erlangen AöR

Immune System Diseases

Germany

27/03/2026

Phase III

Randomised, Open-label, Phase III Study of AZD5335 Versus Mirvetuximab Soravtansine in FRα-high and AZD5335 Versus Investigator’s Choice Chemotherapy in FRα-low Expressing High-grade Platinum-resistant Epithelial Ovarian Cancer Patients (TREVI-OC-01)

2025-520466-22-00Advanced Platinum-resistant Epithelial Ovarian Cancer

AstraZeneca AB

Pathological Conditions, Signs and Symptoms

Ireland, Greece, Czechia, France, Sweden, Belgium, Denmark, Spain, Italy, Germany

27/03/2026

Phase III

J3R-MC-YDAG - A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Obesity or Overweight, Without Type 2 Diabetes

2025-523657-34-00Obesity, Overweight

Eli Lilly & Co.

Nutritional and Metabolic Diseases

Germany, Poland, Belgium

27/03/2026

Phase III

A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator’s Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy

2024-519818-31-01Endometrial Cancer Advanced, Recurrent, Metastatic, or Prim…

DrugsDoxorubicin·Paclitaxel

Genmab A/S

Neoplasms

Poland, Denmark, Finland, Lithuania, France, Germany, Spain, Belgium, Greece, Norway, Italy

26/03/2026

Phase II

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Proof of Concept (POC) Study Evaluating the Safety, Tolerability, and Efficacy of Nintedanib Solution for Inhalation (AP02) in Participants with Idiopathic Pulmonary Fibrosis (IPF) (AURA-IPF)

2025-523431-19-00Idiopathic Pulmonary Fibrosis (IPF)

Avalyn Pharma Inc.

Respiratory Tract Diseases

Germany, Italy, Spain, Ireland

26/03/2026

Phase I

A study to learn about how a new nurandociguat tablet is absorbed and processed in the body compared to an old tablet and how food affects the way the new tablet is absorbed and processed in the body

2025-524176-36-00Chronic Kidney Disease

Bayer AG

Cardiovascular Diseases

Germany

25/03/2026

Phase II

PNOC029_Tovorafenib for the treatment of newly diagnosed or recurrent craniopharyngioma in children and young adults

2024-511510-20-00craniopharyngioma

DrugTovorafenib

Prinses Maxima Centrum voor Kinderoncologie B.V.

Neoplasms

Netherlands, France, Germany

25/03/2026

Phase III

IB1001-304: Effects of N-Acetyl-L-Leucine on CACNA1A Disorders: A Phase III, randomized, placebo-controlled, double-blind, crossover study

2025-523828-51-00CACNA1A Disorders

Intrabio Limited, IntraBio Inc

Nervous System Diseases

Italy, Germany, Austria, Greece

25/03/2026

Phase II

A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study of NAV-240 in Adult Participants with Moderate-to-Severe Hidradenitis Suppurativa

2025-523557-33-00Moderate-to-Severe Hidradenitis Suppurativa

Navigator Medicines Inc.

Skin and Connective Tissue Diseases

Hungary, Poland, Germany, Bulgaria, Romania

25/03/2026

Phase III

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study of Barzolvolimab in Participants with Cold Induced Urticaria and Symptomatic Dermographism (EMBARQ-COLDU and SD)

2025-522583-32-00Cold-Induced Urticaria and Symptomatic Dermographism

Celldex Therapeutics Inc.

Skin and Connective Tissue Diseases

Germany, Lithuania, Spain, Poland

25/03/2026

Phase II

A Phase 2, randomized, placebo-controlled, double-blind clinical study to evaluate efficacy and safety of LAD603 in adult subjects with severe to very severe alopecia areata

2025-523342-27-00Alopecia areata

Almirall S.A.

Skin and Connective Tissue Diseases

Bulgaria, Romania, Poland, Germany, Spain

24/03/2026

Phase III

Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure (AMAZE 4)

2024-520443-16-00Overweight or obesity, and obstructive sleep apnoea treated…

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Poland, Spain, Germany

24/03/2026

Phase III

J3R-MC-YDAF - A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants with Obesity or Overweight, and Type 2 Diabetes

2025-523658-15-00Obesity, Overweight

Eli Lilly & Co.

Nutritional and Metabolic Diseases

Germany, Spain, Poland, Czechia, Slovakia

24/03/2026

Phase III

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients with Heart Failure with Preserved Left Ventricular Ejection Fraction

2025-522475-28-00Pulmonary Hypertension (PH) with Heart Failure with preserv…

Tenax Therapeutics Inc.

Cardiovascular Diseases

France, Italy, Germany, Czechia, Austria, Poland, Hungary, Bulgaria, Spain

24/03/2026

Phase III

AN INTERVENTIONAL PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER

2025-523461-17-01LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER

Pfizer Inc.

Neoplasms

France, Italy, Hungary, Greece, Czechia, Spain, Poland, Germany

24/03/2026

Phase I

A study to investigate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of a CD19/CD20 T-cell engager in participants with B-cell driven ARD.

2025-522932-15-00Systemic Lupus Erythematosus

Glaxosmithkline Research & Development Limited

Immune System Diseases

Germany, France, Italy, Spain, Poland

23/03/2026

Phase III

Phase III, Randomized, Open-label, Global, Multicenter Study of Rilvegostomig or Durvalumab in Combination With Chemotherapy as a First-line Treatment for Patients With Advanced Biliary Tract Cancer (ARTEMIDE-Biliary02).

2025-523085-24-00Biliary Tract Cancer

AstraZeneca AB

Neoplasms

Germany, Poland, Italy, Belgium, France, Netherlands, Spain

23/03/2026

Phase III

A Phase 3, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Study With a Double-Blind Extension Evaluating Efficacy and Safety of Lebrikizumab Administered to Adult Patients With Nummular Eczema who are not Adequately Controlled With Topical Corticosteroids or When This Treatment is not Medically Advisable (LUMINE)

2025-522403-17-00Nummular Dermatitis

Almirall S.A.

Skin and Connective Tissue Diseases

Italy, Bulgaria, Spain, Germany, Poland, France

23/03/2026

Phase II

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib plus Ribociclib plus Fulvestrant Versus Placebo plus Ribociclib plus Fulvestrant in Patients with Endocrine-Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer with Chromosome 8P Loss and Without a PIK3CA Mutation

2025-523013-28-00Endocrine-Resistant Hormone-Receptor-Positive, HER2-Negativ…

F. Hoffmann-La Roche AG

Neoplasms

France, Italy, Poland, Germany, Spain

23/03/2026

Phase II

A Phase 2 Study of ACR-368 Therapy in Subjects with Endometrial Cancer

2025-524542-10-00Endometrial cancer

Acrivon Therapeutics Inc.

Neoplasms

Italy, Germany, Spain, France

23/03/2026

Phase III

C6461003 - AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER

2025-523521-18-00Metastatic Colorectal Cancer

DrugsPF-08634404·Calcium folinate·Fluorouracil·Oxaliplatin

Pfizer Inc.

Neoplasms

Spain, Belgium, France, Italy, Netherlands, Germany, Poland, Denmark

23/03/2026

Phase II

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-88545223 for the Treatment of Participants with Active Psoriatic Arthritis

2025-523141-10-00Active Psoriatic Arthritis

Janssen Cilag International

Immune System Diseases

Spain, Poland, Czechia, Germany, Hungary

20/03/2026

Phase I

A study in healthy people to test how vicadrostat affects the heart

2025-524106-14-00Healthy volunteer trial

Boehringer Ingelheim International GmbH

Not possible to specify

Germany

20/03/2026

Phase II

A Phase 2 Posology Study with Long-Term Extension in Participants with Well‑Controlled Recurrent Pericarditis to Evaluate the Efficacy and Safety of Transition Regimens to KPL-387 Monotherapy from Standard Therapies

2025-523234-66-00Well-Controlled Recurrent Pericarditis

Kiniksa Pharmaceuticals GmbH

Therapeutics

Spain, Greece, Germany, France, Italy, Poland

19/03/2026

Phase II

SEZanne: A Phase 2 Randomized, Open label, Multicenter Study to Evaluate the Optimal Dose, Safety, and Efficacy of ABBV-706 in Combination with Atezolizumab versus Standard of Care as First-Line Treatment in Subjects with Previously Untreated Extensive Stage Small Cell Lung Cancer (ES-SCLC)

2024-517490-24-00Small Cell Lung Cancer

AbbVie Deutschland GmbH & Co. KG

Neoplasms

Spain, Germany, Italy, Poland, Belgium

18/03/2026

Phase II

J6E-MC-KWAN: A Phase 2, Multicenter, Randomized, Double-Blind, Active-Controlled Study of LY4268989 (MORF-057) Co-Administered with Mirikizumab in Adults with Moderately to Severely Active Ulcerative Colitis

2025-522338-30-00Ulcerative Colitis

Eli Lilly & Co.

Digestive System Diseases

Hungary, Spain, Denmark, Netherlands, Poland, Romania, Germany, Italy, Austria

18/03/2026

Phase I

A study in healthy men to test how well different doses of BI 3821001 are tolerated

2025-523899-23-00Healthy volunteer trial

Boehringer Ingelheim International GmbH

Not possible to specify

Germany

18/03/2026

Phase II

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN13335, an Anti-PDGF-B Monoclonal Antibody, in Adults with Pulmonary Arterial Hypertension

2024-514754-79-00Pulmonary Arterial Hypertension (PAH)

Regeneron Pharmaceuticals Inc.

Cardiovascular Diseases

Latvia, Belgium, France, Poland, Germany, Spain, Czechia

18/03/2026

Phase III

A prospective, open-label, randomized, multicenter phase-III trial to evaluate the efficacy of pirtobrutinib and epcoritamab compared with R-(mini)-CHOP for treatment of patients with Richter Transformation - CLLRT2

2024-513445-37-00previously untreated RT, irrespective of risk factors and d…

DrugsEpcoritamab·Pirtobrutinib·Prednisolone·Vincristine

University Of Cologne

Neoplasms

Austria, Germany, Denmark, Ireland, Netherlands, Italy

18/03/2026

Phase III

A Phase 3, Randomized, Double-blind, Placebo-controlled, 3-Part Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant XR Tablet for Prophylaxis and Deucrictibant Soft Capsule for On-demand Treatment of Angioedema Attacks in Adults with Acquired Angioedema due to C1 Inhibitor Deficiency

2025-522051-26-00Acquired Angioedema due to C1 Inhibitor Deficiency

DrugDeucrictibant

Pharvaris Netherlands B.V.

Immune System Diseases

Hungary, Spain, Austria, Germany, Poland, Netherlands, France, Italy, Bulgaria

17/03/2026

Phase II

An open-label, uncontrolled, multicenter study to assess the effect of zigakibart treatment on histologic, circulating, and excreted markers of kidney disease and dysfunction in adult patients with IgA nephropathy

2024-519699-24-00IgA nephropathy

Novartis Pharma AG

Immune System Diseases

Czechia, Germany, Spain, Italy, Poland

17/03/2026

Phase II

A Phase 2, Randomized, Masked, Placebo-Controlled Study of Subcutaneously Administered ADX-038 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

2025-521779-30-00Geographic atrophy secondary to age-related macular degener…

Adarx Pharmaceuticals Inc.

Eye Diseases

Germany, Portugal, Italy, Spain

17/03/2026

Phase I

A study to investigate the pharmacokinetics and safety of a single dose of duvakitug in healthy adult participants

2025-524617-84-00Healthy Volunteers

Sanofi-Aventis Recherche & Developpement

Digestive System Diseases

Germany

17/03/2026

Phase I/II

A Phase Ib/II, Multicenter, Open-Label Study to Evaluate Safety, Efficacy, and Pharmacokinetics of YL201 in Combination with Other Anti-Cancer Therapies in Patients with Advanced Solid Tumors

2025-523742-27-00Advanced solid tumors

Medilink Therapeutics (Suzhou) Co. Ltd.

Neoplasms

Poland, Spain, France, Romania, Italy, Belgium, Hungary, Germany

17/03/2026

Phase III

A multicentre, randomised, double-blind, parallel group, placebo-controlled trial to assess the effects of oral TRPC6 inhibitor BI 764198 taken over a 104 week treatment period in adult and adolescent participants with primary focal segmental glomerulosclerosis (pFSGS) or genetic FSGS related to TRPC6 gene variants

2025-522191-86-00Focal segmental glomerulosclerosis

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Male Urogenital Diseases

Germany, Croatia, Poland, Sweden, Portugal, Netherlands, Italy, Denmark, Slovakia, Spain, Norway, Romania, Belgium, Greece, France

17/03/2026

Phase IV

Evaluating the clinical effectiveness of sodium bicarbonate for critically ill patients with metabolic acidosis and acute kidney injury

2025-523914-10-00Critical illness, Acute kidney injury, Metabolic acidosis

Universitaet Muenster

Nutritional and Metabolic Diseases

Germany

17/03/2026

Phase I/II

Phase I/II combination umbrella trial in progressive/relapsed/refractory pediatric low-grade glioma (pLGG) (EPILOGUE)

2024-516896-34-00progressive/relapsed/refractory pediatric low-grade glioma …

DrugTovorafenib

Universitaetsklinikum Heidelberg AöR

Nervous System Diseases

Denmark, Czechia, Austria, Sweden, Germany

17/03/2026

Phase III

A Phase 3b Long-term Efficacy and Safety Extension Study of Barzolvolimab in Participants with Chronic Spontaneous Urticaria Who Have Completed CDX0159-12 or CDX0159-13 (EMBARQ-CSU LTE)

2025-522878-36-00Chronic Spontaneous Urticaria

Celldex Therapeutics Inc.

Skin and Connective Tissue Diseases

Croatia, France, Netherlands, Bulgaria, Portugal, Slovakia, Hungary, Italy, Greece, Germany, Czechia, Lithuania, Spain, Belgium, Denmark, Poland

16/03/2026

Phase I

A study to learn if bimekizumab given in different ways is safe and moves similarly throughout the body over time in adults

2025-522782-30-00CCI

UCB Biopharma

Immune System Diseases

Croatia, Poland, Germany, Czechia, Slovakia, Bulgaria

16/03/2026

Phase I

Study in healthy volunteers to compare the blood levels after epoetin alfa (Blau EPO) and Erypo, administered as a single intravenous injection as well as safety, tolerability and the effects on certain blood values.

2025-522244-40-00It is used to treat symptomatic anaemia in chronic renal fa…

Blau Farmaceutica S.A.

Hemic and Lymphatic Diseases

Germany

13/03/2026

Phase IV

Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axial Spondyloarthritis (UP-FOR-U)

2025-522118-21-00Axial Spondyloarthritis, Acute Anterior Uveitis

DrugUpadacitinib

Care Arthritis Ltd.

Eye Diseases

Spain, Poland, Netherlands, France, Bulgaria, Germany

13/03/2026

Phase I

A research study looking at how NNC0487-0111 affects food intake, appetite and metabolism after meals in people with obesity

2025-521393-34-00Participants with obesity, but otherwise healthy

Novo Nordisk A/S

Not possible to specify

Germany

13/03/2026

Phase II

A phase 2b, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of Usnoflast administered to adult subjects with Amyotrophic Lateral Sclerosis (ALS)

2025-522580-15-00Amyotrophic Lateral Sclerosis (ALS)

Zydus Therapeutics Inc.

Nervous System Diseases

Spain, Germany, Sweden, Ireland, Poland, Italy, Belgium, France, Netherlands

12/03/2026

Phase I

Safety and Preliminary Efficacy of CTX112 in Adult Participants with Relapsed/Refractory Hematologic Autoimmune Disease

2025-523845-90-00Relapsed/Refractory Hematologic Autoimmune Disease

CRISPR Therapeutics AG

Hemic and Lymphatic Diseases

Spain, Germany, France, Denmark, Italy, Netherlands

12/03/2026

Phase III

A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of L606 (Treprostinil Liposome Inhalation Suspension) in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease (WHO Group 3)

2024-517943-29-00Pulmonary Hypertension associated with interstitial lung di…

DrugTreprostinil

Liquidia Technologies Inc.

Respiratory Tract Diseases

Latvia, Germany, Italy, Czechia, France, Belgium, Portugal, Poland, Austria, Spain

11/03/2026

Phase II

B7981119 A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 16-Week Study Evaluating the Safety and Efficacy of Ritlecitinib (PF-06651600) in Adults with Moderate to Severe Hidradenitis Suppurativa

2025-522705-37-00HIDRADENITIS SUPPURATIVA

Pfizer Inc.

Skin and Connective Tissue Diseases

Germany, Poland, Spain, Greece

11/03/2026

Phase II

A Phase II, multinational, multicentre, double-blind, randomised, active-controlled, 3-way cross-over study to evaluate the therapeutic equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a versus CHF5993 pMDI 100/6/12.5 µg HFA-134a in subjects with mild to moderate asthma. [TRECONY]

2025-521456-35-00Mild to moderate asthma

Chiesi Farmaceutici S.p.A.

Respiratory Tract Diseases

Slovakia, Czechia, Romania, Latvia, Germany, Hungary, Bulgaria, Poland

11/03/2026

Phase III

Adjuvant Dynamic marker - Adjusted Personalized Therapy comparing adjuvant Elacestrant with standard endocrine treatment in genomically and/or clinically high-risk ER+/HER2- early breast cancer (ADAPTela)

2025-522484-15-00ER+/HER2- early breast cancer

WSG Women's Cancer Study Group GmbH

Neoplasms

Germany, Spain, Austria

11/03/2026

Phase III

ROSETTA Gastric-204: A Blinded, Randomized, Phase 2/3 Study of Pumitamig in Combination with Chemotherapy Versus Nivolumab in Combination with Chemotherapy in Participants with Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

2025-523263-37-00Previously Untreated Advanced or Metastatic Gastric, Gastro…

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Germany, Spain, Poland, France, Italy, Romania

10/03/2026

Phase III

ROSETTA CRC-203: A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination with Chemotherapy Versus Bevacizumab in Combination with Chemotherapy in Participants with Previously Untreated, Unresectable, or Metastatic Colorectal Cancer

2025-523224-45-00Untreated, Unresectable or Metastatic Colorectal Cancer

DrugsCalcium folinate·Fluorouracil·Irinotecan·Capecitabine

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Sweden, Czechia, Belgium, Romania, Netherlands, Italy, France, Spain, Germany, Poland, Austria

10/03/2026

Phase II

A phase II, randomized, observer-blinded, controlled, parallel group clinical trial with decentralized elements to evaluate the safety and efficacy of PB-TX-01 in patients with chronic wounds colonized by Pseudomonas aeruginosa.

