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Updated 11 Sep 2026 · EMA CTIS official data

Clinical Trials in Italy

← All EU trials

The most recently authorised clinical trials across the European Union - drawn live from the European Medicines Agency's Clinical Trials Information System (CTIS), the single register for every trial run under the EU Clinical Trials Regulation. Searchable by country, phase, sponsor and condition.

153
Recent authorisations
84
Phase III trials
Italy
Selected country
Showing 153 trials
Phase III Nutritional and Metabolic Diseases Authorised 09/09/2026

C6491013 - A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Once-Monthly PF-08653944 in Adults with Overweight or Obesity (VESPER 6)

Overweight or Obesity
Pfizer Inc.
65 participants planned
Germany · Italy
2026-525318-75-00 on CTIS ↗
Phase II Immune System Diseases Authorised 09/09/2026

A Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long Term Safety and Tolerability of KT-621 in Participants With Asthma Previously Enrolled in a KT-621 Asthma Study

Uncontrolled Moderate to Severe Eosinophilic Asthma
Kymera Therapeutics Inc.
25 participants planned
Germany · Italy · Slovakia
2026-526241-98-00 on CTIS ↗
Phase I Hemic and Lymphatic Diseases Authorised 08/09/2026

A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers

Lymphoma, Non-Hodgkin's Lymphoma, Diffuse Large B-Cell Follicular Lymphoma
Eli Lilly & Co.
126 participants planned
Italy · France · Germany
2025-523601-16-00 on CTIS ↗
Phase IV Hormonal diseases Authorised 08/09/2026

A double-blind, randomised, 30-week placebo-controlled phase IV study to assess the efficacy and safety of osilodrostat in patients with hypertension caused by hypercortisolaemia due to Cushing’s Syndrome

Cushing's syndrome
Recordati AG
51 participants planned
Germany · France · Italy
2025-524649-28-00 on CTIS ↗
Phase I Neoplasms Authorised 08/09/2026

A clinical trial to learn about the effects of 225Ac-ETN029 in people with advanced solid tumors

Small Cell Lung Cancer (SCLC), Neuroendocrine Prostate Cancer (NEPC), Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC), Large Cell Neuroendocrine Carcinoma (LCNEC) of the lung
Novartis Pharma AG
37 participants planned
France · Spain · Italy · Germany
2024-519111-34-00 on CTIS ↗
Phase II Neoplasms Authorised 07/09/2026

A Phase 2, Randomized, Open-label, Study Assessing the Safety, Tolerability and Efficacy of Imzokitug in Combination with Pumitamig and Platinum-Doublet Chemotherapy (PDCT) versus Pumitamig and PDCT as First-line Treatment for Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Bristol-Myers Squibb Services Unlimited Company
29 participants planned
Italy · Germany
2026-525170-19-00 on CTIS ↗
Phase I Neoplasms Authorised 07/09/2026

A Study of RO7806767 as Single Agent and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors

Advanced Solid Tumors
F. Hoffmann-La Roche AG
69 participants planned
Hungary · Italy · Belgium · Denmark · France
2026-525215-13-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 04/09/2026

Efficacy and safety of zenagamtide s.c. once weekly compared to insulin glargine s.c. once daily in participants with type 2 diabetes and increased cardiovascular risk inadequately controlled on 1–3 oral glucose-lowering medications (AMBITION 7)

Type 2 diabetes (T2D) and increased cardiovascular (CV) risk not in adequate glycaemic control on 1–3 marketed oral glucose lowering medications.
Novo Nordisk A/S
477 participants planned
Greece · Germany · Italy · Czechia · Poland · Bulgaria · Spain
2026-525209-11-00 on CTIS ↗
Phase I Neoplasms Authorised 03/09/2026

A Phase I dose escalation study of intrapleural administration of Oncofid-P-M in patients with unresectable recurrent/progressive pleural mesothelioma after first-line treatment

unresectable recurrent/progressive pleural mesothelioma
Fidia Farmaceutici S.p.A.
30 participants planned
Italy
2026-526119-12-00 on CTIS ↗
Phase III Neoplasms Authorised 03/09/2026

Sequence Strategy of Immuneoncology (IO-IO) vs IO-tyrosine kinase inhibitors (TKI) followed by TKI in metastatic renal cell carcinoma (mRCC): A randomized phase 3 study Meet uro and FICOG trial. COMBO-Seq trial.

