Clinical Trials in Italy 2026 - 162 Recent EU Authorisations

Phase II Neoplasms Authorised 03/07/2026

A multicenter open-label phase II study of Cemiplimab plus chemotherapy, selected on the basis of baseline cytidine deaminase activity, in advanced squamous non-small cell lung cancer - CECYDE trial - GOIRC-04-2024

Advanced squamous non-small cell lung cancer
G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica · 108 participants

📍 Italy

2024-517799-40-00 on CTIS ↗

Phase III Mental Disorders Authorised 01/07/2026

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

First Episode Psychosis (FEP)
University Of Oxford · 124 participants

📍 Greece · Germany · Italy · Austria

2025-521929-32-01 on CTIS ↗

Phase III Neoplasms Authorised 01/07/2026

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

Relapsed or Refractory Multiple Myeloma
Janssen Cilag International · 181 participants

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

2025-523815-12-00 on CTIS ↗

Phase I Immune System Diseases Authorised 01/07/2026

A Study to Evaluate Targeted Therapies for Patients with Rheumatoid Arthritis

Rheumatoid Arthritis
AbbVie Deutschland GmbH & Co. KG · 19 participants

📍 Belgium · Netherlands · Spain · Germany · Italy

2025-523127-21-00 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 · 189 participants

📍 Finland · Belgium · France · Denmark · Austria · Germany · Italy · Czechia · Norway

2025-522167-15-00 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. · 128 participants

📍 Greece · France · Italy · Belgium · Denmark · Germany · Czechia · Portugal · Austria

2025-521769-29-00 on CTIS ↗

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

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

Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease
Merck Healthcare KGaA · 40 participants

📍 Germany · Bulgaria · Belgium · Spain · 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 · 46 participants

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

2025-523871-44-00 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. · 9 participants

📍 France · Italy

2025-524686-24-00 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. · 227 participants

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

2025-524623-50-00 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. · 205 participants

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

2025-525009-18-00 on CTIS ↗

Phase IV Hormonal diseases Authorised 26/06/2026

Prospective, multicenter, randomized study on combined LT4 + LT3 therapy versus LT4 in the control of TSH in patients with advanced thyroid cancer treated with tyrosine kinase inhibitors.

Advanced thyroid carcinoma. Post-thyroidectomy hypothyroidism.
Ceinge Biotecnologie Avanzate Franco Salvatore S.c.a.r.l. · 110 participants

📍 Italy

2026-526113-28-00 on CTIS ↗

Phase III Nervous 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 Male Urogenital Diseases Authorised 23/06/2026

SERENDIPITY: phase III multicentric randomized study assessing the reduction of chronic prostate inflammation with Permixon®

Benign prostatic hypertrophy
Azienda Ospedaliero Universitaria Careggi, University Of Florence · 410 participants

📍 Italy

2025-525123-27-00 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 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 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 III Cardiovascular Diseases Authorised 22/06/2026

Effects of bempedoic acid/ezetimibe/high-intensity statin on plaque regression and stabilisation of coronary atherosclerosis among patients without cardiovascular events

Coronary atherosclerosis
Daiichi Sankyo Europe GmbH · 103 participants

📍 Italy · Spain · Germany

2025-524625-41-00 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 III Neoplasms Authorised 18/06/2026

Paclitaxel plus ramucirumab and tislelizumab as switch maintenance versus continuation of chemotherapy and tislelizumab in patients with advanced HER2-negative and PD-L1 positive gastroesophageal adenocarcinoma: the ARMANI-2/ENGIC08 trial by GONO

Advanced HER2-negative and PD-L1 positive gastroesophageal adenocarcinoma
Fondazione GONO G.I. · 212 participants

📍 Spain · Germany · Italy

2025-524048-36-00 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 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 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 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 Musculoskeletal Diseases Authorised 15/06/2026

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

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

📍 Germany · Denmark · Netherlands · Italy · Norway

2025-524371-23-00 on CTIS ↗

Phase 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 III Neoplasms Authorised 12/06/2026

