Clinical Trials in France 2026 - 222 Recent EU Authorisations

Adult patients with a diagnosis of fibrotic Hypersensitivity Pneumonitis (HP) (“definite” or “high confidence”) after multi-disciplinary discussion (MDD) with a mild to moderate disease severity, and never treated for fibrotic HP.
Assistance Publique Hopitaux De Paris · 120 participants

📍 France

2025-521591-64-00 on CTIS ↗

Phase III Neoplasms Authorised 03/08/2026

A Randomized Phase 2/3 Study Evaluating the Safety and Efficacy of Pivekimab Sunirine (PVEK) in Combination with Venetoclax and Azacitidine in Adult Subjects with Newly Diagnosed Acute Myeloid Leukemia (AML) Ineligible to Receive Intensive Chemotherapy

Acute Myeloid Leukemia
AbbVie Deutschland GmbH & Co. KG · 25 participants

📍 France · Austria · Spain

2025-523724-47-00 on CTIS ↗

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

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

Systemic sclerosis
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 124 participants

📍 Denmark · Sweden · Netherlands · Germany · Belgium · France · Greece · Norway · Finland · Czechia · Portugal · Bulgaria · Spain · Estonia · Lithuania

2025-523884-39-00 on CTIS ↗

Phase III Immune System Diseases Authorised 03/08/2026

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

Moderately to Severely Active Crohn’s Disease
Janssen Cilag International · 194 participants

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

2026-525922-39-00 on CTIS ↗

Phase III Immune System Diseases Authorised 03/08/2026

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

Moderately to Severely Active Ulcerative Colitis
Janssen Cilag International · 302 participants

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

2026-525923-26-00 on CTIS ↗

Phase II Nervous System Diseases Authorised 31/07/2026

A Multicenter, Open-Label, Long-Term, Safety and Tolerability Extension Study of PTI5803 as adjunctive therapy in patients ≥ 14 years of age with drug-resistant seizures associated to focal cortical dysplasia.

Drug resistant focal epilepsy related to focal cortical dysplasia
PannTheraPi · 15 participants

📍 France

2026-525161-40-00 on CTIS ↗

Phase I/II Nervous System Diseases Authorised 30/07/2026

A Phase 1b/2a first-in-human, multicentre, randomized, double-blind, placebo-controlled study of multiple ascending dose (Part1) followed by an open-label extension (Part2) to assess the safety, tolerability, and pharmacokinetics of intrathecally administered S233107 in participants with spinocerebellar ataxia type 3

Spinocerebellar ataxia type 3
Institut De Recherches Internationales Servier IRIS · 50 participants

📍 France · Denmark · Spain · Portugal

2025-525111-17-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 29/07/2026

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

Heart failure with preserved ejection fraction (HFpEF) and heart failure with mildly reduced ejection fraction (HFmrEF); on background SGLT2i.
AstraZeneca AB · 2343 participants

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

2026-526304-79-00 on CTIS ↗

Phase II Neoplasms Authorised 28/07/2026

A Phase 2 Study of Alisertib in Combination with Paclitaxel in Patients with Small Cell Lung Cancer

Small Cell Lung Cancer (SCLC)
Puma Biotechnology Inc. · 30 participants

📍 France · Poland · Spain

2026-525382-47-00 on CTIS ↗

Phase IV Nervous System Diseases Authorised 28/07/2026

Comparative study of two vaccination schedules for the subunit Herpes Zoster vaccine in Multiple Sclerosis and Neuromyelitis optica spectrum disease patients treated with anti-CD20 therapy: an open-label randomised controlled trial.

Multiple Sclerosis and Neuromyelitis optica spectrum
Centre Hospitalier Universitaire De Toulouse · 160 participants

📍 France

2025-525106-37-00 on CTIS ↗

Phase II Immune System Diseases Authorised 28/07/2026

OBINUSS - Safety and efficacy of obinutuzumab in systemic sclerosis: a phase II, randomized, double-blinded versus placebo-controlled trial

Patients with newly or active diffuse Systemic sclerosis at the time of screening.
Assistance Publique Hopitaux De Paris · 74 participants

📍 France

2025-524003-68-00 on CTIS ↗

Phase I Neoplasms Authorised 27/07/2026

A Study to Assess Adverse Events, Change in Disease Activity and How Intravenous (IV) ABBV901 Moves Through the Body Alone or in Combination with Bevacizumab in Adult Participants with Ovarian Cancer

Ovarian Cancer
AbbVie Deutschland GmbH & Co. KG · 44 participants

📍 Portugal · Denmark · Spain · France

2025-522209-40-00 on CTIS ↗

Phase I Neoplasms Authorised 27/07/2026

A Phase 1 Study of PRT12396 in Participants with Select Myeloproliferative Neoplasms

Post-Essential Thrombocythemia Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Intermediate-1, Intermediate-2, or High-Risk Primary Myelofibrosis, High-risk Polycythemia Vera
Prelude Therapeutics Inc. · 22 participants

📍 Italy · France · Spain

2026-525484-40-00 on CTIS ↗

Phase II Neoplasms Authorised 27/07/2026

A Cancer Research UK Phase II trial of CY-101 given via intratumoural administration in locally advanced or metastatic adrenocortical carcinoma (CLARITY)

LOCALLY ADVANCED OR METASTATIC ADRENOCORTICAL CARCINOMA
Cancer Research UK · 26 participants

📍 Spain · France · Germany · Norway

2025-522757-19-00 on CTIS ↗

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

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

Participants with obesity with or without type 2 diabetes
Novo Nordisk A/S · 1140 participants

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

2025-522488-14-00 on CTIS ↗

Phase III Congenital, Hereditary, and Neonatal Diseases and Abnormalities Authorised 27/07/2026

4TAZPower: A Phase 3b/4, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Patients with Genetically Confirmed Barth Syndrome

Barth Syndrome
Stealth Biotherapeutics Inc. · 22 participants

📍 Ireland · Netherlands · France · Italy

2025-523837-25-00 on CTIS ↗

Phase III Neoplasms Authorised 27/07/2026

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

Small Cell Lung Cancer
AbbVie Deutschland GmbH & Co. KG · 125 participants

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

2025-523819-11-00 on CTIS ↗

Phase III Neoplasms Authorised 27/07/2026

An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients with Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease

Advanced or Metastatic HR+/HER2- Breast Cancer
BeOne Medicines I GmbH · 233 participants

📍 Poland · Italy · Germany · France · Spain

2025-523960-19-00 on CTIS ↗

Phase II Nervous System Diseases Authorised 24/07/2026

Evaluation of the effect of botulinum toxin on refractory upper limb rest tremor in parkinsonian patients, double-blind, placebo-controlled cross-over study : TOX PARK

parkinson disease
Centre Hospitalier Universitaire De Toulouse · 39 participants

📍 France

2026-525862-23-00 on CTIS ↗

Phase II Neoplasms Authorised 24/07/2026

DECREASE-IPC 2025-068 : De-Ecalating neoadjuvant Chemoimmunotherapy in early triple-negative BREASt cancer

triple‑negative breast cancer
Institut Paoli Calmettes · 84 participants

📍 France

2025-525040-18-00 on CTIS ↗

Phase II Not possible to specify Authorised 24/07/2026

functional imaging of digital osteoarthritis and rheumatoid arthritis using 99mTc-NTP15-5 in nuclear medicine : phase II clinical study

Arthritis rheumatoid and finger osteoarthritis
Centre Jean Perrin · 80 participants

📍 France

2025-523650-14-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 24/07/2026

An Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Salanersen (BIIB115) in Participants Aged 15-60 Years With Spinal Muscular Atrophy Who Are Either Treatment-Naïve or Have Previously Been Treated With Risdiplam