Metastatic renal cell carcinoma
Fondazione IRCCS Istituto Nazionale Dei Tumori
500 participants planned
Italy
2025-523903-31-00 on CTIS ↗
Phase II Neoplasms Authorised 02/09/2026

Hyperthermic Intraperitoneal Chemotherapy and Regional Adrenalectomy in the management of Stage II & III Adrenocortical Carcinoma

Adrenocortical Carcinoma
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
32 participants planned
Italy
2026-525406-36-00 on CTIS ↗
Phase III Immune System Diseases Authorised 02/09/2026

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

Immune system diseases
Sanofi-Aventis Recherche & Developpement
338 participants planned
Belgium · Czechia · Hungary · Sweden · Lithuania · Croatia · Netherlands · Slovakia · Poland · Austria · Norway · France · Italy · Bulgaria · Spain · Germany · Romania · Slovenia · Estonia · Portugal · Greece · Denmark
2026-525913-30-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 02/09/2026

A phase III, randomized, prospective, double-blind, parallel design, multi-arm, multicenter study to compare the efficacy and safety of alogliptin and empagliflozin combination therapy versus alogliptin alone and empagliflozin alone in metformin-treated participants with type 2 diabetes mellitus and insufficient glycemic control despite diet and exercise (ODISSEIA 2026).

Type 2 Diabetes mellitus
Tecnimede-Sociedade Tecnico-Medicinal S.A.
760 participants planned
Poland · Germany · Portugal · Italy · Spain
2025-524606-15-00 on CTIS ↗
Phase II Eye Diseases Authorised 01/09/2026

Randomized, Multicenter, Vehicle-Controlled, Double-Masked Study to Evaluate the Efficacy and Safety of Intranasal Cenegermin (Recombinant Human Nerve Growth Factor [rhNGF]) in Adult Participants with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)

Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Dompe' Farmaceutici S.p.A.
171 participants planned
Denmark · Italy · Germany · Hungary · Netherlands · Spain · Belgium · France · Portugal
2025-524748-37-00 on CTIS ↗
Phase III Neoplasms Authorised 01/09/2026

A Phase III Open-Label, Randomised, Multicentre Study of Consolidation with a Single Administration of AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against BCMA and CD19, Compared with Continuous Standard Therapy in Participants with NDMM Who Are Ineligible to Receive ASCT as Initial Therapy (DURGA-5).

Newly Diagnosed Multiple Myeloma
AstraZeneca AB
234 participants planned
Poland · Italy · Denmark · France · Sweden · Germany · Spain
2025-524014-29-00 on CTIS ↗
Phase III Congenital, Hereditary, and Neonatal Diseases and Abnormalities Authorised 31/08/2026

A Phase 3, Randomized, Double-blind, Placebo‑controlled Study to Assess the Efficacy and Safety of Engasertib in Subjects With Moderate to Severe Hereditary Hemorrhagic Telangiectasia (HHT)

Hereditary Hemorrhagic Telangiectasia (HHT)
Vaderis Therapeutics AG
130 participants planned
Hungary · Netherlands · Germany · Bulgaria · France · Italy · Lithuania · Spain · Belgium
2025-524490-17-00 on CTIS ↗
Phase III Nervous System Diseases Authorised 31/08/2026

A Phase 3, Randomized, Double-Blinded Study to Evaluate the Safety and Efficacy of Salanersen (BIIB115) After Onasemnogene Abeparvovec Treatment in Infants with Genetically Diagnosed Spinal Muscular Atrophy

Spinal Muscular Atrophy
Biogen Idec Research Limited
24 participants planned
Portugal · Italy · Belgium · Croatia · Hungary · Germany · Ireland · France · Norway · Poland
2025-523857-32-00 on CTIS ↗
Phase III Bacterial Infections and Mycoses Authorised 31/08/2026

Targeted versus standard peri-operative prophylaxis in patients colonized with carbapenemase-producing Enterobacterales undergoing liver transplantation: a stepped-wedge cluster randomization trial

Patients colonized with CPE undergoing liver transplantation (LT)
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
168 participants planned
Italy
2025-523453-34-00 on CTIS ↗
Phase III Neoplasms Authorised 28/08/2026

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

Resected Stage II-III Kirsten rat sarcoma virus oncogene homolog glycine 12 to Cysteine (KRAS G12C) -Positive Non-Small Cell Lung Cancer
F. Hoffmann-La Roche AG
178 participants planned
France · Spain · Austria · Greece · Portugal · Belgium · Italy · Germany · Netherlands
2025-524263-21-01 on CTIS ↗
Phase I/II Neoplasms Authorised 27/08/2026

A Phase 1/2, Open-Label, Multicenter, Multi-cohort Study of S241656 as Monotherapy or in Combination with other Antileukemic Agents in participants with Selected Myeloid Malignancies

Patients with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome /Acute Myeloid Leukemia (MDS/AML) or Chronic Myelomonocytic Leukemia (CMML)
Institut De Recherches Internationales Servier IRIS
38 participants planned
Netherlands · Spain · Germany · Italy · France · Finland
2025-525128-88-00 on CTIS ↗
Phase II Respiratory Tract Diseases Authorised 26/08/2026

