Clinical Trials in Greece 2026 - 61 Recent EU Authorisations

Phase III Immune System Diseases Authorised 02/09/2026

A parallel group, Phase 3, randomized, open-label, 2-arm study to demonstrate the superiority of belumosudil versus best available therapy (BAT) in participants at least 12 years of age with chronic graft versus host disease (cGVHD) refractory to or recurrent after 2 to 5 prior lines of systemic therapy

Immune system diseases

Sanofi-Aventis Recherche & Developpement

263 participants planned

Belgium · Czechia · Hungary · Sweden · Lithuania · Croatia · Netherlands · Slovakia · Poland · Norway · France · Italy · Bulgaria · Germany · Slovenia · Estonia · Portugal · Greece · Denmark

2026-525913-30-00 on CTIS ↗

Phase III Neoplasms Authorised 28/08/2026

A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF DIVARASIB COMPARED WITH INVESTIGATOR’S CHOICE OF IMMUNOTHERAPY OR OBSERVATION IN PATIENTS WITH RESECTED STAGE II-III KRAS G12C-POSITIVE NON-SMALL CELL LUNG CANCER

Resected Stage II-III Kirsten rat sarcoma virus oncogene homolog glycine 12 to Cysteine (KRAS G12C) -Positive Non-Small Cell Lung Cancer

F. Hoffmann-La Roche AG

103 participants planned

Greece · Portugal · Belgium · Italy · Germany

2025-524263-21-01 on CTIS ↗

Phase II Respiratory Tract Diseases Authorised 26/08/2026

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE-791 in Subjects with Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis (IPF)

Contineum Therapeutics Inc.

133 participants planned

Italy · Belgium · Denmark · Austria · Greece · Germany · France · Netherlands · Portugal · Poland

2025-521901-42-00 on CTIS ↗

Phase III Immune System Diseases Authorised 25/08/2026

A Phase 3, open-label extension study to evaluate the long-term safety and efficacy of rozanolixizumab in adult participants with ocular myasthenia gravis

Ocular Myasthenia Gravis

UCB Biopharma

46 participants planned

Hungary · France · Greece · Poland · Spain · Italy · Germany

2025-524757-14-00 on CTIS ↗

Phase II Neoplasms Authorised 25/08/2026

Phase 2 Randomized, Double-blind, Placebo-controlled Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma

Relapsed/Refractory Multiple Myeloma

Janssen Cilag International

123 participants planned

Sweden · Spain · Greece · Portugal · France · Hungary

2025-524793-42-00 on CTIS ↗

Phase II Neoplasms Authorised 25/08/2026

Solid tumor Study for Long term Treatment of Cancer Patients Who Have Participated in BMS-Parent Studies Investigating Adagrasib (BMS-986503)

Solid tumor

Bristol-Myers Squibb Services Unlimited Company

116 participants planned

Greece · Hungary · Poland · Belgium · Spain · Netherlands · Germany · France · Portugal · Italy · Romania

2025-524905-34-00 on CTIS ↗

Phase III Neoplasms Authorised 21/08/2026

A Phase 3, Randomized, Multicenter, Open-Label Study of Velzatinib (GSK6042981) versus Imatinib in Participants with Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST)

Neoplasms, Gastrointestinal Stromal

Glaxosmithkline Research & Development Limited

302 participants planned

Italy · Portugal · Germany · Sweden · Poland · Romania · Finland · Greece · Norway · Spain · Netherlands · France · Hungary

2025-524934-24-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 21/08/2026

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Subjects With α- or β-Non–Transfusion-Dependent Thalassemia (ENERGIZEKids)

Non-Transfusion-Dependent Alpha- or Beta-Thalassemia

Agios Pharmaceuticals Inc.

3 participants planned

Italy · Greece

2025-524706-15-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 20/08/2026

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Subjects With α- or β-Transfusion-Dependent Thalassemia (ENERGIZEKids-T)

Transfusion-Dependent Alpha- or Beta-Thalassemia

Agios Pharmaceuticals Inc.

8 participants planned

Italy · Greece

2025-524707-71-00 on CTIS ↗

Phase III Neoplasms Authorised 20/08/2026

A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants with Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma

High Risk Smoldering Multiple Myeloma (HR-SMM)

Regeneron Pharmaceuticals Inc.

108 participants planned

Italy · Spain · Poland · France · Norway · Greece · Germany

2025-523252-31-00 on CTIS ↗

Phase III Mental Disorders Authorised 19/08/2026

JS2-MC-GZMI: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment with Brenipatide in Delaying Time to Relapse Compared with Placebo in Adult Participants with Major Depressive Disorder (RENEW-MDD- 2)

Depressive Disorder, Major

Eli Lilly & Co.

