Clinical Trials in Netherlands 2026 - 135 Recent EU Authorisations

Chronic pain, refractory epilepsy, and other neurological disorders of excitation/inhibition (E/I) imbalance within neuronal circuits.
Axonis Therapeutics Inc. · 64 participants

📍 Netherlands

2025-524019-35-00 on CTIS ↗

Phase III Digestive System Diseases Authorised 23/06/2026

ALBUMINUS: Dose reduction of human albumin during large-volume paracentesis in patients with cirrhosis

liver cirrhosis
Amsterdam UMC Stichting · 634 participants

📍 Netherlands

2026-526167-38-00 on CTIS ↗

Phase II Respiratory Tract Diseases Authorised 23/06/2026

A Randomized, Double-blinded, Placebo-controlled, Parallel Group, Phase 2a Study to Assess the Activity, Safety, and Tolerability of SAR445399 in Adult Participants with Non-Cystic Fibrosis Bronchiectasis (NCFB).

Non-cystic fibrosis bronchiectasis
Sanofi-Aventis Recherche & Developpement · 41 participants

📍 Poland · Spain · France · Netherlands · Germany

2025-523403-29-00 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 · 467 participants

📍 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

📍 Italy · Greece · Netherlands · Poland · Germany · France

2025-523479-49-00 on CTIS ↗

Phase I/II Musculoskeletal Diseases Authorised 22/06/2026

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 / 2 Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of Single Ascending Doses of TRCN-1023 Administered by Intrathecal Injections to Adult People Living with Amyotrophic Lateral Sclerosis

Amyotrophic lateral sclerosis
Trace Neuroscience Inc. · 20 participants

📍 Germany · Netherlands

2025-523111-11-00 on CTIS ↗

Phase IV Musculoskeletal Diseases Authorised 22/06/2026

Sample Collection Study to Monitor the Risk of Malignancy Due to Insertional Oncogenesis in Early Onset Patients with Metachromatic Leukodystrophy Treated with OTL-200 in the Clinical Development Program

Metachromatic leukodystrophy
Orchard Therapeutics (Europe) Limited · 29 participants

📍 Netherlands · Germany · Italy · Sweden · France

2025-522275-28-00 on CTIS ↗

Phase II Mental Disorders Authorised 22/06/2026

Psilocybin-Assisted Psychotherapy for Posttraumatic Stress Disorder in Military Veterans: A Pilot Feasibility Study

Posttraumatic stress disorder
ARQ National Psychotrauma Centrum · 12 participants

📍 Netherlands

2025-521488-11-00 on CTIS ↗

Phase II Bacterial Infections and Mycoses Authorised 22/06/2026

Supplementary Oxygen Therapy after Limb Debridement and Reconstruction Surgery in Infected Extremity Fractures (SOLDIER): a pilot, non-blinded, randomized controlled trial

Fracture-Related Infection
Amsterdam UMC Stichting · 50 participants

📍 Netherlands

2026-525871-24-00 on CTIS ↗

Phase II Musculoskeletal Diseases Authorised 22/06/2026

A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of AGA2115 in Adults with Type I, III, or IV Osteogenesis Imperfecta (OI)

Osteogenesis Imperfecta
Angitia Inc. Ltd. · 40 participants

📍 Netherlands · France · Denmark

2025-522951-24-00 on CTIS ↗

Phase IV Digestive System Diseases Authorised 19/06/2026

Tacrolimus as prophylaxis of post-ERCP pancreatitis: a DPSG (Dutch Pancreatitis Study Group) multicenter, double-blind, randomized, placebo-controlled study.

Post-ERCP Pancreatitis
Amsterdam UMC Stichting · 520 participants

📍 Netherlands

2025-522900-26-00 on CTIS ↗

Phase I Not possible to specify Authorised 19/06/2026

A study to see how safe a new medicine (NNC6022-0004) is in healthy people and people living with obesity

Cardiometabolic
Novo Nordisk A/S · 128 participants

📍 Netherlands

2026-525179-26-00 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

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

2025-522373-10-00 on CTIS ↗

Phase I Skin and Connective Tissue Diseases Authorised 16/06/2026

A First‑in‑Human Phase 1 Study to Investigate the Safety, Tolerability, and PK of AB102 in Healthy Participants

Healthy volunteers
Arcus Biosciences Inc. · 130 participants

📍 Netherlands

2026-526279-52-00 on CTIS ↗

Phase II Neoplasms Authorised 16/06/2026

RADICAL-IO: thRee cycles of immunotherApy without raDical therapy In mediCALly InOperable stage I non-small cell lung cancer

Stage I non-small cell lung cancer
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting · 30 participants

📍 Netherlands

2025-524305-32-00 on CTIS ↗

Phase II Musculoskeletal Diseases Authorised 16/06/2026

A Phase 2, Open-Label Long-Term Extension Study in Participants With Duchenne Muscular Dystrophy Amenable to Exon Skipping to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Efficacy of Endosomal Escape Vehicle Phosphorodiamidate Morpholino Oligomer Platform Products (ELEVATE-LTE)

Duchenne Muscular Dystrophy
Entrada Therapeutics Inc. · 56 participants

📍 Belgium · Italy · Netherlands · Spain

2025-525124-10-00 on CTIS ↗

Phase III Neoplasms Authorised 16/06/2026

A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug vedotin in Combination with Capecitabine with or without Rilvegostomig in First-line Claudin18.2-positive, HER2-negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)

Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Cancer Expressing Claudin18.2
AstraZeneca AB · 516 participants

📍 France · Italy · Spain · Hungary · Poland · Belgium · Germany · Netherlands

2024-519787-40-00 on CTIS ↗

Phase I/II Neoplasms Authorised 16/06/2026

A Phase I/II Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6621, a T Cell-engaging Antibody That Targets STEAP2, CD3, and CD8 in Adult Participants With Metastatic Prostate Cancer (ACTIVATED-4-PC)