Spinal Muscular Atrophy
Biogen Idec Research Limited · 40 participants

📍 Finland · Spain · Italy · Poland · Ireland · Germany · France

2025-524054-34-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 24/07/2026

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

Chronic kidney disease (CKD) in adults, with specified ranges of eGFR and albuminuria (UACR), irrespective of T2DM status; background SGLT2i dapagliflozin 10 mg as GDMT.
AstraZeneca AB · 1600 participants

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

2025-523994-41-00 on CTIS ↗

Phase I/II Respiratory Tract Diseases Authorised 22/07/2026

A Phase 1/2, dose escalation and expansion study of TRI-611, an oral ALK molecular glue degrader in participants with advanced ALK-positive NSCLC

Advanced ALK-positive NSCLC
Triana Biomedicines Inc. · 4 participants

📍 France · Italy · Germany · Spain

2025-524418-27-00 on CTIS ↗

Phase I Neoplasms Authorised 21/07/2026

Phase 1/1b Study of BMS-986463 in Advanced Malignant Tumors

Advanced Malignant Tumors; High-grade Serous Ovarian Carcinoma (HGSOC), Uterine Serous Carcinoma (USC), Non-small Cell Lung Cancer (NSCLC)
Bristol-Myers Squibb Services Unlimited Company · 20 participants

📍 Spain · France · Italy

2025-523067-38-01 on CTIS ↗

Phase III Digestive System Diseases Authorised 21/07/2026

A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis

Primary Sclerosing Cholangitis
Ipsen Bioscience Inc. · 127 participants

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

2026-525242-29-00 on CTIS ↗

Phase I/II Neoplasms Authorised 21/07/2026

A Phase 1/2 First-Time-in-Human, open-label, multicenter, dose escalation and dose optimization study of GSK5471713 in adult participants with metastatic castration resistant prostate cancer (mCRPC).

Neoplasms, Prostate
Glaxosmithkline Research & Development Limited · 18 participants

📍 Netherlands · France · Spain

2025-523874-17-00 on CTIS ↗

Phase III Virus Diseases Authorised 21/07/2026

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to a Regimen of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination with Capsid Inhibitor Lenacapavir Twice Yearly in Virologically Suppressed Adults with HIV-1 Infection on Stable Oral Treatment Regimens

HIV-1
Gilead Sciences Inc. · 183 participants

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

2025-524336-19-00 on CTIS ↗

Phase III Virus Diseases Authorised 21/07/2026

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to Long-acting Antiretroviral Therapy of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination With the Capsid Inhibitor Lenacapavir Twice-Yearly Versus Cabotegravir and Rilpivirine Every 8 Weeks in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy

HIV-1
Gilead Sciences Inc. · 183 participants

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

2025-524335-39-00 on CTIS ↗

Phase III Skin and Connective Tissue Diseases Authorised 21/07/2026

A Phase 3, Double-blinded, Vehicle-controlled Trial to Investigate the Efficacy and Safety of Twice-daily Delgocitinib Cream in Adult Participants with Lichen Sclerosus During a 12-Week Initial Treatment Period Followed by a 40-Week Continuation Treatment Period

Lichen Sclerosus
Leo Pharma A/S · 205 participants

📍 Italy · France · Spain · Poland · Germany

2025-524873-17-00 on CTIS ↗

Phase II Neoplasms Authorised 21/07/2026

J2J-MC-JZLL - preEMBER: A Phase 2, Open-label Study Evaluating Imlunestrant in Premenopausal Women with Estrogen Receptor-Positive, HER2-Negative Breast Cancer.

Breast Neoplasms
Eli Lilly & Co. · 361 participants

📍 Belgium · France · Italy · Germany

2025-523258-15-00 on CTIS ↗

Phase II Bacterial Infections and Mycoses Authorised 20/07/2026

DOXYCYCLINE PENETRATION INTO BONE AND JOINT.

Patients requiring total hip arthroplasty for coxofemoral osteoarthritis
Centre Hospitalier Universitaire De Caen Normandie · 30 participants

📍 France

2025-524744-36-00 on CTIS ↗

Phase II Cardiovascular Diseases Authorised 20/07/2026

A Phase IIb, randomised, double-blind, placebo-controlled, multicentre study to evaluate the efficacy and safety of concomitant use of eplontersen and ALXN2220 compared with eplontersen and placebo in adult participants with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM).

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
AstraZeneca AB · 158 participants

📍 Germany · Italy · Spain · France · Sweden

2025-523908-75-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 20/07/2026

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

Huntington’s Disease
Novartis Pharma AG · 368 participants

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

2025-522227-99-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 20/07/2026

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. · 116 participants

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

2025-524711-36-00 on CTIS ↗

Phase II Nervous System Diseases Authorised 20/07/2026

A Phase 2a, multi centric, open label clinical study to explore the safety and tolerability, the pharmacokinetics and pharmacodynamics profile and first signs of efficacy of PTI5803 administered as adjunctive therapy with a 3-dose escalation regimen in patients >= 14 years of age with drug-resistant seizures associated to focal cortical dysplasia, followed by an optional open-label extension study.

Drug resistant seizures associated to Focal Cortical Dysplasia
PannTheraPi · 15 participants

📍 France

2026-525162-21-00 on CTIS ↗

Phase II Pathological Conditions, Signs and Symptoms Authorised 17/07/2026

SETRAPED : A prospective, multicenter study evaluating the efficacy and tolerance of transmucosal midazolam for proportionate palliative sedation in children with refractory symptoms

Children with refractory symptoms
Centre Leon Berard · 50 participants

📍 France

2025-523840-11-00 on CTIS ↗

Phase III Male Urogenital Diseases Authorised 16/07/2026

FOSFORMEN : Randomized, multicenter, non-inferiority trial comparing the efficacy of fosfomycin versus fluoroquinolones or cotrimoxazole as oral follow-up treatment in febrile urinary tract infections in men caused by susceptible enterobacteria

Febrile male urinary tract infections caused by Escherichia coli
Assistance Publique Hopitaux De Paris · 312 participants

📍 France

2026-525972-25-00 on CTIS ↗

Phase II Neoplasms Authorised 16/07/2026

PITALC. Pilot study on the effect of PITAC (Pressurized IntraThoracic Aerosol Chemotherapy) by videothoracoscopy in patients with malignant pleural effusion in the light of the results of a retrospective historical cohort treated with talc pleurodesis by videothoracoscopy

neoplastic pleural effusion
Hospices Civils De Lyon · 20 participants

📍 France

2025-523482-23-00 on CTIS ↗

Phase III Not possible to specify Authorised 16/07/2026

PROPHY-SEIN - Evaluation of the effect of antibiotic prophylaxis during lumpectomy for breast cancer: prospective randomised double-blind noninferiority study of placebo vs cefazolin

Breast Cancer
University Hospital Of Clermont-Ferrand · 1600 participants

📍 France

2025-525020-99-00 on CTIS ↗

Phase III Neoplasms Authorised 15/07/2026

A Phase 3, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants with Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy

Relapsed or refractory large B-cell lymphoma (r/r LBCL)
Kite Pharma Inc. · 192 participants

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

2025-524403-80-00 on CTIS ↗

Phase II Pathological Conditions, Signs and Symptoms Authorised 15/07/2026

Obinutuzumab for systemic lupus erythematosus pure membranous nephropathy: a phase II trial (OBLUMEN)

systemic lupus erythematosus pure membranous nephropathy
Assistance Publique Hopitaux De Paris · 65 participants

📍 France

2024-519985-35-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 14/07/2026

The MODIFY Study: A Phase 3b/4 randomized, double-blind, placebo-controlled, multicentre study evaluating the impact of early intervention with depemokimab on exacerbation rate, clinical remission, lung function decline, and safety in adults and adolescents with at risk Type 2 asthma, conducted up to 156 weeks.