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

Idiopathic Pulmonary Fibrosis (IPF)
Contineum Therapeutics Inc.
156 participants planned
Italy · Belgium · Denmark · Austria · Greece · Germany · France · Netherlands · Portugal · Poland · Spain
2025-521901-42-00 on CTIS ↗
Phase II Neoplasms Authorised 26/08/2026

C6461010 - An Interventional, Open-Label, Phase 2 Study to Investigate the Safety and Efficacy of PF-08634404 Monotherapy or in Combination in Adult Participants with Early-Stage Resectable or Locally Advanced Unresectable Non-Small Cell Lung Cancer

Early-Stage Resectable or Locally Advanced Unresectable Non-Small Cell Lung Cancer
Pfizer Inc.
33 participants planned
Spain · France · Italy · Ireland · Germany · Poland
2025-524825-42-00 on CTIS ↗
Phase II Neoplasms Authorised 26/08/2026

A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina S) in Participants With Advanced Gastrointestinal (GI) Cancers

Gastrointestinal Cancers
Genmab A/S
67 participants planned
Italy · Belgium · France · Spain · Denmark · Netherlands · Germany
2025-524130-26-00 on CTIS ↗
Phase III Immune System Diseases Authorised 25/08/2026

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

Ocular Myasthenia Gravis
UCB Biopharma
46 participants planned
Hungary · France · Greece · Poland · Spain · Italy · Germany
2025-524757-14-00 on CTIS ↗
Phase III Nervous System Diseases Authorised 25/08/2026

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants with Narcolepsy Followed by an Open-label Extension

narcolepsy
Harmony Biosciences Management Inc.
92 participants planned
Belgium · Italy · Germany · France · Spain · Poland
2025-523821-17-00 on CTIS ↗
Phase II Neoplasms Authorised 25/08/2026

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

Solid tumor
Bristol-Myers Squibb Services Unlimited Company
116 participants planned
Greece · Hungary · Poland · Belgium · Spain · Netherlands · Germany · France · Portugal · Italy · Romania
2025-524905-34-00 on CTIS ↗
Phase I Neoplasms Authorised 24/08/2026

A Phase 1 Study of TT125-802 as Monotherapy and in Combination with Pomalidomide and Dexamethasone in Participants with Multiple Myeloma

Relapsed and Refractory Multiple Myeloma
TOLREMO therapeutics AG
25 participants planned
Italy · Spain
2025-523536-39-00 on CTIS ↗
Phase III Neoplasms Authorised 24/08/2026

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (modified FOLFIRINOX or Gemcitabine plus Nab-paclitaxel) with or without Zoldonrasib (RMC-9805) as First-line Treatment in Patients with Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma (RASolute 305)

Pancreatic Adenocarcinoma
Revolution Medicines Inc.
281 participants planned
Sweden · Spain · France · Poland · Italy · Norway · Belgium · Germany · Czechia · Austria · Netherlands · Denmark
2025-524928-21-00 on CTIS ↗
Phase III Hemic and Lymphatic Diseases Authorised 21/08/2026

A Phase 3 Randomized, Double-blind, Placebo-controlled Global Study of Sapablursen in Polycythemia Vera

Polycythemia Vera
Deciphera Pharmaceuticals Inc.
106 participants planned
Austria · Czechia · Italy · Portugal · Germany · France · Hungary · Spain · Poland
2025-524669-25-00 on CTIS ↗
Phase III Neoplasms Authorised 21/08/2026

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

Neoplasms, Gastrointestinal Stromal
Glaxosmithkline Research & Development Limited
302 participants planned
Italy · Portugal · Germany · Sweden · Poland · Romania · Finland · Greece · Norway · Spain · Netherlands · France · Hungary
2025-524934-24-00 on CTIS ↗
Phase III Eye Diseases Authorised 21/08/2026

A Randomized, Double-Masked, Placebo-Controlled Study Assessing the Efficacy and Safety Of Privosegtor (OCS-05) as add-on to IV Methylprednisolone in Participants with Optic Neuritis (PIONEER 1)

Optic Neuritis
Oculis Operations SARL
82 participants planned
Italy · Germany · France · Poland · Spain
2025-525075-91-00 on CTIS ↗
Phase III Hemic and Lymphatic Diseases Authorised 21/08/2026

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

Non-Transfusion-Dependent Alpha- or Beta-Thalassemia
Agios Pharmaceuticals Inc.
3 participants planned
Italy · Greece
2025-524706-15-00 on CTIS ↗
Phase III Neoplasms Authorised 21/08/2026