Metastatic Prostate Cancer
AstraZeneca AB · 45 participants

📍 Belgium · Spain · Poland · Italy · Netherlands

2025-520626-37-00 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

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

2025-522643-18-00 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

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

2024-511296-15-00 on CTIS ↗

Phase III Musculoskeletal Diseases Authorised 15/06/2026

An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of BBP-418 (Ribitol) in Participants with Limb-Girdle Muscular Dystrophy 2I/R9 (LGMD2I/R9)

Limb Girdle Muscular Dystrophy (LGMD) Type 2I
ML Bio Solutions Inc. · 35 participants

📍 Germany · Denmark · Netherlands · Italy · Norway

2025-524371-23-00 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

📍 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

📍 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

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

2025-523674-16-00 on CTIS ↗

Phase IV Immune System Diseases Authorised 09/06/2026

DISCO-RA:DIScontinuation of COncomitant disease modifying anti-rheumatic drugs (DMARDs) in rheumatoid arthritis patients also using TNF inhibitors - a randomized long-term non-inferiority strategy trial

Rheumatoid arthritis
Sint Maartenskliniek Stichting · 202 participants

📍 Netherlands

2026-525316-33-00 on CTIS ↗

Phase I/II Neoplasms Authorised 09/06/2026

A Phase 1/2, Open-label Study of VS-7375, a KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and in Combination, in Patients with Advanced KRAS G12D-Mutant Solid Tumors

Advanced KRAS G12D-Mutant Solid Tumors
Verastem Inc. · 210 participants

📍 Italy · France · Germany · Belgium · Spain · Netherlands

2025-523432-39-01 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 08/06/2026

HOVON 182 CLL: Prospective randomized phase 3 study of treatment with rituximab (6 cycles) in combination with 6 or 26 cycles of venetoclax in patients with relapsed or refractory chronic lymphocytic leukemia RED RIVER CLL study: Reduced Duration Rituximab VEnetoclax in Relapsed/refractory CLL

Relapsed or refractory chronic lymphocytic leukemia, Relapsed or refractory small lymphocytic lymphoma
Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting · 456 participants

📍 Netherlands

2025-524283-38-00 on CTIS ↗

Phase II Skin and Connective Tissue Diseases Authorised 08/06/2026

A multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase IIb study to assess the efficacy and safety of GIA632 in adult participants with non-segmental vitiligo followed by an extension period

Nonsegmental vitiligo
Novartis Pharma AG · 80 participants

📍 Germany · Spain · Netherlands · France · Italy

2025-522301-37-00 on CTIS ↗

Phase II Immune System Diseases Authorised 08/06/2026

J5D-MC-FPAC: A Phase 2a, Randomized, Multicenter, Double-Blind, Placebo-Controlled Proof of Concept Study to Investigate Efficacy and Safety of LY4005130 in Adult Participants With Severe Alopecia Areata

Alopecia Areata
Eli Lilly & Co. · 14 participants

📍 Poland · Netherlands

2025-524727-41-00 on CTIS ↗

Phase I/II Respiratory Tract Diseases Authorised 08/06/2026

TSRA196-AAT-201: A Phase 1/2, Open-Label, Multi-Center, Dose Escalation, Dose Expansion, and Single Repeat Dose Study of TSRA-196 in Adults With the PiZZ Genotype Who Have Lung and/or Liver Disease Associated with Severe Alpha-1 Antitrypsin Deficiency

Lung and/or Liver Disease Associated with Alpha-1 Antitrypsin Deficiency (AATD)
Tessera Therapeutics Inc. · 25 participants

📍 Ireland · Sweden · Netherlands

2025-523497-16-00 on CTIS ↗

Phase III Neoplasms Authorised 08/06/2026

A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody Drug Conjugate (ADC), Compared to Investigator’s Choice Therapy in Participants with Relapsed Small Cell Lung Cancer

Small Cell Lung Cancer (SCLC)
Zai Lab (US) LLC · 234 participants

📍 Belgium · Czechia · Germany · Denmark · Greece · Netherlands · Poland · Spain · Austria · Italy · France

2025-522818-23-00 on CTIS ↗

Phase II Immune System Diseases Authorised 08/06/2026

REpurposed drug evaluation for DEceleration of immunE aging & Mitigation of chronic inflammation (REDEEM)

Immune Aging, Chronic inflammation
Radboud universitair medisch centrum Stichting · 150 participants

📍 Netherlands

2026-526084-38-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 08/06/2026

A prospective, open-label, non-randomized, multicentre trial to assess the safety and PD of Cangrelor as procedural platelet inhibitor in paediatric subjects from birth to <18 years of age undergoing diagnostic and/or therapeutic percutaneous vascular procedures for management of congenital heart disease

Congenital Heart Disease
Chiesi Farmaceutici S.p.A. · 48 participants

📍 Netherlands · Germany · Portugal · Austria

2025-523109-14-00 on CTIS ↗

Phase I Neoplasms Authorised 08/06/2026

A study to learn more about how safe BAY 3771249 is and how well it works in people with advanced or metastatic colorectal cancer that has a KRAS G12D mutation

adenocarcinoma of the colon or rectum
Bayer Consumer Care AG · 49 participants

📍 Finland · Spain · Sweden · Italy · Denmark · Netherlands · Belgium

2025-523648-11-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 08/06/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa in Participants With Biopsy-Confirmed F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-1)

Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Glaxosmithkline Research & Development Limited · 173 participants

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

2025-523675-39-00 on CTIS ↗

Phase IV Respiratory Tract Diseases Authorised 05/06/2026

BIOlogical treatment GRAdual Interval Longing in severe Asthma (BIO-GRAIL)

Severe Asthma
Amsterdam UMC Stichting · 142 participants

📍 Netherlands

2025-524741-28-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 04/06/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2

Narcolepsy Type 2
Alkermes Inc. · 98 participants

📍 Spain · Netherlands · Belgium · Italy · France

2025-523912-35-00 on CTIS ↗

Phase I Diagnosis Authorised 04/06/2026

T cell imaging in kidney transplantation (TIK)

Renal allograft rejection
Radboud universitair medisch centrum Stichting · 9 participants

📍 Netherlands

2025-522490-11-00 on CTIS ↗

Phase II Nervous System Diseases Authorised 04/06/2026

Cosmos Trial: Cerebroprotection Of AST-004 in Mild Complicated Traumatic Brain Injuries

Traumatic brain injury
Astrocyte Pharmaceuticals Inc. · 48 participants

📍 Netherlands

2026-525554-11-00 on CTIS ↗

Phase I/II Nervous System Diseases Authorised 03/06/2026

A Phase 1b/2 Study to Evaluate NB-4746 in Participants with Amyotrophic Lateral Sclerosis.