Asthma
Glaxosmithkline Research & Development Limited · 229 participants

📍 Ireland · Spain · Germany · Czechia · Bulgaria · France · Belgium · Romania · Italy

2025-524463-20-00 on CTIS ↗

Phase II Nervous System Diseases Authorised 14/07/2026

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

Acute Ischemic Stroke
Takeda Development Center Americas Inc. · 67 participants

📍 Greece · Belgium · France · Germany

2025-522734-31-00 on CTIS ↗

Phase III Neoplasms Authorised 14/07/2026

A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan with or Without Bevacizumab Compared to Trifluridine/Tipiracil plus Bevacizumab in Participants with Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)

Metastatic colorectal cancer
Merck Healthcare KGaA · 323 participants

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

2025-524648-37-00 on CTIS ↗

Phase III Female Urogenital Diseases and Pregnancy Complications Authorised 14/07/2026

A Sequential Phase 2/3, Single-Arm, Open-Label Study in Adults Followed by a Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults and Adolescents with Focal Segmental Glomerulosclerosis

Focal segmental glomerulosclerosis (FSGS)
Apellis Pharmaceuticals Inc. · 97 participants

📍 France · Portugal · Spain · Slovakia · Italy · Germany · Poland

2025-524448-36-00 on CTIS ↗

Phase III Digestive System Diseases Authorised 14/07/2026

RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients with Metastatic Pancreatic Adenocarcinoma

Metastatic Pancreatic Adenocarcinoma
Revolution Medicines Inc. · 337 participants

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

2025-525088-34-00 on CTIS ↗

Phase II Immune System Diseases Authorised 13/07/2026

A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surovatamig in Adults with Antibody-mediated Kidney Disease

Antibody-mediated Kidney Disease
AstraZeneca AB · 17 participants

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

2025-524139-38-00 on CTIS ↗

Phase I/II Neoplasms Authorised 13/07/2026

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

Multiple Myeloma (MM), Multiple Myeloma (MM)
AbbVie Deutschland GmbH & Co. KG · 88 participants

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

2025-525105-20-00 on CTIS ↗

Phase I Neoplasms Authorised 13/07/2026

A Phase 1 Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies

Relapsed or Refractory acute myeloid leukemia, Relapsed or Refractory chronic lymphocytic leukemia, Relapsed or Refractory higher-risk myelodysplastic syndromes, Relapsed or Refractory small lymphocytic lymphoma
Janssen Cilag International · 175 participants

📍 France · Spain · Germany · Denmark · Belgium

2026-525234-39-00 on CTIS ↗

Phase II Neoplasms Authorised 09/07/2026

A Phase 2, Open-Label, Single-Arm Study of Lirafugratinib in Patients With Previously Treated, Unresectable, Locally Advanced or Metastatic Solid Tumors (Excluding Cholangiocarcinoma) With FGFR2 Fusion or Rearrangement

Previously Treated, Unresectable, Locally Advanced or Metastatic Solid Tumors (Excluding Cholangiocarcinoma) With FGFR2 Fusion or Rearrangement
Elevar Therapeutics Inc. · 14 participants

📍 France · Spain

2025-523923-22-00 on CTIS ↗

Phase III Neoplasms Authorised 08/07/2026

Fight Osteosarcoma Through European Research evolving study platform from diagnosis to relapse (FOSTER evolving study platform)

Osteosarcoma
Institut Gustave Roussy · 508 participants

📍 Sweden · Poland · Denmark · Finland · Netherlands · Italy · France · Spain

2023-505575-69-01 on CTIS ↗

Phase II Neoplasms Authorised 07/07/2026

A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination with Other Agents in Participants with Advanced and/or Metastatic Solid Tumors with Homozygous MTAP Deletion

Advanced and/or Metastatic Solid Tumors with Homozygous MTAP Deletion
Bristol-Myers Squibb Services Unlimited Company · 123 participants

📍 Belgium · Ireland · Germany · Norway · Italy · France · Spain

2025-524285-18-00 on CTIS ↗

Phase I/II Nutritional and Metabolic Diseases Authorised 07/07/2026

A PHASE 1/2 STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFECTS ON CLINICAL OUTCOMES OF PEGTIBATINASE (TVT-058) ADMINISTERED SUBCUTANEOUSLY IN SUBJECTS WITH CYSTATHIONINE BETASYNTHASE-DEFICIENT HOMOCYSTINURIA (COMPOSE)

Classical Homocystinuria
Travere Therapeutics Switzerland GmbH, Travere Therapeutics Inc. · 6 participants

📍 France

2023-509074-31-00 on CTIS ↗

Phase III Neoplasms Authorised 07/07/2026

C6461016 - A PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA

LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA
Pfizer Inc. · 91 participants

📍 France · Spain · Italy

2025-524717-86-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 07/07/2026

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

Fibrosing interstitial lung disease
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 20 participants

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

2025-523369-32-00 on CTIS ↗

Phase III Neoplasms Authorised 07/07/2026

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

Multiple Myeloma
F. Hoffmann-La Roche AG · 133 participants

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

2025-524028-23-00 on CTIS ↗

Phase III Neoplasms Authorised 06/07/2026

Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan in Combination with FOLFOX Compared to Standard of Care in Subjects with First-Line Metastatic Pancreatic Ductal Adenocarcinoma - AndroMETa-PDAC-288

Metastatic Pancreatic Ductal Adenocarcinoma; PDAC
AbbVie Deutschland GmbH & Co. KG · 194 participants

📍 Portugal · Spain · France · Italy · Germany · Austria

2025-522563-15-00 on CTIS ↗

Phase III Neoplasms Authorised 06/07/2026

TAILORswitch (PADA-2): rising ctDNA to tailor endocrine therapy switch in patients with ER+/HER2- metastatic breast cancer

Patients with advanced or metastatic ER+ HER2- breast cancer
Unicancer · 526 participants

📍 France

2025-524213-84-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 06/07/2026

Macroleave: Impact of discontinuation of long-term macrolides in stable Non Cystic Fibrosis Bronchiectasis : a multicenter randomized controlled trial

bronchiectasis unrelated to cystic fibrosis
Centre Hospitalier Intercommunal Creteil · 185 participants

📍 France

2025-521493-33-00 on CTIS ↗

Phase II Surgical Procedures, Operative Authorised 06/07/2026

Immunogenicity and safety of two respiratory syncytial virus vaccine strategies in lung and allogeneic haematopoietic stem cell transplant recipients: A phase 2 trial RSVaxID

allogeneic haematopoietic stem cell transplant recipient, lung transplant
Hospices Civils De Lyon · 400 participants

📍 France

2025-524374-42-00 on CTIS ↗

Phase II Therapeutics Authorised 06/07/2026

Shared decision-making in uncomplicated appendicitis: a pragmatic randomized trial comparing patient-driven choice (antibiotics only or appendectomy) with systematic appendectomy (FRENCH 47 — ALACARTE trial)

Adult patients diagnosed with uncomplicated acute appendicitis
Assistance Publique Hopitaux De Paris · 560 participants

📍 France

2025-520783-17-01 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 06/07/2026

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

Respiratory tract diseases
Sanofi-Aventis Recherche & Developpement · 613 participants

📍 Denmark · Sweden · Poland · Estonia · Portugal · Latvia · Spain · Hungary · Germany · Finland · Italy · Belgium · France