2024-517491-38-00Chronic wound colonized by Pseudomonas aeruginosa

PathoBlock Therapeutics GmbH & Co. KG

Bacterial Infections and Mycoses

Germany

10/03/2026

Phase III

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

2025-522775-29-00Depressive episodes associated with Bipolar disorder I or I…

Xenon Pharmaceuticals Inc.

Mental Disorders

Germany, Bulgaria, Spain, Poland

10/03/2026

Phase II

A Phase 2a Multicenter Platform Study of Investigational Products for the Treatment of Adult Subjects with Idiopathic Pulmonary Fibrosis

2024-518013-25-00Idiopathic Pulmonary Fibrosis

AbbVie Deutschland GmbH & Co. KG

Respiratory Tract Diseases

Greece, Italy, Sweden, Germany, Portugal, Spain, France, Hungary, Poland, Bulgaria, Romania

10/03/2026

Phase III

REVEAL Study: Phase 3 Study of the Efficacy and Safety of ION582 in Children and Adults with Angelman Syndrome

2024-519711-33-01Angelman syndrome

Ionis Pharmaceuticals Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Italy, Germany, Poland, Spain

09/03/2026

Phase III

A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell-redirecting Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer

2025-522713-29-00Metastatic Castration-resistant Prostate Cancer (mCRPC)

Janssen Cilag International

Neoplasms

Belgium, Italy, Spain, Germany, France

09/03/2026

Phase III

PaTHway Adolescent - A Phase 3, Multicenter, Open-Label Single-Arm Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Palopegteriparatide Administered Subcutaneously Daily in the Adolescent Population (12 Years to Less Than 18 Years of Age) with Chronic Hypoparathyroidism

2025-523928-52-00Chronic hypoparathyroidism

Ascendis Pharma Bone Diseases A/S

Hormonal diseases

Germany, France, Romania, Poland

09/03/2026

Phase II

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF GALVOKIMIG IN ADULT STUDY PARTICIPANTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS

2025-522578-35-00Atopic Dermatitis

UCB Biopharma

Skin and Connective Tissue Diseases

Bulgaria, Czechia, Germany, Poland, Hungary

09/03/2026

Phase I

A study to learn more about how safe nurandociguat is and how it affects the way the body processes rosuvastatin and dabigatran in healthy adults

2025-524178-40-00Chronic Kidney Disease

Bayer AG

Cardiovascular Diseases

Germany

09/03/2026

Phase I

Investigating how NNC0487-0111 regulates insulin in adults with type 2 diabetes

2025-521595-55-00Type 2 Diabetes

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Germany

09/03/2026

Phase II

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Assess Efficacy and Safety of Zasocitinib in Moderate to Severe Hidradenitis Suppurativa

2025-522831-33-00Hidradenitis Suppurativa

Takeda Development Center Americas Inc.

Skin and Connective Tissue Diseases

France, Poland, Netherlands, Germany

06/03/2026

Phase III

A Long-Term Follow-Up Study for Participants Previously Treated with KYV-101 (KYSA-4)

2024-511198-31-00Myasthenia Gravis, Rheumatoid Arthritis, Lupus Nephritis, S…

Kyverna Therapeutics Inc.

Immune System Diseases

Germany

06/03/2026

Phase II

A Phase II, Randomized, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of the Combination of Inavolisib Plus Enzalutamide Versus Physician's Choice of ARPI or Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer

2025-521327-67-00Metastatic Castration-Resistant Prostate Cancer

F. Hoffmann-La Roche AG

Neoplasms

Germany, France, Italy, Spain

06/03/2026

Phase I/II

An Adaptive Dose Escalation and Expansion Basket Trial to Explore the Safety, Pharmacology, and Clinical Activity of TGD001 in Immune-Mediated Thrombotic Thrombocytopenic Purpura (iTTP) and Other Thrombotic Microangiopathies

2025-523802-34-00Immune-Mediated Thrombotic Thrombocytopenic Purpura, Thromb…

TargED Biopharmaceuticals B.V.

Hemic and Lymphatic Diseases

Germany, France, Italy, Spain

06/03/2026

Phase II

A multinational, multicenter extension study to investigate the long-term safety, tolerability and efficacy of balinatunfib in adults with Crohn’s disease or ulcerative colitis

2025-522511-42-00Colitis Ulcerative, Crohn's disease

Sanofi-Aventis Recherche & Developpement

Digestive System Diseases

Belgium, Germany, Czechia, Netherlands, Spain, Austria, Italy, Greece, Croatia, Bulgaria, Poland, France, Romania, Hungary

06/03/2026

Phase I

(21174) Relative bioavailability study to investigate the pharmacokinetics of a single oral dose of asundexian administered as 50 mg pediatric formulation in comparison to 50 mg tablet (adult formulation) in fasted state and to investigate the effect of a high-fat, high-calorie meal on the 50 mg pediatric formulation in healthy adult participants

2025-523677-41-00Prevention of thromboembolic events

Bayer AG

Cardiovascular Diseases

Germany

06/03/2026

Phase I/II

A phase Ib/II open-label, multi-center study of the DNA protein kinase inhibitor AMO959 with lutetium (177Lu) vipivotide tetraxetan (AAA617) in combination with an androgen receptor pathway inhibitor (ARPI) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC)

2025-521859-23-00PSMA-positive mCRPC with prior exposure to at least one pri…

Novartis Pharma AG

Neoplasms

Germany, France, Spain, Italy

05/03/2026

Phase I

A Study of LY4257496 in Participants With Cancer (OMNIRAY)

2025-522367-15-00Breast Neoplasms Colorectal Neoplasms Prostate Neoplasm End…

Eli Lilly & Co.

Neoplasms

Germany

05/03/2026

Phase III

A Phase III, multisite, randomized, double-blind trial of BNT327 in combination with chemotherapy versus placebo with chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic TNBC determined ineligible for PD(L)1 therapy based on PD-L1 negative disease

2025-521884-12-00First line triple-negative breast cancer (TNBC)

DrugsEribulin·Gemcitabine·Paclitaxel·Carboplatin

BioNTech SE

Neoplasms

Czechia, Poland, Italy, France, Belgium, Netherlands, Germany, Spain

04/03/2026

Phase I

Crossover study to investigate the safety and tolerability as well as the blood levels after three single doses of Tacrolimus, of which 2 are administered via the cheek mucosa and 1 dose via the mouth (oral).

2025-525076-29-00Phase I study in healthy male volunteers. Intended indicati…

Nucleus Medical GmbH

Immune system processes

Germany

04/03/2026

Phase II

A Phase 2, Multi-center, Randomized, Dose-Ranging, Placebo-Controlled, Double-blind Study of the Relaxin Agonist R2R01 in Patients at High Risk for Cardiac Surgery Associated - Acute Kidney Injury.

2025-523037-25-00Patients at high risk for Cardiac Surgery Associated – Acut…

River 2 Renal Corp.

Pathological Conditions, Signs and Symptoms

Italy, Germany

04/03/2026

Phase I/II

Protocol Title: KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

2024-512248-47-00Non-small Cell Lung Cancer (NSCLC)

DrugsCalderasib·Patritumab deruxtecan·Sacituzumab tirumotecan·Cetuximab

Merck Sharp & Dohme LLC

Neoplasms

Italy, Germany, Greece, Poland, Hungary, Spain

04/03/2026

Phase III

A randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis

2025-521546-23-00Secondary progressive multiple sclerosis

Novartis Pharma AG

Nervous System Diseases

Denmark, Slovenia, Netherlands, Portugal, Ireland, Sweden, Croatia, Greece, Germany, Latvia, Czechia, Spain, Romania, Belgium, Austria, Lithuania, Slovakia, Poland, Estonia, Bulgaria, France, Italy, Hungary, Finland, Norway

03/03/2026

Phase III

A double blind, randomized, placebo-controlled exploratory trial to investigate the efficacy and safety of nerandomilast over 24 months when administered in individuals with interstitial lung abnormalities and a family history of pulmonary fibrosis to reduce the risk of worsening (DROP-FPF)

2025-522383-33-00Pulmonary fibrosis, Interstitial lung diseases, Familial pu…

Boehringer Ingelheim International GmbH

Respiratory Tract Diseases

Belgium, Spain, Netherlands, Italy, Germany, France

03/03/2026

Phase II

An open label extension study to evaluate the long-term safety and efficacy of subcutaneous lunsekimig in adult participants with asthma who participated in study DRI16762 or ACT18301. AIRPHRODITE

2025-522896-27-00Asthma

Sanofi-Aventis Recherche & Developpement

Respiratory Tract Diseases

Poland, Italy, Belgium, Sweden, Hungary, France, Germany, Spain, Denmark

02/03/2026

Phase II

A randomized, double-blind, placebo-controlled, Phase 2, dose-finding study to investigate the efficacy and safety of SAR445399 in participants with moderate to severe hidradenitis suppurativa

2025-522695-83-00Hidradenitis suppurativa

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

Hungary, Spain, France, Belgium, Sweden, Germany, Italy

02/03/2026

Phase II

C5041018 - A Phase 2 Open-Label, Single Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

2025-523100-77-00Ulcerative Colitis

Pfizer Inc.

Digestive System Diseases

Finland, Poland, France, Germany, Italy, Slovakia

27/02/2026

Phase III

HighLiGHts - A Pivotal, Parallel-Arm, Phase 3, Open-Label, Active-controlled, Global, Multicenter, Randomized Basket Trial Investigating the Efficacy and Safety of Once-weekly Lonapegsomatropin Compared to Daily Somatropin in Prepubertal Children and Adolescents with Growth Failure or Short Stature due to Growth Hormone Sufficient Disorders – Turner Syndrome, SHOX Deficiency, Small for Gestational Age, and Idiopathic Short Stature

2025-523079-44-00Turner Syndrome (TS), idiopathic short stature (ISS), short…

Ascendis Pharma Endocrinology Division A/S

Musculoskeletal Diseases

Germany, Spain, Italy, France, Romania

27/02/2026

Phase I

A study testing a new treatment called TK-6302 for the first time in people with advanced cancers that have a genetic marker called HLA-A02:01 and a tumour protein called PRAME.

2025-521603-46-00Advanced PRAME Positive Solid Tumors

T-Knife GmbH

Neoplasms

Germany

27/02/2026

Phase III

A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)

2024-520101-39-00TROP2 NMR-positive advanced or metastatic non-squamous non-…

AstraZeneca AB

Neoplasms

Spain, Poland, Hungary, Italy, Germany, France, Belgium, Austria

26/02/2026

Phase II

A double-blind, randomized, placebo-controlled, two arm, phase II clinical trial in parallel groups to evaluate the efficacy and tolerability of a rectal treatment with budesonide suppositories compared to placebo suppositories for amelioration of acute radiation proctitis symptoms in male patients aged 18 years or older with prostate carcinoma

2024-519359-27-00Acute radiation proctitis symptoms in male patients aged 18…

Dr. Falk Pharma GmbH

Digestive System Diseases

Germany, Austria

26/02/2026

Phase II

B7981118 - A Phase 2b Randomized, Double Blind, 12-Week Placebo Controlled Study With a 12-Week Double-Blind Extension Period to Evaluate the Efficacy, Safety and Tolerability of Ritlecitinib (PF 06651600) in Adult Participants with Chronic Spontaneous Urticaria

2025-522642-44-00CHRONIC SPONTANEOUS URTICARIA

Pfizer Inc.

Immune System Diseases

Spain, Germany, Bulgaria, Poland

25/02/2026

Phase III

Studying Treatments in patients receiving androgen deprivation therapy (ADT) for Metastatic Prostate Cancer: Evaluation of Drug and radiation Efficacy: A 2nd multi-arm multi-stage randomised controlled trial (STAMPEDE2)

2025-522145-21-00Metastatic hormone sensitive prostate cancer

University College London

Neoplasms

Ireland, Germany, Spain

25/02/2026

Phase III

A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with psoriatic arthritis (PsA)

2025-522471-28-00psoriatic arthritis (PsA)

DrugSonelokimab

MoonLake Immunotherapeutics AG

Musculoskeletal Diseases

Estonia, Croatia, Slovakia, Lithuania, Romania, Hungary, Germany, France, Latvia, Poland, Portugal, Greece, Czechia, Bulgaria, Finland, Spain

25/02/2026

Phase III

J2A-MC-GZPW: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants With Established Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease

2025-523123-22-00Atherosclerosis Cardiovascular Disease, Chronic Kidney Dise…

Eli Lilly & Co.

Cardiovascular Diseases

Germany, Czechia, Lithuania, Spain, Austria, France, Hungary, Greece, Estonia, Netherlands, Slovakia, Poland, Romania, Bulgaria, Italy, Belgium

24/02/2026

Phase III

A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn’s disease

2025-521037-86-00Immune system diseases

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

Spain, Czechia, Lithuania, Hungary, Greece, Bulgaria, Poland, Belgium, France, Germany, Norway, Austria, Netherlands, Italy, Slovakia

24/02/2026

Phase III

A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn’s Disease

2025-521036-11-00Immune system disseases

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

Slovakia, Netherlands, Poland, Greece, Czechia, Italy, Bulgaria, Belgium, Germany, Lithuania, Austria, Spain, Hungary, Norway, France

24/02/2026

Phase II

Open-label safety and efficacy trial of chlorhexidine and/or metronidazole pre-treatment followed by FB301 in women with bacterial vaginosis (BV)

2025-524362-20-00Bacterial vaginosis

Freya Biosciences ApS

Bacterial Infections and Mycoses

Germany

23/02/2026

Phase I

Relative bioavailability and safety study of pasireotide after a single-dose subcutaneous administration in the arm or in the thigh compared to in the abdomen using a ServoPen in healthy subjects.

2025-521830-27-00Post-bariatric hypoglycaemia

Recordati AG

Hormonal diseases

Germany

23/02/2026

Phase III

A seamless Phase 2/3 randomized, open-label study to investigate efficacy and safety of frexalimab versus tacrolimus in adult kidney transplant recipients

2025-521521-33-00Kidney transplant rejection

DrugsFrexalimab·Tacrolimus

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

Germany, Hungary, Italy, Belgium, Czechia, Finland, Spain, Austria, Sweden, France, Denmark, Netherlands

23/02/2026

Phase III

Multicenter, Safety Follow-up Study to Assess Safety of Prior Treatment with Romosozumab in Children and Adolescents with Osteogenesis Imperfecta

2023-503293-21-00Osteogenesis Imperfecta

DrugRomosozumab

Amgen Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Germany, Hungary, Italy, Belgium, Austria, Slovakia, Spain, Poland

23/02/2026

Phase III

Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination with Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients with Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia

2025-521314-25-00NPM1-m and KMT2A-r Acute Myeloid Leukemia

Kura Oncology Inc.

Neoplasms

Belgium, Spain, Italy, Czechia, Hungary, Poland, France, Portugal, Germany, Greece

20/02/2026

Phase III

TRITON-PN: A Phase 3, Global, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Nucresiran in Patients with Hereditary Transthyretin-Mediated Amyloidosis with Polyneuropathy (hATTR-PN)

2025-522544-40-00Hereditary transthyretin-mediated amyloidosis with polyneur…

Alnylam Pharmaceuticals Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

France, Italy, Greece, Spain, Sweden, Ireland, Cyprus, Portugal, Germany

20/02/2026

Phase I

A study to test different doses of BI 3923948 alone and in combination with an anti-PD-1 antibody in people with different types of advanced cancer (solid tumors)

2025-521438-27-00advanced, unresectable and/or metastatic solid tumors

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Neoplasms

Sweden, France, Spain, Germany

19/02/2026

Phase II

Master Protocol Full Title: A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis. ISA 1 Full Title: An ISA to Master Protocol ARGX-999-2-MG-2000 for an Exploratory, Phase 2a, Proof-of-Concept Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV as Add-On Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod.

2025-522492-28-00AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthe…

Argenx

Immune System Diseases

Spain, Poland, Germany, Netherlands, Greece, Italy, Belgium

18/02/2026

Phase III

A phase 3 randomized, double-blind, active-controlled study of palazestrant with ribociclib versus letrozole with ribociclib for the first-line treatment of ER+, HER2- advanced breast cancer (OPERA-02)

2025-522873-12-00ER+, HER2- Advanced Breast Cancer

Olema Pharmaceuticals Inc.

Neoplasms

Hungary, Portugal, Italy, France, Poland, Czechia, Germany, Spain, Belgium, Austria, Romania, Greece, Netherlands

17/02/2026

Phase III

A randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of early in hospital initiation of inclisiran treatment in patients with acute coronary syndromes: Victorion – RIDES

2025-521670-34-00Acute coronary syndrome (ST-elevation myocardial infarction…

Novartis Pharma AG

Cardiovascular Diseases

Germany, Hungary, Poland, France, Spain

16/02/2026

Phase II

Revumenib Treatment in Combination with FLA Chemotherapy in Paediatric Refractory/Relapsed KMT2A-r, NUP98-r or NPM1-mut Acute Myeloid Leukemia (AML)

2025-521390-14-00Acute Myeloid Leukemia

DrugsRevumenib·Cytarabine·Fludarabine

Pediatric Research International GmbH

Neoplasms

Denmark, Italy, Czechia, Sweden, Poland, Netherlands, Germany, Austria

16/02/2026

Phase I

A phase I open-label, multi-center study to evaluate the safety, tolerability, dosimetry, and preliminary activity of [177Lu]Lu-DFC413 and safety and imaging properties of [68Ga]Ga-NNS309 in patients with solid tumors

2025-521702-18-00Locally advanced unresectable or metastatic soft tissue sar…

Novartis Pharma AG

Neoplasms

Germany, Portugal, France, Spain, Denmark

16/02/2026

Phase II

A Phase IIb, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AZD5148 for Prevention of Recurrence of Clostridioides difficile Infection in Individuals 18 Years of Age and Above

2025-521416-19-00Recurrence of Clostridioides difficile Infection

AstraZeneca AB

Bacterial Infections and Mycoses

Greece, Spain, France, Germany, Italy, Hungary, Denmark, Sweden

16/02/2026

Phase III

Adaptive, Phase 2/3, Randomized, Double-Blind Trial Investigating the Efficacy and Safety of Visugromab versus Placebo in Patients with Cancer-associated Cachexia

2025-523533-25-00Cancer-associated Cachexia

CatalYm GmbH

Nutritional and Metabolic Diseases

France, Czechia, Romania, Italy, Germany, Poland, Spain, Bulgaria, Norway, Ireland, Netherlands

13/02/2026

Phase III

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination with Intensive Chemotherapy in Participants with Newly Diagnosed AML with an NPM1 mutation (REVEAL-ND NPM1)

2025-522279-27-00Newly Diagnosed AML with an NPM1 mutation

Syndax Pharmaceuticals Inc.