A Randomized, Open-Label Phase 3 Study of Azenosertib Versus Investigator’s Choice of Chemotherapy in Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression

High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
K-Group Beta Inc.
197 participants planned
Germany · Spain · Italy · Belgium · Poland · France · Ireland
2025-524641-27-00 on CTIS ↗
Phase III Hemic and Lymphatic Diseases Authorised 20/08/2026

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

Transfusion-Dependent Alpha- or Beta-Thalassemia
Agios Pharmaceuticals Inc.
8 participants planned
Italy · Greece
2025-524707-71-00 on CTIS ↗
Phase III Neoplasms Authorised 20/08/2026

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

High Risk Smoldering Multiple Myeloma (HR-SMM)
Regeneron Pharmaceuticals Inc.
108 participants planned
Italy · Spain · Poland · France · Norway · Greece · Germany
2025-523252-31-00 on CTIS ↗
Phase III Eye Diseases Authorised 20/08/2026

A Phase 3 Multicenter, Double-Masked, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Efficacy of Gildeuretinol Acetate (ALK-001) on the Progression of Stargardt Disease (STGD) - NORTHSTAR

Stargardt Disease (STGD1)
Alkeus Pharmaceuticals Inc.
64 participants planned
Belgium · France · Spain · Italy · Germany
2026-525296-60-00 on CTIS ↗
Phase III Neoplasms Authorised 20/08/2026

Impact of Hyperthermic Intrathoracic Chemotherapy (HITHOC) and Pleurectomy in the local treatment of pleural tumors. A Prospective Randomized Study The Tic-Tac Trial

malignant pleural effusion
Universita' Degli Studi Di Torino
64 participants planned
Italy
2026-526109-13-00 on CTIS ↗
Phase III Immune System Diseases Authorised 18/08/2026

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

Ocular Myasthenia Gravis
UCB Biopharma
46 participants planned
Hungary · Greece · Italy · Spain · Germany · Poland · France
2025-524756-54-00 on CTIS ↗
Phase II Neoplasms Authorised 18/08/2026

A Phase II, Randomized, Open-label, Multi-center Study of AK104 in Combination with Lenvatinib versus Lenvatinib in Participants with Advanced Hepatocellular Carcinoma Who Have Progressed on Atezolizumab and Bevacizumab

Hepatocellular Carcinoma
Akeso Biopharma Co. Ltd.
37 participants planned
Poland · France · Spain · Italy
2025-524591-30-00 on CTIS ↗
Phase I Neoplasms Authorised 17/08/2026

A clinical trial to learn about the effects of INR731 alone or with an androgen receptor pathway inhibitor (ARPI) in men with prostate cancer

Metastatic castration resistant prostate cancer
Novartis Pharma AG
26 participants planned
France · Italy · Spain · Germany
2025-524080-20-00 on CTIS ↗
Phase III Bacterial Infections and Mycoses Authorised 17/08/2026

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

Pneumoccoccal Immunisation
Pfizer Inc.
1345 participants planned
Spain · Finland · Poland · Germany · Greece · Hungary · Italy
2025-523447-35-02 on CTIS ↗
Phase I/II Neoplasms Authorised 17/08/2026

A Phase 1/2 Open-label, Multi-center Study to Evaluate the Safety and Clinical Activity of GSK5926371 in Adult Participants with Relapsed or Refractory B-cell Non-Hodgkin Lymphomas (B-NHL)

Lymphoma, Non-Hodgkin
Glaxosmithkline Research & Development Limited
30 participants planned
Italy · Germany · Spain · Finland · France
2025-524915-36-00 on CTIS ↗
Phase III Male Urogenital Diseases Authorised 17/08/2026

A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer

Metastatic castration-resistant prostate cancer (mCRPC)
BioNTech SE
183 participants planned
Belgium · Spain · Italy · Poland · Germany · Hungary
2025-524445-27-00 on CTIS ↗
Phase II Mental Disorders Authorised 14/08/2026

A phase IIa open-label dose-finding study with lead-in phase evaluating the safety, pharmacokinetics, and attenuating effects of trazodone on the consciousness-altering effects of psilocybin in individuals with Treatment-Resistant Depression

Treatment-Resistant Depression
Universita' Degli Studi G. D'Annunzio Di Chieti
30 participants planned
Italy
2025-523346-27-00 on CTIS ↗
Phase III Neoplasms Authorised 14/08/2026

The HCC patient-journey study: a prospective, adaptive, master protocol, to assess the value of the available sequences of treatment for patients with advanced hepatocellular carcinoma. The Journey of liver cancer patient - J-LI