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

Locally advanced, unresected (unresectable or medically inoperable or refuse surgery) Stage II-III NSCLC with KRAS G12C mutation
Merck Sharp & Dohme LLC · 88 participants

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

2025-522038-29-00 on CTIS ↗

Phase III Neoplasms Authorised 12/06/2026

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

Relapsed/refractory B-cell Acute Lymphoblastic Leukemia
Merck Sharp & Dohme LLC · 109 participants

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

2025-522267-15-00 on CTIS ↗

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

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

Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Glaxosmithkline Research & Development Limited · 210 participants

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

2025-523674-16-00 on CTIS ↗

Phase II Neoplasms Authorised 12/06/2026

A PHASE 2 STUDY OF STRIDE (durvalumab + tremelimumab) With Lenvatinib Versus STRIDE Alone in Patients With Unresectable Hepatocellular Carcinoma (SLIDE-HCC) - HE.2

patients with unrestectable hepatocellular carcinoma (SLIDE-HCC)
IRCCS Istituto Nazionale Tumori Fondazione Pascale · 56 participants

📍 Italy

2025-521608-23-00 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 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 Moderate, Ulcerative Colitis, Active Severe, Ulcerative Colitis (UC)
Eli Lilly & Co. · 104 participants

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

2025-524404-29-00 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 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 Neoplasms Authorised 08/06/2026

Radium223 dichloride (223RaCl) in the treatment of symptomatic bone metastases from breast cancer.

Symptomatic bone metastases from breast cancer
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone · 50 participants

📍 Italy

2025-524208-31-00 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 Nervous System Diseases Authorised 08/06/2026

OCTAGON:A Phase 4, Single Arm Study to Investigate Oral Corticosteroid Tapering in Adult Patients with Generalized Myasthenia Gravis Treated with Ravulizumab

Generalized Myasthenia Gravis
Alexion Pharmaceuticals Inc. · 15 participants

📍 Italy · Germany

2025-522555-26-00 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 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. · 98 participants

📍 Spain · Netherlands · Belgium · Italy · France

2025-523912-35-00 on CTIS ↗

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

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

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

📍 Poland · Netherlands · Italy · Spain

2025-523939-18-00 on CTIS ↗

Phase 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 · 97 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 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 II Mental Disorders Authorised 29/05/2026

Leveraging the neural mechanisms of social reward for drug relapse prevention

substance use disorder
Fondazione Santa Lucia IRCCS · 70 participants

📍 Italy

2023-504518-31-01 on CTIS ↗

Phase III Neoplasms Authorised 29/05/2026

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

Myelofibrosis
Novartis Pharma AG · 173 participants

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

2025-523555-66-00 on CTIS ↗

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

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

Cystic fibrosis
Vertex Pharmaceuticals Inc. · 80 participants

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

2025-523400-72-00 on CTIS ↗

Phase 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 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 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 · 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 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 Neoplasms Authorised 22/05/2026

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

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

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

2025-523576-23-00 on CTIS ↗

Phase II Neoplasms Authorised 21/05/2026

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

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

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

2025-525013-23-00 on CTIS ↗

Phase 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 IV Neoplasms Authorised 21/05/2026

Intensified Monitoring of PhArmacology of Cabozantinib as a tool for Toxicity management in patients with renal cell carcinoma

Renal cell carcinoma
Centro Di Riferimento Oncologico Di Aviano · 216 participants

📍 Italy

2026-525267-40-00 on CTIS ↗

Phase I/II Genetic Phenomena Authorised 20/05/2026

An Open Label, Single Arm, Phase I/II Clinical Study of Autologous CD4+ T-Cells Edited Ex-Vivo at the CD40LG Locus by CRISPR/Cas9 and IDLV-based vector in Patients with X-linked Hyper IgM Syndrome Type 1 (HIGM1)

X-linked immunodeficiency with hyper-IgM type 1 (HIGM1)
Fondazione Telethon Ets, San Raffaele Hospital · 4 participants

📍 Italy

2025-524635-39-00 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 IV Respiratory Tract Diseases Authorised 20/05/2026

Erdosteine effect on oxidative stress, inflammatory response and immune modulation in patients with COPD. A single center, open label, double arm, controlled, 4-week, explorative, ex vivo study.