Amyotrofic Lateral Sclerosis (ALS)
Nura Bio Inc. · 46 participants

📍 Poland · Netherlands · Italy · Spain

2025-523939-18-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 02/06/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

Narcolepsy Type 1
Alkermes Inc. · 75 participants

📍 Italy · France · Netherlands · Spain · Belgium

2025-523911-13-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 01/06/2026

A MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF NXT007 PROPHYLAXIS VERSUS FACTOR VIII PROPHYLAXIS IN PEOPLE WITH HEMOPHILIA A WITHOUT INHIBITORS

Hemophilia A Without Inhibitors
F. Hoffmann-La Roche AG · 42 participants

📍 France · Austria · Poland · Netherlands · Spain · Denmark · Italy · Germany · Hungary

2025-522434-32-00 on CTIS ↗

Phase I Neoplasms Authorised 01/06/2026

GRAIN, Prospective Pilot Study

Esophageal adenocarcinoma, Barrett's esophagus, Esophageal dysplasia
Universitair Medisch Centrum Groningen · 49 participants

📍 Netherlands

2025-524470-41-00 on CTIS ↗

Phase III Virus Diseases Authorised 01/06/2026

Post-INFECT: Investigating Neuroinflammation and its eFEcts in post-COVID syndrome: an imaging sTudy

post-COVID syndrome
Amsterdam UMC Stichting · 65 participants

📍 Netherlands

2025-522349-23-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 01/06/2026

A MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF NXT007 PROPHYLAXIS VERSUS EMICIZUMAB PROPHYLAXIS IN PEOPLE WITH HEMOPHILIA A

Hemophilia A
F. Hoffmann-La Roche AG · 124 participants

📍 Hungary · Spain · Ireland · Poland · Austria · Germany · Denmark · Belgium · Netherlands · Italy · France

2025-522435-33-00 on CTIS ↗

Phase I/II Musculoskeletal Diseases Authorised 01/06/2026

A Phase 1b/2a, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL952 in Adult Participants with Late-Onset Pompe Disease

Late-Onset Pompe Disease
Denali Therapeutics Inc. · 6 participants

📍 Germany · Netherlands

2025-524082-25-00 on CTIS ↗

Phase II Hemic and Lymphatic Diseases Authorised 29/05/2026

A PRECISION MEDICINE RANDOMIZED TRIAL FOR PATIENTS WITH RELAPSED OR REFRACTORY T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA BASED ON A FUNCTIONAL APPROACH. ALL-TARGET TRIAL

Relapsed/refractory T-cell Acute Lymphoblastic Leukemia
Centre Hospitalier De Versailles · 86 participants

📍 Germany · France · Czechia · Netherlands · Spain

2024-516570-30-00 on CTIS ↗

Phase I/II Neoplasms Authorised 29/05/2026

C6461006 - An Interventional Phase 1b/2, Open-Label Study to Investigate the Safety, Antitumor Activity, and Pharmacokinetics of PF-08634404 Monotherapy or in Combination With Enfortumab Vedotin in Adult Participants With Locally Advanced or Metastatic Urothelial Cancer.

Locally Advanced or Metastatic Urothelial Cancer
Pfizer Inc. · 36 participants

📍 Netherlands · Spain

2025-523523-21-00 on CTIS ↗

Phase III Neoplasms Authorised 29/05/2026

A Phase 3, Randomized, Double-Blind, Active-Control Study of Pelabresib (DAK539) and Ruxolitinib vs. Placebo and Ruxolitinib in Adult Patients with Myelofibrosis who are JAK inhibitor naive

Myelofibrosis
Novartis Pharma AG · 173 participants

📍 Belgium · Germany · Austria · Poland · Spain · Italy · Netherlands · Czechia · France

2025-523555-66-00 on CTIS ↗

Phase II Congenital, Hereditary, and Neonatal Diseases and Abnormalities Authorised 29/05/2026

A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX‑828/Deutivacaftor With and Without Tezacaftor in Subjects Aged 18 Years and Older With Cystic Fibrosis

Cystic fibrosis
Vertex Pharmaceuticals Inc. · 80 participants

📍 Spain · Sweden · Germany · Italy · Belgium · Czechia · Ireland · Portugal · Netherlands · France · Denmark

2025-523400-72-00 on CTIS ↗

Phase III Immune System Diseases Authorised 27/05/2026

A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab versus Risankizumab in the Treatment of Participants with Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
Janssen Cilag International · 302 participants

📍 Slovakia · Germany · Denmark · France · Spain · Italy · Netherlands · Belgium · Poland · Sweden · Austria · Czechia · Hungary

2025-521590-13-00 on CTIS ↗

Phase III Musculoskeletal Diseases Authorised 26/05/2026

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy of a Single Intravenous Dose of SGT-003 in Ambulant Males With Duchenne Muscular Dystrophy

Duchenne muscular dystrophy
Solid Biosciences Inc. · 62 participants

📍 Spain · Netherlands · France · Italy · Belgium · Germany

2025-522949-22-00 on CTIS ↗

Phase II Musculoskeletal Diseases Authorised 26/05/2026

Repurposed Drug Evaluation for Biological Aging, Pain, and Inflammation Reduction in Osteoarthritis

Osteoarthritis
Radboud universitair medisch centrum Stichting · 175 participants

📍 Netherlands

2025-524885-12-00 on CTIS ↗

Phase I Not possible to specify Authorised 22/05/2026

Thorough QT/QTc study with GLPG3667, placebo, and active comparator in healthy subjects