228 participants planned

Poland · Greece · Spain · Germany

2025-522310-24-00 on CTIS ↗

Phase III Immune System Diseases Authorised 18/08/2026

A Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rozanolixizumab in adult participants with ocular myasthenia gravis

Ocular Myasthenia Gravis

UCB Biopharma

46 participants planned

Hungary · Greece · Italy · Spain · Germany · Poland · France

2025-524756-54-00 on CTIS ↗

Phase III Bacterial Infections and Mycoses Authorised 17/08/2026

C4931007 - A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS

Pneumoccoccal Immunisation

Pfizer Inc.

1345 participants planned

Spain · Finland · Poland · Germany · Greece · Hungary · Italy

2025-523447-35-02 on CTIS ↗

Phase II Respiratory Tract Diseases Authorised 14/08/2026

A Phase 2 Randomized Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Three Doses of Frevecitinib (KN-002) in Patients with Severe Asthma not Adequately Controlled with Medium to High Dose ICS/LABA Therapy (PANAIRAMA)

Severe asthma

Kinaset Therapeutics Inc.

350 participants planned

Czechia · Bulgaria · Romania · Hungary · Germany · Poland · Greece

2023-509125-41-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 10/08/2026

Efficacy and safety of once daily oral semaglutide in adults with overweight or obesity

Overweight and obesity

Novo Nordisk A/S

315 participants planned

Netherlands · Belgium · Greece · Poland · Spain · Denmark · France · Bulgaria · Sweden

2025-524626-18-00 on CTIS ↗

Phase III Hormonal diseases Authorised 07/08/2026

A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves’ Disease Inadequately Controlled With Antithyroid Drugs

Graves' Disease (GD)

Argenx

145 participants planned

Italy · Czechia · Spain · Denmark · Belgium · Romania · Latvia · France · Germany · Greece · Sweden · Poland · Lithuania · Bulgaria

2025-523333-26-00 on CTIS ↗

Phase II Respiratory Tract Diseases Authorised 04/08/2026

A Phase IIb Study to Evaluate the Efficacy, Safety, and Tolerability of AZD8965 in Participants with Idiopathic Pulmonary Fibrosis (IPF)) (ARGiNAUT)

Idiopathic Pulmonary Fibrosis

AstraZeneca AB

139 participants planned

Poland · Hungary · Netherlands · Germany · Spain · Greece · Bulgaria · Italy · France · Denmark

2025-525016-41-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 03/08/2026

A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron and Dapagliflozin in Combination, Compared with Elecoglipron Alone and Dapagliflozin Alone, in Adults with Type 2 Diabetes Mellitus (Eluminate-5)

type 2 diabetes mellitus

AstraZeneca AB

360 participants planned

Slovakia · Poland · Czechia · Germany · Hungary · Greece · Denmark

2025-523941-81-00 on CTIS ↗

Phase III Skin and Connective Tissue Diseases Authorised 03/08/2026

A double-blind, randomised, placebo-controlled trial evaluating the efficacy and safety of oral nerandomilast treatment in patients with systemic sclerosis (SSc)

Systemic sclerosis

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

179 participants planned

Denmark · Hungary · Sweden · Netherlands · Germany · Belgium · France · Greece · Norway · Finland · Czechia · Portugal · Bulgaria · Spain · Austria · Romania · Croatia · Poland · Estonia · Italy · Lithuania

2025-523884-39-00 on CTIS ↗

Phase III Immune System Diseases Authorised 03/08/2026

A Phase 3, Randomized, Double-blind, and Active‑controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ‑78934804 in Participants With Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease

Janssen Cilag International

194 participants planned

Norway · Romania · Austria · Italy · Slovakia · Germany · Hungary · Netherlands · Belgium · France · Portugal · Czechia · Poland · Spain · Greece

2026-525922-39-00 on CTIS ↗

Phase III Immune System Diseases Authorised 03/08/2026

A Phase 3 Randomized, Double-blind, and Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants with Moderately to Severely Active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis

Janssen Cilag International

302 participants planned

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

2026-525923-26-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 29/07/2026

A Phase III, Randomized, Double-blind, Parallel-group, Placebo controlled, Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Cardiovascular Outcomes in Participants with HFpEF and HFmrEF (Elevate-HF)

Heart failure with preserved ejection fraction (HFpEF) and heart failure with mildly reduced ejection fraction (HFmrEF); on background SGLT2i.