Neoplasms

Greece, Poland, Spain, Austria, Italy, Romania, Belgium, France, Lithuania, Germany, Hungary, Czechia, Portugal

13/02/2026

Phase III

HELIOS: An Open-Label, Long-Term Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP).

2025-523275-27-00Erythropoietic Protoporphyria (EPP), X-Linked Protoporphyri…

Disc Medicine Inc.

Nutritional and Metabolic Diseases

Italy, France, Ireland, Belgium, Sweden, Germany, Netherlands, Norway, Spain

12/02/2026

Phase III

A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with FOLFOX versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer (HARMONi-GI3)

2025-521587-35-00Metastatic colorectal cancer

DrugsFolinic acid·Ivonescimab·Fluorouracil·Oxaliplatin

Summit Therapeutics Inc.

Neoplasms

Belgium, Italy, Spain, Germany, France, Poland, Czechia, Hungary, Ireland

12/02/2026

Phase I

A Participant- and Investigator--Blinded, Placebo-Controlled, Randomized, Multipart, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants with Chronic Kidney Disease

2025-520978-18-00Chronic Kidney Disease

Novartis Pharma AG

Female Urogenital Diseases and Pregnancy Complications

Germany, Romania

10/02/2026

Phase II

Total Neoadjuvant Treatment with or without Tislelizumab for Locally Advanced Rectal Cancer: An Open-label Randomized Controlled Phase II Study (The TOTAL Trial)

2025-522120-28-00Locally Advanced Rectal Cancer (LARC) stage II (T3-4N0M0) o…

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Rabin Medical Center

Neoplasms

Germany

10/02/2026

Phase II

PREFer: Phase II trial of anti-PD-1 antibody treatment and radiotherapy in early-stage favorable classic Hodgkin lymphoma

2024-520138-31-00Early-stage favorable classic Hodgkin lymphoma

University Of Cologne

Neoplasms

Germany

10/02/2026

Phase I/II

A Phase 1/2, Randomized, Double-blind, Placebo-controlled 2-part Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-4324 in Overweight to Obese Adult Healthy Volunteers and Multiple Dose ALN-4324 in Overweight to Obese Patients With Type 2 Diabetes Mellitus (T2DM)

2024-519005-35-00Type 2 Diabetes Mellitus

Alnylam Pharmaceuticals Inc.

Hormonal diseases

Germany, Poland

10/02/2026

Phase II

A Phase 2 study of intratumoral administration of L19IL2/L19TNF in locally advanced Cutaneous Squamous Cell Carcinoma patients progressing on or intolerant to systemic treatment.

2025-523231-19-00Cutaneous Squamous Cell Carcinoma

Philogen S.p.A.

Neoplasms

Italy, Germany, Greece, Spain, Austria, France, Netherlands

10/02/2026

Phase II

A Phase 2 controlled randomized study of the efficacy of L19IL2 or L19TNF or L19IL2/L19TNF intralesional injections for the treatment of locally advanced basal cell carcinoma patients.

2025-523229-16-00locally advanced basal cell carcinoma patients

Philogen S.p.A.

Neoplasms

Greece, Italy, Germany, Spain, Netherlands, Austria, France

10/02/2026

Phase III

An Open-label, Randomized Phase 3 Study of Linvoseltamab Monotherapy and Linvoseltamab plus Carfilzomib versus Standard of Care Combination Regimens in Patients with Relapsed/Refractory Multiple Myeloma

2024-519504-27-00Relapsed Refractory Multiple Myeloma

DrugsDiphenhydramine hydrochloride·Linvoseltamab·Paracetamol·Velcade

Regeneron Pharmaceuticals Inc.

Neoplasms

Greece, Spain, Poland, Italy, Austria, Czechia, Belgium, Germany, Netherlands, France

10/02/2026

Phase II

A Phase 2 study of intratumoral administration of L19IL2/L19TNF in locally advanced Basal Cell Carcinoma patients progressed on or intolerant to systemic treatment.

2025-523230-77-00Patients with locally advanced Basal Cell Carcinoma (LaBCC)…

Philogen S.p.A.

Neoplasms

Germany, Italy, Greece, Spain, Austria, France

10/02/2026

Phase III

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants with Obstructive Sleep Apnea on Positive Airway Pressure Therapy and Living with Overweight or Obesity (MARITIME-OSA-1)

2025-522703-14-00"Moderate to severe obstructive sleep apnea (OSA) in adults…

Amgen Inc.

Respiratory Tract Diseases

Poland, Germany, Czechia, Hungary, Spain, France

10/02/2026

Phase III

Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis (SMART-JIA)

2025-520923-25-00Juvenile Idiopathic Arthritis

Duke Clinical Research Institute

Immune System Diseases

Italy, Netherlands, Germany

10/02/2026

Phase I/II

Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta.

2025-522729-36-00Chronic Hepatitis Delta.

Gilead Sciences Inc.

Virus Diseases

Italy, Romania, Germany, Bulgaria

09/02/2026

Phase IV

Long-term Safety Outcomes in Patients Treated With Replimune Oncolytic Immunotherapy Products

2025-521621-33-00Hepatocellular Carcinoma, Metastatic Melanoma, Melanoma, Ad…

Replimune Group Inc.

Neoplasms

Germany, Greece, France, Poland, Spain

09/02/2026

Phase III

Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan, Monotherapy or in Combination with Osimertinib, Compared to Standard of Care in Subjects with Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI - AndroMETa-Lung-713

2025-521124-29-00Non-Small Cell Lung Cancer

AbbVie Deutschland GmbH & Co. KG

Neoplasms

Portugal, Italy, Spain, Poland, Netherlands, Germany, Belgium, Austria, France

09/02/2026

Phase III

A Phase 3 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants with Hereditary Angioedema – ORBIT-EXPANSE

2025-521142-22-00Hereditary Angioedema

Astria Therapeutics Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Netherlands, Spain, Poland, Germany, Czechia, Austria, Portugal, Hungary, France, Italy, Bulgaria

09/02/2026

Phase III

A Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled, Phase 3 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants with Moderately to Severely Active Ulcerative Colitis

2025-521038-27-00Immune system diseases

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

Slovakia, Germany, Austria, Italy, Czechia, Netherlands, Poland, Belgium, Hungary, Lithuania, Greece, France, Bulgaria, Spain, Norway

09/02/2026

Phase III

2025-521035-37-00Immune system diseases

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

Austria, France, Norway, Hungary, Bulgaria, Netherlands, Czechia, Slovakia, Germany, Lithuania, Greece, Belgium, Italy, Spain, Poland

09/02/2026

Phase II

A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab in Recipients of Kidney Transplants with Late Isolated Microvascular Inflammation (MVI)- (299AR201-TRANSPIRE)

2025-521742-15-00Treatment of Late Isolated Microvascular Inflammation in Re…

Biogen Idec Research Limited

Immune System Diseases

Germany, Austria, Spain, Czechia, France

09/02/2026

Phase II

A Phase 2 randomized, double-blind, placebo-controlled study to investigate efficacy, safety, immunogenicity, and pharmacokinetics, of GSK3862995B in participants with bronchiectasis

2025-522892-27-00Bronchiectasis

GSK PLC

Respiratory Tract Diseases

Denmark, France, Spain, Italy, Germany, Poland

09/02/2026

Phase IV

(23026) A prospective, single-arm, Phase 4 study to evaluate the course of serum transthyretin (TTR) level with acoramidis in adult patients with variant or wild-type transthyretin amyloidosis with cardiomyopathy (ATTR-CM) previously treated with tafamidis.

2025-521831-35-00Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Bayer Consumer Care AG

Cardiovascular Diseases

Austria, Germany, Italy, Belgium

07/02/2026

Phase III

A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) versus Sunitinib in Participants with Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) after Imatinib Therapy (StrateGIST 3)

2025-522229-37-00Gastrointestinal Neoplasms

Glaxosmithkline Research & Development Limited

Neoplasms

France, Romania, Spain, Netherlands, Norway, Belgium, Hungary, Italy, Poland, Germany

06/02/2026

Phase III

J2S-MC-GZME: A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared with Placebo for the Treatment of Adult Participants with Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)

2025-522313-38-00Alcohol Use Disorder

Eli Lilly & Co.

Behavioral Disciplines and Activities

Belgium, Germany

05/02/2026

Phase II

An Open-Label Extension, Multi-centered, Phase 2 Trial to Describe the Safety and Efficacy of TEV-56286 (Emrusolmin) in Participants with Multiple System Atrophy

2025-521642-14-00Multiple System Atrophy

Teva Branded Pharmaceutical Products R&D LLC

Nervous System Diseases

France, Germany, Italy, Spain

04/02/2026

Phase II

An Open-label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Induction Treatment with Melphalan/HDS Followed by Consolidation Treatment with Eribulin or Vinorelbine or Capecitabine Versus Eribulin or Vinorelbine or Capecitabine Alone in Patients with Metastatic Breast Cancer with Liver Dominant Disease

2025-521966-91-00Refractory Metastatic Breast Cancer with Liver Dominant Dis…

Delcath Systems Inc.

Neoplasms

Italy, Spain, Sweden, France, Germany

04/02/2026

Phase III

A Phase 2b/3, Open-Label, Multicenter Trial Evaluating the Efficacy and Safety of Switching to Brelovitug for the Treatment of Chronic Hepatitis Delta Infection in Participants Receiving Bulevirtide (AZURE-3)

2025-522015-42-00Chronic Hepatitis D Infection

Mirum Pharmaceuticals Inc.

Virus Diseases

Czechia, Austria, Spain, Romania, Germany, Italy, France

03/02/2026

Phase I

A study to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of surovatamig in adult participants with rheumatoid arthritis or systemic lupus erythematosus.

2025-522273-10-00Rheumatoid Arthritis, Systemic Lupus Erythematosus

AstraZeneca AB

Immune System Diseases

Germany, Spain, Belgium

03/02/2026

Phase III

I4V-MC-JAJK: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed With Type 1 Diabetes Aged ≥1 to <36 Years

2025-522170-36-00Diabetes Mellitus, Type 1

Eli Lilly & Co.

Nutritional and Metabolic Diseases

Finland, Germany, Italy, France, Sweden, Poland, Spain, Belgium, Czechia, Netherlands, Portugal, Norway

03/02/2026

Phase III

ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients with Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease

2025-522960-34-00High cardiovascular risk, Hypertension, Established cardiov…

Alnylam Pharmaceuticals Inc.

Cardiovascular Diseases

Belgium, Hungary, Czechia, Austria, Germany, France, Greece, Spain, Romania, Netherlands, Italy, Poland, Slovakia, Sweden, Portugal, Denmark, Bulgaria

03/02/2026

Phase II

A Phase 2b, Randomised, Double-Blind, Placebo-Controlled, Parallel-Arm Dose Finding Study Evaluating the Efficacy and Safety of SAB-142 for Delaying the Progression of Type 1 Diabetes (T1D) in Patients with Stage 3 New Onset of Type 1 Diabetes (NOT1D)

2025-521560-36-00Type 1 Diabetes

Sab Biotherapeutics Inc.

Nutritional and Metabolic Diseases

Austria, Germany, Poland, Italy, Denmark, Spain, Belgium, Finland, France, Lithuania, Slovenia

02/02/2026

Phase II

Efficacy and safety of SP16 in preventing Acute Kidney Injury in at-risk subjects with chronic kidney disease undergoing elective cardiac surgery using the heart-lung-machine: A prospective, randomized, double-blind, placebo-controlled clinical trial (EASE-AKI)

2025-522491-89-00Cardiovascular Disease, Valvular Disease, Chronic Kidney Di…

Universitaetsklinikum Erlangen AöR

Cardiovascular Diseases

Germany

02/02/2026

Phase I/II

An open label, phase I/II study investigating the safety and efficacy of a CD3/CD20 bispecific T-cell engager therapy in patients with active, treatment refractory, ANCA-IgG-positive associated vasculitis. The RENEWAL study

2025-522853-21-01Active, treatment refractory, ANCA-IgG-positive associated …

Fraunhofer Institute For Translational Medicine And Pharmacology ITMP

Immune System Diseases

Germany

30/01/2026

Phase I/II

First-in-human, Open-label, Multi-site, Phase I/IIa, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT329 in Participants With Advanced Solid Tumors Known to Express CA19-9

2025-522613-26-00Advanced Solid Cancers

BioNTech SE

Neoplasms

Spain, Germany

29/01/2026

Phase I/II

A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARO-DM1 in Subjects With Type 1 Myotonic Dystrophy Who are ≥18 to ≤65 Years

2024-513579-42-00Type 1 Myotonic Dystrophy

Sarepta Therapeutics Inc.

Nervous System Diseases

Spain, Germany, Belgium, Italy

29/01/2026

Phase III

J2S-MC-GZMP: A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Alcohol Use Disorder (RENEW-ALC-2)

2025-522312-16-00Alcohol Use Disorder

Eli Lilly & Co.

Behavioral Disciplines and Activities

Germany, Belgium

29/01/2026

Phase III

A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY OF NEOADJUVANT DAROVASERTIB IN SUBJECTS WITH PRIMARY NON-METASTATIC UVEAL MELANOMA (OptimUM-10)

2025-522387-32-00Uveal Melanoma

Ideaya Biosciences Inc.

Eye Diseases

France, Spain, Poland, Italy, Czechia, Belgium, Austria, Netherlands, Denmark, Germany, Slovenia

29/01/2026

Phase II

A Multi-Center, Double-Blind, Placebo-Controlled, Phase II Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489, A Monoacylglycerol Lipase Inhibitor, as Add-On Therapy to Ocrelizumab, in Participants with Progressive Forms of Multiple Sclerosis

2025-521636-10-00Progressive Forms of Multiple Sclerosis (PMS)

F. Hoffmann-La Roche AG

Nervous System Diseases

Germany, Spain, France, Hungary, Italy, Poland, Portugal

28/01/2026

Phase I

A study in healthy people or otherwise healthy with overweight or obesity to compare 2 formulations of survodutide given in different ways, either as a pre-filled syringe or a pen-like injector

2024-519614-30-00Healthy volunteer trial

Boehringer Ingelheim International GmbH

Not possible to specify

Germany

28/01/2026

Phase II

Antisense Oligonucleotide Eye Drops against IRS-1 to Optimize Pretransplant Lymphangio-regression Prior to High-Risk Keratoplasty (Olisens-Precon)

2025-522099-10-00Pathologically prevascularized corneas due to herpetic kera…

University Of Cologne

Eye Diseases

Germany

28/01/2026

Phase III

A Phase 3 Randomized, Double-blind,Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants with Obstructive Sleep Apnea not on Positive Airway Pressure Therapy and Living with Overweight or Obesity (MARITIME-OSA-2)

2025-522699-94-00Moderate to severe obstructive sleep apnea (OSA) in adults …

Amgen Inc.

Respiratory Tract Diseases

Poland, Czechia, Germany, Hungary, France, Spain

27/01/2026

Phase III

An Open-label, Multicenter, Randomized, Non-Inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Weekly Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Patients with Alpha1-Antitrypsin Deficiency Compared to Corresponding Standard 60 mg/kg/week and 120 mg/kg/week Doses of Intravenous Alpha1-Proteinase Inhibitor (5%)

2025-522792-29-00Alpha-1 Antitrypsin Deficiency

DrugIVIG

Grifols Therapeutics LLC

Respiratory Tract Diseases

Poland, Denmark, Netherlands, Ireland, Sweden, Spain, Portugal, Germany, France

27/01/2026

Phase III

N1T-MC-MALO: A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Who Are at Increased Risk of Developing Major Adverse Liver Outcomes (SYNERGY-Outcomes); N1T-MC-TZ01 Tirzepatide in participants with high-risk MASLD; N1T-MC-RT01 Retatrutide in participants with high-risk MASLD

2025-522674-36-00Metabolic Dysfunction-Associated Steatotic Liver Disease

Eli Lilly & Co.

Nutritional and Metabolic Diseases

Czechia, France, Netherlands, Bulgaria, Norway, Austria, Poland, Spain, Italy, Hungary, Germany, Romania, Sweden, Portugal, Belgium

27/01/2026

Phase III

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallelgroup Study to Evaluate the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease

2025-521558-40-00Pulmonary Hypertension Associated with Interstitial Lung Di…

Insmed Inc.

Respiratory Tract Diseases

Portugal, Italy, Czechia, Poland, Denmark, Greece, Germany, Romania, Spain, France, Belgium, Austria

26/01/2026

Phase III

Patient-Centered Study of Trastuzumab Deruxtecan (T-DXd) in First-Line HER2-POsitive Metastatic Breast Cancer with Proactive Toxicity ManagementReflecting Real-World Clinical Practice / TOP-REAL Trial

2025-521805-41-00Patients with HER2-positive, locally advanced or metastatic…

DrugsPertuzumab·Trastuzumab deruxtecan

Solti Group

Neoplasms

France, Germany, Spain

26/01/2026

Phase I

Safety, Tolerability and Efficacy against Controlled Human Malaria Infection of PfSPZ-LARC2 Vaccine in Malaria-naïve Adults

2024-518273-34-02Malaria

Universitaetsklinikum Tuebingen AöR

Parasitic Diseases

Germany

26/01/2026

Phase III

An Operationally Seamless Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants with Heterozygous Familial Hypercholesterolemia

2024-519068-42-00Heterozygous Familial Hypercholesterolemia in pediatric p…

Merck Sharp & Dohme LLC

Cardiovascular Diseases

Germany, Spain, Belgium, Czechia, Norway, France, Poland, Netherlands, Italy, Finland

26/01/2026

Phase I

A study understanding how much CDR132L enters the bloodstream after injection under the skin compared to injection into a vein in healthy participants

2025-521329-34-00Healthy volunteers, treatment for heart failure

Novo Nordisk A/S

Cardiovascular Diseases

Germany

26/01/2026

Phase I

A study to investigate the effect of capivasertib on the pharmacokinetics of oral dextromethorphan (CYP2D6) in healthy participants

2025-523995-21-00Healthy participants

AstraZeneca AB

Not possible to specify

Germany

26/01/2026

Phase III

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder

2025-523202-32-00Major Depressive Disorder

Xenon Pharmaceuticals Inc.