Healthy volunteers
Galapagos · 25 participants

📍 Netherlands

2026-525788-42-00 on CTIS ↗

Phase I Immune System Diseases Authorised 22/05/2026

150 mg CIT-013 phase 1 trial

Immune mediated inflammatory diseases
Citryll B.V. · 10 participants

📍 Netherlands

2026-526153-34-00 on CTIS ↗

Phase III Neoplasms Authorised 22/05/2026

ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 study of Pumitamig Monotherapy Compared to Durvalumab in Participants with Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy

Unresectable Stage III non-small cell lung cancer without progression
Bristol-Myers Squibb Services Unlimited Company · 279 participants

📍 France · Ireland · Germany · Greece · Bulgaria · Spain · Netherlands · Italy · Sweden · Romania · Hungary · Belgium · Austria · Poland

2025-523576-23-00 on CTIS ↗

Phase II Neoplasms Authorised 21/05/2026

A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Participants with Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008).

Stage 4 (IV) Non-Small Cell Lung Cancer (NSCLC)
Eikon Therapeutics Inc. · 115 participants

📍 Germany · Spain · Netherlands · Romania · Greece · Italy

2025-525013-23-00 on CTIS ↗

Phase I Respiratory Tract Diseases Authorised 21/05/2026

Clinical trial to evaluate the safety, tolerability and effectiveness of a medicinal nasal insert in the treatment of chronic hay fever.- Inspicare

Chronic allergic rhinitis
Dianosic · 25 participants

📍 Netherlands

2026-525200-99-00 on CTIS ↗

Phase I Immune System Diseases Authorised 20/05/2026

SAR447971 first-in-human study

Hidradenitis
Sanofi-Aventis Recherche & Developpement · 134 participants

📍 Netherlands

2026-525333-22-00 on CTIS ↗

Phase III Musculoskeletal Diseases Authorised 20/05/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Global Study with an Open-Label Extension to Evaluate the Efficacy and Safety of Intravenous AOC 1044 (delpacibart zotadirsen) for the Treatment of DMD with Gene Mutations Amenable to Exon 44 Skipping

Duchenne muscular dystrophy
Avidity Biosciences Inc. · 42 participants

📍 Italy · Germany · France · Spain · Belgium · Poland · Netherlands

2025-523087-20-00 on CTIS ↗

Phase II Immune System Diseases Authorised 19/05/2026

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of ELV001 as Add-on Therapy in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)

Rheumatoid arthritis
Elevara Medicines Limited · 95 participants

📍 Czechia · Bulgaria · Hungary · Netherlands · Poland · Spain

2025-524005-32-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 19/05/2026

A Phase 3 prospective randomised clinical trial of VMX-C001 vs usual pharmacological care in patients receiving a FXa direct oral anticoagulant (FXa DOAC) who require urgent surgery or other invasive procedure that is associated with a high risk of bleeding, with or without planned administration of heparin (EQUILIBRIX-S)

Patients on Factor Xa inhibitor treatment needing an urgent intervention associated with a high risk of bleeding
VarmX B.V. · 443 participants

📍 Belgium · Germany · Italy · France · Czechia · Bulgaria · Hungary · Spain · Netherlands · Poland · Austria · Estonia · Romania · Portugal · Lithuania

2025-521632-12-00 on CTIS ↗

Phase II Nutritional and Metabolic Diseases Authorised 19/05/2026

PODOMOUNT-Basket, a Phase II, multicentre, randomised, 2-arm parallel-group, double-blind, placebo-controlled basket trial to assess safety, tolerability, PK, and efficacy of BI 764198 in four proteinuric kidney diseases

Proteinuric kidney diseases
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 66 participants

📍 Portugal · Greece · Italy · Poland · Estonia · Slovakia · Sweden · Denmark · Belgium · Norway · Romania · France · Spain · Germany · Netherlands · Croatia

2025-523425-17-00 on CTIS ↗

Phase II Neoplasms Authorised 19/05/2026

An Open-label, Single-arm, Global Study of Perioperative Durvalumab With Cisplatin-based Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer (NIAGARA-2)

Patients With Muscle-Invasive Bladder Cancer
AstraZeneca AB · 60 participants

📍 Italy · Spain · France · Netherlands

2024-519246-75-01 on CTIS ↗

Phase III Neoplasms Authorised 19/05/2026

A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer

Metastatic Microsatellite Stable Colorectal Cancer
Incyte Corp. · 292 participants

📍 Poland · France · Denmark · Norway · Spain · Germany · Belgium · Netherlands · Austria · Italy

2025-523735-19-00 on CTIS ↗

Phase I Nervous System Diseases Authorised 18/05/2026

A multi-part study to investigate MTX325 in healthy volunteers and patients with Parkinson's Disease

Parkinson's Disease
Mission Therapeutics Limited · 18 participants

📍 Germany · Netherlands · France

2024-517310-15-00 on CTIS ↗

Phase I Immune System Diseases Authorised 18/05/2026

Mass Balance and Absolute Oral Bioavailability of [14C]VH4524184

human immunodeficiency virus (HIV)
Viiv Healthcare UK Limited · 9 participants

📍 Netherlands

2026-525590-40-00 on CTIS ↗

Phase II Immune System Diseases Authorised 18/05/2026

THRILL: Treat Hyperinflammation in child oncology study - A single arm, historically controlled, open label phase II study on the efficacy and safety of the recombinant interleukin (IL)-1R antagonist anakinra in pediatric cancer patients admitted to the intensive care with sepsis and signs of hyperinflammation

Sepsis, Hyperinflammation
Prinses Maxima Centrum voor Kinderoncologie B.V. · 76 participants

📍 Netherlands

2025-524541-27-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 18/05/2026

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

Primary Progressive Multiple Sclerosis (PPMS)
Zenas Biopharma (USA) LLC · 398 participants

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

2025-524316-11-00 on CTIS ↗

Phase II Neoplasms Authorised 18/05/2026

A phase II, multicenter, open-label, single arm study to evaluate the safety and efficacy of asciminib in pediatric participants newly diagnosed or previously treated with Philadelphia positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) with or without known T315I mutation