COPD
ASST Fatebenefratelli Sacco · 30 participants

📍 Italy

2025-524821-42-00 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

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 II Neoplasms Authorised 19/05/2026

A Phase II, Open-Label Randomized Study of Intravenous Tambiciclib in Combination with the Standard of care Venetoclax and Azacitidine in Patients with Newly Diagnosed AML Who Failed to Achieve at Least MLFS After the First Two Cycles of Treatment with Venetoclax and Azacitidine Alone

Acute myeloid leukemia
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l., IIS La Fe · 40 participants

📍 Italy · Spain

2025-524308-31-00 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 IV Reproductive and Urinary Physiological Phenomena Authorised 18/05/2026

A Multicenter Randomized Controlled Trial Assessing the Efficacy and Safety of Recombinant Human Follicle Stimulating Hormone (r-hFSH-alfa originator) and Human Chorionic Gonadotropin (hCG) in Enhancing Sperm Concentration in Men with Oligozoospermia, Low Testosterone, and Normal FSH Serum Levels (APHRODITE Group 3): A Collaborative Research Initiative

Male Infertility
Martin-Luther-Universitaet Halle-Wittenberg · 138 participants

📍 Italy · Spain · Germany

2025-525005-20-00 on CTIS ↗

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

A Phase 2a, Randomized, Open-Label, Active-Controlled, Crossover Study to Evaluate Safety and Explore Efficacy of Different Doses of New Lipase NHS7108 Administered Orally in Participants with Exocrine Pancreatic Insufficiency.

Exocrine Pancreatic Insufficiency
Aimmune Nestle Health Science US R&D LLC · 29 participants

📍 Poland · Hungary · Spain · Bulgaria · Italy

2025-521816-20-00 on CTIS ↗

Phase I/II Neoplasms Authorised 18/05/2026

A Phase 1/2 Study of BMS-986525 as Monotherapy and in Combination with Nivolumab in Participants with Relapsed/Refractory Small Cell Lung Cancer

Relapsed/Refractory Small Cell Lung Cancer
Bristol-Myers Squibb Services Unlimited Company · 21 participants

📍 Italy · Spain · Romania

2025-524090-16-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 18/05/2026

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

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

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

2025-524316-11-00 on CTIS ↗

Phase II Neoplasms Authorised 18/05/2026

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

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

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

2025-522138-29-00 on CTIS ↗

Phase 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. · 49 participants

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

2026-525248-13-00 on CTIS ↗

Phase II Neoplasms Authorised 14/05/2026

A Phase 2, Open-label Study of JNJ-79635322 in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) 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 (RRMM)
Janssen Cilag International · 54 participants

📍 Poland · Italy

2025-521976-80-00 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

A Pivotal Open-label Phase 3 Clinical Study Evaluating the Efficacy and Safety of QTX-2101 in Combination With All-trans Retinoic Acid in Newly Diagnosed, Low-risk Acute Promyelocytic Leukemia

Acute Promyelocytic Leukemia
Quetzal Therapeutics LLC · 89 participants

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

2025-524810-28-00 on CTIS ↗

Phase III Neoplasms Authorised 13/05/2026

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

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

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

2025-523869-22-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 13/05/2026

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 and Type 2 Diabetes

Obesity or Overweight and Type 2 Diabetes
F. Hoffmann-La Roche AG · 551 participants

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

2025-523106-32-00 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 II Neoplasms Authorised 12/05/2026

Maintenance AVElumab after SECond line platinum-based chemotherapy for metastatic urothelial carcinoma: AVESEC trial - GOIRC-02-2025

metastatic urothelial carcinoma
G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica · 144 participants