Mental Disorders

Spain, Czechia, Slovakia, Romania, Poland, Finland, Germany

26/01/2026

Phase II

Antisense Oligonucleotide Eye Drops Against IRS-1 to Treat Pathological Corneal Neovascularisation in Aniridia-Associated Keratopathy (Olisens-Aniridia)

2025-522609-39-00Corneal Neovascularization in Aniridia-associated Keratopat…

University Of Cologne

Eye Diseases

Germany

23/01/2026

Phase III

Phase 3 Study to Evaluate the Efficacy and Safety of Zodasiran in Adolescent and Adult Subjects with Homozygous Familial Hypercholesterolemia (YOSEMITE)

2025-521792-31-01Homozygous Familial Hypercholesterolemia (HoFH)

DrugZodasiran

Arrowhead Pharmaceuticals Inc.

Cardiovascular Diseases

Greece, France, Belgium, Germany, Netherlands, Austria, Sweden, Spain, Czechia, Italy

23/01/2026

Phase II

A Phase 2b Randomized, Open-Label Active Controlled Study Evaluating the Safety and Efficacy of oral VH4524184 Coadministered with Emtricitabine and Tenofovir Alafenamide in Treatment Naïve Viremic Persons with HIV-1.( INNOVATE Study)

2025-521918-26-00HIV Infections

Viiv Healthcare UK Limited

Virus Diseases

Spain, Belgium, France, Germany, Italy, Portugal, Poland

23/01/2026

Phase III

Study on the influence of FLUMAzenil regarding the incidence of pediatric emergence delirium (ED) in children undergoing ENT surgery – FLUMA Study

2025-523543-36-00pediatric emergence delirium

Rheinische Friedrich-Wilhelms-Universitaet Bonn

Not possible to specify

Germany

23/01/2026

Phase I/II

A First-in-Human, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Intrathecally Administered LTX-002 in Adult Participants with Amyotrophic Lateral Sclerosis

2025-522039-33-00Amyotrophic Lateral Sclerosis

Leal Therapeutics Inc.

Nervous System Diseases

Sweden, Italy, Germany, Netherlands

23/01/2026

Phase I

(22597) A study to learn about how safe nitroglycerin is and how it affects the body when taken along with nurandociguat in people with coronary artery disease.

2025-522335-34-00Chronic kidney disease, Coronary artery disease

Bayer AG

Cardiovascular Diseases

Germany, Bulgaria

22/01/2026

Phase II

J2S-MC-GZMR: A Phase 2, Multicenter, Randomized, Double-blind, 52-week Study, to Investigate the Efficacy and Safety of Brenipatide Compared with Placebo for the Treatment of Adult Participants with Uncontrolled Moderate to Severe Asthma

2025-522640-41-00Asthma

Eli Lilly & Co.

Respiratory Tract Diseases

Germany, Netherlands, France, Poland

21/01/2026

Phase I/II

A PHASE 1/1B STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND IMMUNOGENICITY OF SINGLE AND MULTIPLE ASCENDING DOSES OF BCX17725 IN HEALTHY PARTICIPANTS AND MULTIPLE DOSES OF BCX17725 IN PARTICIPANTS WITH NETHERTON SYNDROME

2025-521973-16-00Netherton Syndrome

Biocryst Pharmaceuticals Inc.

Skin and Connective Tissue Diseases

France, Netherlands, Germany

20/01/2026

Phase II

A randomized, double-blind, placebo-controlled study to assess the effects of high concentration capsaicin patch (Qutenza) on neuropathic symptoms, nerve fibers, and microcirculation in painful diabetic peripheral neuropathy

2025-523597-17-00Painful diabetic peripheral neuropathy

Deutsche Diabetes Forschungsgesellschaft e.V.

Nervous System Diseases

Germany

20/01/2026

Phase III

Beamion LUNG-3: A randomized, controlled, multi-center trial evaluating zongertinib as an adjuvant monotherapy compared with standard of care in patients with early-stage, resectable non-small cell lung cancer (Stage II-IIIB) harboring tyrosine kinase domain activating HER2 mutations

2025-521284-12-00Non-small cell lung cancer

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Neoplasms

Austria, Portugal, Netherlands, Greece, Belgium, Spain, Germany, France, Romania, Sweden, Italy, Denmark

19/01/2026

Phase III

IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-based Chemotherapy in Patients with EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy

2025-521908-22-00EGFR-mutated Non-small Cell Lung Cancer

DrugsPegfilgrastim·Iza-bren·Pemetrexed·Cisplatin

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Poland, Germany, Italy, Norway, Netherlands, Belgium, Romania, France, Greece, Spain

19/01/2026

Phase III

A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants with Moderate-to-Severe Plaque Psoriasis (PRAGMATYK)

2023-503766-24-00Moderate to Severe Plaque Psoriasis

Bristol-Myers Squibb Services Unlimited Company

Immune System Diseases

Romania, Bulgaria, Germany, Spain, Czechia, France, Hungary, Italy, Sweden, Poland, Denmark, Belgium

19/01/2026

Phase I

A study to determine the safety and effect of antibodies against hepatitis D (the SAMBA-D study)

2025-522125-36-00Chronic hepatitis D infection

Region Midtjylland

Virus Diseases

Germany, Denmark

19/01/2026

Phase III

An open-label, parallel, Phase 3, two-arm study to investigate the efficacy and safety of fitusiran prophylaxis in male participants aged 1 to less than 12 years with hemophilia A or B with or without inhibitory antibodies to Factors VIII or IX

2025-521858-42-00Hemophilia

Sanofi-Aventis Recherche & Developpement

Hemic and Lymphatic Diseases

Belgium, Italy, Romania, Germany, Hungary, Spain, Poland

15/01/2026

Phase III

HOVON 181 AML: Bleximenib or Placebo in Combination with Standard Induction and Consolidation Therapy followed by Maintenance for the Treatment of Patients with Newly Diagnosed KMT2A-rearranged or NPM1-mutant Acute Myeloid Leukemia Eligible for Intensive Chemotherapy: a double-blind phase 3 study

2025-522767-15-00Acute Myeloid Leukemia

Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

Neoplasms

Belgium, Netherlands, Germany, Austria, Denmark, Estonia, Finland, Ireland, Italy, Lithuania, Spain, Sweden, Norway, Poland

15/01/2026

Phase II

A phase 2, three-arm, randomized study of the efficacy of intratumorally administered L19IL2 or L19TNF or L19IL2/L19TNF, all in combination with systemic anti-PD1 pembrolizumab, in stage III and IV unresectable melanoma patients with resistance to or progressing upon anti-PD1 checkpoint inhibitors and with presence of injectable metastases

2024-519326-20-00Patients with diagnosis of unresectable clinical stage III …

Philogen S.p.A.

Neoplasms

Italy, Germany

14/01/2026

Phase III

A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants with Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

2025-521917-24-00Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous…

Janssen Cilag International

Neoplasms

Italy, Portugal, Spain, Romania, Hungary, France, Czechia, Germany, Netherlands, Austria, Poland, Belgium

14/01/2026

Phase II

A multicenter, randomized, participant- and investigator -blinded, placebo-controlled, phase 2a study to assess the efficacy, safety and tolerability of GIA632 in adult participants with moderate to severe atopic dermatitis

2025-521503-43-00Atopic dermatitis

Novartis Pharma AG

Skin and Connective Tissue Diseases

France, Germany, Poland, Czechia, Bulgaria

14/01/2026

Phase I

A Phase 1, Open-Label, Multicenter Study of INCB160058 in Participants With Myeloproliferative Neoplasms.

2024-520353-21-00Myeloproliferative Neoplasms

Incyte Corp.

Neoplasms

Norway, Germany, France, Italy

14/01/2026

Phase III

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)

2025-521514-26-00Persistent, Recurrent, or Newly Diagnosed Metastatic Cervic…

Merck Sharp & Dohme LLC

Neoplasms

Greece, Ireland, France, Belgium, Czechia, Hungary, Austria, Spain, Sweden, Germany, Poland, Denmark, Italy

14/01/2026

Phase II

A Phase IIa, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Assess the Efficacy, Safety, and Tolerability of AZD4144 in Participants with Sepsis-associated Acute Kidney Injury (SERENIA)

2025-522232-13-00Sepsis-associated acute kidney injury (AKI)

DrugAZD4144

AstraZeneca AB

Not possible to specify

Germany, France, Spain, Italy, Belgium, Czechia, Greece, Denmark, Hungary

14/01/2026

Phase II

A multi- center, randomized, double-blind, placebo-controlled parallel–group, dose-finding study to evaluate efficacy, safety, and tolerability of DII235 in adults with elevated Lipoprotein(a)

2025-521912-21-00Cardiovascular risk reduction in participants with elevated…

Novartis Pharma AG

Cardiovascular Diseases

Germany

13/01/2026

Phase II

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging Study With an Open-label Period Investigating the Efficacy and Safety Profile of KT-621 Administered Orally to Participants with Moderate to Severe Atopic Dermatitis

2025-522370-36-00Moderate to Severe Atopic Dermatitis

Kymera Therapeutics Inc.

Skin and Connective Tissue Diseases

Czechia, Germany, Poland

13/01/2026

Phase III

Phase II-III study to assess the efficacy and safety of sublingual immunotherapy in patients suffering from house dust mite allergy. A prospective, international, randomized, double-blind, placebo-controlled, multicentre, phase II-III trial.

2025-523119-12-00Patients with moderate-to-severe allergic rhinitis / rhinoc…

ROXALL Medizin GmbH

Immune System Diseases

Germany, Spain

13/01/2026

Phase I

A trial to learn how well different doses of andexanet alfa work and how they affect blood clotting throughout the body in healthy adults who have taken an FXa inhibitor

2025-522513-30-00Healthy Volunteers

AstraZeneca AB

Not possible to specify

Germany

09/01/2026

Phase III

A Phase 2/3, multicenter, randomized open-label study of zanzalintinib vs everolimus in participants with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors

2025-521043-20-00Neuroendocrine tumors

Exelixis Inc.

Neoplasms

France, Poland, Netherlands, Belgium, Germany, Spain, Italy, Austria

09/01/2026

Phase II

NeoMatryx - Neoadjuvant Merkel cell carcinoma therapy (Tx) with the PD-1 inhibitor Cemiplimab – A randomized, double-blind, placebo-controlled, non-comparative Phase II study

2025-522091-84-00Merkel Cell Carcinoma

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Neoplasms

Germany

09/01/2026

Phase I

A study to compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 with US-Dupixent®, and EU-Dupixent® in Healthy Adult Participants.

2025-523115-11-00Phase I study in healthy participants. Intended indication:…

Chong Kun Dang Pharmaceutical Corp.

Immune System Diseases

Germany

09/01/2026

Phase III

J2A-MC-GZPT A Phase 3 Study to Investigate the Efficacy and Safety of Orfor-glipron Once Daily in Participants Who Have Obesity or Overweight and Osteoar-thritis of the Knee: A Multicenter, Randomized, Double-Blind, Parallel-Arm, Pla-cebo-Controlled Trial List of Intervention-Specific Appendices (ISAs): ISA1 (GZT1): A Study to Investigate Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee ISA2 (GZT2): A Study to Investigate Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee

2025-522631-34-00Osteoarthritis

Eli Lilly & Co.

Musculoskeletal Diseases

Germany, Spain

29/12/2025

Phase III

A Randomized, Phase 2/3, Open-Label Study to Investigate the Efficacy and Safety of RP2 in Combination with Nivolumab versus Ipilimumab in Combination with Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients with Metastatic Uveal Melanoma

2023-508784-68-00metastatic uveal melanoma

DrugsRP2·Ipilimumab·Nivolumab

Replimune Inc.

Neoplasms

Germany, Italy, France, Spain, Poland

23/12/2025

Phase II

A Phase 2b, Randomized, Blinded Trial Investigating the Efficacy and Safety of Visugromab in combination with Nivolumab and Lenvatinib compared to Double Placebo and Lenvatinib in Participants with Unresectable or Metastatic Hepatocellular Carcinoma and Compensated Liver Function (Child-Pugh A) after Failure of First-Line Treatment that Included an Anti-PD-(L)1 Compound (GDFATHER-HCC-01)

2025-520675-86-00Unresectable or Metastatic Hepatocellular Carcinoma and Com…

CatalYm GmbH

Neoplasms

Germany, France, Italy, Spain

23/12/2025

Phase III

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early-Stage Parkinson’s Disease

2025-522683-32-00Early-Stage Parkinson’s Disease (PD)

F. Hoffmann-La Roche AG

Nervous System Diseases

France, Austria, Portugal, Netherlands, Poland, Germany, Spain, Denmark, Italy

23/12/2025

Phase II

PHASE II STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CAMIZESTRANT PLUS RIBOCICLIB IN PATIENTS WITH HORMONE RECEPTOR-POSITIVE (HR+) BREAST CANCER (THE CADILLAC STUDY)

2024-520027-88-00Patients with hormone receptor-positive (HR+) breast cancer

DrugsCamizestrant·Ribociclib

Medica Scientia Innovation Research S.L.

Neoplasms

Spain, Germany, Italy

23/12/2025

Phase I/II

Phase 1b/2 Dose-Ranging Study of the Safety, PK, PD & Efficacy of the Activin Signaling Inhibitor HS235 vs placebo added to background therapy in PAH (SEASIde)

2025-523010-89-00Pulmonary arterial hypertension

35Pharma Inc.

Cardiovascular Diseases

Hungary, Spain, Poland, Germany, Czechia

23/12/2025

Phase III

I4V-MC-JAJJ: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to <36 Years

2025-521797-34-00Diabetes Mellitus, Type 1

DrugBaricitinib

Eli Lilly & Co.

Immune System Diseases

Belgium, Spain, Norway, Germany, Sweden, Netherlands, France, Italy, Finland, Portugal, Poland

23/12/2025

Phase II

A randomized, double-blind, placebo-controlled, dose-ranging Phase 2 study of brivekimig followed by a maintenance period in participants with moderate to severe hidradenitis suppurativa

2025-522333-61-00Hidradenitis suppurativa

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

Poland, Hungary, Netherlands, Germany, Czechia, Spain, France, Italy, Greece

22/12/2025

Phase II

A Phase 2, randomized, multicenter, open-label neoadjuvant study evaluating zanidatamab in combination with chemotherapy in participants with HER2-positive breast cancer

2025-523204-68-00HER2-positive breast cancer

Jazz Pharmaceuticals Ireland Limited

Neoplasms

Italy, Spain, Germany

22/12/2025

Phase III

A Phase 3, multicentre, randomised (1:1), parallel-group, active-controlled, central reader colonoscopist-blind study to evaluate the bowel cleansing efficacy, safety, tolerability, palatability, and acceptability of PLENVU® as compared to sodium picosulfate in paediatric participants from 1 to < 18 years of age in preparation for colonoscopy (CLARITY)

2025-522046-42-00Colonic disease

Norgine Limited

Digestive System Diseases

Poland, Netherlands, Hungary, Spain, Italy, Belgium, Germany, Croatia, Portugal

22/12/2025

Phase III

A Double-blind, Randomized, Placebo-controlled, Multi-center Study Evaluating the Safety, Tolerability, and Effect of Olpasiran on Coronary Artery Plaque Burden Assessed by Coronary Computed Tomography Angiography in Participants With Stable Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)

2025-521117-88-00Cardiovascular Disease

Amgen Inc.

Cardiovascular Diseases

France, Denmark, Germany, Spain, Italy, Netherlands

22/12/2025

Phase III

A Phase III, multisite, double-blinded randomized trial of BNT327 in combination with chemotherapy (etoposide/carboplatin) compared to atezolizumab in combination with chemotherapy (etoposide/carboplatin) in participants with first-line extensive-stage small-cell lung cancer

2024-515765-34-00English First-line extensive-stage small-cell lung cancer (…

BioNTech SE

Neoplasms

Poland, Spain, France, Italy, Germany, Romania, Netherlands

22/12/2025

Phase I

A clinical trial investigating the safety and biological activity of the antibody BNT351 in adults living without and with HIV

2025-523846-29-00HIV-1 infection

BioNTech SE

Virus Diseases

Germany

22/12/2025

Phase III

C2321008: A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY OF MEVROMETOSTAT (PF-06821497) WITH ENZALUTAMIDE IN METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MEVPRO-3)

2024-519369-24-00METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER

Pfizer Inc.

Not possible to specify

Belgium, Finland, France, Germany, Netherlands, Bulgaria, Spain, Slovakia, Italy, Czechia, Poland, Greece

22/12/2025

Phase III

IZABRIGHT-BLADDER01: A Randomized, Open-label, Phase 2/3 trial of Izalontamab Brengitecan versus platinum-based chemotherapy for metastatic urothelial cancer in participants with disease progression on or after an immunotherapy-based treatment

2025-522400-24-00Metastatic urothelial cancer

Bristol-Myers Squibb Services Unlimited Company

Male Urogenital Diseases

Ireland, Belgium, Germany, Italy, Norway, Spain, Austria, Sweden, France, Romania, Czechia

19/12/2025

Phase III

A Phase III, randomised, double-blind, placebo-controlled, parallel-group, pivotal trial to assess the efficacy and safety of sonlicromanol in adult subjects with a genetically confirmed mitochondrial DNA tRNALeu(UUR) m.3243A>G variant.

2025-522361-30-00Primary Mitochondrial Disease, Mitochondrial DNA 3243A>G va…

DrugSonlicromanol

Khondrion B.V.

