Clinical Trials in Belgium 2026 - 105 Recent EU Authorisations

📍 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 I Neoplasms Authorised 22/06/2026

Safety and Tolerability of REGN17235 in Adult Participants with Clonal Cytopenia of Undetermined Significance and Low-Risk Myelodysplastic Syndrome with SF3B1 Mutation

Clonal Cytopenia of Undetermined Significance with SF3B1 mutation, Low-Risk Myelodysplastic Syndrome with SF3B1 mutation
Regeneron Pharmaceuticals Inc. · 15 participants

📍 Belgium

2026-525464-18-00 on CTIS ↗

Phase I Virus Diseases Authorised 18/06/2026

A first study in healthy volunteers to examine the safety and tolerability of convalescent plasma given through the nose, as well as the duration of its presence in the nose

Healthy volunteers
Rode Kruis-Vlaanderen · 104 participants

📍 Belgium

2025-525085-29-00 on CTIS ↗

Phase I Neoplasms Authorised 17/06/2026

A Study to Learn About How Different Forms of Study Medicine Prifetrastat are Taken Up Into the Blood in Healthy Adults

Locally advanced or metastatic ER+/HER2- breast cancer
Pfizer Inc. · 32 participants

📍 Belgium

2026-526038-26-00 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 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 I Neoplasms Authorised 16/06/2026

A Phase 1, Open-Label, Multicenter Study of INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies

Hematological malignancies, Advanced solid tumors
Incyte Corp. · 150 participants

📍 Italy · Belgium · Denmark

2025-523130-11-00 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 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

📍 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

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

2024-511296-15-00 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 II Digestive System Diseases Authorised 11/06/2026

J6Z-MC-IIBD - A Master Protocol for Phase 2, Randomized, Controlled Studies of Multiple Interventions for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease J6Z-MC-CD01 - A Phase 2, Multicenter, Randomized, Open-Label, Active-Controlled Study to Investigate LY4395089/Mirikizumab Co-administration Compared with Mirikizumab in Adults with Moderately to Severely Active Crohn’s Disease

J6Z-MC-IIBD - Colitis, Ulcerative Crohn Disease J6Z-MC-CD01 - Crohn Disease
Eli Lilly & Co. · 37 participants

📍 Italy · Germany · Hungary · Poland · Belgium

2025-524112-11-00 on CTIS ↗

Phase I Neoplasms Authorised 09/06/2026

A trial in healthy participants to find out how long JNJ-101556143 stays in and acts on the body when administered as different formulations and under different food conditions

Prostate Cancer
Janssen Cilag International · 48 participants

📍 Belgium

2026-526263-38-00 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 IV Nutritional and Metabolic Diseases Authorised 08/06/2026

A neuropsychobiological approach to optimize patient selection for GLP-1-based pharmacotherapy for weight management across the binge eating spectrum

obesity
UZ Leuven · 96 participants

📍 Belgium

2026-526016-36-00 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 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 I/II Neoplasms Authorised 08/06/2026

KontRASt-R: An open-label, multi-center, rollover study for participants who have been previously enrolled into a Novartis-sponsored opnurasib (JDQ443) study and are continuing to benefit from opnurasib as a single agent or in combination with other study treatments

Locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer; advanced solid tumors harboring the KRAS G12C mutation.
Novartis Pharma AG · 31 participants

📍 Spain · Italy · France · Denmark · Belgium

2025-523537-26-00 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 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/II Respiratory Tract Diseases Authorised 04/06/2026

A study on the safety of and immune response to different doses of RSV/hMPV combination and hMPV vaccines in adults

Respiratory Syncytial Virus Infections+Metapneumovirus
GlaxoSmithKline Biologicals · 464 participants

📍 Belgium

2025-524456-58-00 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 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 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 Immune System Diseases Authorised 29/05/2026

J5D-MC-FPAD: A Phase 2a, Randomized, 24-Week, Multicenter, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Investigate Efficacy and Safety of LY4005130 in Adult Participants with Non-Segmental Vitiligo

Non-Segmental Vitiligo (NSV), Vitiligo
Eli Lilly & Co. · 14 participants

📍 Poland · Belgium

2025-524726-18-00 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 II Immune System Diseases Authorised 27/05/2026

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

moderate to severe rheumatoid arthritis (RA)
F. Hoffmann-La Roche AG · 46 participants

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

2025-523579-47-00 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 I/II Neoplasms Authorised 26/05/2026

LIGHTBEAM-U01 Substudy 01D: A Phase 1b/2 Substudy to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors

Neoplasm malignant
Merck Sharp & Dohme LLC · 21 participants

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

2025-522339-32-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 26/05/2026

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. · 73 participants

📍 Italy · Slovakia · Spain · Ireland · Belgium · France

2025-524040-35-00 on CTIS ↗

Phase I Behavior and Behavior Mechanisms Authorised 22/05/2026

A PET Study to Assess the Occupancy of M4 Muscarinic Acetylcholine Receptors by BMS-986521 in Healthy Adult Participants

Neuropsychiatric indications and potentially other conditions
Bristol-Myers Squibb Services Unlimited Company · 12 participants

📍 Belgium

2025-524564-38-00 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 Metabolism Authorised 21/05/2026

An open-label, single-arm extension study to evaluate the long-term safety, tolerability, and efficacy of KL1333 (napazimone) in patients with primary mitochondrial disease

Adult patients with primary mitochondrial disease
Pharming Technologies B.V. · 117 participants

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

2025-524367-20-00 on CTIS ↗

Phase III Immune System Diseases Authorised 20/05/2026

A double-blind, double-dummy, parallel group, multicenter Phase 3 extension study evaluating the long-term safety and efficacy of 2 doses of remibrutinib in adult participants with moderate to severe hidradenitis suppurativa

Hidradenitis Suppurativa (HS)
Novartis Pharma AG · 307 participants

📍 Portugal · Greece · Germany · Hungary · France · Spain · Bulgaria · Slovakia · Poland · Czechia · Belgium · Italy

2025-523259-72-00 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 I Digestive System Diseases Authorised 19/05/2026

An Early-Stage Study in Multiple Clinics of how Afimkibart May Affect the Body’s Processing of Medicines that Rely on Cytochrome P450 Enzymes in Patients with Ulcerative Colitis

Active Ulcerative Colitis (UC)
F. Hoffmann-La Roche AG · 19 participants

📍 Germany · Poland · Belgium

2025-524060-38-00 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 III Virus Diseases Authorised 19/05/2026

A multicentre, open-label trial in healthy volunteers to assess the boostability of three different rabies pre-exposure prophylaxis regimens when administering a single-dose, intramuscular vaccination as simulated post-exposure prophylaxis at least five years following priming. "BAZOOKA_221"

Rabies infection/prophylaxis
Institute Of Tropical Medicine · 561 participants

📍 Belgium

2025-524765-24-00 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 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 IV Cardiovascular Diseases Authorised 18/05/2026

The effect of beta-blockers on how you feel and recover after a heart attack when your heart is still pumping well

Myocardial infarction with preserved ejection fraction
UZ Leuven · 160 participants

📍 Belgium

2026-525475-96-00 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 III Nervous System Diseases Authorised 14/05/2026

A Phase 3, Multi-regional, Open-label, Randomized Study of Tirabrutinib vs Rituximab and Temozolomide in Participants with Relapsed/Refractory Primary Central Nervous System Lymphoma

Relapsed/refractory primary central nervous system lymphoma
Deciphera Pharmaceuticals Inc. · 74 participants

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

2025-523389-26-00 on CTIS ↗

Phase IV Reproductive and Urinary Physiological Phenomena Authorised 13/05/2026

Reproductive outcomes with letrozole co-treatment during ovarian stimulation in women with endometriosis undergoing IVF/ICSI: a randomised, multicentre, parallel group pragmatic trial

Women with endometriosis undergoing IVF/ICSI
UZ Brussel · 854 participants

📍 Belgium

2025-524995-53-00 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 II Skin and Connective Tissue Diseases Authorised 13/05/2026

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of ICP-332 in Participants with Prurigo Nodularis

Prurigo Nodularis
Innocare Pharma Inc. · 56 participants

📍 Belgium · Poland · Germany · France · Austria

2025-523404-74-00 on CTIS ↗

Phase I Cardiovascular Diseases Authorised 12/05/2026

A clinical trial of MK-1824 in healthy participants (MK-1824-001)

Heart failure with preserved ejection fraction
Merck Sharp & Dohme LLC · 16 participants

📍 Belgium

2026-525748-14-00 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 III Musculoskeletal Diseases Authorised 12/05/2026

A Phase 3, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who are Either Biologic DMARD-Naïve or Biologic DMARD-Experienced, Including Those With Inadequate Response to Biologic DMARDs

Psoriatic Arthritis
Takeda Development Center Americas Inc. · 638 participants

📍 Germany · Belgium · Spain · Czechia · Croatia · Portugal · Poland · Latvia · Bulgaria · France · Estonia · Hungary · Italy

2025-522586-30-00 on CTIS ↗

Phase III Bacterial Infections and Mycoses Authorised 11/05/2026

A randomized controlled non-inferiority trial comparing 7 versus 14 days of ciprofloxacin for male urinary tract infections with systemic involvement.