2024-518016-39-00 on CTIS ↗

Phase I/II Neoplasms Authorised 03/07/2026

A Phase 1b-2, Open-Label, Dose-Escalation, Expansion and Optimization Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of LRK-4189 Alone and in Combination with mFOLFOX6 or FOLFIRI in Patients with Solid Tumors

Solid tumors
Larkspur Biosciences Inc. · 80 participants

📍 France

2026-525629-20-00 on CTIS ↗

Phase II Hemic and Lymphatic Diseases Authorised 02/07/2026

Interleukin-1 inhibition to improve the response of myeloproliferative neoplasms resistant to cytoreductive treatment

myeloproliferative neoplasms
Centre Hospitalier Regional Et Universitaire De Brest · 50 participants

📍 France

2025-523921-17-00 on CTIS ↗

Phase II Diagnosis Authorised 02/07/2026

18F-fluoro-ethyl-tyrosine (18FET) PET for difficult clinical situations in functional pituitary adenoma. A prospective, single arm, single center study. (FET-PIT)

Patients (male or female) ≥18 years old with Suspected functional pituitary adenoma (prolactinoma, Cushing's disease, acromegaly, thyrotropic adenoma), de novo or recurrence/persistence, With indeterminate pituitary MRI.
Centre Hospitalier Universitaire De Lille · 30 participants

📍 France

2025-523829-17-00 on CTIS ↗

Phase II Neoplasms Authorised 02/07/2026

IFCT-2501 IDEATION ctDNA-guIDEd consolidATION immunotherapy after chemoradiotherapy in patients with stage III non-small cell lung cancer

Stage III Non Small Cell Lung Cancer
Intergroupe Francophone De Cancerologie Thoracique · 177 participants

📍 France

2025-522801-39-00 on CTIS ↗

Phase I/II Neoplasms Authorised 01/07/2026

A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE849 in Patients with DLL3 Expressing Tumors Including Small Cell Lung Cancer

DLL3 Expressing Tumors Including Small Cell Lung Cancer
Ideaya Biosciences Inc. · 35 participants

📍 France · Spain

2025-523438-24-00 on CTIS ↗

Phase III Neoplasms Authorised 01/07/2026

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

Relapsed or Refractory Multiple Myeloma
Janssen Cilag International · 206 participants

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

2025-523815-12-00 on CTIS ↗

Phase III Neoplasms Authorised 01/07/2026

A Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment After 2L PlatinumBased Doublet Chemotherapy in Participants With Recurrent Platinum-Sensitive Ovarian Cancer (PSOC)

Ovarian Cancer Platinum-Sensitive Ovarian Cancer (PSOC)
Genmab A/S · 257 participants

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

2025-522167-15-00 on CTIS ↗

Phase I/II Neoplasms Authorised 30/06/2026

A Phase 1/2 Study of Inhaled KB707 in Patients with Advanced Solid Tumor Malignancies Affecting the Lungs

solid tumor
Krystal Biotech Inc. · 40 participants

📍 France · Spain

2025-522723-98-00 on CTIS ↗

Phase III Immune System Diseases Authorised 30/06/2026

Phase III, Open-label Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, Efficacy, and Immunogenicity of Benralizumab in Children with Eosinophilic Disease (CLIPS)

Eosinophilic Disease
AstraZeneca AB · 7 participants

📍 Poland · Netherlands · France

2023-508533-14-00 on CTIS ↗

Phase III Neoplasms Authorised 30/06/2026

A Phase 3 Multicenter Double-blind Randomized Study of Taletrectinib Versus Placebo in Patients With ROS1-Fusion Positive Stage IB-IIIA Non-Small Cell Lung Cancer Who Have Undergone Complete Tumor Resection

Non Small Cell Lung Cancer (NSCLC)
Nuvation Bio Inc. · 45 participants

📍 Spain · Belgium · France · Italy · Germany

2025-521971-29-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 30/06/2026

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

Pulmonary Hypertension Associated with Interstitial Lung Disease
Insmed Inc. · 165 participants

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

2025-521769-29-00 on CTIS ↗

Phase I/II Nervous System Diseases Authorised 30/06/2026

Phase 1-2, Open-Label, Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally-Administered ION337 in Patients with Dravet Syndrome

Dravet Syndrome
Ionis Pharmaceuticals Inc. · 12 participants

📍 Spain · France · Belgium · Portugal · Germany

2025-523835-20-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 30/06/2026

A Phase 2/3 Study to Characterize and Evaluate the Efficacy, Safety, and Tolerability of hu14.18K322A Treatment Given in Combination with Chemotherapy in Participants with High-Risk Neuroblastoma

Participants with relapsed HRNB and participants with HRNB refractory to treatment The clinical trial will recruit participants aged ≥18 months to <18 years, and therefore all participants will be minors at the time of consent.
Renaissance Pharma Limited · 111 participants

📍 Spain · France · Denmark · Ireland · Germany

2025-524397-42-00 on CTIS ↗

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

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

Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease
Merck Healthcare KGaA · 57 participants

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

2025-524855-30-00 on CTIS ↗

Phase III Immune System Diseases Authorised 29/06/2026

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

Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease
Merck Healthcare KGaA · 54 participants

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

2025-523871-44-00 on CTIS ↗

Phase III Not possible to specify Authorised 29/06/2026

Methoxyflurane versus Standard Care for Non-Traumatic Pain in the Emergency Department (PAIN-THROX) : A Multicenter, Randomized, Controlled, Superiority Trial

Non-traumatic pain
Centre Hospitalier Regional Universitaire De Tours · 164 participants

📍 France

2025-525001-21-00 on CTIS ↗

Phase II Neoplasms Authorised 29/06/2026

C6461014 - A Phase 2 Interventional Study of PF-08634404 in Combination with Chemotherapy in Participants with Previously Untreated Transformed Small Cell Lung Cancer

Small Cell Lung Cancer
Pfizer Inc. · 15 participants

📍 France · Italy · Spain

2025-524686-24-00 on CTIS ↗

Phase II Mental Disorders Authorised 29/06/2026

Randomised open-label pilot Study on Thiamine supplementation to REduce braiN injury associated with chronic Alcohol use in outpatients with alcohol use disorder : STRENA

Alcoholism
Institut National De La Sante Et De La Recherche Medicale · 60 participants

📍 France

2025-524148-36-00 on CTIS ↗

Phase I/II Neoplasms Authorised 29/06/2026

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

Solid Tumors
Revolution Medicines Inc. · 252 participants

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

2025-524623-50-00 on CTIS ↗

Phase II Immune System Diseases Authorised 29/06/2026

A Phase 2 Randomized, Double-blind, Placebo-Controlled Study to Assess the Safety and Efficacy of MTX-474 in the Treatment of Participants with Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Diffuse Cutaneous Systemic Sclerosis (dcSSc)
Mediar Therapeutics Inc. · 36 participants

📍 Netherlands · Romania · Poland · France · Italy · Spain

2025-523288-39-00 on CTIS ↗

Phase III Neoplasms Authorised 26/06/2026

A Randomized, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303)

Pancreatic Ductal Adenocarcinoma
Incyte Corp. · 239 participants

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

2025-525009-18-00 on CTIS ↗

Phase I Neoplasms Authorised 26/06/2026

A Phase 1 Study of BMS-986460 in Metastatic Castration-resistant Prostate Cancer

Metastatic Castration-resistant Prostate Cancer
Bristol-Myers Squibb Services Unlimited Company · 22 participants

📍 France

2024-513987-24-00 on CTIS ↗

Phase II Eye Diseases Authorised 25/06/2026

An open-label multiple dose safety, tolerability and exploratory efficacy clinical trial of PST-611 in patients with geographic atrophy secondary to age-related macular degeneration