Philadelphia positive Chronic Myeloid leukemia in Chronic Phase with newly diagnosed and resistant/intolerant to previous TKIs, with or without the T315I mutation
Novartis Pharma AG · 14 participants

📍 Spain · France · Germany · Poland · Italy · Netherlands

2025-522138-29-00 on CTIS ↗

Phase III Neoplasms Authorised 18/05/2026

A Phase 3 Randomized Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti-CD38 Antibody

Relapsed or Refractory Multiple Myeloma
Janssen Cilag International · 157 participants

📍 Spain · Norway · Germany · Greece · France · Italy · Netherlands

2025-522007-18-00 on CTIS ↗

Phase III Neoplasms Authorised 15/05/2026

ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with PD-L1 ≥ 50%

Non-Small Cell Lung Cancer
Bristol-Myers Squibb Services Unlimited Company · 265 participants

📍 Portugal · Norway · Sweden · Bulgaria · France · Belgium · Austria · Germany · Finland · Poland · Romania · Netherlands · Spain · Italy · Hungary · Czechia

2025-523586-18-00 on CTIS ↗

Phase I Nutritional and Metabolic Diseases Authorised 15/05/2026

Multiple Dose Study of RO7795068 and its effect on Gastric Emptying, and on PK of Oral Contraceptives

Healthy Overweight or Obese
F. Hoffmann-La Roche AG · 60 participants

📍 Netherlands

2025-524052-58-00 on CTIS ↗

Phase I Cardiovascular Diseases Authorised 13/05/2026

A Randomized Study in Healthy Participants to Identify the Optimal Subcutaneous Injection Strategy for COR-1167

Chronic Heart Failure
Corteria Pharmaceuticals · 20 participants

📍 Netherlands

2026-526096-31-00 on CTIS ↗

Phase III Neoplasms Authorised 13/05/2026

A Phase III, multi-center, open-label, randomised, controlled trial of intravenous obrixtamig in combination with carboplatin and etoposide vs. carboplatin and etoposide as first-line therapy in DLL3-positive patients with unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinomas.

advanced or metastatic extrapulmonary neuroendocrine carcinoma
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 144 participants

📍 Portugal · Spain · Poland · Sweden · Italy · Czechia · France · Netherlands · Finland · Denmark · Austria · Germany · Belgium · Norway

2025-523869-22-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 12/05/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of GB-0895 Adjunctive Therapy in Adults and Adolescents with Severe Uncontrolled Asthma

severe uncontrolled asthma
Generate Biomedicines Inc. · 271 participants

📍 Latvia · Hungary · Bulgaria · Romania · Portugal · Netherlands · Croatia · Germany · Greece · Czechia

2025-521950-41-00 on CTIS ↗

Phase III Neoplasms Authorised 12/05/2026

DAREON®-Lung-1: A Phase III multi-center, open-label, randomised trial of intravenous obrixtamig in combination with atezolizumab, carboplatin, and etoposide vs. atezolizumab, carboplatin, and etoposide as first-line treatment in patients with extensive-stage small cell lung cancer.

small cell lung cancer
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 295 participants

📍 Czechia · Sweden · Poland · Netherlands · Greece · Latvia · Finland · Norway · Belgium · Austria · Portugal · Romania · Italy · Estonia · France · Ireland · Germany · Spain · Bulgaria · Hungary

2025-520565-51-00 on CTIS ↗

Phase II Mental Disorders Authorised 11/05/2026

Microdosing with a serotonergic agent for ADHD and emotion regulation: biological factors explaining and predicting treatment response

Attention Deficit Hyperactivity Disorder (ADHD)
Universiteit Maastricht · 120 participants

📍 Netherlands

2025-520906-36-00 on CTIS ↗

Phase I Nutritional and Metabolic Diseases Authorised 11/05/2026

A research study to see how NNC0487-0111 affects the body’s energy use after a weight loss in adults living with obesity, compared to a low-calorie diet or placebo

Obesity
Novo Nordisk A/S · 120 participants

📍 Netherlands · Denmark

2025-522744-40-00 on CTIS ↗

Phase IV Neoplasms Authorised 11/05/2026

PROTECx - Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer

Metastatic cervical cancer
Universitair Medisch Centrum Groningen · 261 participants

📍 Netherlands

2025-522883-34-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 11/05/2026

A Double-Blind, Randomized, Comparative Study of Obicetrapib and Bempedoic Acid on top of Maximally Tolerated Lipid-Lowering Therapy in Patients With Dyslipidemia at High to Very High Cardiovascular Risk (MEDICI Study)

Dyslipidemia at High to Very High Cardiovascular Risk
A. Menarini International Licensing S.A. · 338 participants

📍 Spain · Poland · Netherlands · Italy · Slovakia · Czechia · Germany

2025-524265-24-00 on CTIS ↗

Phase III Neoplasms Authorised 11/05/2026

J5E-MC-JZXB - FRAmework-01: A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and Sofetabart Mipitecan plus Bevacizumab versus Platinum-Based Chemotherapy plus Bevacizumab in Platinum-Sensitive Ovarian Cancer

Fallopian Tube Neoplasms, Neoplasm Metastasis, Ovarian Neoplasms, Peritoneal Neoplasms
Eli Lilly & Co. · 486 participants

📍 Netherlands · Hungary · France · Austria · Poland · Italy · Denmark · Romania · Greece · Norway · Czechia · Belgium · Spain · Ireland · Germany

2025-522255-25-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 11/05/2026

A double-blinded extension study to evaluate the long-term safety and tolerability of itepekimab in adult participants with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) who participated in either EFC18418 or EFC18419 clinical studies

Chronic rhinosinusitis with nasal polyps
Sanofi-Aventis Recherche & Developpement · 146 participants

📍 Germany · Netherlands · Portugal · Denmark · Sweden · Finland · France · Spain · Austria · Italy · Hungary · Romania · Belgium · Czechia · Poland