Urinary tract infection with systemic involvement (UTI: definite, probable, or possible UTI according to the diagnostic criteria of the research reference standard for UTI proposed by Bilsen et al (see reference 19 in protocol)). Systemic involvement: one or more of the following, attributable to the UTI: • Temperature ≥38°C • Flank pain or costovertebral angle tenderness • Systolic blood pressure <90 mmHg without alternative cause • Significant elevation of inflammatory markers related to the UTI: o C-reactive protein concentration ≥50 mg/L, Procalcitonin concentration ≥0·5 ng/mL or white blood cell count ≥12×10^9 per L (all without other plausible source, based on at least history and examination). • Bacteraemia with the same pathogen as isolated from urine culture
UZ Brussel · 264 participants

📍 Belgium

2025-524703-76-00 on CTIS ↗

Phase I Not possible to specify Authorised 11/05/2026

A First in Human Study to Assess Safety, Tolerability and Pharmacokinetics of a single dose of REGN22044 in Healthy Adults

Heathy volunteer trial
Regeneron Pharmaceuticals Inc. · 64 participants

📍 Belgium

2025-523562-24-00 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 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 Nervous System Diseases Authorised 06/05/2026

A clinical trial of MK-4605 in healthy participants (MK-4605-001)

Dementia
Merck Sharp & Dohme LLC · 16 participants

📍 Belgium

2026-525627-24-00 on CTIS ↗

Phase I Neoplasms Authorised 05/05/2026

Phase 1b Study of Tarlatamab + ZL-1310 +/- Anti-PD-L1 in Small Cell Lung Cancer

Small Cell Lung Cancer
Amgen Inc. · 53 participants

📍 Spain · Germany · Poland · Belgium · France

2025-522888-15-00 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 Nutritional and Metabolic Diseases Authorised 04/05/2026

Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with obesity (AMAZE 1)

Obesity
Novo Nordisk A/S · 270 participants

📍 Denmark · France · Germany · Belgium

2024-520440-42-00 on CTIS ↗

Phase III Immune System Diseases Authorised 04/05/2026

A multicenter open-label extension study to evaluate the long-term safety and tolerability of zigakibart in adults with primary IgA nephropathy

IgA nephropathy
Novartis Pharma AG · 69 participants

📍 Belgium · France · Czechia · Croatia · Greece · Germany · Italy · Spain

2024-519638-22-00 on CTIS ↗

Phase I Skin and Connective Tissue Diseases Authorised 30/04/2026

First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants with Atopic Dermatitis

Atopic Dermatits
Regeneron Pharmaceuticals Inc. · 64 participants

📍 Belgium

2025-524205-32-00 on CTIS ↗

Phase I Virus Diseases Authorised 30/04/2026

Study to Learn How Safe EV25 is and the Amount of EV25 in the Body Over a Period of Time, When Given as a Single Dose to Adult Healthy People [CCI]

Influenza
Eradivir Inc. · 16 participants

📍 Belgium

2026-525176-26-00 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 I Neoplasms Authorised 28/04/2026

AMG 436 as monotherapy and combination therapy in participants with Microsatellite Instability-High/Mismatch Repair Deficient Solid Tumors

microsatellite instability high/mismatch repair deficient (MSI-H/dMMR) solid tumors
Amgen Inc. · 77 participants

📍 Spain · France · Belgium

2025-524056-63-00 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 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 III Neoplasms Authorised 28/04/2026

A two-part, seamless, multicenter, RANDOMIZED, open-label, ADAPTIVE Phase ii/III STUDY OF THE BLOOD-BRAIN barrier PENETRANT RO7771950 versus Tucatinib, both in combination with trastuzumab and capecitabine, in patients with Pretreated unresectable locally advanced or metastatic HER2-positive breast cancer, with or without central nervous system metastases

Pretreated Unresectable Locally Advanced or Metastatic human epidermal growth factor receptor 2 (HER2)-Positive Breast Cancer, with or without Central Nervous System (CNS) Metastases
F. Hoffmann-La Roche AG · 237 participants

📍 Belgium · France · Italy · Austria · Romania · Poland · Portugal · Czechia · Germany · Spain · Hungary