Geographic atrophy secondary to age-related macular degeneration
PulseSight Therapeutics · 24 participants

📍 France

2025-525008-12-00 on CTIS ↗

Phase IV Diagnosis Authorised 25/06/2026

ECETEP : Pilot study evaluating PSMA positron emission tomography for monitoring clinically significant prostate cancer after focal HIFU treatment

prostate cancer
Centre Hospitalier Universitaire De Toulouse · 30 participants

📍 France

2026-525181-22-00 on CTIS ↗

Phase III Immune System Diseases Authorised 24/06/2026

A PHASE III, OPEN-LABEL, SINGLE-ARM, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND USE OF AN ON-BODY DELIVERY SYSTEM FOR THE SUBCUTANEOUS HOME ADMINISTRATION OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS

Multiple Sclerosis
F. Hoffmann-La Roche AG · 54 participants

📍 Spain · France · Poland · Italy

2025-523726-40-00 on CTIS ↗

Phase III Mental Disorders Authorised 24/06/2026

Women victims of violences : PTSD treatment by traumatic memory reactivation under the influence of propranolol (VIOFEM)

Post-traumatic stress disorder (PTSD)
Centre Hospitalier Universitaire De Toulouse · 76 participants

📍 France

2025-523107-30-01 on CTIS ↗

Phase I Immune System Diseases Authorised 24/06/2026

THERIPEX - A phase I/II open label non-randomized study, monocentric, single-arm, evaluating Safety and Efficacy of induced T-CD4 Treg by LV vector transduction expressing the FoxP3 cDNA in patients with IPEX syndrom

IPEX syndrome is a primary immunodeficiency caused by hemizygous mutations in the gene FOXP3, which encodes an essential transcription factor required to maintain immunological tolerance by thymus-derived regulatory T (Treg) cells., Patients affected by IPEX syndrome, proven by molecular diagnosis, with any active autoimmune complications or controlled under immunosuppressive therapy can be enrolled in this trial.
Assistance Publique Hopitaux De Paris · 5 participants

📍 France

2025-523305-15-00 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 Musculoskeletal Diseases Authorised 23/06/2026

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

Small for gestational age (SGA) and idiopathic short stature (ISS)
Schneider Children's Medical Center Of Israel · 95 participants

📍 Greece · Poland · France · Czechia

2025-523832-38-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 23/06/2026

ECSIP : Early Corticosteroids in Severe Influenza Pneumonia, a phase III randomized controlled trial

patients with influenza-induced acute hypoxemic respiratory failure
Centre Hospital Region Metz Thionville · 544 participants

📍 France

2025-524976-40-00 on CTIS ↗

Phase II Nervous System Diseases Authorised 23/06/2026

An Open-Label Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis (RRMS)
F. Hoffmann-La Roche AG · 9 participants

📍 Poland · Germany · France

2025-524164-37-00 on CTIS ↗

Phase III Immune System Diseases Authorised 22/06/2026

A Phase 3 Extension Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema

Hereditary Angioedema
Adarx Pharmaceuticals Inc. · 45 participants

📍 Poland · Italy · Hungary · France · Austria · Czechia · Belgium · Spain · Bulgaria · Germany · Croatia

2025-521353-16-00 on CTIS ↗

Phase I/II Neoplasms Authorised 22/06/2026

Exploratory study of the performance of dynamic PET-CT acquisition to predict 6-month morphological response in patients with hepatocellular carcinoma treated with selective internal radiotherapy

HCC – Hepatocellular Carcinoma
Centr Georges Francois Leclerc · 30 participants

📍 France

2026-526324-48-00 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 Neoplasms Authorised 22/06/2026

An Open-label, Single-Arm, Phase 2 Study to Evaluate Enfortumab Vedotin plus Pembrolizumab for Bladder Preservation in Participants with Muscle-invasive Bladder Cancer (EV-209).

Muscle-invasive Bladder Cancer
Astellas Pharma Global Development Inc. · 88 participants

📍 Germany · France · Poland · Italy · Spain

2025-524488-18-00 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 II Neoplasms Authorised 22/06/2026

Open-Label Extension Study to Provide Continued Access to Avutometinib Alone or in Combination with Defactinib in Patients with Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
Verastem Inc. · 4 participants

📍 France

2025-524713-88-00 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 Nervous System Diseases Authorised 22/06/2026

A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 for the Treatment of Narcolepsy with Cataplexy (Narcolepsy Type 1)

Narcolepsy with Cataplexy (NT1)
Takeda Development Center Americas Inc. · 69 participants

📍 Spain · Italy · France

2025-522587-33-00 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 III Immune System Diseases Authorised 19/06/2026

A Phase 3, Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of BMS-986353, CD19-targeted NEX-T CAR T Cells, Versus Standard of Care in Participants with Active Systemic Sclerosis (Breakfree-SSc)

Systemic Sclerosis
Celgene Corp. · 33 participants

📍 Spain · Germany · France · Italy

2025-524337-11-00 on CTIS ↗

Phase I/II Congenital, Hereditary, and Neonatal Diseases and Abnormalities Authorised 18/06/2026

Long-term Follow-up (LTFU) Study of Participants in any iECURE Protocol Using an Investigational Product

Ornithine Transcarbamylase Deficiency (OTC)
Iecure Inc. · 3 participants

📍 Spain · France

2024-514190-21-00 on CTIS ↗

Phase II Nervous System Diseases Authorised 18/06/2026

A randomized, double-blind, placebo-controlled, 104-week proof-of-concept study to evaluate the efficacy of intravenous prasinezumab in participants with Parkinson's disease carrying a severe mutation in the GBA gene (prevent cognitive decline in GBA-associated PD)

PARKINSON’S DISEASE
Universitaetsklinikum Tuebingen AöR · 110 participants

📍 Spain · Germany · Italy · Sweden · France · Luxembourg

2024-513496-40-00 on CTIS ↗

Phase II Musculoskeletal Diseases Authorised 17/06/2026

Preventive effect of 5% lidocaine patch on the development of neuropathic pain following an osteoporotic vertebral fracture: A proof-of-concept, controlled, randomized trial

Osteoporotic Fracture
University Hospital Of Clermont-Ferrand · 30 participants

📍 France

2025-524889-25-00 on CTIS ↗

Phase IV Digestive System Diseases Authorised 17/06/2026

STOP - Safety and efficacy of a STOPping strategy versus classical maintenance dose of JAK inhibitors in deep remission patients with ulcerative colitis: a randomized controlled trial

ulcerative colitis
Centre Hospitalier Regional De Marseille · 224 participants

📍 France

2026-525643-32-00 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 Skin and Connective Tissue Diseases Authorised 17/06/2026

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

Systemic sclerosis
Galderma S.A. · 56 participants

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

2025-522294-11-00 on CTIS ↗

Phase I Neoplasms Authorised 16/06/2026

Open-label study of BBO-11818 in adult subjects with KRAS mutant cancer

Solid Tumors
Theras Inc. · 2999997 participants

📍 Spain · Italy · France

2025-524690-16-00 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 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 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 Cardiovascular Diseases Authorised 15/06/2026

Achieve - ACetazolamide in patients with Heart failure, to decrease weight and relIEVE symptoms

Heart failure
Centre Hospitalier Universitaire De Montpellier · 1050 participants

📍 France

2025-524344-35-00 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 IV Immune System Diseases Authorised 15/06/2026

Real-World Effectiveness and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy (C3G) or Primary Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN): A Multi-Country Study (PRISMC3)

Primary Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN), C3 Glomerulopathy (C3G)
Swedish Orphan Biovitrum AB (publ) · 69 participants

📍 France · Italy · Spain · Germany

2025-524487-37-00 on CTIS ↗

Phase II Diagnosis Authorised 13/06/2026

Exploratory study evaluating the relevance of [68Ga]Ga-FAPI-46 for staging and identifying progressing patients with transthyretin cardiac amyloidosis

Transthyretin cardiac amyloidosis
Centre Hospitalier Universitaire De Nantes · 40 participants

📍 France

2025-523616-36-00 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 I Not possible to specify Authorised 12/06/2026

A Safety Study to Test a New Medicine (ANT3310) Alone and When Taken with an Antibiotic (Meropenem) in Healthy Adult Participants.