Advanced hepatocellular carcinoma
Azienda Sanitaria Locale Napoli 1 Centro
1700 participants planned
Italy
2026-525898-39-00 on CTIS ↗
Phase II Musculoskeletal Diseases Authorised 14/08/2026

Denosumab or Zoledronic acid for erosive hand osteoarthritis (EHOA) in patients with osteoporosis a randomized controlled trial (ZODIAC trial)

Erosive hand osteoarthritis (EHOA)
Azienda Ospedaliera Universitaria Integrata Verona
150 participants planned
Italy
2026-526828-41-00 on CTIS ↗
Phase II Cardiovascular Diseases Authorised 14/08/2026

A Phase 2, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of CRD-4730 in patients with heart failure with reduced ejection fraction (HFREF) (CALIBRATE-HF)

heart failure
Cardurion Pharmaceuticals Inc.
369 participants planned
Latvia · Slovakia · Lithuania · Hungary · Italy · Netherlands · Spain · Poland · Bulgaria · Czechia
2025-525033-31-00 on CTIS ↗
Phase II Neoplasms Authorised 13/08/2026

A TWO-STAGE, SINGLE-ARM, PHASE II STUDY OF ZONGERTINIB PLUS FULVESTRANT IN PARTICIPANTS WITH HORMONE RECEPTOR-POSITIVE/HER2-NEGATIVE ADVANCED BREAST CANCER HARBORING HER2 MUTATIONS (AGATHA)

HR-positive/HER2-negative advanced breast cancer
Medica Scientia Innovation Research S.L.
25 participants planned
Spain · Italy · Germany
2026-525328-10-00 on CTIS ↗
Phase III Neoplasms Authorised 13/08/2026

SERAFA-1: A Single arm, Open label, Multicentre, Phase IIIb Study Of Camizestrant plus Ribociclib in 1st line Treatment of ER-positive, HER2-negative Advanced Breast Cancer Patients

Breast Cancer
AstraZeneca AB
79 participants planned
Poland · Spain · France · Germany · Italy
2025-523444-12-00 on CTIS ↗
Phase IV Respiratory Tract Diseases Authorised 13/08/2026

A randomized, double blind, placebo-controlled study comparing the efficacy of dupilumab to standard of care (SOC) treatment following hospitalization for a COPD exacerbation

Chronic obstructive pulmonary disease (COPD)
Regeneron Pharmaceuticals Inc.
190 participants planned
Belgium · Italy · Spain
2025-524392-23-00 on CTIS ↗
Phase II Genetic Phenomena Authorised 12/08/2026

AN OPEN LABEL, SINGLE ARM, EXPLORATIVE TRIAL TO EVALUATE EFFICACY AND SAFETY OF BEROTRALSTAT IN PREVENTING ANGIOEDEMA ATTACKS IN SUBJECTS WITH ACQUIRED ANGIOEDEMA DUE TO C1 INHIBITOR DEFICIENCY (AAE)

Acquired angioedema due to C1 inhibitor deficiency
Policlinico San Donato S.p.A.
16 participants planned
Italy
2025-524747-13-00 on CTIS ↗
Phase II Musculoskeletal Diseases Authorised 12/08/2026

A RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, CLINICAL TRIAL OF COLCHICINE IN AMYOTROPHIC LATERAL SCLEROSIS (CO-ALS II)

AMYOTROPHIC LATERAL SCLEROSIS
Azienda Ospedaliero Universitaria Di Modena
87 participants planned
Italy
2026-526460-20-00 on CTIS ↗
Phase III Neoplasms Authorised 11/08/2026

Premedication with dexamethasone for preventing interstitial lung disease in patients with breast cancer treated with trastuzumab deruxtecan

Breast Cancer
Istituto Di Ricerche Farmacologiche Mario Negri
244 participants planned
Italy
2025-521798-15-00 on CTIS ↗
Phase I Neoplasms Authorised 11/08/2026

A dose escalation and expansion study of XB010 as a single agent and combination therapy in subjects with locally advanced or metastatic solid tumors

Locally Advanced or Metastatic Solid Tumors
Exelixis Inc.
40 participants planned
Italy · Netherlands · France · Spain
2025-524805-34-00 on CTIS ↗
Phase III Cardiovascular Diseases Authorised 11/08/2026

A multicentre randomised study on percutaneous stellate ganglion block as first line treatment in patients with electrical storm: the STAR 2 study

electrical storm
Fondazione IRCCS Policlinico San Matteo
180 participants planned
Italy
2024-520387-34-01 on CTIS ↗
Phase II Neoplasms Authorised 11/08/2026

Valproic acid and lenvatinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma

Recurrent and/or Metastatic Adenoid Cystic Carcinom
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
15 participants planned
Italy
2026-525733-24-00 on CTIS ↗
Phase I Neoplasms Authorised 10/08/2026