Nervous System Diseases

Italy, Germany, France, Netherlands, Denmark

19/12/2025

Phase I/II

TulmiSTAR-02: A two-part Phase I dose escalation study of tulmimetostat (DZR123) in combination with darolutamide or abiraterone followed by open-label, randomized, Phase II dose expansion study to assess the safety and efficacy of tulmimetostat in combination with darolutamide versus darolutamide alone in patients with metastatic hormone-sensitive prostate cancer

2025-521873-15-00Metastatic hormone-sensitive prostate cancer

Novartis Pharma AG

Neoplasms

Hungary, Spain, Italy, Germany, France

18/12/2025

Phase III

An Open-label Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of 12-month Treatment with Migalastat in Pediatric Subjects (aged 2 to < 12 years) with Fabry Disease and Amenable GLA Variants

2025-521244-38-00Fabry disease

DrugMigalastat HCl

Amicus Therapeutics Inc.

Nutritional and Metabolic Diseases

Spain, Germany, Belgium

17/12/2025

Phase III

C3651021: A PHASE 2b/3, RANDOMIZED, DOUBLE-BLIND STUDY TO INVESTIGATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PONSEGROMAB (PF-06946860) COMPARED WITH PLACEBO BOTH WITH BACKGROUND FIRST-LINE CHEMOTHERAPY IN ADULT PARTICIPANTS WITH CACHEXIA AND METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA

2025-522093-36-00Cancer cachexia

Pfizer Inc.

Nutritional and Metabolic Diseases

Slovakia, Italy, Belgium, Germany, Spain, France, Bulgaria, Poland

16/12/2025

Phase I

A study in healthy men to test how itraconazole influences the amount of BI 764198 in the blood

2025-523135-19-00Healthy volunteer trial

Boehringer Ingelheim International GmbH

Not possible to specify

Germany

16/12/2025

Phase III

Thrombolysis with Tenecteplase for Acute Ischemic Stroke in Patients taking Direct Oral Anticoagulants – a multicentre randomised placebo-controlled clinical trial

2025-521762-99-00acute ischemic stroke

University Medical Center Hamburg-Eppendorf

Cardiovascular Diseases

Germany

16/12/2025

Phase III

A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants with Early Parkinson’s Disease

2025-521113-13-00Early Parkinson’s Disease

Biohaven Therapeutics Ltd.

Nervous System Diseases

Germany, France, Italy, Belgium, Czechia, Poland, Austria, Netherlands, Spain, Portugal

15/12/2025

Phase I

A Phase 1b, Prospective, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Safety and Tolerability of Multiple Oral Doses of IRL757 in Participants with Parkinson’s Disease and Apathy

2025-523612-37-00Parkinson's Disease and Apathy

Integrative Research Laboratories Sweden AB

Nervous System Diseases

Bulgaria, Poland, Spain, Germany

12/12/2025

Phase I

A phase 1 glucose clamp trial investigating the bioequivalence of CVC-001 cartridge vs U.S.-Licensed Lantus® in healthy male volunteers

2024-516472-15-00Type 1 diabetes mellitus (healthy participants)

Civica Inc.

Nutritional and Metabolic Diseases

Germany

12/12/2025

Phase III

A Phase 2b/3 Adaptive, Randomized, Active controlled Study Evaluating the Efficacy, Safety, and Tolerability of Povetacicept Versus Calcineurin Inhibitor in the Treatment of Primary Membranous Nephropathy

2025-521661-27-00Primary Membranous Nephropathy

Vertex Pharmaceuticals Inc.

Immune System Diseases

Hungary, Ireland, Czechia, Italy, Spain, Germany, Netherlands

12/12/2025

Phase III

A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy With or Without Radiotherapy as Adjuvant Treatment for HER2-Expressing (IHC 3+/2+) Endometrial Cancer (DESTINY-Endometrial02/ GOG-3122/ ENGOT-en30/GINECO)

2024-519444-33-00HER2-expressing endometrial cancer (IHC 3+/2+)

Daiichi Sankyo Inc.

Neoplasms

Germany, Poland, France, Greece, Spain, Portugal, Italy

11/12/2025

Phase III

A prospective, randomised, multi-centre, double-blind, placebo-controlled Phase III trial to investigate the efficacy and safety of lozenges with benzydamine hydrochloride and dichlorobenzyl alcohol in the symptomatic treatment of patients suffering from acute pharyngitis

2025-521764-35-01acute pharyngitis

MEDICE Arzneimittel Puetter GmbH & Co. KG

Otorhinolaryngologic Diseases

Germany

11/12/2025

Phase III

Efficacy and Safety of Nipocalimab vs Efgartigimod for Patients with Generalized Myasthenia Gravis in a Randomized, Open-label, Phase 3b, Interventional Trial Including Within Class Switching From Efgartigimod to Nipocalimab

2025-521130-28-00generalized myasthenia gravis

Janssen Cilag International

Immune System Diseases

Austria, Germany, Spain, Italy

10/12/2025

Phase III

AALL2131/EsPhALL2022, An International Pilot Study of Chemotherapy and Tyrosine Kinase Inhibitor with Blinatumomab in Patients with Newly Diagnosed Philadelphia Chromosome Positive or ABL-class Philadelphia Chromosome-Like B-cell Acute Lymphoblastic Leukemia

2025-520982-39-00Philadelphia Chromosome Positive or ABL-class Philadelphia …

Universita Degli Studi Di Milano Bicocca

Neoplasms

France, Lithuania, Norway, Finland, Spain, Italy, Czechia, Germany, Hungary, Slovakia, Denmark, Austria, Netherlands

09/12/2025

Phase III

A Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Atumelnant Treatment in Pediatric Participants with Congenital Adrenal Hyperplasia Including a Long-Term Extension

2024-519578-38-00Classic congenital adrenal hyperplasia

Crinetics Pharmaceuticals Inc.

Hormonal diseases

Italy, Germany, France, Belgium, Netherlands, Poland

09/12/2025

Phase III

CLEOPATTRA: Effects of NNC6019-0001 versus placebo on cardiovascular outcomes in participants with transthyretin amyloid cardiomyopathy (ATTR-CM).

2024-518899-31-00Variant or wild-type transthyretin (TTR) amyloid cardiomyop…

Novo Nordisk A/S

Cardiovascular Diseases

Germany, France, Belgium, Italy, Denmark, Netherlands, Spain, Czechia, Sweden

09/12/2025

Phase III

International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 - A Randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group - IntReALL BCP 2020

2023-509392-17-00Relapsed Acute Lymphoblastic Leukemia (ALL)

DrugsIdarubicin·Inotuzumab Ozogamicin·Pegaspargase·Mercaptopurine

Charite Universitaetsmedizin Berlin KöR

Hemic and Lymphatic Diseases

Netherlands, Czechia, Italy, Spain, Denmark, Austria, Norway, Sweden, Germany, France, Finland, Slovenia

09/12/2025

Phase III

A Prospective, Multicenter, Open-label, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Prophylactic VGA039 in Adolescent and Adult Patients with von Willebrand Disease (VIVID-6)

2025-522056-10-01von Willebrand Disease

Vega Therapeutics Inc.

Hemic and Lymphatic Diseases

Austria, Italy, Ireland, Germany, Finland

08/12/2025

Phase I/II

A Modular Phase I/II, Open-label, Multi-Centre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants with Advanced Haematologic Malignancies with KMT2Ar, NPM1m, or Other Genotypes Associated with HOX Overexpression

2025-521299-76-00Relapsed or refractory acute leukaemia or Myelodysplastic S…

AstraZeneca AB

Neoplasms

Germany, Italy, Denmark

08/12/2025

Phase III

AndroMETa-CRC-064: An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Monotherapy to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with Refractory Metastatic Colorectal Cancer Expressing c-Met Protein Level Above a Defined Cutoff

2024-512804-20-00Metastatic Colorectal Cancer

AbbVie Deutschland GmbH & Co. KG

Neoplasms

Germany, Poland, France, Italy, Netherlands, Spain

08/12/2025

Phase II

Exploratory Study of Ianalumab in Adults with Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) who Have Previously Benefited from Ianalumab (VAY RE-HIT)

2024-518231-11-00Immune thrombocytopenia (ITP) Warm autoimmune hemolytic an…

Novartis Pharma AG

Hemic and Lymphatic Diseases

Germany, Czechia, Belgium, Spain, Italy, Bulgaria, Romania, France, Hungary

08/12/2025

Phase II

(22419) A randomized, double-blind, placebo-controlled, parallel group Phase 2a study with an extension phase to evaluate the efficacy and safety of BAY 3401016 in participants aged 18 to 45 with Alport syndrome

2024-516471-33-00Chronic kidney disease, Alport Syndrome

Bayer AG

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Spain, Italy, Poland, Czechia, Germany, Portugal, France

05/12/2025

Phase II

A Phase II, Randomized, Open-Label, Parallel Group, Multicenter Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Patients with Multiple Sclerosis

2024-517980-22-00Multiple Sclerosis (MS)

F. Hoffmann-La Roche AG

Immune System Diseases

Poland, Italy, France, Spain, Germany

05/12/2025

Phase III

(21467) A Phase 3, single-arm, open-label extension study to evaluate the safety of finerenone in addition to standard of care, in pediatric heart failure patients, from birth to 18 years of age, with left ventricular systolic dysfunction (LVSD)

2024-519830-22-00Heart failure due to systemic left ventricular systolic dys…

DrugFinerenone

Bayer AG

Cardiovascular Diseases

Czechia, Germany, Greece, Italy, Finland, Bulgaria, Belgium, Poland, Austria, Portugal, Spain, Hungary, Sweden

05/12/2025

Phase III

(21466) A multicenter, randomized, double-blind, placebo-controlled, Phase 3 study to investigate the efficacy, safety, and PK/ PD of finerenone, in addition to standard-of-care, in pediatric patients, 6 months to < 18 years of age, with heart failure (HF) and left ventricular systolic dysfunction (LVSD)

2024-519829-38-00Heart failure due to systemic left ventricular systolic dys…

Bayer AG

Cardiovascular Diseases

Czechia, Poland, Portugal, Austria, Finland, Greece, Bulgaria, Sweden, Spain, Italy, Belgium, Hungary, Germany

05/12/2025

Phase II

Phase 2 Trial to determine the efficacy of belumosudil for patients with steroid-refractory overlap of syndrome Graft-versus-Host-Disease (SR-osGVHD) - BEAT-GVHD

2025-521940-39-00steroid-refractory overlap syndrom Graft-versus-Host-Disease

Medical Center - University Of Freiburg

Immune System Diseases

Germany

05/12/2025

Phase III

A Phase 3, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Multicenter Trial to Confirm the Efficacy and Safety of Glepaglutide 10 mg Twice-Weekly, Followed by a Long-Term, Open-Label Safety Evaluation in Patients with Short Bowel Syndrome–Intestinal Failure (SBS-IF)

2024-512486-14-00Short Bowel Syndrome

DrugGlepaglutide

Zealand Pharma A/S

Digestive System Diseases

Finland, France, Belgium, Germany, Hungary, Spain, Austria, Netherlands, Italy, Denmark, Czechia, Norway, Poland, Sweden, Estonia

04/12/2025

Phase II

A PHASE 2A, OPEN-LABEL SINGLE ARM MULTICENTER EXPLORATORY STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF ORAL DOSES OF ROC-101 IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) AND PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE (ILD-PH)

2025-522074-37-00Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertensi…

Allrock Bio Inc.

Cardiovascular Diseases

Spain, Italy, Poland, France, Latvia, Germany

04/12/2025

Phase III

A Randomized, Controlled, Partially Masked, Phase 3b Study to Assess the Injection Burden, Efficacy, Safety, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec (ABBV-RGX-314) in a Real-World Context in Subjects with Neovascular Age-Related Macular Degeneration (nAMD)

2024-512298-28-00Neovascular age-related macular degeneration

DrugsSurabgene Lomparvovec·Ranibizumab

AbbVie Deutschland GmbH & Co. KG

Eye Diseases

Czechia, Portugal, Hungary, Spain, Belgium, Italy, Austria, France, Slovakia, Croatia, Germany, Bulgaria, Greece

02/12/2025

Phase III

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atumelnant in Adult Participants with Classic Congenital Adrenal Hyperplasia

2024-519579-24-00Classic Congenital Adrenal Hyperplasia

Crinetics Pharmaceuticals Inc.

Hormonal diseases

Sweden, Austria, Poland, Netherlands, Italy, France, Germany

02/12/2025

Phase II

C5001004 - A Phase 2, Open-Label Extension Study to Investigate the Safety and Efficacy of PF-07868489 Administered to Adult Participants With Pulmonary Arterial Hypertension

2025-521155-23-00Pulmonary Arterial Hypertension

Pfizer Inc.

Cardiovascular Diseases

Italy, Czechia, Germany, Greece, Spain, Belgium, France

02/12/2025

Phase I/II

A Phase Ib/II, multi-site, open-label, dose finding trial to evaluate the safety, efficacy, and pharmacokinetics of BNT326 in combination with BNT327 in participants with advanced non-small cell lung cancer (NSCLC)

2024-519344-32-00Non-small Cell Lung Cancer

BioNTech SE

Neoplasms

Poland, Germany, Italy, Spain

02/12/2025

Phase III

A phase 3, randomized, double-blind, placebo-controlled, multicenter study with open-label extension to evaluate the efficacy and safety of bimekizumab in study participants with palmoplantar pustulosis

2024-520337-80-00Palmoplantar Pustulosis

UCB Biopharma

Immune System Diseases

Czechia, Denmark, Spain, Poland, Germany, Hungary, Italy, France

02/12/2025

Phase III

A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

2025-521382-27-00Moderately to Severely Active Crohn's Disease

Janssen Cilag International

Immune System Diseases

Netherlands, Italy, Portugal, Spain, Czechia, Romania, France, Sweden, Hungary, Belgium, Germany, Greece, Poland

01/12/2025

Phase III

A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults with an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis

2025-521381-10-00Moderately to Severely Active Ulcerative Colitis

Janssen Cilag International

Digestive System Diseases

Netherlands, Romania, Italy, Spain, Sweden, Czechia, Greece, Hungary, France, Portugal, Belgium, Germany, Poland

01/12/2025

Phase I/II

TulmiSTAR-01: A two-part, Phase I dose escalation and expansion followed by a randomized, open-label multicenter, Phase II study to assess the safety and efficacy of the combination of tulmimetostat (DZR123) and JSB462 (luxdegalutamide) vs standard of care in patients with progressive metastatic castrate resistant prostate cancer

2025-521880-10-00Metastatic castrate resistant prostate cancer (mCRPC)

Novartis Pharma AG

Neoplasms

Italy, Germany, Poland, France, Denmark, Spain

01/12/2025

Phase III

An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)

2025-521970-33-00Pulmonary Arterial Hypertension (PAH)

Merck Sharp & Dohme LLC

Cardiovascular Diseases

Czechia, Germany, Sweden, Greece, Croatia, Belgium, Poland, Spain, Portugal, Italy, Denmark, France, Netherlands

01/12/2025

Phase III

A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Intravenous Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

2024-520097-36-00Chronic inflammatory demyelinating polyneuropathy (CIDP)

DrugEmpasiprubart

Argenx

Nervous System Diseases

Czechia, Bulgaria, Netherlands, Hungary, Sweden, Slovakia, Slovenia, Greece, Norway, Poland, Italy, Spain, Estonia, Denmark, France, Romania, Portugal, Austria, Germany

01/12/2025

Phase II

A phase 2, multicenter, randomized, placebo-controlled, double-blind study to investigate the safety, pharmacodynamics, and preliminary efficacy of S-606001 as an add-on to enzyme replacement therapy in patients with late-onset Pompe disease.

2025-522146-40-00Late-onset Pompe disease.

Shionogi B.V.

Nutritional and Metabolic Diseases

Belgium, Germany, Denmark, France, Italy, Spain, Netherlands

01/12/2025

Phase II

A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-407 in Subjects with Autosomal Dominant Polycystic Kidney Disease Who Have a Subset of PKD1 Gene Variants

2024-517393-13-00Autosomal Dominant Polycystic Kidney Disease (ADPKD)

DrugVX-407

Vertex Pharmaceuticals Inc.

Genetic Phenomena

France, Germany, Italy, Belgium, Spain, Netherlands

28/11/2025

Phase I/II

An open label, phase I/II study investigating the safety and efficacy of the bispecific T-cell engaging antibody cizutamig (BCMAxCD3) in patients with immune-mediated inflammatory diseases – the SPLENDID Trial

2025-522857-20-00Severe, treatment refractory primary Sjögren’s disease (pSj…

Fraunhofer Institute For Translational Medicine And Pharmacology ITMP

Immune System Diseases

Germany

28/11/2025

Phase III

A Randomized, Phase 2/3 Study Comparing Navlimetostat (BMS-986504) in Combination With Nab-Paclitaxel and Gemcitabine versus Placebo in Combination With Nab-Paclitaxel and Gemcitabine in Participants with Untreated Metastatic Pancreatic Ductal Adenocarcinoma Harboring Homozygous MTAP Deletion

2025-522598-12-00Untreated Metastatic Pancreatic Ductal Adenocarcinoma

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Czechia, Austria, Belgium, Ireland, Spain, Germany, Romania, Netherlands, Slovakia, Greece, Poland, Italy, Denmark, France, Sweden

28/11/2025

Phase I

A Double-blind, Placebo-controlled, Multiple-Dose, 2-Period Crossover Study to Evaluate the Effect of Steady-state AZD6793 on the Steady-state Pharmacokinetics/Pharmacodynamics of Metformin in Participants with Type 2 Diabetes Mellitus

2025-522551-25-00Type 2 Diabetes Mellitus

AstraZeneca AB

Nutritional and Metabolic Diseases

Germany

27/11/2025

Phase II

A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination with Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination with Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

2025-520730-28-00Common EGFR-Mutated Locally Advanced or Metastatic Non-Smal…

Janssen Cilag International

Neoplasms

Germany, Spain, Finland, Greece, Portugal, Italy, Belgium, Poland, France

27/11/2025

Phase III

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)

2024-514500-14-00Participants with KRAS G12C-Mutant, Advanced or Metastatic …

Merck Sharp & Dohme LLC

Neoplasms

Germany, Italy, France, Poland, Spain, Hungary, Romania, Greece, Austria, Netherlands, Belgium

27/11/2025

Phase I/II

InsigHHT: A Phase 1/2, Randomized, Double-blind, Placebo-controlled, 2 part Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-6400 in Adult Healthy Volunteers and Multiple Dose ALN 6400 in Adult Patients with Hereditary Hemorrhagic Telangiectasia (HHT)

2025-522510-23-00Hereditary Hemorrhagic Telangiectasia (HHT)

Alnylam Pharmaceuticals Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

France, Spain, Germany

26/11/2025

Phase III

A 104-week, multicenter, open-label, single-arm, phase 3 extension trial investigating the long-term safety and efficacy of Glepaglutide in adult patients with short bowel syndrome (SBS) rolling over from the EASE SBS 2 or 3 trials

2025-520775-81-00Short Bowel Syndrome

Zealand Pharma A/S

Digestive System Diseases

Poland, France, Germany, Belgium

26/11/2025

Phase II

A Phase 2, multicenter, open-label study of lifileucel (tumor-infiltrating lymphocytes [TIL]) in participants with previously treated advanced melanoma

2025-522054-40-00Previously treated advanced melanoma

Iovance Biotherapeutics Inc.