2025-522983-33-00 on CTIS ↗

Phase III Neoplasms Authorised 11/05/2026

A national randomised multi-centre phase II/III trial using MesoPher in ABC borderline resectable pancreatic cancer (PREOPANC-6 trial)

ABC borderline resectable pancreatic cancer
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) · 143 participants

📍 Netherlands

2025-523134-28-00 on CTIS ↗

Phase I/II Virus Diseases Authorised 07/05/2026

LAMP-COVID: Locating Amyloid-containing Microclots with total-body PET in post-COVID syndrome

post-COVID syndrome (long COVID)
Amsterdam UMC Stichting · 65 participants

📍 Netherlands

2025-522348-42-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 07/05/2026

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight Without Type 2 Diabetes

Obesity or Overweight Without Type 2 Diabetes
F. Hoffmann-La Roche AG · 754 participants

📍 Poland · Hungary · France · Belgium · Italy · Netherlands · Czechia · Germany · Spain

2025-523104-71-00 on CTIS ↗

Phase I Congenital, Hereditary, and Neonatal Diseases and Abnormalities Authorised 06/05/2026

A study to investigate the safety, tolerability, pharmacokinetics, immunogenicity and pharmacodynamics of a single subcutaneous dose of GSK4771261 in healthy participants aged 25 to 55 years of age inclusive

Autosomal Dominant Polycystic Kidney Disease
Glaxosmithkline Research & Development Limited · 30 participants

📍 Netherlands

2025-525073-37-00 on CTIS ↗

Phase III Eye Diseases Authorised 05/05/2026

Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Recombinant Human Nerve Growth Factor Eye Drop Solution in Participants With Persistent Corneal Epithelial Defect (PCED)

Persistent Corneal Epithelial Defect (PCED)
Dompe' Farmaceutici S.p.A. · 91 participants

📍 Czechia · Italy · Netherlands · Poland · Germany · Spain · Hungary · France

2025-523443-35-00 on CTIS ↗

Phase II Immune System Diseases Authorised 05/05/2026

A Long-Term Extension Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Patients With Graves' Disease

Graves’ Disease
Immunovant Sciences GmbH · 128 participants

📍 Italy · Greece · Germany · Hungary · Poland · Czechia · Netherlands · Spain · Belgium · Bulgaria · Latvia

2025-524001-33-00 on CTIS ↗

Phase III Digestive System Diseases Authorised 04/05/2026

Modafinil for debilitating fatigue in quiescent inflammatory bowel disease: a multicentre, randomised, double-blind, placebo-controlled, clinical trial (MODIFI-IBD trial)

Inflammatory bowel disease, Fatigue
Radboud universitair medisch centrum Stichting · 60 participants

📍 Netherlands

2026-525163-41-00 on CTIS ↗

Phase III Neoplasms Authorised 04/05/2026

A Phase 3, Randomized, Double-blind, Study of Belzutifan + Zanzalintinib Versus Belzutifan + Placebo in Participants with Advanced RCC who have progressed on or after both PD-1/L1 and VEGF-TKI therapies in sequence or in combination (LITESPARK-034)

Renal Cell Carcinoma
Merck Sharp & Dohme LLC · 311 participants

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

2024-516993-31-00 on CTIS ↗

Phase I Not possible to specify Authorised 01/05/2026

A PHASE 1, OPEN-LABEL, SINGLE-DOSE MASS BALANCE AND METABOLITE PROFILING STUDY OF 14C-LABELED IZICOPAN (INF904) IN HEALTHY MALE PARTICIPANTS

Not applicable, healthy volunteers
InflaRx GmbH · 8 participants

📍 Netherlands

2026-525517-31-00 on CTIS ↗

Phase I Immune System Diseases Authorised 30/04/2026

A first in human study of the safety, pharmacokinetics and pharmacodynamics of KLR-003 in healthy participants and patients with immune mediated diseases.

Psoriasis
Klear Bio Inc. · 182 participants

📍 Netherlands

2026-525575-22-00 on CTIS ↗

Phase I Bacterial Infections and Mycoses Authorised 30/04/2026

A study to assess the safety, and blood levels of CTX-187 after single and repeated intravenous doses in healthy volunteers and patients with bacterial infection

Bacterial Infection
Centauri Therapeutics Limited · 68 participants

📍 Netherlands

2026-525619-15-00 on CTIS ↗

Phase I Not possible to specify Authorised 30/04/2026

A PHASE 1, OPEN-LABEL STUDY TO ASSESS THE ABSORPTION, DISTRIBUTION, METABOLISM, AND EXCRETION, INCLUDING THE MASS BALANCE, OF A SINGLE ORAL DOSE OF [14C]-VAFIDEMSTAT IN HEALTHY MALE PARTICIPANTS

Healthy volunteers
Oryzon Genomics S.A. · 8 participants

📍 Netherlands

2025-524832-20-00 on CTIS ↗

Phase II Neoplasms Authorised 30/04/2026

GLO-Surgery: Indocyanine Green and near infrared fLuorescence in paediatric Oncology surgery

Patients with pulmonary metastasis from any primary tumour, or who have an abdominal or thoracic Rhabdomyosarcoma (RMS), Non-rhabdomyosarcomatous soft tissue sarcoma (NRSTS), Neuroblastoma (NBL) or a Malignant Germ cell tumour (mGCT) where complete resection by keyhole or open surgery is planned, and/or patients with a renal tumour or para-testicular RMS (ptRMS) requiring lymph node dissection
The University Of Birmingham · 30 participants

📍 Netherlands

2024-514089-37-00 on CTIS ↗

Phase I Nervous System Diseases Authorised 29/04/2026

Effect of NBI-921355 on corticospinal excitability in healthy participants

Epilepsy
Neurocrine Biosciences Inc. · 24 participants

📍 Netherlands

2025-524134-26-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 29/04/2026

An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Trial on the Effects of EA-230 on the Length of Hospital Stay Following On-Pump Coronary Artery Bypass Grafting Surgery

Coronary artery disease
EBI Anti Sepsis B.V. · 150 participants

📍 Belgium · Netherlands

2025-525053-39-00 on CTIS ↗

Phase III Neoplasms Authorised 29/04/2026

HO183 CAR T: A phase III randomized trial comparing academically produced BCMA-directed CAR T-cells (ARI0002h) with standard of care regimen in patients with relapsed/refractory multiple myeloma

relapsed/refractory multiple myeloma
Universitair Medisch Centrum Groningen · 126 participants

📍 Netherlands

2025-524876-43-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 28/04/2026

An Adaptive, 2-Part, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of IKT-001 in Pulmonary Arterial Hypertension.