📍 Italy

2025-524077-16-00 on CTIS ↗

Phase II Neoplasms Authorised 12/05/2026

A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors

Non-small cell lung cancer (NSCLC), Cervical cancer (CC), Melanoma, Hepatocellular carcinoma (HCC), Ovarian cancer (OC), Squamous cell carcinoma of head and neck
Dualitybio Inc. · 102 participants

📍 Italy · Poland · France · Spain · Germany

2025-523895-22-00 on CTIS ↗

Phase I Nervous System Diseases Authorised 11/05/2026

A Study to Assess the Safety of RG6496 in Huntington’s Disease Gene Expansion Carriers with the Selected Genetic Variant (POINT-HD)

Huntington’s Disease Gene Expansion Carriers
F. Hoffmann-La Roche AG · 43 participants

📍 Italy · Poland · Denmark · Germany · Portugal · Spain

2025-520631-17-00 on CTIS ↗

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

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

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

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

2025-524265-24-00 on CTIS ↗

Phase III Immune System Diseases Authorised 11/05/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infections in Patients with Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment with B-cell Depletion Therapy ("PROTECT")

Prevention of a Major infection in patients with Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions receiving treatment with B-cell depletion therapy.
Octapharma Pharmazeutika Produktionsgesellschaft mbH · 215 participants

📍 Czechia · Lithuania · Greece · Poland · Germany · Latvia · Bulgaria · Italy

2025-522854-37-00 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 I/II Neoplasms Authorised 08/05/2026

A Phase 1/2a, Open-Label, Dose-Escalation and Dose-Expansion First-In-Human Study of the Safety, Tolerability, Activity, and Pharmacokinetics of REGN10597 (Anti PD-1-IL2RA-IL2 Fusion Protein) Alone or in Combination with Cemiplimab in Patients with Advanced Solid Organ Malignancies

Advanced Solid Tumours, Melanoma, Clear-Cell Renal-Cell Carcinoma (ccRCC)
Regeneron Pharmaceuticals Inc. · 99 participants

📍 Italy · Spain · Germany · France

2025-523399-22-00 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 II Respiratory Tract Diseases Authorised 06/05/2026

A prospective, multinational, multicenter, randomized, sequential, double-blind, placebo-controlled, phase 2a clinical study to assess the safety and pharmacokinetics (PK) of OMN6 in hospital-acquired bacterial pneumonia (HABP) or ventilated-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC).

Hospital-acquired bacterial pneumonia or ventilated-associated bacterial pneumonia caused by Acinetobacter baumannii complex.
Omnix Medical Ltd. · 32 participants

📍 Italy · Hungary · Greece

2025-524200-29-00 on CTIS ↗

Phase II Neoplasms Authorised 06/05/2026

A Master Protocol of an Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)

Non-Small Cell Lung Cancer
AstraZeneca AB · 70 participants

📍 France · Italy · Spain

2025-524843-11-00 on CTIS ↗

Phase II Neoplasms Authorised 05/05/2026

A Phase II, Multi-Center, Master Protocol to Evaluate the Efficacy and Safety of Volrustomig as Monotherapy or in Combination with Anti-cancer Agents in Participants with Advanced/Metastatic Solid Tumors (eVOLVE-02)

Sub-study 5: Unresectable Pleural Mesothelioma (Volrustomig Monotherapy), Sub-study 4: Esophageal Squamous Cell Carcinoma (Volrustomig in Combination with Chemotherapy).
AstraZeneca AB · 42 participants

📍 Italy · Germany

2025-523947-36-00 on CTIS ↗

Phase III Eye Diseases Authorised 05/05/2026

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

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

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

2025-523443-35-00 on CTIS ↗

Phase II Immune System Diseases Authorised 05/05/2026

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

Graves’ Disease
Immunovant Sciences GmbH · 128 participants

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

2025-524001-33-00 on CTIS ↗

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

A Multicenter, Randomized, Operationally Seamless Phase 2/3 Study to Evaluate the Efficacy and Safety of BMN 333 versus Vosoritide in Children with Achondroplasia