Skin and Connective Tissue Diseases

France, Italy, Germany, Spain

26/11/2025

Phase I

A Phase 1B, Open-Label Study of Mirdametinib in Infants and Toddlers with Neurofibromatosis Type 1 associated Plexiform Neurofibromas

2025-522000-24-00Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofi…

DrugMirdametinib

Merck Healthcare KGaA

Neoplasms

Spain, Germany

26/11/2025

Phase I/II

A Phase Ib/ II Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination with Giredestrant in Comparison with Abemaciclib and Giredestrant in Participants with Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer who Have Previously Progressed During or After a CDK4/6 Inhibitor

2025-521128-31-00Locally Advanced or Metastatic Estrogen Receptor-Positive, …

Genentech Inc.

Neoplasms

Spain, Italy, France, Germany

26/11/2025

Phase I

A Phase 1b open label pilot study of CLN-978 for the treatment of moderate to severe systemic lupus erythematosus (SLE)

2024-518780-36-00Systemic Lupus Erythematosus

Cullinan Therapeutics Inc.

Musculoskeletal Diseases

Bulgaria, Romania, France, Germany, Spain, Poland

25/11/2025

Phase II

ZANGEA – Phase II Study of Zanidatamab in Combination with Pembrolizumab and Chemotherapy in HER2 and PD-L1 Positive Metastatic Gastroesophageal Adenocarcinoma (GEA) Patients

2025-522718-22-00Gastroesophageal Adenocarcinoma

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Digestive System Diseases

Germany

25/11/2025

Phase I

CLonE-specific CAR T-Cell therapy in relapsed or refractory AL amyloidosis - a single-center Phase I trial (CLEAR AL)

2025-520790-39-00relapsed or refractory AL amyloidosis

Universitaetsklinikum Heidelberg AöR

Immune System Diseases

Germany

25/11/2025

Phase III

Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

2024-515023-11-00Advanced Clear Cell Renal Cell Carcinoma, Metastatic Clear …

DrugsCasdatifan·Cabozantinib

Arcus Biosciences Inc.

Neoplasms

Italy, Spain, Romania, Germany, Netherlands, Poland, France, Czechia, Hungary

24/11/2025

Phase II

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants with Primary Sjogren’s Disease with Moderate to Severe Systemic Disease Activity

2025-520831-18-00Primary Sjogren’s Disease

Immunovant Sciences GmbH

Immune System Diseases

Germany, Greece, Romania, Spain, Poland, Italy, Hungary

24/11/2025

Phase III

A randomized, double-blind, placebo-controlled, parallel-group, multicenter study of the efficacy and safety of depemokimab in adult participants with COPD with Type 2 inflammation.

2024-520418-22-00Chronic Obstructive Pulmonary Disease

Glaxosmithkline Research & Development Limited

Respiratory Tract Diseases

Slovakia, Denmark, France, Sweden, Ireland, Belgium, Netherlands, Spain, Croatia, Germany, Poland, Hungary, Norway, Portugal

24/11/2025

Phase III

A randomized, double-blind, placebo-controlled, parallel-group, multicenter study of the efficacy and safety of depemokimab in adult participants with COPD with Type 2 inflammation

2024-520417-41-00Chronic Obstructive Pulmonary Disease

Glaxosmithkline Research & Development Limited

Respiratory Tract Diseases

Czechia, Greece, Latvia, Austria, Germany, Bulgaria, Romania, Italy

24/11/2025

Phase II

A Phase II, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of RO7790121 in Patients with Moderate to Severe Rheumatoid Arthritis who have an Inadequate Response or Intolerance to TNF and/or JAK Inhibitors

2025-521034-28-00Moderate to Severe Rheumatoid Arthritis (RA)

DrugAfimkibart

F. Hoffmann-La Roche AG

Immune System Phenomena

Italy, Denmark, France, Poland, Germany, Spain, Belgium

23/11/2025

Phase I/II

A Phase 1/2 Dose Escalation Study of CRN09682 With an Expansion Phase in Participants with Progressive Metastatic Somatostatin Receptor Type 2 (SST2)-Expressing Neuroendocrine Neoplasms (NENs) and Other SST2-Expressing Solid Tumors

2025-521672-60-00Metastatic or locally advanced SST2-positive neuroendocrine…

Crinetics Pharmaceuticals Inc.

Neoplasms

Spain, France, Germany, Italy

21/11/2025

Phase III

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal Injection of 4D-150 in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration (4FRONT-2)

2025-521349-25-00Macular neovascularization secondary to age-related macular…

4d Molecular Therapeutics Inc.

Eye Diseases

Germany, Italy, Hungary, Bulgaria, Lithuania, France, Spain, Latvia, Portugal

21/11/2025

Phase III

Randomized study to compare first-line treatment with either continuous or intermittent cetuximab plus FOLFIRI in patients with RAS/BRAF-wild-type metastatic colorectal cancer (mCRC): AIO-KRK-0524 / FIRE-11

2025-522377-12-00metastatic colorectal cancer

DrugsFolinic acid·Fluorouracil·Irinotecan·Cetuximab

Charite Universitaetsmedizin Berlin KöR

Neoplasms

Germany

20/11/2025

Phase I

A research study of a new medicine NNC0363-1063 in participants with type 1 diabetes

2025-521593-33-00Diabetes type 1

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Germany

20/11/2025

Phase II

A Global Phase 2b, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients with Symptomatic Non Obstructive Hypertrophic Cardiomyopathy – FORTITUDE-HCM

2024-515125-28-00Non-obstructive hypertrophic cardiomyopathy

Imbria Pharmaceuticals Inc.

Cardiovascular Diseases

Austria, Germany, Belgium, France, Portugal, Spain, Netherlands, Italy, Poland

20/11/2025

Phase I/II

A Randomised, Placebo-Controlled, Double-Blind, Single-Ascending Dose and Multiple-Ascending Dose First-In-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered ALE1 With or Without Food in Healthy Adult Participants and Adult Patients With Hypophosphatasia

2025-522378-36-00Hypophosphatasia

Alesta Therapeutics B.V.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Germany

19/11/2025

Phase III

A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

2025-522860-34-00Small lymphocytic lymphoma (SLL), Chronic lymphocytic leuke…

BeOne Medicines AG

Neoplasms

Sweden, Belgium, Spain, Germany, Austria, Netherlands, Italy, Romania, Poland, France

18/11/2025

Phase III

A Phase 3 Randomized, Double-blind, Placebo-controlled Study of JNJ-78278343, a T-cell-redirecting Agent Targeting Human Kallikrein 2 Versus Placebo for Metastatic Castration-resistant Prostate Cancer

2025-520927-26-00Metastatic Castration-resistant Prostate Cancer (mCRPC)

Janssen Cilag International

Neoplasms

France, Belgium, Spain, Poland, Italy, Netherlands, Germany

18/11/2025

Phase I/II

C5731006 - A PHASE 1B/2, OPEN-LABEL, MULTICOHORT STUDY OF DISITAMAB VEDOTIN IN ADULTS WITH HER2 EXPRESSING ADVANCED BREAST CANCER

2025-521003-52-00HER2 Expressing Advanced Breast Cancer

Pfizer Inc.

Neoplasms

Germany, Spain, Italy

18/11/2025

Phase II

Phase 2, Randomized, Double-Blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Tarperprumig in Adult Participants with Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

2025-521706-17-00Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasc…

Alexion Pharmaceuticals Inc.

Hemic and Lymphatic Diseases

Spain, France, Italy, Germany, Poland

17/11/2025

Phase II

A randomized, placebo-controlled, participant- and investigator-blinded study to evaluate the efficacy in reducing atrial fibrillation burden (AFB) as well as the safety, tolerability, and pharmacokinetics of oral PKN605 in participants with atrial fibrillation

2025-520518-79-00Atrial Fibrillation

Novartis Pharma AG

Cardiovascular Diseases

Netherlands, Germany

17/11/2025

Phase III

C5851005 - PADLINK-005: A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY TO EVALUATE PF-08046054/SGN-PDL1V VERSUS DOCETAXEL IN ADULT PARTICIPANTS WITH PREVIOUSLY-TREATED PROGRAMMED CELL DEATH LIGAND 1 (PD-L1) POSITIVE NON-SMALL-CELL LUNG CANCER (NSCLC)

2025-521281-97-00Non-Small Cell Lung Cancer (NSCLC)

Pfizer Inc.

Neoplasms

Greece, Italy, Belgium, Slovakia, Czechia, Germany, France, Poland, Denmark, Spain, Netherlands, Sweden, Finland, Bulgaria

17/11/2025

Phase III

NoLEEta - No chemotherapy in intermediate-risk HR+ HER2- early breast cancer treated with Ribociclib (LEE-011) in the adjuvant setting, a noninferiority Phase III trial

2025-520979-13-00Patients with HR+ HER2- early breast cancer at intermediate…

Unicancer

Neoplasms

Germany, Spain, Netherlands, France, Italy

17/11/2025

Phase I

Pharmacokinetics, pharmacodynamics, safety, and tolerability of an acetonic milk thistle extract, standardized to silymarin, in subjects with MASLD

2025-522423-95-00chronic liver disease

Bionorica SE

Nutritional and Metabolic Diseases

Germany

17/11/2025

Phase III

A Phase III, Randomized, Open-Label, Multicenter, Global Study of Puxitatug Samrotecan (AZD8205) Monotherapy versus Physician’s Choice of Chemotherapy in Participants with B7-H4-Selected Advanced/Metastatic Endometrial Cancer Who Progressed On or After Platinum-Based Chemotherapy and Anti-PD-1/Anti-PD-L1 Therapy (Bluestar-Endometrial01)

2024-518777-34-00B7-H4-Selected Advanced/Metastatic Endometrial Cancer.

DrugsDoxorubicin·Paclitaxel

AstraZeneca AB

Neoplasms

Italy, Netherlands, Lithuania, Finland, Greece, Austria, Belgium, Hungary, Spain, Poland, Czechia, Germany, France, Denmark, Slovenia

17/11/2025

Phase III

Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL.

2025-522052-13-00Framework for Optimizing, Refining, and Unifying Management…

DrugsTreosulfan·Thiotepa·Busulfan·Blinatumomab

Ospedale Pediatrico Bambino Gesu

Hemic and Lymphatic Diseases

Germany, Denmark, Finland, Norway, Austria, Italy, Poland, France, Czechia, Belgium, Croatia, Hungary, Lithuania, Sweden, Netherlands, Slovakia, Spain

17/11/2025

Phase II

A Phase II Randomized Clinical Trial Comparing Two Cycles Versus Four Cycles of Combination Therapy with Cetuximab, Avelumab, Cisplatin, and Docetaxel in Patients with Recurrent Metastatic Head and Neck Cancer - AVETUX-HN

2025-521738-27-00Recurrent Metastatic Head and Neck Cancer

Charite Universitaetsmedizin Berlin KöR

Otorhinolaryngologic Diseases

Germany

17/11/2025

Phase I/II

A phase I/II study of CAR-T cells in AutoiMmune disease resistant to B cell Abrogation - CARAMBA

2025-521530-28-00Progressive systemic autoimmune disease resistant to B cell…

Universitaetsklinikum Erlangen AöR

Immune System Diseases

Germany

17/11/2025

Phase II

A single-centre, open-label, randomised, phase II study on the maintenance of ovulation inhibition after intentional application errors during 84 days of treatment with MR-130A-01 contraceptive transdermal patch

2025-522565-30-00Investigation of maintenance of ovulation inhibition after …

Mylan Pharmaceuticals Inc.

Reproductive and Urinary Physiological Phenomena

Germany

17/11/2025

Phase I

Investigating the pharmacokinetics of petrelintide using different drug product concentrations in participants with a BMI ≥27.0 kg/m2

2025-520598-38-00Weight reduction

Zealand Pharma A/S

Nutritional and Metabolic Diseases

Germany

17/11/2025

Phase I

Open label study to investigate patch adhesion of an Esflurbiprofen-containing patch in healthy volunteers

2025-523577-42-00Patch adhesion trial with healthy subjects, therapeutical i…

Teikoku Seiyaku Co. Ltd.

Musculoskeletal Diseases

Germany

13/11/2025

Phase I

A single dose, randomized, double-blind 2-arm parallel-group study to compare the pharmacokinetics, immunogenicity, and safety for PB016 versus US-licensed Entyvio® after subcutaneous administration in healthy participants

2025-522534-31-00Not applicable, healthy volunteers

Polpharma Biologics S.A.

Not possible to specify

Germany

13/11/2025

Phase II

An Extension Study to Evaluate the Long-Term Safety and Efficacy of Afimkibart (RO7790121) in Patients with Atopic Dermatitis who Participated in Previous Afimkibart Clinical Trials

2025-520771-59-00Atopic Dermatitis

F. Hoffmann-La Roche AG

Skin and Connective Tissue Diseases

Italy, Poland, Germany, Spain, France

13/11/2025

Phase III

A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients with BRCAm Localised High-risk Prostate Cancer Receiving Radiotherapy with Androgen Deprivation Therapy (EvoPAR-Prostate02)

2024-513586-39-00Prostate Cancer

AstraZeneca AB

Male Urogenital Diseases

Austria, Sweden, Spain, France, Netherlands, Germany, Belgium, Finland, Hungary, Poland, Italy

12/11/2025

Phase I

A first study in humans testing the safety and effects of KUP-101A in patients with certain advanced solid cancers

2025-522402-21-00Advanced solid tumors (cutaneous melanoma, mucosal melanoma…

Kupando GmbH

Neoplasms

Germany

12/11/2025

Phase I

A study to learn how safe nurandociguat is when taken with sildenafil in men with arterial hypertension.

2025-522336-14-00Arterial hypertension, Chronic Kidney Disease

Bayer AG

Cardiovascular Diseases

Germany

12/11/2025

Phase II

A Phase 2, Open-Label, Multicenter, Tumor-agnostic Study of MK-1084 as Monotherapy and in Combination with Cetuximab, in Participants with KRAS G12C-Mutant, Advanced Solid Tumors (KANDLELIT-014)

2025-521737-91-00Neoplasm malignant with KRAS G12C mutation

Merck Sharp & Dohme LLC

Neoplasms

Norway, Spain, Sweden, Italy, Denmark, France, Poland, Germany, Greece

12/11/2025

Phase II

A 26-Week (with 26 Week Extension) Randomized, Multi-Center, Double-Blind Phase 2 Study to Evaluate the Efficacy and Safety of XC001 Gene Therapy as an Adjunct to Coronary Artery Bypass Graft Surgery for Patients with Symptomatic Coronary Artery Disease with Left Ventricular Dysfunction at Risk for Incomplete Revascularization

2025-521325-33-00Chronic angina and left ventricular dysfunction due to coro…

Xylocor Therapeutics Inc.

Cardiovascular Diseases

Netherlands, Germany, Hungary, Poland

11/11/2025

Phase I

A first-in-human study to learn about how safe BAY 3620122 is, how much of it gets absorbed in the blood, and how it affects the body of healthy participants

2025-523301-15-00Vasodilatory shock

Bayer AG

Cardiovascular Diseases

Germany

11/11/2025

Phase III

A Phase 3 Open-label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment with a CDK4/6 Inhibitor

2025-523083-21-00PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Gr…

Relay Therapeutics Inc.

Neoplasms

Hungary, Spain, Italy, Belgium, Netherlands, Austria, Germany, Greece, Czechia, Denmark, Poland, Bulgaria, Portugal, France, Ireland, Romania

11/11/2025

Phase II

Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis

2025-521242-26-00Moderately to Severely Active Ulcerative Colitis

DrugsSPYPBO-101·SPY001·SPY002·SPY003

Spyre Therapeutics Inc.

Digestive System Diseases

Belgium, Hungary, Lithuania, Netherlands, Croatia, Czechia, Bulgaria, Romania, Spain, France, Austria, Italy, Greece, Poland, Germany, Slovakia

10/11/2025

Phase III

A Phase 3, Randomized, Open-label Study of Belzutifan + Zanzalintinib Versus Cabozantinib in Participants with Advanced RCC who Experienced Disease Recurrence During or After Prior Adjuvant Anti-PD-1/L1 Therapy (LITESPARK-033)

2024-517136-21-00Renal Cell Carcinoma

Merck Sharp & Dohme LLC

Neoplasms

Greece, Germany, France, Italy, Croatia, Denmark, Czechia, Austria, Belgium, Ireland, Spain, Poland

10/11/2025

Phase II

A Phase 2 Randomized, Double-blind Placebo-Controlled Study to Evaluate the Pharmacokinetics, Immunogenicity, Safety and Efficacy of WIN378 in Adult Participants with Moderate or Severe Asthma (the POLARIS trial)

2025-521391-58-00Asthma

Windward Bio AG

Respiratory Tract Diseases

Germany, France, Sweden, Bulgaria, Spain

10/11/2025

Phase III

A randomised, double-blind, placebo-controlled trial with an open-label extension to assess the pharmacokinetics, safety, and efficacy of empagliflozin tablets in paediatric patients with chronic kidney disease (EMPA-KIDNEY Kids)

2024-512577-27-00Chronic kidney disease in paediatric patients

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Nutritional and Metabolic Diseases

Spain, Germany, Portugal, Netherlands, Belgium, Poland, Italy, France, Sweden, Hungary

06/11/2025

Phase II

A 6-Week, Multicenter, Open-Label, Monotherapy, Extension Study of SPT-300 in Adults with Major Depressive Disorder, With or Without Anxious Distress

2025-522347-18-00Major Depressive Disorder (MDD), with or without Anxious Di…

Seaport Therapeutics Inc.