AstraZeneca AB

2343 participants planned

Spain · Hungary · Germany · Poland · Italy · Bulgaria · Netherlands · Austria · Romania · Sweden · France · Greece · Slovakia · Czechia

2026-526304-79-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 27/07/2026

A clinical study to compare efficacy and safety of two different doses of CagriSema and semaglutide in participants with obesity with or without type 2 diabetes

Participants with obesity with or without type 2 diabetes

Novo Nordisk A/S

1140 participants planned

Greece · Portugal · France · Slovakia · Bulgaria · Netherlands · Romania · Italy · Austria · Poland · Hungary · Spain · Czechia · Belgium

2025-522488-14-00 on CTIS ↗

Phase III Neoplasms Authorised 27/07/2026

A Phase 3 Randomized, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of ABBV-706 versus Standard of Care in Subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC)

Small Cell Lung Cancer

AbbVie Deutschland GmbH & Co. KG

125 participants planned

Italy · Greece · Spain · Belgium · France · Austria · Germany

2025-523819-11-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 24/07/2026

A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Renal Outcomes and Mortality in Participants with Chronic Kidney Disease (Elevate-CKD)

Chronic kidney disease (CKD) in adults, with specified ranges of eGFR and albuminuria (UACR), irrespective of T2DM status; background SGLT2i dapagliflozin 10 mg as GDMT.

AstraZeneca AB

1600 participants planned

Czechia · Italy · Hungary · Romania · Bulgaria · Sweden · Denmark · Poland · Spain · Norway · Finland · Greece · France · Germany

2025-523994-41-00 on CTIS ↗

Phase II Immune System Diseases Authorised 21/07/2026

A Phase 2, open-label, randomized, dose optimization study evaluating the efficacy and safety of belantamab mafodotin administered in combination with cyclophosphamide, bortezomib, and dexamethasone in adult participants with newly diagnosed amyloid light chain amyloidosis (ALANIS)

newly diagnosed amyloid light chain amyloidosis

Glaxosmithkline Research & Development Limited

17 participants planned

Italy · Greece · Spain

2025-522803-60-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 20/07/2026

A placebo-controlled comparability study to compare two presentations of cagrilintide for weight management in participants with overweight or obesity

Participants with overweight or obesity

Novo Nordisk A/S

171 participants planned

Sweden · Greece · Hungary · Portugal

2025-524249-29-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 20/07/2026

A randomized, placebo-controlled, double-blind Phase 3 study to evaluate the efficacy, safety and tolerability of votoplam in participants with Huntington’s Disease

Huntington’s Disease

Novartis Pharma AG

368 participants planned

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

2025-522227-99-00 on CTIS ↗

Phase II Otorhinolaryngologic Diseases Authorised 16/07/2026

Randomized, observer-blind, placebo-controlled, four Parallel Group, Clinical Trial for exploring the Efficacy and Tolerability of two different strengths ketotifen nasal spray (Ketotifen 0.025 mcg/ml and 0.050 mcg/ml) vs sodium cromoglicate nasal spray 2% in Patients with Rhinitis

Rhinitis

Eudemus Pharmaceuticals Limited

120 participants planned

Greece

2026-525419-16-00 on CTIS ↗

Phase II Nervous System Diseases Authorised 14/07/2026

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-755 in Acute Ischemic Stroke

Acute Ischemic Stroke

Takeda Development Center Americas Inc.

67 participants planned

Greece · Belgium · France · Germany

2025-522734-31-00 on CTIS ↗

Phase I/II Neoplasms Authorised 13/07/2026

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

Multiple Myeloma (MM), Multiple Myeloma (MM)

AbbVie Deutschland GmbH & Co. KG

88 participants planned

Germany · Poland · Czechia · Belgium · France · Greece · Sweden · Portugal · Italy

2025-525105-20-00 on CTIS ↗

Phase II Immune System Diseases Authorised 08/07/2026

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 2 to Master Protocol ARGX-999-2-MG-2000 – an Exploratory, Phase 2a, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis

AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis, MG, gMG

Argenx

29 participants planned

Greece · Italy · Germany · Belgium · Netherlands · Spain · Poland

2025-522939-33-00 on CTIS ↗

Phase III Eye Diseases Authorised 07/07/2026

Multicenter, randomized, double-blind, parallel-group clinical study comparing RD03/2016 (levoFloxacin and ketorolac trometAmol) eye drops vs Leviosa® (levofloxacin and dexamethaSone 21-phosphaTe) eye drops for 7 days for the prevention and treatment of inflammation and prevention of infection associated with cataract surgery in adults. (FAST 7)

Cataract

Ntc S.r.l.