Not applicable for phase I study
Antabio · 40 participants

📍 France

2026-526411-11-00 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 II Neoplasms Authorised 11/06/2026

A Phase 2, Open-Label, Multicenter, Randomized Study to Evaluate Denikitug as Monotherapy or in Combination With Nivolumab or Chemotherapy in Participants With HER2-Negative, Unresectable, Recurrent, and/or Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas

HER2-negative, unresectable, recurrent, and/or metastatic gastric, GEJ, and esophageal adenocarcinomas
Gilead Sciences Inc. · 45 participants

📍 Spain · France

2025-524095-27-00 on CTIS ↗

Phase I/II Not possible to specify Authorised 10/06/2026

ACTIVATE - Phase 1 Clinical Trial evaluating the combination of Actinomycin D and venetoclax in patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)

Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)
Assistance Publique Hopitaux De Paris · 36 participants

📍 France

2025-524728-22-01 on CTIS ↗

Phase III Neoplasms Authorised 10/06/2026

First adjuvant trial in locally resected aggressive pancreatic neuroendocrine tumors: a randomized phase III investigating the efficacy of systemic chemotherapy (ADJUPANET)

Pancreatic NeuroEndocrine Tumors (PanNET) ; Aggressive stage I-III well differentiated R0 resected
Institut Gustave Roussy · 504 participants

📍 France

2025-523593-16-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 10/06/2026

J6E-MC-KWAM: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Development Program to Evaluate the Efficacy and Safety of LY4268989 (MORF-057) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis (EMERALD-3)

Ulcerative Colitis, Active Severe, Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
Eli Lilly & Co. · 104 participants

📍 Latvia · Portugal · Greece · France · Czechia · Italy · Poland · Slovakia · Hungary · Croatia · Lithuania

2025-524404-29-00 on CTIS ↗

Phase III Neoplasms Authorised 09/06/2026

Long-term follow-up study of patients who have previously been exposed to UCART19 (allogeneic engineered T-cells expressing a lentiviral-based anti-CD19 chimeric antigen receptor)

Advanced lymphoid leukemia
Institut De Recherches Internationales Servier IRIS · 1 participants

📍 France

2026-526212-37-00 on CTIS ↗

Phase III Neoplasms Authorised 09/06/2026

A Phase 2/3 randomized, open-label study of MK-1045 in combination with rituximab in patients with 1L follicular lymphoma.

Follicular Lymphoma
Merck Sharp & Dohme LLC · 9 participants

📍 France · Spain · Greece

2025-522777-10-00 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 Cardiovascular Diseases Authorised 08/06/2026

A Phase 2b/3, Randomized, Double-Blinded, Placebo Controlled Study ChecKing the Efficacy and Safety of ATAciguat to Slow the Progression of VaLvular DYsfunction in Participants with Moderate Calcific Aortic Valve STenosis (KATALYST-AV)

Moderate Calcific Aortic Valve Stenosis (CAVS)
Kardigan Inc. · 496 participants

📍 Norway · Czechia · Portugal · Austria · Poland · France · Spain

2025-522176-86-01 on CTIS ↗

Phase I/II Neoplasms Authorised 08/06/2026

A Phase 1b/2 Open-label Study Evaluating different MK-6070 and Ifinatamab Deruxtecan (MK-2400)-based regimens in First-line Extensive Stage Small Cell Lung Cancer

Small cell lung cancer extensive stage
Merck Sharp & Dohme LLC · 79 participants

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

2025-521032-11-00 on CTIS ↗

Phase I Mental Disorders Authorised 08/06/2026

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ST‑905‑AG1 in Healthy Volunteers

Schizophrenia
Syremis Therapeutics Ltd. · 280 participants

📍 France

2026-525700-10-00 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 Neoplasms Authorised 08/06/2026

A Phase 2, Open Label, Multicenter, Randomized Study, to Evaluate the Efficacy and Safety of Denikitug Monotherapy and Denikitug-based Combinations in Participants With Advanced Microsatellite Stable (MSS) Colorectal Cancer (CRC).

Advanced Microsatellite Stable (MSS) Colorectal Cancer (CRC)
Gilead Sciences Inc. · 94 participants

📍 Spain · Italy · France

2025-523984-39-00 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 Respiratory Tract Diseases Authorised 08/06/2026

C4531031 - AN INTERVENTIONAL PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, THIRD PARTY-UNBLINDED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF PF-07275315 IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Pfizer Inc. · 318 participants

📍 Spain · Germany · Poland · Czechia · Greece · Italy · Bulgaria · France · Hungary

2024-518587-12-00 on CTIS ↗

Phase IV Immune System Diseases Authorised 08/06/2026

PREP-ANCA - Comparison of a strategy based on clinic-biological surveillance versus pre-emptive treatment with rituximab in the event of ANCA (anti-neutrophil cytoplasm antibodies) repositivation in patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)

granulomatosis with polyangiitis and microscopic polyangiitis
Assistance Publique Hopitaux De Paris · 70 participants

📍 France

2025-522049-23-00 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 Anesthesia and Analgesia Authorised 05/06/2026

OFA-VATS : Impact of opioid free anesthesia on postoperative quality of recovery and analgesia after video or robot assisted thoracic surgery

indication for pulmonary resection surgery (segmentectomy or lobectomy), video-assisted thoracoscopy or scheduled robot-assisted surgery.
Centre Hospitalier Universitaire De Rennes · 176 participants

📍 France

2025-524240-35-00 on CTIS ↗

Phase III Mental Disorders Authorised 05/06/2026

ERPPAD - Efficacy in Relapse Prevention: Psilocybin in Alcohol use disorder with Depressive symptoms

Alcohol use disorder, depressive symptoms
Centre Hospitalier Universitaire De Nimes · 172 participants

📍 France

2025-525069-65-00 on CTIS ↗

Phase III Neoplasms Authorised 05/06/2026

PACHA-02_Postoperative hepatic arterial chemotherapy after resection of colorectal liver metastases in patients at high risk of recurrence

Participants with R0/R1 resected liver metastases from colorectal cancer (CRLM).
Unicancer · 272 participants

📍 France

2025-523913-27-00 on CTIS ↗

Phase IV Bacterial Infections and Mycoses Authorised 05/06/2026

ANTIMIDIS - Cefazolin mediastinal distribution using microdialysis

Infection prophylaxis
Assistance Publique Hopitaux De Paris · 10 participants

📍 France

2025-521988-13-00 on CTIS ↗

Phase II Investigative Techniques Authorised 05/06/2026

Phase IIb Multicenter Randomized Controlled Trial Evaluating the Efficacy of Sivelestat in Patients with Septic Coagulopathy

Septic Coagulopathy
Les Hopitaux Universitaires De Strasbourg · 120 participants

📍 France

2025-523397-16-00 on CTIS ↗

Phase III Eye Diseases Authorised 05/06/2026

A randomized double-masked, multicenter, 3-arm, pivotal Phase 2/3 study to evaluate the efficacy and safety of intravitreal (IVT) EYE201/MK-8748 compared to aflibercept (2 mg) in participants with neovascular age-related macular degeneration (NVAMD)

Neovascular age-related macular degeneration (NVAMD)
Eyebiotech Limited · 250 participants

📍 Austria · Slovakia · Portugal · Czechia · Hungary · Spain · France · Denmark · Italy · Croatia

2025-524894-17-00 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. · 106 participants

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

2025-523912-35-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 04/06/2026

TicAgreLor versus placebo to prevent cerebral ISCHemia in anEuRysmal low grade SAH A double blinded randomised controlled study TALISCHER - SAH

Aneurysmal subarachnoid hemorrhage
Centre Hospitalier Universitaire De Toulouse · 274 participants

📍 France

2023-509795-42-00 on CTIS ↗

Phase I/II Neoplasms Authorised 04/06/2026

REGENOVAR: A Phase I/II Study of Ubamatamab Plus Carboplatin, Paclitaxel, and Bevacizumab as Salvage Therapy in Ovarian Cancer with Poor Response to First-Line Chemotherapy.