Mental Disorders

Bulgaria, Czechia, Germany, Poland, Hungary, Slovakia, Romania

06/11/2025

Phase III

STOP-PKD: SGLT2-inhibition to improve Prognosis in Polycystic Kidney Disease

2025-521276-59-00Autosomal dominant polycystic kidney disease (ADPKD)

University Of Cologne

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Netherlands, Austria, Spain, Germany

06/11/2025

Phase III

An Open-Label Study of Mibavademab (REGN4461), a Leptin Receptor Agonist, for the Treatment of Monogenic Obesity Due to Biallelic Loss of Function Variants of the LEP Gene

2024-518674-14-00Monogenic obesity

Regeneron Pharmaceuticals Inc.

Hormonal diseases

Germany, Spain

06/11/2025

Phase I

A study in healthy people to test whether BI 764198 influences the amount of metformin in the body

2025-522432-14-00Healthy volunteer trial

Boehringer Ingelheim International GmbH

Not possible to specify

Germany

05/11/2025

Phase II

Endocardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment: A 26-Week (with 26 Week Extension) Phase 2b Randomized, Multi-Center, Double-Blind, Sham Controlled Study to Evaluate Efficacy and Safety (EXACT-2 Trial)

2024-514874-36-01Refractory angina due to obstructive coronary artery disease

Xylocor Therapeutics Inc.

Cardiovascular Diseases

Belgium, Poland, Hungary, Netherlands, Germany

04/11/2025

Phase III

A Phase 3, Open-label, Multicenter Continuation Trial to Evaluate the Long-term Safety and Efficacy of Mezagitamab Subcutaneous Injection in Adults with Chronic Primary Immune Thrombocytopenia

2025-521692-31-00Chronic Primary Immune Thrombocytopenia

Takeda Development Center Americas Inc.

Hemic and Lymphatic Diseases

Bulgaria, Spain, Netherlands, Italy, Poland, Greece, Germany, France, Czechia, Croatia, Norway, Sweden

04/11/2025

Phase III

Dehydroepiandrosterone (DHEA) as augmentation of standard antidepressants in treatment-resistant depression: a randomized controlled trial (DARE-Trial) - A multicenter, randomized, double-blind, placebo-controlled trial with group sequential design

2024-517963-21-00Treatment Resistant Depression (TRD)

Charite Universitaetsmedizin Berlin KöR

Mental Disorders

Germany

04/11/2025

Phase III

EORTC-2427-BTG: Vorasidenib as maintenance treatment after first-line chemoradiotherapy in IDH-mutant grade 2 or 3 astrocytoma: a placebo-controlled, triple-blind, randomized phase III study (VIGOR)

2024-519404-27-00IDH-mutant grade 2 or 3 astrocytoma

Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi

Neoplasms

Germany, France, Italy, Austria, Netherlands, Spain, Czechia, Belgium

04/11/2025

Phase III

ENGIC 06 (PRODIGE 114) – FFCD 2401 – FRUQUITAS Randomized phase III trial to compare trifluridine/tipiracil + Fruquintinib versus trifluridine/tipiracil alone for metastatic oeso-gastric adenocarcinoma.

2025-522395-92-00metastatic oeso-gastric adenocarcinoma

Fondation Franc.Cancerologie Digestive

Neoplasms

France, Germany, Spain

04/11/2025

Phase III

A Phase III, Multicenter, Randomized, Double blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Participants with Early Symptomatic Alzheimer’s Disease (MCI to Mild Dementia due to AD)

2024-518008-33-00Early Symptomatic Alzheimer’s Disease (MCI to Mild Dementia…

F. Hoffmann-La Roche AG

Nervous System Diseases

Poland, France, Germany, Netherlands, Spain, Italy, Denmark

04/11/2025

Phase III

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Participants with Early Symptomatic Alzheimer’s Disease (MCI to Mild Dementia Due to AD)

2024-518006-40-00Early Symptomatic Alzheimer’s Disease (MCI to Mild Dementia…

DrugsFlorbetaben·Trontinemab

F. Hoffmann-La Roche AG

Nervous System Diseases

Spain, Poland, Italy, Denmark, France, Germany

04/11/2025

Phase III

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous AOC 1020 for the Treatment of Facioscapulohumeral Muscular Dystrophy (FSHD)

2025-521012-18-00Facioscapulohumeral Muscular Dystrophy (FSHD)

Avidity Biosciences Inc.

Musculoskeletal Diseases

Italy, France, Germany, Spain, Denmark, Netherlands

04/11/2025

Phase II

A Seamless Phase 2a/2b, Randomized, Double-Blind, Placebo- and Active-Controlled, Multiple-Arm, Multiple-Stage, Adaptive Study Evaluating the Efficacy and Safety of LAD191 in Adults With Moderate-to-Severe Hidradenitis Suppurativa

2025-521293-34-00Moderate-to-severe hidradenitis suppurativa

Almirall S.A.

Skin and Connective Tissue Diseases

Germany, Italy, Ireland, Poland, Spain, France

03/11/2025

Phase III

A Phase 3, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Investigator’s Choice of Intravesical Chemotherapy in Participants with High-risk Non-muscle-invasive Bladder Cancer with Susceptible FGFR Alterations Who Had Received Intravesical Bacillus Calmette-Guérin (BCG)

2024-519493-39-00High-risk Non-muscle-invasive Bladder Cancer with Susceptib…

Janssen Cilag International

Neoplasms

France, Germany, Spain, Netherlands, Italy, Belgium, Greece

03/11/2025

Phase III

A Phase 3, Open-Label, Long-Term Extension Study to Evaluate the Safety and Efficacy of Vosoritide in Children with Hypochondroplasia

2024-517238-16-00Hypochondroplasia

Biomarin Pharmaceutical Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

France, Spain, Italy, Germany

03/11/2025

Phase III

A Phase 3, Double-Blind, Randomized, Two-Period, Multicenter, Placebo-Controlled, Efficacy and Safety Study of JNT-517 for the Treatment of Participants with Phenylketonuria

2024-519554-37-00Phenylketonuria

Otsuka Pharmaceutical Development & Commercialization Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Czechia, Italy, Spain, Netherlands, Poland, France, Germany

03/11/2025

Phase II

Double-blind, Placebo-Controlled, Randomized Exploratory Trial: Topical VDA-1102 Ointment in Rapidly Proliferating Actinic Keratosis

2025-522482-30-00Actinic keratosis

Vidac Pharma Ltd.

Skin and Connective Tissue Diseases

Germany

03/11/2025

Phase III

A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer

2025-520555-89-00Metastatic castration-resistant prostate cancer (mCRPC)

Amgen Inc.

Neoplasms

Austria, Netherlands, Portugal, Spain, Belgium, Greece, France, Italy, Germany

03/11/2025

Phase II

A Phase IIb Randomized, Double-blind, Placebo-controlled, Parallel, Multidose Study to Evaluate the Efficacy, Safety, and PK of AZD0292 in Participants 12 years of Age and Older With Bronchiectasis and Chronic Pseudomonas aeruginosa Colonization

2025-523009-14-00Bronchiectasis with chronic pseudomonas aeruginosa coloniza…

AstraZeneca AB

Respiratory Tract Diseases

Netherlands, Italy, Greece, Denmark, Belgium, Spain, France, Germany

31/10/2025

Phase II

A Phase 2, Parallel-arm, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of BFB759 in Patients with Atopic Dermatitis (COMPASS 2-AD)

2025-521624-30-00Atopic dermatitis

Bluefin Biomedicine Inc.

Immune System Diseases

Poland, Bulgaria, Germany, Czechia, Spain

31/10/2025

Phase I/II

A Phase 1b/2a Open-Label Dose-Finding Followed by Randomized, Double-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of TGD001 in Patients with Acute Ischemic Stroke

2025-522455-26-00Acute Ischemic Stroke

TargED Biopharmaceuticals B.V.

Nervous System Diseases

Poland, Germany, Spain

31/10/2025

Phase II

A single-arm phase II-study to confirm efficacy and feasibility of tarlatamab treatment in patients with extensive stage small-cell lung cancer with poor performance status (SPACE-T) [without IMPD-Q]

2025-522437-65-00small-cell lung cancer

AIO-Studien gGmbH

Neoplasms

Germany

31/10/2025

Phase II

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Radiographic Axial Spondyloarthritis (Ankylosing Spondylitis)

2025-521059-21-00Radiographic axial spondyloarthritis (as known as ankylosin…

Merck Sharp & Dohme LLC

Musculoskeletal Diseases

Netherlands, Germany, Poland

30/10/2025

Phase II

DEPECA-1 – DEfeating PEnile CAncer 1 – A Phase II study to evaluate a first-line systemic therapy with enfortumab vedotin plus avelumab for advanced and metastatic penile carcinoma

2025-521644-37-00locally advanced or metastatic penile squamous cell carcino…

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Neoplasms

Germany

29/10/2025

Phase II

The CAROLYN Trial: Lisocabtagene Maraleucel as First-Line Therapy for Primary Central Nervous System Lymphoma (PCNSL) in Transplant-Ineligible Patients

2025-521144-38-00Primary Central Nervous System Lymphoma

Bristol-Myers Squibb Services Unlimited Company

Nervous System Diseases

France, Germany

29/10/2025

Phase II

An open-label phase II trial to evaluate the clinical efficacy, safety and tolerability of MAS825 in pediatric and adult participants with Still’s disease

2024-520208-25-00Still’s disease

Novartis Pharma AG

Immune System Diseases

Italy, Netherlands, Spain, France, Germany

28/10/2025

Phase I

AMG 410 Alone and in Combination with other agents in Participants with KRAS Altered Advanced or Metastatic Solid Tumors

2025-521707-48-00KRAS Altered Advanced or Metastatic Solid Tumors

Amgen Inc.

Neoplasms

France, Netherlands, Germany, Denmark, Spain, Italy, Belgium

28/10/2025

Phase II

A Phase 2b, Multi-center, Randomized, Double-blind, Placebo controlled Study of IMVT-1402 Treatment in Adult Participants with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

2024-517614-14-00Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Immunovant Sciences GmbH

Immune System Diseases

Austria, Hungary, Slovenia, Greece, Denmark, Ireland, Finland, Estonia, Spain, Slovakia, Netherlands, Poland, Norway, Italy, Portugal, Belgium, Germany, Romania, Bulgaria

28/10/2025

Phase II

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Rheumatoid Arthritis

2025-521745-25-00Rheumatoid Arthritis

Merck Sharp & Dohme LLC

Immune System Diseases

Poland, Spain, Germany

27/10/2025

Phase III

A Phase III, randomized, multi-site, open-label trial of BNT323/DB-1303 versus investigator’s choice of chemotherapy in previously treated patients with HER2- expressing recurrent endometrial cancer

2023-507525-42-00Endometrial cancer

BioNTech SE

Female Urogenital Diseases and Pregnancy Complications

Denmark, Poland, Italy, Finland, Czechia, Sweden, Greece, Belgium, Norway, Hungary, Germany, Austria, France, Spain, Netherlands

27/10/2025

Phase III

A Phase 3, Multi-Site, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of eRapa to Improve Clinical Outcomes in Participants with Familial Adenomatous Polyposis

2025-522946-37-00Familial adenomatous polyposis (FAP)

Biodexa Limited, Rapamycin Holdings Inc.

Virus Diseases

Denmark, Spain, Germany, Netherlands, Italy

27/10/2025

Phase I/II

A single-arm, multicenter, open-label, Phase I/II trial of Allo-QuadCAR01-T, an allogeneic CAR-T-cell therapy targeting CD19 and CD20, for the treatment of relapsed or refractory B-cell malignancies

2025-521735-36-00Relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL)…

Avencell Therapeutics Inc.

Neoplasms

Germany

27/10/2025

Phase I

A research study of a new medicine, NNC9733-0001, in healthy participants and participants with type 2 diabetes

2024-519382-22-00Healthy Participants and Participants with type 2 diabetes

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Germany

24/10/2025

Phase III

A Randomized Phase 2/3 Study of Navlimetostat (BMS-986504) in Combination with Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants with Homozygous MTAP Deletion.

2025-521511-40-00metastatic non-small cell lung cancer

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Greece, Czechia, France, Sweden, Romania, Belgium, Austria, Bulgaria, Italy, Netherlands, Denmark, Germany, Poland, Hungary, Spain

24/10/2025

Phase III

A randomized, Phase 3, double-blind, 52-week study to evaluate the efficacy and safety of rilzabrutinib (SAR444671) compared to placebo in adult participants with active IgG4-related disease

2025-521398-15-00Immune system diseases

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

Netherlands, Spain, France, Belgium, Sweden, Germany, Poland, Italy

24/10/2025

Phase II

Efficacy and Safety Study of Acasunlimab as Monotherapy and in Combination With Pembrolizumab in Subjects With Relapsed/Refractory, Unresectable Locally Advanced or Metastatic Cutaneous Melanoma That Progressed On or After Treatment With a Checkpoint Inhibitor

2025-520468-16-00Cutaneous Melanoma, Relapsed/Refractory, Locally Advanced U…

Genmab A/S

Neoplasms

France, Spain, Netherlands, Germany

23/10/2025

Phase II

Local tenecteplase applicatiOn subsequent to endovasCular recanalization in Anterior circuLation stroke - the LOCAL trial

2024-516544-26-00acute ischemic stroke

Universitaetsklinikum Heidelberg AöR

Cardiovascular Diseases

Germany

23/10/2025

Phase II

An open-label randomised, phase II trial of Datopotamab deruxtecan plus Durvalumab versus Datopotamab deruxtecan in patients with PDL1-negative metastatic triple-negative breast cancer

2024-519913-76-00PDL1-negative metastatic triple-negative breast cancer

Queen Mary University Of London

Neoplasms

Spain, Germany

23/10/2025

Phase II

A Multi-Center, Single Arm, Open-Label Extension Study to Evaluate the Long-term Safety and Efficacy of GSK4527226 [AL101] in Participants with Early Alzheimer’s Disease.

2025-521107-42-00Alzheimer's Disease

Glaxosmithkline Research & Development Limited

Nervous System Diseases

Sweden, Norway, Italy, France, Spain, Finland, Netherlands, Germany

23/10/2025

Phase III

A Phase 3, Open-Label, Multicenter, Extension Study of Acoramidis in Patients with Newly Diagnosed Variant Transthyretin Amyloid Cardiomyopathy (ACT-EARLY OLE)

2024-513676-18-00Transthyretin Amyloidosis

DrugAcoramidis

Eidos Therapeutics Inc.

Cardiovascular Diseases

Germany, Portugal, Netherlands, France, Spain, Italy, Ireland, Belgium, Sweden, Denmark, Greece

22/10/2025

Phase II

A Phase 2, Open-label, Multi-cohort Study to Assess the Efficacy and Safety of ASP5541 in Participants with Advanced Prostate Cancer

2024-517653-27-00Prostate Cancer

Astellas Pharma Global Development Inc.

Neoplasms

Italy, Poland, Spain, France, Germany

22/10/2025

Phase III

STOP-HAE: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema

2025-521352-38-00Hereditary Angioedema

Adarx Pharmaceuticals Inc.

Immune System Diseases

Belgium, Poland, Italy, Czechia, Hungary, Spain, Germany, Croatia, France, Bulgaria, Austria

22/10/2025

Phase III

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Mezagitamab Subcutaneous Injection in Participants with Chronic Primary Immune Thrombocytopenia

2024-514401-54-00Chronic Primary Immune Thrombocytopenia

Takeda Development Center Americas Inc.

Hemic and Lymphatic Diseases

Poland, Spain, Bulgaria, Italy, Netherlands, Croatia, Germany, Sweden, Greece, Czechia, Norway, France

22/10/2025

Phase II

A Phase IIb Randomized, Double-blind, Placebo-controlled, Multi-Dose Study to Evaluate the Effects of PHENOGENE-1a (Cromolyn) as an Adjuvant Treatment in Subjects with Mild to Moderate Amyotrophic Lateral Sclerosis (ALS)

2025-520688-42-00Amyotrophic Lateral Sclerosis (ALS)

Phenonet Inc.

Nervous System Diseases

Germany, Czechia, Poland, Spain

21/10/2025

Phase III

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for the Treatment of Cognitive Impairment Associated with Mild to Moderate Alzheimer’s Disease (MINDSET 1)

2025-520746-30-00Mild to moderate Alzheimer’s Disease

Bristol-Myers Squibb Services Unlimited Company

Mental Disorders

Germany, Croatia, Italy, Poland, Romania, Czechia, Greece, Spain, France, Netherlands

21/10/2025

Phase I/II

A Phase 1b/2a, Multicenter, Open-label Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination with Elranatamab in Participants with Relapsed and/or Refractory Multiple Myeloma

2025-522090-11-00Relapsed or Refractory Multiple Myeloma (RRMM)

Celgene Corp.

Neoplasms

Norway, Greece, Germany, Spain

21/10/2025

Phase III

2025-520747-32-00Mild to moderate Alzheimer’s Disease

Bristol-Myers Squibb Services Unlimited Company

Mental Disorders

Germany, Netherlands, Portugal, France, Spain, Poland, Greece, Romania, Italy, Finland

21/10/2025

Phase III

A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF DIVARASIB AND PEMBROLIZUMAB VERSUS PEMBROLIZUMAB AND PEMETREXED AND CARBOPLATIN OR CISPLATIN IN PATIENTS WITH PREVIOUSLY UNTREATED, KRAS G12C-MUTATED, ADVANCED OR METASTATIC NON-SQUAMOUS NON-SMALL CELL LUNG CANCER

2024-518365-10-00Previously Untreated Advanced or Metastatic Non-Squamous No…

F. Hoffmann-La Roche AG

Neoplasms

Ireland, Greece, Hungary, Netherlands, France, Denmark, Germany, Poland, Italy, Portugal, Spain, Belgium

21/10/2025

Phase II

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Vosoritide in Infants and Young Children with Hypochondroplasia, Aged 0 to < 36 Months

2024-512261-14-00Hypochondroplasia

Biomarin Pharmaceutical Inc.