A Phase 1, Open-Label, Multicenter Study of INCA036978 in Participants With Myeloproliferative Neoplasms

Myeloproliferative Neoplasms
Incyte Corp.
60 participants planned
Italy · Belgium · Germany · France · Spain
2026-525217-31-00 on CTIS ↗
Phase III Hormonal diseases Authorised 07/08/2026

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

Graves' Disease (GD)
Argenx
145 participants planned
Italy · Czechia · Spain · Denmark · Belgium · Romania · Latvia · France · Germany · Greece · Sweden · Poland · Lithuania · Bulgaria
2025-523333-26-00 on CTIS ↗
Phase II Cardiovascular Diseases Authorised 06/08/2026

[22961] A placebo-controlled, parallel-group, double blind, randomized, multi-cohort Phase 2 study to investigate efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of BAY 3670549 in adult participants with atrial fibrillation.

Atrial fibrillation
Bayer AG
105 participants planned
Belgium · Netherlands · Germany · Poland · Italy · Hungary · Bulgaria
2025-523807-31-00 on CTIS ↗
Phase III Respiratory Tract Diseases Authorised 04/08/2026

ROSY-F: Roll-Over Study for Participants Who Have Completed a Previous Study with Benralizumab (Fasenra) and Are Judged by the Investigator to Clinically Benefit from Continued Treatment

Eosinophilic Granulomatosis with Polyangiitis (EGPA), Hypereosinophilic Syndrome (HES), Asthma
AstraZeneca AB
94 participants planned
Denmark · Belgium · France · Italy · Netherlands · Austria · Poland
2025-523307-29-00 on CTIS ↗
Phase II Respiratory Tract Diseases Authorised 04/08/2026

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

Idiopathic Pulmonary Fibrosis
AstraZeneca AB
139 participants planned
Poland · Hungary · Netherlands · Germany · Spain · Greece · Bulgaria · Italy · France · Denmark
2025-525016-41-00 on CTIS ↗
Phase I Neoplasms Authorised 03/08/2026

A First-in-Human Study of INCA035784 in Participants With Myeloproliferative Neoplasms

Myeloproliferative Neoplasms
Incyte Corp.
40 participants planned
Italy · Belgium · Germany
2026-525360-18-00 on CTIS ↗
Phase III Skin and Connective Tissue Diseases Authorised 03/08/2026

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

Systemic sclerosis
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
179 participants planned
Denmark · Hungary · Sweden · Netherlands · Germany · Belgium · France · Greece · Norway · Finland · Czechia · Portugal · Bulgaria · Spain · Austria · Romania · Croatia · Poland · Estonia · Italy · Lithuania
2025-523884-39-00 on CTIS ↗
Phase III Immune System Diseases Authorised 03/08/2026

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

Moderately to Severely Active Crohn’s Disease
Janssen Cilag International
194 participants planned
Norway · Romania · Austria · Italy · Slovakia · Germany · Hungary · Netherlands · Belgium · France · Portugal · Czechia · Poland · Spain · Greece
2026-525922-39-00 on CTIS ↗
Phase III Immune System Diseases Authorised 03/08/2026

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

Moderately to Severely Active Ulcerative Colitis
Janssen Cilag International
302 participants planned
France · Bulgaria · Romania · Slovakia · Norway · Denmark · Greece · Italy · Austria · Poland · Netherlands · Czechia · Germany · Belgium · Spain · Hungary · Portugal
2026-525923-26-00 on CTIS ↗
Phase III Cardiovascular Diseases Authorised 29/07/2026

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

Heart failure with preserved ejection fraction (HFpEF) and heart failure with mildly reduced ejection fraction (HFmrEF); on background SGLT2i.
AstraZeneca AB
2343 participants planned
Spain · Hungary · Germany · Poland · Italy · Bulgaria · Netherlands · Austria · Romania · Sweden · France · Greece · Slovakia · Czechia
2026-526304-79-00 on CTIS ↗
Phase 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 planned
Italy · France · Spain
2026-525484-40-00 on CTIS ↗
Phase III Cardiovascular Diseases Authorised 27/07/2026

A Randomized Controlled Study Evaluating Short-Term Dual Antiplatelet Therapy with Low-Dose Ticagrelor (60 mg) Followed by Monotherapy versus Standard-Duration Dual Antiplatelet Therapy with Clopidogrel in Patients with Chronic Coronary Syndrome Undergoing Percutaneous Coronary Intervention: the STELAR trial

Chronic Coronary Syndrome in patients undergoing percutaneous coronary intervention (PCI)
Azienda Ospedaliera Universitaria Gaetano Martino Messina
500 participants planned
Italy
2026-526368-18-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 27/07/2026