536 participants planned

Spain · Poland · Greece · Sweden · Italy

2026-525594-39-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 07/07/2026

A study to evaluate the dose-exposure, safety, and exploratory efficacy of nerandomilast in children and adolescents from 2 years to less than 18 years of age with fibrosing interstitial lung disease (Part A: double-blind, placebo-controlled in children from 6 to less than 18 years of age and open-label active treatment in children from 2 to less than 6 years of age), followed by an open-label phase with active treatment (Part B)

Fibrosing interstitial lung disease

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

20 participants planned

Belgium · Greece · Germany · France · Finland · Spain · Czechia · Poland · Italy · Netherlands · Denmark · Portugal

2025-523369-32-00 on CTIS ↗

Phase III Neoplasms Authorised 07/07/2026

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Cevostamab in Combination with Pomalidomide and Dexamethasone Versus Standard of Care in Patients with Multiple Myeloma who Have Received One to Three Prior Lines of Therapy

Multiple Myeloma

F. Hoffmann-La Roche AG

133 participants planned

France · Germany · Italy · Greece · Denmark · Czechia · Spain · Poland

2025-524028-23-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 06/07/2026

A Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multicenter study, to investigate the efficacy and safety of lunsekimig in adult participants with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype

Respiratory tract diseases

Sanofi-Aventis Recherche & Developpement

550 participants planned

Germany · Romania · Greece · Norway · Netherlands · Poland · Lithuania · Czechia · Slovakia · Spain

2024-518213-25-00 on CTIS ↗

Phase III Mental Disorders Authorised 01/07/2026

AugmENtation witH cAnnabidiol iN first episode psyChosis: a doublE blind randomised controlled trial (STEP-ENHANCE Trial)

First Episode Psychosis (FEP)

University Of Oxford

156 participants planned

Netherlands · Greece · Germany · Italy · Austria · Spain

2025-521929-32-01 on CTIS ↗

Phase III Neoplasms Authorised 01/07/2026

"A Phase 3 Randomized Study Comparing JNJ-79635322 versus Teclistamab in Participants with Relapsed or Refractory Multiple Myeloma after 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Antibody and Lenalidomide"

Relapsed or Refractory Multiple Myeloma

Janssen Cilag International

206 participants planned

Poland · Spain · Czechia · France · Italy · Germany · Greece

2025-523815-12-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 30/06/2026

A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease

Pulmonary Hypertension Associated with Interstitial Lung Disease

Insmed Inc.

165 participants planned

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

2025-521769-29-00 on CTIS ↗

Phase III Skin and Connective Tissue Diseases Authorised 29/06/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants with Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care

Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease

Merck Healthcare KGaA

57 participants planned

Germany · Romania · France · Bulgaria · Belgium · Spain · Poland · Greece · Italy · Czechia

2025-524855-30-00 on CTIS ↗

Phase III Immune System Diseases Authorised 29/06/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants with Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care

Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease

Merck Healthcare KGaA

54 participants planned

Spain · Belgium · France · Germany · Slovakia · Romania · Bulgaria · Italy · Poland · Greece

2025-523871-44-00 on CTIS ↗

Phase III Neoplasms Authorised 29/06/2026

AndroMETa-CRC-560: An Open-Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with Refractory Metastatic Colorectal Cancer

Colorectal Cancer

AbbVie Deutschland GmbH & Co. KG

243 participants planned

Greece · Portugal · Germany · Belgium · Spain

2025-521712-19-00 on CTIS ↗

Phase I/II Neoplasms Authorised 29/06/2026

A Phase 1/2 Open-Label, Multicenter Study of RAS(ON) inhibitors in Combination with Ivonescimab with or without Other Anti-Cancer Agents in Patients with Solid Tumors

Solid Tumors

Revolution Medicines Inc.

252 participants planned

France · Poland · Ireland · Spain · Greece · Germany · Italy · Sweden · Belgium

2025-524623-50-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 29/06/2026

CLARITHROMYCIN TO PREVENT SECONDARY INFECTIONS IN PATIENTS WITH SEPSIS FOLLOWING LOWER RESPIRATORY TRACT INFECTIONS: THE CLASSIFY TRIAL

Community- acquired pneumonia related sepsis with evidence of Sepsis Induced Immunoparalysis SII

Elliniko Institouto Meletis Tis Sipsis

252 participants planned

Greece

2025-525058-20-00 on CTIS ↗

Phase III Musculoskeletal Diseases Authorised 23/06/2026

Multicenter Interventional Study Somatrogon Impact on Outcomes in Naive Small for Gestational Age or Idiopathic Short Stature paediatric patients compared with daily growth hormone