2025-524498-17-00 on CTIS ↗

Phase I Nervous System Diseases Authorised 28/04/2026

A Study to Compare the Blood Levels of Two Dosage Formulations of the Study Medicine in Healthy Adults

Migraine with or without aura
Pfizer Inc. · 36 participants

📍 Belgium

2025-525125-12-00 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 Neoplasms Authorised 28/04/2026

A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced HRD-Negative Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/ GOG-3102)

Ovarian cancer
Merck Sharp & Dohme LLC · 349 participants

📍 Norway · Ireland · Spain · Greece · France · Poland · Denmark · Austria · Hungary · Belgium · Czechia · Finland · Germany · Italy · Sweden

2023-508047-40-00 on CTIS ↗

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

A Phase 3, Parallel-group Treatment, Blinded, Randomized, Placebo-controlled Study to Assess the Efficacy and Safety of Pegtibatinase Administered Subcutaneously in Addition to Standard of Care in Participants with Classical Homocystinuria due to Cystathionine Beta Synthase Deficiency (HARMONY)

Classical Homocystinuria
Travere Therapeutics Inc. · 22 participants

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

2023-504135-40-00 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 III Hemic and Lymphatic Diseases Authorised 27/04/2026

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against FXI, for Primary Prophylaxis of Cancer-Associated Thrombosis for Participants with Solid Tumors Undergoing Cancer Treatment (ROXI-CAT-I)

Cancer-Associated Thrombosis (CAT).
Regeneron Pharmaceuticals Inc. · 324 participants

📍 Belgium · Czechia · France · Romania · Germany · Poland · Bulgaria · Spain

2024-519298-21-00 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 Immune System Diseases Authorised 27/04/2026

Relative bioavailability and effect of food study with GLPG3667 in healthy subjects

inflammatory and autoimmune diseases
Galapagos · 16 participants

📍 Belgium

2026-525706-35-00 on CTIS ↗

Phase II Neoplasms Authorised 22/04/2026

A phase II trial evaluating treatment intensification with Ezabenlimab in patients with PD-L1–expressing, locally advanced head and neck squamous cell carcinoma (LA-HNSCC) with minimal residual disease (MRD) as detected by circulating tumor DNA (ctDNA) after curative-intent chemoradiation

Locally advanced head and neck squamous cell carcinoma (LA-HNSCC)
Cliniques Universitaires Saint-Luc · 160 participants

📍 Belgium

2025-523575-36-00 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 III Nutritional and Metabolic Diseases Authorised 21/04/2026

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

Obesity, Overweight
Eli Lilly & Co. · 286 participants

📍 Spain · Romania · Belgium · Czechia

2025-523659-73-00 on CTIS ↗

Phase II Not possible to specify Authorised 21/04/2026

A single center study to evaluate the safety and tolerability of oral Azathioprine in patients with ADPKD

Autosomal dominant polycystic kidney and liver disease
UZ Leuven · 40 participants

📍 Belgium

2025-524313-86-00 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 I Neoplasms Authorised 20/04/2026

A study to test how well different doses of BI 3820768 are tolerated by people with advanced cancer (solid tumours)

Advanced relapsed or refractory ovarian cancer, Advanced relapsed or refractory endometrial cancer, Advanced relapsed or refractory germ cell tumours
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 102 participants

📍 Spain · France · Belgium · Germany

2025-522913-45-00 on CTIS ↗

Phase I Neoplasms Authorised 20/04/2026

A Phase 1b Study of the Safety and Pharmacokinetics of Pivekimab Sunirine in Pediatric Subjects with Relapsed or Refractory Acute Myeloid Leukemia (AML).

Relapsed or Refractory Acute Myeloid Leukemia; Acute Myeloid Leukemia, Acute Myeloid Leukemia
AbbVie Deutschland GmbH & Co. KG · 18 participants

📍 Spain · Hungary · Czechia · France · Italy · Belgium

2024-520125-36-00 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 II Immune System Diseases Authorised 20/04/2026

An autologous and antigen-specific cell-based therapy of vitamin D3-treated and myelin-derived peptide loaded tolerogenic dendritic cells in subjects with progressive forms of multiple sclerosis: a phase IIa, open-label, self-controlled, multi-center clinical trial.

Multiple Sclerosis
Universitair Ziekenhuis Antwerpen, Hospital Germans Trias I Pujol · 14 participants

📍 Belgium · Spain

2025-522040-40-01 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 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 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 ↗