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

Participants with obesity with or without type 2 diabetes
Novo Nordisk A/S
1140 participants planned
Greece · Portugal · France · Slovakia · Bulgaria · Netherlands · Romania · Italy · Austria · Poland · Hungary · Spain · Czechia · Belgium
2025-522488-14-00 on CTIS ↗
Phase III 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 planned
Ireland · Netherlands · France · Italy
2025-523837-25-00 on CTIS ↗
Phase I/II Neoplasms Authorised 27/07/2026

Phase I/II Trial to Determine Safety and Efficacy of non-Viral Allogeneic Dual CD123/33-Chimeric Antigen Receptor CIK (CARCIK-CD123/33) Cells in Adult and Pediatric Patients with Relapse/Refractory Acute Myeloid Leukemia (AML) and Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Acute myeloid leukemia and Blastic plasmacytoid dendritic cell neoplasm
Fondazione Tettamanti, Fondazione IRCCS San Gerardo Dei Tintori
18 participants planned
Italy
2025-524977-18-00 on CTIS ↗
Phase III Neoplasms Authorised 27/07/2026

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

Small Cell Lung Cancer
AbbVie Deutschland GmbH & Co. KG
125 participants planned
Italy · Greece · Spain · Belgium · France · Austria · Germany
2025-523819-11-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 27/07/2026

A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Master Protocol to Evaluate the Efficacy and Safety of Elecoglipron in Participants with Obesity or Overweight with or without Type 2 Diabetes Mellitus (Embold)

Participants Living with Obesity or Overweight with at least 1 comorbidity with or without Type 2 Diabetes Mellitus
AstraZeneca AB
1010 participants planned
Spain · Germany · Italy · Poland
2025-524688-19-00 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 planned
Poland · Italy · Germany · France · Spain
2025-523960-19-00 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 planned
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 planned
Czechia · Italy · Hungary · Romania · Bulgaria · Sweden · Denmark · Poland · Spain · Norway · Finland · Greece · France · Germany
2025-523994-41-00 on CTIS ↗
Phase II Neoplasms Authorised 23/07/2026

Immune dynamics and biomarkers of anti-tumor response in BMS-986340 (anti-CCR8) and nivolumab (anti-PD-1) co-treatment of metastatic tumors

Metastatic solid tumors, with the following specific indications: Non–Small Cell Lung Cancer (NSCLC), metastatic, PD-(L)1–refractory/resistant Gastric adenocarcinoma, metastatic, PD-(L)1–refractory/resistant Colorectal cancer (microsatellite stable, MSS), metastatic, immunotherapy‑naïve Pancreatic adenocarcinoma, metastatic, immunotherapy‑naïve
Humanitas Mirasole S.p.A., Fondazione Humanitas Per La Ricerca Ets
30 participants planned
Italy
2025-524125-40-01 on CTIS ↗
Phase II Immune System Diseases Authorised 23/07/2026

A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of SIR9900 in Patients with VEXAS Syndrome (SIVEX)

VEXAS Syndrome
Sironax USA Inc.
24 participants planned
Italy
2025-524918-28-00 on CTIS ↗
Phase III Hormonal diseases Authorised 23/07/2026

A Phase 3b, Open-Label Study of Crinecerfont to Evaluate Androgen Reduction and Related Outcomes in Adults With Classic Congenital Adrenal Hyperplasia

Classic Congenital Adrenal Hyperplasia (CAH)
Neurocrine Biosciences Inc.
71 participants planned
Czechia · Germany · Sweden · Portugal · Romania · Bulgaria · Italy · Austria · Spain
2025-524282-24-00 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 planned
France · Italy · Germany · Spain
2025-524418-27-00 on CTIS ↗
Phase I/II Immune System Diseases Authorised 22/07/2026

A Phase 1/2a, Open-label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of BMS-986528 in Participants with Refractory Rheumatoid Arthritis

Refractory, difficult-to-treat Rheumatoid Arthritis
Bristol-Myers Squibb Services Unlimited Company
21 participants planned
Poland · Italy · Spain · Germany
2025-520666-22-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 22/07/2026

A Randomized, Open-label, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared with Oral Semaglutide in Adults with Type 2 Diabetes Mellitus (Eluminate-2)

type 2 diabetes mellitus
AstraZeneca AB
335 participants planned
Poland · Hungary · Italy · Bulgaria · Germany
2025-523933-24-00 on CTIS ↗
Phase II Nervous System Diseases Authorised 22/07/2026

A Phase 2, Multicenter, Randomized, Double-blind, Placebocontrolled Study, to Evaluate Efficacy, Safety, Tolerability, and Pharmacodynamics of Intrathecally Administered Mivelsiran in Adult Participants with Early-Stage Down Syndrome-Associated Alzheimer’s Disease (DS-AD)