Genetic Phenomena

Germany, Italy, France

20/10/2025

Phase III

C4551002 - An Interventional, Open-Label, Randomized, Multicenter, Phase 3 Study of PF-07248144 Plus Fulvestrant Compared to Investigator’s Choice of Therapy in Adult Participants with Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4/6 Inhibitor-based Therapy

2025-520566-22-00Hormone Receptor-Positive, HER2-Negative Advanced/Metastati…

Pfizer Inc.

Neoplasms

Hungary, Bulgaria, Czechia, Slovakia, Netherlands, Spain, Greece, Finland, Belgium, Sweden, Poland, Germany, France, Italy

20/10/2025

Phase II

A Phase 2, Multi-Center, Platform Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics with Multiple Therapies in Participants with Active Crohn’s Disease or Active Ulcerative Colitis (ASCEND-IBD)

2025-522001-38-00Crohn’s Disease, Ulcerative Colitis

DrugMT-201

Mirador Therapeutics Inc.

Digestive System Diseases

Poland, Bulgaria, Croatia, Germany, Belgium, Slovakia, Czechia, Italy

20/10/2025

Phase III

A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of IMVT-1402 in Patients With Mild to Severe Generalized Myasthenia Gravis

2024-515979-35-00Generalized Myasthenia Gravis

Immunovant Sciences GmbH

Nervous System Diseases

Czechia, Greece, Spain, Italy, Denmark, Germany, Romania, Poland, Hungary

20/10/2025

Phase III

The IMAGINE study: A phase 3b open label, single arm study to assess the effect of depemokimab on airway structure and function in asthma with Type 2 inflammation characterized by an eosinophilic phenotype utilizing quantitative high-resolution CT and bronchoscopic airway sampling in a sub study

2024-519976-19-00Asthma with type 2 inflammation characterized by an eosinop…

Glaxosmithkline Research & Development Limited

Respiratory Tract Diseases

Belgium, Spain, Italy, Greece, France, Germany

20/10/2025

Phase II

EPIK-P4: A Phase II single arm study to assess the efficacy, safety and pharmacokinetics of alpelisib (BYL719) in pediatric and adult patients with PIK3CA-related overgrowth spectrum (PROS)

2024-519960-42-00PIK3CA-Related Overgrowth Spectrum (PROS)

Novartis Pharma AG

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Italy, Netherlands, Belgium, Spain, Austria, Germany, France

20/10/2025

Phase III

IZABRIGHT-Breast01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) versus Treatment of Physician’s Choice in Patients with Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer (TNBC) or ER-low, HER2-negative BC who are Ineligible for Anti-PD1/PD-L1 Treatment

2024-519871-24-00Breast cancer, Triple-negative breast cancer

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

France, Portugal, Romania, Greece, Italy, Spain, Sweden, Austria, Poland, Germany

17/10/2025

Phase I/II

A Phase I/II, open-label, adaptive two-part trial to evaluate the safety, efficacy, optimal dose and pharmacokinetics of BNT326 as monotherapy and in combination with cancer immunotherapies in participants with advanced solid tumors

2024-517261-16-00Advanced solid tumors

BioNTech SE

Neoplasms

Belgium, Germany, Spain, Italy

17/10/2025

Phase II

A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease

2025-521920-31-00Graves’ Disease

Immunovant Sciences GmbH

Immune System Diseases

Italy, Poland, Greece, Germany, Netherlands, Czechia, Spain, Latvia, Bulgaria

17/10/2025

Phase II

A Phase 2, Randomized, Open-Label Study Of Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)

2025-521849-25-00Chronic Graft-Versus-Host Disease

Incyte Corp.

Immune System Diseases

Spain, Belgium, Germany, Italy

17/10/2025

Phase I/II

A Phase 1/2, Open-Label, Dose Finding Study to Investigate the Safety, Tolerability, and Efficacy of ALXN2350 Gene Therapy in Adult Participants with Symptomatic BAG3 Mutation-Associated Dilated Cardiomyopathy

2024-519674-40-00BAG3 Mutation Associated Dilated Cardiomyopathy

DrugSirolimus

Alexion Pharmaceuticals Inc.

Cardiovascular Diseases

Spain, Italy, Germany

16/10/2025

Phase I

A Trial to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Insulin GZR33 Compared with Insulin Degludec at steady state in participants with Type 1 Diabetes

2025-523052-32-00Type 1 diabetes Mellitus

Gan & Lee Pharmaceuticals USA Corp.

Hormonal diseases

Germany

15/10/2025

Phase III

A Randomized, Open-Label, Phase 2/3 Study of Datopotamab Deruxtecan (Dato-DXd) plus Carboplatin or Cisplatin versus Gemcitabine plus Carboplatin or Cisplatin in Participants with Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) who Progressed During or After Enfortumab Vedotin (EV) plus Pembrolizumab Combination Treatment. TROPION-Urothelial03 (TU03).

2024-516906-47-00Locally Advanced or Metastatic Urothelial Carcinoma

DrugsDato-DXd·Cisplatin·Carboplatin

Daiichi Sankyo Inc.

Neoplasms

Netherlands, Germany, Norway, Denmark, France, Austria, Italy, Spain, Belgium, Czechia, Greece

15/10/2025

Phase III

TRITON-CM: A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nucresiran in Patients with Transthyretin-Mediated Amyloidosis with Cardiomyopathy (ATTR amyloidosis with cardiomyopathy)

2024-519917-72-00Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloid…

Alnylam Pharmaceuticals Inc.

Cardiovascular Diseases

France, Germany, Italy, Greece, Belgium, Portugal, Netherlands, Austria, Sweden, Denmark, Spain, Czechia, Hungary, Ireland, Romania, Norway, Poland, Slovakia

14/10/2025

Phase III

J2O-MC-EKBG: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Muvalaplin on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) Who Have Had a Prior Atherosclerotic Cardiovascular Event or Are at Risk for a First Atherosclerotic Cardiovascular Event - MOVE-Lp(a)

2025-521067-13-00Elevated Lp(a), Atherosclerotic Cardiovascular Disease (ASC…

Eli Lilly & Co.

Cardiovascular Diseases

Italy, Poland, Germany, Austria, Romania, Spain, Czechia, France, Denmark, Greece, Hungary, Slovakia, Belgium, Netherlands

13/10/2025

Phase I

Assessment of the safety and effects on the body of investigational products when used on psoriatic skin

2025-522446-51-00Plaque psoriasis

Bacoba AG

Immune System Diseases

Germany

09/10/2025

Phase II

A double-blind, randomised, placebo-controlled, parallel group, Phase IIa trial to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of BI 765423 administered intravenously with or without standard of care in patients with idiopathic pulmonary fibrosis

2025-520658-12-00Idiopathic Pulmonary Fibrosis (IPF)

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Respiratory Tract Diseases

Germany, Italy, Spain, Belgium

09/10/2025

Phase I

A multi-part, adaptive, Phase 1, first time in human study in healthy participants and participants with atopic dermatitis (AD) to assess the safety, tolerability, pharmacokinetics (PK) of single ascending (SAD), multiple ascending doses (MAD) and selected dose of SYX-5219 (AD Participants)

2025-522216-17-00Atopic Dermatitis

Sitryx Therapeutics Limited

Skin and Connective Tissue Diseases

Germany, Bulgaria, Ireland, Denmark

09/10/2025

Phase III

SGLT2 INHIBITION FOR CARDIOVASCULAR ENDPOINT REDUCTION IN HYPERTENSION

2025-520794-39-00Arterial Hypertension

Universitaetsklinikum Schleswig-Holstein AöR

Cardiovascular Diseases

Germany, Slovenia, Spain, Austria, Portugal, Italy

08/10/2025

Phase III

A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Deucravacitinib in Adolescent Subjects (12 years to less than 18 years) with Moderate to Severe Plaque Psoriasis

2023-506296-97-00Moderate to Severe Plaque Psoriasis

Bristol-Myers Squibb Services Unlimited Company

Immune System Diseases

Germany, Romania, Italy, Belgium, Poland, Hungary, Spain

08/10/2025

Phase III

ETOP 27-23 ARCH – A randomised phase III trial of adjuvant cemiplimab in patients with resected stage IIA-IIIB NSCLC who have not received prior adjuvant chemotherapy.

2024-519901-36-00Patients with resected stage IIA-IIIB non-small cell lung c…

ETOP IBCSG Partners Foundation

Neoplasms

France, Estonia, Spain, Austria, Italy, Germany, Ireland

08/10/2025

Phase III

Efficacy and safety of cagrilintide for weight management in participants with overweight or obesity

2024-519530-24-00Overweight and obesity

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Norway, France, Italy, Germany, Poland

07/10/2025

Phase I

Dose Escalation Study with Bispecific Antibodies in Adult Patients with Lupus Nephritis

2024-518288-37-00Lupus Nephritis

Regeneron Pharmaceuticals Inc.

Immune System Diseases

Spain, France, Germany

07/10/2025

Phase III

A multi-center, open-label, single-arm study to evaluate the efficacy and safety of oral rilzabrutinib in adults with immune thrombocytopenia (ITP) who failed first-line treatment

2025-522070-36-00immune thrombocytopenia (ITP)

DrugRilzabrutinib

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

France, Spain, Italy, Germany, Czechia, Poland, Hungary, Austria, Norway

07/10/2025

Phase II

A Phase 2, Multicenter, Open-Label Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants with Active SLE (Including Lupus Nephritis) with Inadequate Response to Glucocorticoids and at Least 2 Immunosuppressants (Breakfree-SLE)

2024-519278-37-00Lupus Nephritis, Systemic Lupus Erythematosus

Celgene Corp.

Immune System Diseases

France, Spain, Portugal, Germany, Belgium, Poland, Italy, Denmark, Austria

06/10/2025

Phase III

Open Label Extension Clinical Trial of Vormatrigine in Adult Patients with Epilepsy.

2025-521640-38-00Focal onset seizures or primary generalized tonic-clonic se…

Praxis Precision Medicines Inc.

Nervous System Diseases

Germany, Spain, Poland, Italy

06/10/2025

Phase III

A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Phase 3 Study of Zipalertinib Plus Adjuvant Chemotherapy Versus Placebo Plus Adjuvant Chemotherapy in Stage IB-IIIA NSCLC Patients with Uncommon EGFR Mutations Following Complete Tumor Resection (REZILIENT4)

2025-521775-31-00Stage IB-IIIA NSCLC Patients with uncommon EGFR Mutations

DrugsZipalertinib·Cisplatin·Carboplatin

Taiho Oncology Inc.

Neoplasms

Germany, Poland, Spain, France, Belgium, Italy, Greece, Romania, Netherlands

06/10/2025

Phase III

A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (FORTIFI-HN01).

2024-519654-37-00Recurrent or Metastatic Head and Neck Squamous Cell Carcino…

Bicara Therapeutics Inc.

Neoplasms

Belgium, Austria, Italy, Poland, Spain, Germany, Czechia, Ireland, Greece, France, Portugal

06/10/2025

Phase II

A Phase 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab plus Nivolumab with or without Docetaxel versus Docetaxel Monotherapy in Second-Line Treatment of Participants with Metastatic Non-Squamous Non-Small Cell Lung Cancer (GDFATHER-NSCLC-02)

2024-516794-70-00Metastatic non-squamous non-small cell lung cancer

CatalYm GmbH

Neoplasms

Spain, Italy, Germany, Poland, Romania

06/10/2025

Phase II

A Phase 2a double blind, randomized, parallel arm, placebo-controlled trial to investigate the effects of two dose levels of CIT-013 on disease activity in patients with Hidradenitis Suppurativa (HS)

2025-521684-12-00Hidradenitis Suppurativa

Citryll B.V.

Skin and Connective Tissue Diseases

Netherlands, Germany, Poland, Spain

06/10/2025

Phase III

A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination with Pembrolizumab Versus Platinum-based Chemotherapy in Combination with Pembrolizumab, as First-line Therapy in Participants with Locally Advanced Unresectable or Metastatic HER2-overexpressing and PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer. (DESTINY-Lung06)

2024-515658-26-00Unresectable or Metastatic HER2 overexpressing and PD-L1 TP…

DrugsTrastuzumab deruxtecan·Pemetrexed·Cisplatin·Carboplatin

Daiichi Sankyo Inc.

Neoplasms

France, Belgium, Germany, Portugal, Italy, Greece, Romania, Spain, Poland

06/10/2025

Phase III

Multi-centre, double-blind, placebo-controlled, randomised trial to prove the efficacy and safety of Silexan® (WS®1265) in patients with a major depressive episode of mild to moderate severity

2025-521744-37-00Mild to moderate major depressive disorder

Dr. Willmar Schwabe GmbH & Co. KG

Mental Disorders

Germany, Austria

06/10/2025

Phase III

C4951063: An interventional efficacy and safety, Phase 3, double-blind, parallel group study to investigate intermittent prevention of Menstrual Migraine with Rimegepant compared with placebo in women participants 18 to 45 years of age

2024-517121-10-00Menstrual Migraine

Pfizer Inc.

Nervous System Diseases

Netherlands, Italy, Poland, Denmark, Germany, Spain

06/10/2025

Phase III

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impactof Maridebart Cafraglutide on Cardiovascular Outcomes in Participants with Atherosclerotic Cardiovascular Disease and Overweight or Obesity (MARITIME-CV)

2024-516652-18-00Atherosclerotic cardiovascular disease (ASCVD) and obesity …

Amgen Inc.

Cardiovascular Diseases

Slovakia, Denmark, Portugal, Czechia, Poland, Greece, Bulgaria, France, Spain, Sweden, Finland, Belgium, Romania, Germany, Hungary, Netherlands, Italy, Austria

06/10/2025

Phase I

EAST-1 (ERAP-inhibition in Axial Spondyloarthritis Trial-1)

2025-521315-39-00Axial spondyloarthritis

Grey Wolf Therapeutics Limited

Hemic and Lymphatic Diseases

Belgium, Germany, Netherlands, Spain, Poland

06/10/2025

Phase II

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Efficacy of Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Patients with Idiopathic Pulmonary Fibrosis (RENEW)

2025-520715-13-00Idiopathic Pulmonary Fibrosis

Rein Therapeutics Inc.

Cardiovascular Diseases

Germany, Poland, Bulgaria, Romania

06/10/2025

Phase II

A Phase 1b/2 Open-Label, Multicenter Study of Zoldonrasib (RMC-9805) with or without Daraxonrasib (RMC-6236), in Combination with Other Anticancer Agents, in Patients with RAS G12D-Mutated Non-Small Cell Lung Cancer (NSCLC) – Subprotocol C

2025-521147-21-00Lung Cancer

DrugsRMC-9805·Cetuximab·Pemetrexed·Cisplatin

Revolution Medicines Inc.

Respiratory Tract Diseases

Germany, Austria, France, Netherlands, Czechia, Greece, Italy, Spain, Denmark

06/10/2025

Phase I/II

A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor Surzetoclax (ABBV-453) given as Monotherapy or in Combination with Antimyeloma Regimens in Subjects with Multiple Myeloma

2024-517140-65-00Multiple Myeloma (MM).

AbbVie Deutschland GmbH & Co. KG

Neoplasms

Belgium, Portugal, Sweden, Italy, France, Poland, Germany

06/10/2025

Phase IV

A biomarker enrichment trial of anti-EGFR agents in patients with advanced colorectal cancer (aCRC) with wild-type RAS and right primary tumour location (right-PTL) - ARIEL-ENGIC 04 EU trial

2025-521209-42-00advanced colorectal cancer with wild-type RAS and right pri…

DrugsFolinic acid·Fluorouracil·Irinotecan·Cetuximab

Fondazione GONO G.I.

Neoplasms

Italy, Germany, Spain

06/10/2025

Phase II

A Phase IIb, Multicenter, Double-Blind, Placebo-Controlled Induction Study with an Active Treatment Extension to Assess the Efficacy, Safety, and Pharmacokinetics of RO7837195 in Patients with Moderately to Severely Active Ulcerative Colitis

2025-520690-39-00Moderately to Severely Active Ulcerative Colitis (UC)

Genentech Inc.

Digestive System Diseases

France, Italy, Czechia, Poland, Germany

03/10/2025

Phase II

Upfront trastuzumab-deruxtecan plus capecitabine and bevacizumab for patients with HER2 positive metastatic colorectal cancer: the CHIMERA trial

2024-519479-24-00metastatic colorectal cancer

Fondazione GONO G.I.

Neoplasms

Germany, France, Italy, Spain

02/10/2025

Phase III

A Phase 3, Multicenter, Prospective, Randomized, Open-label Efficacy and Safety Study of Intravenous Brincidofovir versus Intravenous Cidofovir for Treatment of Adenovirus Infection in Pediatric and Adult Subjects After Allogeneic Hematopoietic Cell Transplantation (allo HCT)

2025-521903-28-00Adenovirus viremia

Symbio Pharmaceuticals Ltd.

Virus Diseases

Germany, Italy, France, Spain, Portugal, Austria, Sweden, Belgium, Denmark, Netherlands

02/10/2025

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Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 4 November 2026. https://priyalifescience.com/clinical-trials-europe/country/germany?page=2

Query this register directly

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About this register

This register is built from the EU Clinical Trials Information System (CTIS), run by the European Medicines Agency: the single register for every trial authorised under the EU Clinical Trials Regulation (536/2014). CTIS held 12,766 trial records at the last sync on 04 Nov 2026, 03:17 UTC; this register shows the 2,556 most recently authorised of them, a stated recency window rather than the full archive. The list can be downloaded as CSV or JSON.

This page shows the 897 of those trials with a site in Germany.

How many recently authorised EU trials have a site in Germany?

897 of the 2,556 most recently authorised trials in this register list a site in Germany; 421 of them are Phase III. Trials are counted by authorisation on CTIS, not by recruitment status, which CTIS does not publish in the same form as ClinicalTrials.gov.

Listing here is informational and not medical advice; eligibility is determined by each study team. Looking for Irish sites? See the Ireland, UK or USA registers. For approved medicines, see the EMA Approvals Tracker.