Pulmonary Arterial Hypertension
Inhibikase Therapeutics Inc. · 94 participants

📍 Spain · Poland · Italy · Belgium · Latvia · Denmark · Czechia · Germany · France · Netherlands · Portugal · Ireland · Greece

2024-520218-23-00 on CTIS ↗

Phase II Neoplasms Authorised 28/04/2026

A Phase 2 Study of [68Ga]BED003 for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

Colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).
Blue Earth Diagnostics Ireland Limited · 65 participants

📍 Netherlands · Italy

2025-521983-36-00 on CTIS ↗

Phase III Neoplasms Authorised 28/04/2026

A Multicenter, Open-label, Phase 3 Extension Study to Evaluate the Long‑term Efficacy and Safety in Participants Who Are Currently on Treatment in a Belzutifan Study (LITESPARK-043)

Renal Cell Carcinoma, hepatocellular carcinoma, nonMSI-H/dMMR colorectal cancer, pancreatic ductal adenocarcinoma, biliary tract cancer, non-MSIH/dMMR endometrial cancer, esophageal squamous cell carcinoma, Advanced Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor, von Hippel-Lindau (VHL)Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor, Advanced Solid Tumors With HIF-2α related Genetic Alterations
Merck Sharp & Dohme LLC · 37 participants

📍 Czechia · Spain · Poland · Belgium · Finland · Germany · France · Netherlands · Hungary · Denmark

2025-524160-38-00 on CTIS ↗

Phase II Hemic and Lymphatic Diseases Authorised 28/04/2026

Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety of Anumigilimab (CSL324) in Adults with Sickle Cell Disease

Sickle Cell Disease
CSL Behring LLC · 12 participants

📍 Belgium · Netherlands · France · Italy

2025-521154-42-00 on CTIS ↗

Phase IV Skin and Connective Tissue Diseases Authorised 28/04/2026

MERCURE study: MEthotrexate in ReCurrent dVIN

dVIN caused by Lichen Sclerosus
Amsterdam UMC Stichting · 30 participants

📍 Netherlands

2025-524373-17-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 28/04/2026

A Phase 3, Randomized, Double-Blind, 48-Week Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of DYNE-101 Administered to Participants with Myotonic Dystrophy Type 1

Myotonic Dystrophy Type 1
Dyne Therapeutics Inc. · 72 participants

📍 Netherlands · Spain · Italy · Denmark · Germany · Belgium · France

2025-522957-20-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 28/04/2026

Efficacy, safety and pharmacokinetics of cagrilintide s.c. 2.4 mg as monotherapy and in combination with semaglutide s.c. 2.4 mg (CagriSema) once weekly for weight management in children and adolescents with overweight or obesity

Obesity and T2D
Novo Nordisk A/S · 157 participants

📍 Slovakia · Austria · Spain · Romania · Portugal · Italy · Denmark · Belgium · Sweden · Poland · Netherlands · Croatia · Hungary · Bulgaria

2023-509176-42-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 27/04/2026

Efficacy and safety of NNC0487-0111s.c once weekly in participants with obesity who have reached target dose during run-in period (AMAZE12).

Obesity
Novo Nordisk A/S · 325 participants

📍 Belgium · Germany · Bulgaria · France · Spain · Denmark · Italy · Netherlands

2025-523804-62-00 on CTIS ↗

Phase II Respiratory Tract Diseases Authorised 27/04/2026

A Phase IIb, multicentre, randomised, doubleblind, placebocontrolled, three-arm parallel-group study to evaluate the efficacy, safety, and tolerability at Week 24 of 2 doses of CHF10067 (zampilimab), with an optional 24-week doubleblind, placebocontrolled extension phase in participants with idiopathic pulmonary fibrosis

Idiopathic pulmonary fibrosis (IPF)
Chiesi Farmaceutici S.p.A. · 103 participants

📍 Belgium · Germany · Italy · Czechia · Bulgaria · Netherlands · France · Portugal · Poland · Spain · Romania

2024-514246-37-00 on CTIS ↗

Phase I/II Neoplasms Authorised 27/04/2026

A multi-center, open-label, phase I/II study to evaluate the safety and efficacy of asciminib with chemotherapy followed by blinatumomab in pediatric, adolescent, and young adult patients with relapsed or refractory BCR::ABL1-positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)

relapsed or refractory BCR::ABL1-positive (Philadelphia positive, Ph+) or BCR::ABL1-like (Ph-like) acute lymphoblastic leukemia (ALL)
Novartis Pharma AG · 21 participants

📍 Italy · Spain · Germany · Netherlands · France · Denmark · Czechia

2025-522019-40-00 on CTIS ↗

Phase II Virus Diseases Authorised 24/04/2026

Curing HIV: proof of concept randomized clinical trial with Pyrimethamine, Lenalidomide, TOpiramate (PLUTO)

HIV-1
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) · 30 participants

📍 Netherlands

2026-525211-14-00 on CTIS ↗

Phase I/II Nutritional and Metabolic Diseases Authorised 23/04/2026

A Phase 1/2 Open-Label, Single Ascending Dose, First-In-Human Study to Assess Safety and Tolerability of Endoscopic Ultrasound-Guided Pancreatic Infusion of RJVA-001 in Adults With Inadequately Controlled Type 2 Diabetes on Multiple Glucose-Lowering Agents.