Patients with poor prognostic ovarian cancers based on the tumor primary chemonsensitivity and incomplete debulking surgery.
Asso De Recherche Cancers Gynecologiques · 43 participants

📍 France

2025-524232-20-00 on CTIS ↗

Phase I/II Neoplasms Authorised 02/06/2026

A Phase 1/2, Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamic, and Antitumor Activity of CR-001 in Adult Participants with Locally Advanced or Metastatic Solid Tumors.

Locally Advanced or Metastatic Solid Tumors
Crescent Biopharma Inc. · 180 participants

📍 Spain · Ireland · Italy · France · Romania

2025-523590-42-00 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 Immune System Diseases Authorised 02/06/2026

Multinational, Interventional, 52-week, Open-label, Single-arm Study to Evaluate the Treatment Outcomes of Anifrolumab 120 mg Subcutaneous Once Weekly in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus (SUNFLOWER)

Systemic lupus erythematosus
AstraZeneca AB · 108 participants

📍 Poland · Germany · Italy · France · Spain

2025-523670-17-00 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 III Respiratory Tract Diseases Authorised 01/06/2026

A double-dummy, double-blind, randomized, active controlled, two-way cross-over study with 12-week treatment duration per period, to evaluate the efficacy and safety of QVM149 (indacaterol acetate / glycopyrronium bromide / mometasone furoate) compared to salmeterol xinafoate/fluticasone propionate in children from 12 years to less than 18 years of age with asthma.

Asthma
Novartis Pharma AG · 68 participants

📍 Poland · France · Slovakia · Spain · Hungary · Germany · Romania

2022-502365-26-00 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 01/06/2026

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination with Rituximab and Bendamustine (BR) vs. BR in Subjects with Treatment-Naїve Mantle Cell Lymphoma

Treatment-naїve mantle cell lymphoma (MCL)
Innocare Pharma Inc. · 102 participants

📍 Poland · France · Czechia · Spain · Romania

2025-524241-27-00 on CTIS ↗

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

MOOD - MethOxyflurane analgesia in vasoOcclusive crises of sickle cell Disease

Sickle cell disease
Assistance Publique Hopitaux De Paris · 198 participants

📍 France

2024-518043-38-00 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 II Nervous System Diseases Authorised 29/05/2026

Intravenous iron in the management of drug-resistant restless legs syndrome: a randomized controlled delayed-start trial. IRON-RLS

Restless legs syndrome
Centre Hospitalier Universitaire De Montpellier · 60 participants

📍 France

2026-525613-31-00 on CTIS ↗

Phase IV Cardiovascular Diseases Authorised 29/05/2026

Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery: Impact on Postoperative Cardiovascular Outcomes – DISCO Study

heart failure
Centre Hospitalier Universitaire De Toulouse · 458 participants

📍 France

2025-524395-30-00 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 Musculoskeletal Diseases Authorised 29/05/2026

Pilot study comparing the efficacy of intra-articular glenohumeral injection combined with suprascapular nerve block versus intra-articular glenohumeral corticosteroid injection in adhesive capsulitis.

Retractile Capsulitis
Centre Hospitalier Universitaire De Nantes · 38 participants

📍 France

2026-525317-31-00 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 Neoplasms Authorised 28/05/2026

Phase II Clinical Trial of KORTUC (KRC-01) Combined with Radiotherapy for Locally Advanced Rectal Cancer: Towards a New Organ Preservation Approach (K-BOOST)

Locally advanced high‑risk stage III rectal adenocarcinoma (non‑metastatic)
Institut Gustave Roussy · 24 participants

📍 France

2025-524378-40-00 on CTIS ↗

Phase II Neoplasms Authorised 28/05/2026

A Phase 2A/B, Multi-center, Open-Label Study Evaluating the Efficacy and Safety of Dabogratinib (TYRA-300) in Participants with Low Grade Upper Tract Urothelial Carcinoma (SURF303)

Low Grade Upper Tract Urothelial Carcinoma
Tyra Biosciences Inc. · 34 participants

📍 Bulgaria · France · Spain

2025-523539-20-00 on CTIS ↗

Phase I/II Neoplasms Authorised 28/05/2026

A Phase 1b/2 Study to Evaluate the Safety and Efficacy of MK‑1045 Monotherapy or in Combination with Other Anticancer Agents in Participants with Non-Hodgkin Lymphoma

Non-Hodgkin Lymphoma
Merck Sharp & Dohme LLC · 73 participants

📍 Poland · Italy · France · Germany · Spain

2025-523005-15-00 on CTIS ↗

Phase II Respiratory Tract Diseases Authorised 27/05/2026

Efficacy of an anti-TSLP monoclonal antibody in the management of chronic bronchial disease induced by bronchiolitis obliterans syndrome in allogeneic hematopoietic stem cells transplantation recipients.

The medical condition studied in IMMUNO-BOS is Bronchiolitis obliterans syndrome (BOS) after allogeneic stem cell transplantation
Hospital Foch · 36 participants

📍 France

2024-516796-33-00 on CTIS ↗

Phase I/II Neoplasms Authorised 27/05/2026

A Phase I/II open label study of DJI136, a DLL3-targeted CAR-T therapy, in adult patients with ES-SCLC

Extensive stage small cell lung cancer
Novartis Pharma AG · 25 participants

📍 Spain · France

2025-523276-23-00 on CTIS ↗

Phase II Immune System Phenomena 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 I/II Neoplasms Authorised 27/05/2026

Phase 1b/2 Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Previously Treated Unresectable Advanced or Metastatic Sarcomas

Sarcoma
Glaxosmithkline Research & Development Limited · 14 participants

📍 France

2025-523997-18-00 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 II Mental Disorders Authorised 27/05/2026

An Open-Label Study to Assess the Long-Term Safety and Tolerability of ML-007C-MA in Adult Participants with Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis

Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis
Maplight Therapeutics Inc. · 85 participants

📍 Italy · Poland · Czechia · Portugal · Bulgaria · France · Slovakia · Romania · Hungary

2025-521757-16-00 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 · 22 participants

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

2025-522339-32-00 on CTIS ↗

Phase II Musculoskeletal Diseases Authorised 26/05/2026

POMREP - Efficacy and safety of zoledronate versus placebo on pain at week 12 in pediatric patients with chronic recurrent multifocal osteomyelitis resistant to non-steroidal anti-inflammatory drug

Chronic recurrent multifocal osteomyelitis (CRMO)
Assistance Publique Hopitaux De Paris · 30 participants

📍 France

2023-506420-93-00 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. · 80 participants