Achondroplasia
Biomarin Pharmaceutical Inc. · 25 participants

📍 Poland · Italy · Romania

2025-523811-12-00 on CTIS ↗

Phase III Immune System Diseases Authorised 05/05/2026

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults with Moderate to Severe Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
Janssen Cilag International · 271 participants

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

2025-523552-31-00 on CTIS ↗

Phase II Eye Diseases Authorised 04/05/2026

A randomized, double masked, placebo-controlled, multicenter, dose-range finding study to assess the efficacy and safety of FWY003 in patients with geographic atrophy secondary to age-related macular degeneration

Geographic atrophy secondary to age-related macular degeneration
Novartis Pharma AG · 142 participants

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

2025-523704-77-00 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 overweight or obesity, and type 2 diabetes (AMAZE 2)

Overweight or obesity, and type 2 diabetes
Novo Nordisk A/S · 265 participants

📍 Italy · Croatia · Hungary · Slovakia · Romania

2024-520441-23-00 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 III Neoplasms Authorised 04/05/2026

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

Renal Cell Carcinoma
Merck Sharp & Dohme LLC · 311 participants

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

2024-516993-31-00 on CTIS ↗

Phase IV Respiratory Tract Diseases Authorised 30/04/2026

PHASE IV, PROSPECTIVE, OPEN-LABEL, SINGLE ARM STUDY ON THE PAIN-RELIEF EFFECT OF BENZYDAMINE HYDROCHLORIDE LOZENGES 3 MG MINT TASTE (TANTUM VERDE) IN NON STREPTOCOCCAL PHARYNGOTONSILLITIS IN PEDIATRIC AGE (6-11 YEARS OLD).

NON STREPTOCOCCAL PHARYNGOTONSILLITIS
Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesc O A.C.R.A.F. S.p.A. Enunciabile Anche Angelini Pharma Italia S.p.A. Angelini Pharma S.p.A. A.C.R.A.F. S.p.A. Acraf S.p.A. Angelini S.p.A. Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. · 120 participants

📍 Italy

2025-521526-15-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 30/04/2026

A phase III randomised, double-blind, placebo-controlled, multicentre efficacy and safety clinical trial of angiotensin II in paediatric patients of 0 to 17 years of age with refractory hypotension in distributive shock receiving fluid resuscitation and standard-of-care vasopressors

refractory hypotension in distributive shock
Paion Pharma GmbH · 143 participants

📍 Italy · Germany · France · Spain

2025-523750-14-00 on CTIS ↗

Phase III Neoplasms Authorised 30/04/2026

A Phase III Open-label, Randomised, Multicentre Study Comparing AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19, versus Standard Regimens in Participants with Relapsed Refractory Multiple Myeloma (DURGA-4)

Relapsed or Refractory Multiple Myeloma
AstraZeneca AB · 153 participants

📍 Norway · Poland · Spain · Germany · France · Italy

2025-523285-25-00 on CTIS ↗

Phase II Mental Disorders Authorised 29/04/2026

Oral rifaximin in patients with opioid use disorder (OUD): multicenter clinical trial on the microbiota–gut–brain axis

substance use disorder
Fondazione Santa Lucia · 50 participants

📍 Italy

2025-524778-41-00 on CTIS ↗

Phase IV Bacterial Infections and Mycoses Authorised 29/04/2026

EaRly impAct theraPy with ceftazidime-avibactam via rapID diagnostics versus standard of care antibiotics and diagnostics in patients with bloodstream infection, hospital-acquired pneumonia or ventilator-associated pneumonia due to Pseudomonas aeruginosa or carbapenemase producing Enterobacterales ("RAPID")

Bloodstream Infection, Ventilator Associated Pneumonia and Hospital-Acquired Pneumonia
National University Of Singapore · 80 participants

📍 Italy

2024-520067-13-00 on CTIS ↗

Phase I/II Immune System Diseases Authorised 28/04/2026

A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Subjects with Active Idiopathic Inflammatory Myopathy or Active Juvenile Idiopathic Inflammatory Myopathy