Small for gestational age (SGA) and idiopathic short stature (ISS)

Schneider Children's Medical Center Of Israel

95 participants planned

Greece · Poland · France · Czechia

2025-523832-38-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 22/06/2026

A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-Active Secondary Progressive Multiple Sclerosis

Non-active Secondary Progressive Multiple Sclerosis (SPMS)

Zenas Biopharma (USA) LLC

486 participants planned

Germany · Bulgaria · Netherlands · Sweden · Portugal · Croatia · Italy · Austria · Spain · Poland · France · Denmark · Hungary · Romania · Estonia · Slovakia · Belgium · Czechia · Norway · Lithuania · Greece

2025-524322-18-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 22/06/2026

A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-8690 in Adult Participants with Moderately to Severely Active Ulcerative Colitis

Colitis ulcerative

Merck Sharp & Dohme LLC

44 participants planned

Italy · Greece · Netherlands · Poland · Germany · France

2025-523479-49-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 17/06/2026

IM0271016: An Open-label, Multi-center, Long-term Extension Study to Evaluate the Long-term Safety and Tolerability of Admilparant in Participants with Pulmonary Fibrosis

Progressive pulmonary fibrosis and Idiopathic pulmonary fibrosis

Bristol-Myers Squibb Services Unlimited Company

318 participants planned

Finland · Portugal · Hungary · Ireland · Poland · Greece · France · Belgium · Denmark · Italy · Spain · Netherlands · Austria · Germany

2025-522373-10-00 on CTIS ↗

Phase II Skin and Connective Tissue Diseases Authorised 17/06/2026

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Nemolizumab in Adult Patients with Systemic Sclerosis, including a 52-Week Main Treatment Period and a 156-Week Extension Treatment Period

Systemic sclerosis

Galderma S.A.

56 participants planned

Poland · Italy · Bulgaria · France · Greece · Spain · Croatia

2025-522294-11-00 on CTIS ↗

Phase III Neoplasms Authorised 16/06/2026

A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014)

Stage I NSCLC

Merck Sharp & Dohme LLC

283 participants planned

Greece · Poland · Italy · Hungary · Germany · Netherlands · France · Spain

2025-522643-18-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 16/06/2026

A Study to Evaluate the Long-term Safety and Efficacy of Long-acting Antibodies as Single Agents and in Combinations in Participants with Inflammatory Bowel Disease

Ulcerative colitis (Inflammatory Bowel Disease)

Spyre Therapeutics Inc.

228 participants planned

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

2025-524640-35-00 on CTIS ↗

Phase III Musculoskeletal Diseases Authorised 15/06/2026

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of each of two dose levels of sarilumab in adults with early polymyalgia rheumatica

Musculoskeletal diseases

Sanofi-Aventis Recherche & Developpement

177 participants planned

France · Netherlands · Germany · Czechia · Belgium · Austria · Hungary · Greece · Spain

2024-511296-15-00 on CTIS ↗

Phase III Neoplasms Authorised 12/06/2026

A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Study of MK-1084 Plus Durvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platinum-Based Chemoradiotherapy (KANDLELIT-015)

Locally advanced, unresected (unresectable or medically inoperable or refuse surgery) Stage II-III NSCLC with KRAS G12C mutation

Merck Sharp & Dohme LLC

88 participants planned

Italy · Netherlands · France · Germany · Spain · Poland · Greece

2025-522038-29-00 on CTIS ↗

Phase III Neoplasms Authorised 12/06/2026

A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Relapsed/refractory B-cell Acute Lymphoblastic Leukemia

Merck Sharp & Dohme LLC

109 participants planned

Greece · Netherlands · Sweden · France · Italy · Spain · Denmark

2025-522267-15-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 12/06/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Glaxosmithkline Research & Development Limited

210 participants planned

Greece · Germany · Belgium · Netherlands · Poland · Italy · France · Spain · Bulgaria · Austria

2025-523674-16-00 on CTIS ↗

Phase III Bacterial Infections and Mycoses Authorised 10/06/2026

A Phase 3 prospective, randomized, multicenter, active-controlled study to evaluate the efficacy and safety of BV100 plus low-dose polymyxin B compared with colistin plus high-dose ampicillin/sulbactam in the treatment of adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex

Hospital-acquired bacterial pneumonia including ventilator-associated bacterial pneumonia caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex

Bioversys S.A.S.

58 participants planned

Greece · Croatia

2025-524092-23-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 10/06/2026