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

2025-524040-35-00 on CTIS ↗

Phase II Hemic and Lymphatic Diseases Authorised 25/05/2026

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma (r/r MM)

relapsed/refractory multiple myeloma
C4 Therapeutics Inc. · 43 participants

📍 Italy · France · Spain · Poland

2025-524181-26-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 22/05/2026

Comparison of iodinated contrast media injection protocols with reduced flow rates and volumes on image quality in diagnostic cerebral angiography for the evaluation of unruptured intracranial aneurysms: towards a standardization of practices (OPIAC)

Intracranial aneurysms
Les Hopitaux Universitaires De Strasbourg · 244 participants

📍 France

2025-524884-18-01 on CTIS ↗

Phase II Neoplasms Authorised 22/05/2026

UNLOCK - EPIBREAST, a phase II study of prifetrastat (PF-07248144), a KAT6 inhibitor, plus fulvestrant for advanced HR+/HER2- breast cancer with biomarkers analysis

Adult patients with advanced hormone receptor positive (HR+), HER2- breast cancer after at least a first line of endocrine therapy combined with CDK4/6 inhibitor in the metastatic setting
Unicancer · 51 participants

📍 France

2025-521982-29-00 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 I/II Neoplasms Authorised 22/05/2026

A 2-part phase 1/2 open-label trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ODM-212 in combination with anti-cancer therapy in participants with advanced solid tumours

Neoplasms benign malignant and unspecified (incl. cysts and polyps)
Orion Corporation · 85 participants

📍 Finland · Denmark · Spain · France

2025-524620-22-00 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. · 96 participants

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

2025-524367-20-00 on CTIS ↗

Phase I Neoplasms Authorised 21/05/2026

First time in human (FTIH) study to investigate the safety and preliminary activity of GSK5533524 alone or in combination in adult participants with advanced solid tumors

Neoplasms
Glaxosmithkline Research & Development Limited · 52 participants

📍 Spain · Denmark · Finland · France

2025-524165-25-00 on CTIS ↗

Phase II Eye Diseases Authorised 20/05/2026

An Open-Label, Rollover Study for Participants With Thyroid Eye Disease Previously Enrolled in Amgen-Sponsored AMG 732 Studies and are Primary Proptosis Non-responders or who Relapsed During the Safety Follow-up

Thyroid Eye Disease
Amgen Inc. · 8 participants

📍 Spain · Poland · France · Italy

2025-523280-38-00 on CTIS ↗

Phase III Skin and Connective Tissue Diseases Authorised 20/05/2026

An open-label, multi-center protocol for patients who have completed a previous Novartis sponsored remibrutinib study and are judged by the investigator to benefit from continued treatment with remibrutinib

Chronic Spontaneous Urticaria
Novartis Pharma AG · 154 participants

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

2025-524078-40-00 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 III Neoplasms Authorised 19/05/2026

Phase III Randomized, International, Open-Label Clinical Trial of Treatment Intensification with Docetaxel plus Apalutamide in Patients with Metastatic Hormone-Sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment with Apalutamide: REINFORCE Trial

Metastatic hormone-sensitive prostate cancer
Alianza Multidisciplinar Para La Investigacion De Los Tumores Genitourinarios Guard · 292 participants

📍 Spain · Germany · France · Portugal · Italy

2025-524408-30-01 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

Beamion 44: A randomized, open-label, multi-center Phase IIa platform trial to evaluate the safety and tolerability of zongertinib plus Pt-doublet with or without pembrolizumab (and potential other combinations) in treatment-naïve patients with locally advanced/metastatic non-squamous NSCLC with activating HER2 mutations

locally advanced or metastatic NSCLC
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 19 participants

📍 Germany · France · Spain

2025-523567-38-00 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 III Bacterial Infections and Mycoses Authorised 18/05/2026

Efficacy of Temocillin compared to standard of care in the Treatment of Neisseria gonorrhoeae Infections: A Multicenter Randomized Controlled Non-Inferiority Trial (TEMtoGo).

Neisseria gonorrhoeae Infections
Assistance Publique Hopitaux De Paris · 360 participants

📍 France

2025-524475-23-00 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 III Respiratory Tract Diseases Authorised 18/05/2026

EPISSOC : Randomized controlled trial comparing an Early Pleural Irrigation strategy with Saline to the Standard of Care for the management of complicated pleural infections

Pleural infections
Centre Hospitalier Universitaire Amiens Picardie · 244 participants

📍 France

2025-524697-42-00 on CTIS ↗

Phase II Nutritional and Metabolic Diseases Authorised 18/05/2026

INCREDIBLE: INCREmental DIalysis and diet for a Better Life Experience; Clinical relevance of an “add-on” Ketosteril supplementation on incremental haemodialysis period in incident haemodialysis patients. An exploratory randomized controlled trial

Incremental Haemodialysis
Centre Hospitalier Le Mans · 70 participants

📍 France

2025-524093-41-00 on CTIS ↗

Phase II Bacterial Infections and Mycoses Authorised 18/05/2026

Multicentre study evaluating the efficacy of a 7-day course of doxycycline for the treatment of asymptomatic anal lymphogranuloma venereum SHORT-LGV

Asymptomatic anal LGV infection
Centre Hospitalier Universitaire De Bordeaux · 120 participants

📍 France

2025-524978-42-00 on CTIS ↗

Phase I/II Hemic and Lymphatic Diseases Authorised 18/05/2026

mRNA Therapy to restore lymphatic flow in secondary lymphedema

Lymphedema
Centre Hospitalier Universitaire De Toulouse · 9 participants

📍 France

2024-520149-22-00 on CTIS ↗

Phase IV Neoplasms Authorised 18/05/2026

Prognostic value of early assessment by ⁶⁸Ga-DOTATATE PET/CT for the treatment of well-differentiated grade 2 gastroenteropancreatic neuroendocrine tumors with ¹⁷⁷Lutetium-oxodotreotide.”

Gastroenteropancreatic neuroendocrine tumors
Centre De Lutte Contre Le Cancer Eugene Marquis · 40 participants

📍 France

2025-524942-87-00 on CTIS ↗

Phase II Neoplasms Authorised 18/05/2026

A Phase 2 Study to Evaluate the Safety and Efficacy of Telisotuzumab Adizutecan for the Treatment of Subjects with Locally Advanced or Metastatic Solid Tumors that Harbor MET Amplification

Locally Advanced or Metastatic Solid Tumours that harbour MET Amplification gene
AbbVie Deutschland GmbH & Co. KG · 29 participants

📍 Spain · France · Denmark

2024-518871-74-00 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 · 15 participants

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

2025-522138-29-00 on CTIS ↗

Phase IV Respiratory Tract Diseases Authorised 18/05/2026

A pragmatic, phase IV, randomized, open-label, multinational, multicentre, 2-arm parallel group, prospective study comparing efficacy and safety of Single Inhaler ICS/LABA/LAMA (beclometasone/formoterol fumarate/glycopyrronium bromide [87/5/9 pMDI {BD/FF/GB - 100/6/12.5 µg}]) vs Single Inhaler ICS/LABA (beclometasone dipropionate plus formoterol fumarate [200/6 pMDI {BD/FF - 200/6 µg}]) in asthma subjects.

Asthma
Chiesi Farmaceutici S.p.A. · 606 participants

📍 Germany · Romania · Italy · Bulgaria · Poland · Slovakia · Spain · France

2025-524289-56-00 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/II Neoplasms Authorised 15/05/2026

A Multicenter, Multi-Part, Phase 1/2 Study of EIK1005 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors, including Checkpoint Inhibitor Naïve Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors

Advanced Solid Tumors
Eikon Therapeutics Inc. · 63 participants

📍 France · Spain · Norway · Italy · Germany · Austria · Poland · Finland · Portugal

2026-525248-13-00 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 III Neoplasms Authorised 13/05/2026