Active Idiopathic Inflammatory Myopathy including dermatomyositis, anti-synthetase syndrome, immune-mediated necrotizing myopathy or Juvenile Idiopathic Inflammatory Myopathy
Cabaletta Bio Inc. · 13 participants

📍 Italy · Spain · Germany

2025-521145-24-01 on CTIS ↗

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

Efficacy of cell therapy with allo-MSCs in patients with gvhd resistant to ruxolitinib second line therapy: a Phase IIB Clinical Trial - MSC-GRR2 Study

Gvhd Resistant to ruxolitinib and steroids
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia · 26 participants

📍 Italy

2025-523448-10-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 28/04/2026

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

Pulmonary Arterial Hypertension
Inhibikase Therapeutics Inc. · 94 participants

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

2024-520218-23-00 on CTIS ↗

Phase II Neoplasms Authorised 28/04/2026

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

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

📍 Netherlands · Italy

2025-521983-36-00 on CTIS ↗

Phase 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 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 Nervous System Diseases Authorised 28/04/2026

Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Clemizole HCl as Adjunctive Therapy in Patients with Lennox-Gastaut Syndrome

Lennox-Gastaut Syndrome
Epygenix Therapeutics Inc. · 98 participants

📍 Italy · Spain · Hungary · Romania · Czechia · Poland

2025-522552-20-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 28/04/2026

Phase 2/3, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Participants with Alzheimer’s Disease Dementia

Agitation in Alzheimer's Disease Dementia
Exciva GmbH · 222 participants

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

2024-517388-22-00 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 Digestive System Diseases Authorised 27/04/2026

RASolute 304: A Phase 3 Multicenter, Open-label, Randomized, 2‑Arm Study of Adjuvant Daraxonrasib Versus Standard of Care Observation Following Completion of Neoadjuvant and/or Adjuvant Chemotherapy in Patients with Resected Pancreatic Ductal Adenocarcinoma (PDAC)

Resected Pancreatic Ductal Adenocarcinoma (PDAC)
Revolution Medicines Inc. · 98 participants

📍 France · Spain · Italy · Germany

2025-523495-23-00 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 IV Immune System Diseases Authorised 27/04/2026

A Study to Evaluate Mirikizumab Concentrations in Breast Milk Following Administration of Mirikizumab by Subcutaneous Injection in Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication

severely active ulcerative colitis (US) and CD (Crohn’s disease)
Eli Lilly & Co. · 16 participants

📍 Spain · Denmark · Germany · Italy · Poland

2025-522362-78-00 on CTIS ↗

Phase II Neoplasms Authorised 27/04/2026

The MAVRiC Study: A Phase II Study of Disease Risk Mutation-guided Finite Duration Acalabrutinib plus Venetoclax for Relapse in CLL/SLL after First-line Finite covalent BTKi plus BCL2i combination, with or without Obinutuzumab

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
AstraZeneca AB · 63 participants

📍 Italy · Austria · Spain · Ireland · Czechia · Poland

2024-518858-17-00 on CTIS ↗

Phase I/II Neoplasms Authorised 27/04/2026

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

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

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

2025-522019-40-00 on CTIS ↗

Phase II Hemic and Lymphatic Diseases Authorised 23/04/2026

Colchicine to Quench the Inflammatory Response after Deep Vein Thrombosis: The CONQUER-DVT Randomized Controlled Trial

deep vein thrombosis
Universita' Degli Studi G. D'Annunzio Di Chieti · 122 participants

📍 Italy

2025-521836-12-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 23/04/2026

Impact of Oral Semaglutide on Platelet Reactivity in Patients with Diabetes Mellitus or Overweight with High Risk or established Cardiovascular Disease: the SEMA-PLAT Study

Diabetes Mellitus, Cardiovascular disease, Overweight (BMI ≥27 kg/m²), Obesity (BMI≥30kg/m2)
Casa Di Cura Accreditata Istituto Chirurgico Ortopedico Traumatologico Marco Pasquali · 212 participants