Type 2 Diabetes
Fractyl Health Inc. · 15 participants

📍 Netherlands

2025-524438-24-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 21/04/2026

A Phase III, randomized, placebo-controlled, parallel group, double-blind study to evaluate the efficacy and safety of NIO752 in participants with Progressive Supranuclear Palsy followed by an Open Label Extension

Participants with Progressive Supranuclear Palsy Richardson Syndrome (PSP-RS)
Novartis Pharma AG · 138 participants

📍 Netherlands · Germany · Spain · Italy · France · Belgium

2025-523481-24-00 on CTIS ↗

Phase II Nutritional and Metabolic Diseases Authorised 21/04/2026

Albuminuria Reduction Trial and Investigation with Survodutide Treatment in CKD (ARTIST-CKD)

Chronic Kidney Disease
Universitair Medisch Centrum Groningen · 95 participants

📍 Germany · Spain · Netherlands

2025-525068-13-00 on CTIS ↗

Phase III Neoplasms Authorised 20/04/2026

A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) plus Zanubrutinib (BGB-3111) Compared with Venetoclax plus Acalabrutinib in Patients with Previously Untreated Chronic Lymphocytic Leukemia

treatment-naive Chronic Lymphocytic Leukemia
BeOne Medicines I GmbH · 186 participants

📍 Netherlands · Poland · Italy · Germany · Spain · Romania · Czechia · France · Sweden

2025-524366-21-00 on CTIS ↗

Phase II Congenital, Hereditary, and Neonatal Diseases and Abnormalities Authorised 20/04/2026

A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study of the Efficacy and Safety of Vamifeport in Adult Subjects with HFE-related Hereditary Hemochromatosis (FERROCLEAR Study)

Homeostatic iron regulator gene-related hereditary hemochromatosis
CSL Behring LLC · 50 participants

📍 Austria · Poland · Spain · Germany · France · Ireland · Romania · Belgium · Italy · Czechia · Netherlands

2025-523793-16-00 on CTIS ↗

Phase III Neoplasms Authorised 20/04/2026

A Phase 3, Randomized, Open-label Study of Sacituzumab Tirumotecan (MK-2870) Versus Investigator’s Choice of Non-platinum Chemotherapy in Participants with Pretreated Locally Advanced/Metastatic Urothelial Carcinoma

Locally advanced/metastatic urothelial carcinoma
Merck Sharp & Dohme LLC · 265 participants

📍 Netherlands · Greece · Italy · Germany · Spain · Belgium · Sweden · France

2024-520014-22-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 20/04/2026

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants with Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis
Ferrer Internacional S.A., Prilenia Therapeutics B.V. · 420 participants

📍 Belgium · Netherlands · Poland · France · Germany · Ireland · Italy · Sweden · Spain

2025-524002-16-00 on CTIS ↗

Phase III Neoplasms Authorised 20/04/2026

J4G-MC-JZVD - FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined with Enfortumab Vedotin and Pembrolizumab in Adults with Untreated Locally Advanced or Metastatic Urothelial Carcinoma with an FGFR3 Genetic Alteration.

Urinary Bladder Neoplasms, Neoplasm Metastasis, Carcinoma, Transitional Cell
Eli Lilly & Co. · 197 participants

📍 Italy · Poland · Denmark · Czechia · France · Hungary · Germany · Netherlands · Spain

2025-522855-25-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 17/04/2026

A Multicentre, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of MaaT013 in Ruxolitinib-Refractory or Intolerant Paediatric and Adolescent participants with Gastrointestinal Acute Graft-versus-Host Disease

Gastrointestinal Acute Graft-versus-Host Disease (GI-aGvHD)
MaaT PHARMA · 18 participants

📍 Netherlands · Italy · France · Spain

2025-524302-15-00 on CTIS ↗

Phase III Neoplasms Authorised 17/04/2026

A Phase 3, Randomized, Open-Label Study of INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 2)

Ovarian cancer
Incyte Corp. · 308 participants

📍 Ireland · Poland · France · Netherlands · Spain · Italy · Germany · Belgium

2025-522748-42-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 17/04/2026

Efficacy and safety of NNC0487-0111 compared to placebo on morbidity and mortality in people with heart failure with preserved or mildly reduced ejection fraction and obesity (HF-POLARIS).

HFpEF or HFmrEF and obesity
Novo Nordisk A/S · 1992 participants

📍 Denmark · Greece · Bulgaria · Italy · Netherlands · Spain · Poland · Czechia · Germany · France

2025-523717-29-00 on CTIS ↗

Phase I Respiratory Tract Diseases Authorised 17/04/2026

A Phase 1 Study of AIR-001 in Adults with AATD.

Alpha-1 Antitrypsin Deficiency
Airna Corp. · 19 participants

📍 Sweden · Ireland · Spain · Netherlands · Portugal · Germany

2025-523558-14-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 17/04/2026

A Phase 3, Multicenter, Open-Label, Randomized Trial to Compare the Efficacy and Safety of Elritercept versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in ESA-naïve Adult Participants Who Require Red Blood Cell Transfusions

Myelodysplastic neoplasms/syndromes (MDS)
Takeda Development Center Americas Inc. · 114 participants

📍 France · Belgium · Germany · Italy · Bulgaria · Ireland · Lithuania · Norway · Romania · Hungary · Spain · Greece · Poland · Netherlands

2025-523544-12-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 16/04/2026

The INFLUENCE Trial: Improving EveNt Free Survival by Optimizing FLUdarabine Exposure during LymphodepletioN for CAR T CEll Therapy: a randomized, multi-center study of children and young adults with B-cell acute lymphoblastic leukemia

B-cell Acute Lymphoblastic Leukemia
Prinses Maxima Centrum voor Kinderoncologie B.V. · 35 participants

📍 Spain · Germany · Netherlands

2025-523096-34-00 on CTIS ↗

Phase II Respiratory Tract Diseases Authorised 15/04/2026

A single arm phase II study evaluating intracranial efficacy of tarlatamab in patients with asymptomatic active brain metastases from small cell lung cancer

patients with asymptomatic active brain metastases from small cell lung cancer
Academisch Ziekenhuis Maastricht · 35 participants

📍 Netherlands

2025-522162-75-00 on CTIS ↗