📍 Italy

2025-522486-29-01 on CTIS ↗

Phase I/II Neoplasms Authorised 22/04/2026

ROSETTA HCC-206: An Open-Label, Multi-Center, Randomized Phase 1/2 Study of Pumitamig Alone or In Combination with Ipilimumab in Participants with First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC)

Advanced or unresectable Hepatocellular Carcinoma (HCC)
Bristol-Myers Squibb Services Unlimited Company · 47 participants

📍 Poland · Spain · Germany · France · Italy

2025-523602-33-00 on CTIS ↗

Phase I Immune System Diseases Authorised 22/04/2026

Clinical Study to Evaluate the Effects of Cevostamab in Patients with Lupus with or without Active Lupus Nephritis

Systemic Lupus Erythematosus (SLE) With or Without Active Lupus Nephritis (LN)
Genentech Inc. · 17 participants

📍 Italy · Spain · France · Germany

2025-522904-26-00 on CTIS ↗

Phase I Neoplasms Authorised 22/04/2026

A Phase I study to evaluate the safety and dosimetry of imaging with 68Ga-OncoACP3 in prostate cancer.

Patients with prostate cancer with: - suspected metastasis who are candidates for initial definitive therapy - suspected recurrence based on elevated serum prostate-specific antigen (PSA) level (i.e., a progressive and confirmed serum PSA level > 0.2 ng/mL) - metastatic disease who might be candidates for treatment with 177Lu-labelled PSMA ligands
Philogen S.p.A. · 20 participants

📍 Italy

2025-524594-16-00 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 I/II Neoplasms Authorised 21/04/2026

A Phase 1/2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination with Other Anti-Cancer Therapies in Patients with KRAS, BRAF and Other Selected RAS/MAPK Mutation-Positive Malignancies

Malignancies with Documented KRAS, BRAF and Other Selected RAS/MAPK Mutations
Institut De Recherches Internationales Servier IRIS · 105 participants

📍 France · Spain · Denmark · Italy

2025-523474-16-00 on CTIS ↗

Phase III Neoplasms Authorised 20/04/2026

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

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

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

2025-524366-21-00 on CTIS ↗

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

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

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

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

2025-523793-16-00 on CTIS ↗

Phase 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 III Hemic and Lymphatic Diseases Authorised 20/04/2026

C0371017 - A PHASE 3, NON-INVESTIGATIONAL PRODUCT, MULTI COUNTRY COHORT STUDY TO DESCRIBE THE LONG-TERM SAFETY AND EFFECTIVENESS OF A PRIOR SINGLE-DOSE TREATMENT WITH INVESTIGATIVE GIROCTOCOGENE FITELPARVOVEC OR FIDANACOGENE ELAPARVOVEC IN PARTICIPANTS WITH HEMOPHILIA A OR HEMOPHILIA B, RESPECTIVELY

hemophilia A, severe to moderately severe hemophilia B (FIX:C ≤ 2%)
Pfizer Inc. · 31 participants

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

2025-523660-21-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 20/04/2026

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

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

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

2025-524002-16-00 on CTIS ↗

Phase III Neoplasms Authorised 20/04/2026

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

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

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

2025-522855-25-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 17/04/2026

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

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

📍 Netherlands · Italy · France · Spain

2025-524302-15-00 on CTIS ↗

Phase III Neoplasms Authorised 17/04/2026

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

Ovarian cancer
Incyte Corp. · 308 participants

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

2025-522748-42-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 17/04/2026

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

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

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

2025-523717-29-00 on CTIS ↗

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

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

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

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

2025-523544-12-00 on CTIS ↗

Phase I/II Neoplasms Authorised 16/04/2026

An open-label, multi-center, phase I/II study of GVV858 as a single agent and in combination with endocrine therapy in patients with advanced hormone receptor positive, HER2-negative breast cancer and other advanced solid tumors

Advanced HR+/HER- breast cancer
Novartis Pharma AG · 55 participants

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

2025-521911-38-00 on CTIS ↗