Early-Stage Down Syndrome-Associated Alzheimer’s Disease (DS-AD)
Alnylam Pharmaceuticals Inc.
17 participants planned
Italy · Netherlands · Spain · Germany · Ireland
2025-523390-42-00 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 planned
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 planned
Spain · Sweden · Germany · Romania · Finland · Portugal · Austria · Italy · Denmark · Czechia · France · Netherlands · Poland · Belgium · Norway
2026-525242-29-00 on CTIS ↗
Phase II Immune System Diseases Authorised 21/07/2026

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

newly diagnosed amyloid light chain amyloidosis
Glaxosmithkline Research & Development Limited
17 participants planned
Italy · Greece · Spain
2025-522803-60-00 on CTIS ↗
Phase III 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 planned
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 planned
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 planned
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 planned
Belgium · France · Italy · Germany
2025-523258-15-00 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 planned
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 planned
Norway · Poland · Spain · Sweden · Bulgaria · Netherlands · Finland · Portugal · Austria · Italy · Greece · Ireland · Czechia · France · Romania · Belgium · Germany · Denmark · Slovakia · Hungary
2025-522227-99-00 on CTIS ↗
Phase 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 planned
Sweden · Finland · Belgium · Spain · Austria · Netherlands · France · Norway · Germany · Italy · Poland
2025-524711-36-00 on CTIS ↗
Phase III Cardiovascular Diseases Authorised 17/07/2026

Triple oral therapy with bempedoic acid vs usual care in early lipid management of patients with acute coronary syndrome

Acute Coronary Syndrome
Fondazione Per Il Tuo Cuore Onlus Denominabile Anche Fondazione Italiana Per La Lotta Alle Malattie Cardiovascolari Onlus Ed Anche Heart Care Foundation Hcf Onlus
600 participants planned
Italy
2026-525740-15-00 on CTIS ↗
Phase II Digestive System Diseases Authorised 16/07/2026

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Confirm Efficacy and Safety of MH002 and to Assess the Effect of Dose in Patients With Mild-to-Moderate Ulcerative Colitis Insufficiently Controlled With 5-Aminosalicylic Acid

Ulcerative Colitis
Microbial Resource Management Health
109 participants planned
Czechia · Poland · Italy
2025-524682-24-00 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 planned
Ireland · Spain · Germany · Czechia · Bulgaria · France · Belgium · Romania · Italy
2025-524463-20-00 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 planned
Belgium · Germany · France · Denmark · Poland · Spain · Netherlands · Italy · Austria
2025-524648-37-00 on CTIS ↗
Phase II Neoplasms Authorised 14/07/2026

A Phase II, Open-Label, Single-Arm, Multicentre Study of Immunotherapy and non-invasive response evaluation in cutaneous squamous cell carcinoma as an organ preservation strategy: a proof of concept clinical study and translational correlates - INCEPT

cutaneous squamous cell carcinoma
Fondazione GONO Plus
33 participants planned
Italy
2025-523633-25-00 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 planned
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 planned
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 planned
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 planned
Germany · Poland · Czechia · Belgium · France · Greece · Sweden · Portugal · Italy
2025-525105-20-00 on CTIS ↗
Phase II Immune System Diseases Authorised 08/07/2026

Master Protocol Full Title- A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis. ISA 2 to Master Protocol ARGX-999-2-MG-2000 – an Exploratory, Phase 2a, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis

AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis, MG, gMG
Argenx
29 participants planned
Greece · Italy · Germany · Belgium · Netherlands · Spain · Poland
2025-522939-33-00 on CTIS ↗
Phase III 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 planned
Sweden · Poland · Denmark · Finland · Netherlands · Italy · France · Spain
2023-505575-69-01 on CTIS ↗
Phase II Nervous System Diseases Authorised 08/07/2026

A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of E2086 in Adults with Narcolepsy

Narcolepsy
Eisai Limited
51 participants planned
Belgium · Italy · Spain · Germany
2025-523503-30-00 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 planned
Belgium · Ireland · Germany · Norway · Italy · France · Spain
2025-524285-18-00 on CTIS ↗
Phase III Eye Diseases Authorised 07/07/2026

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

Cataract
Ntc S.r.l.
536 participants planned
Spain · Poland · Greece · Sweden · Italy
2026-525594-39-00 on CTIS ↗
Phase III 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 planned
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 planned
Belgium · Greece · Germany · France · Finland · Spain · Czechia · Poland · Italy · Netherlands · Denmark · Portugal
2025-523369-32-00 on CTIS ↗
Phase III Neoplasms Authorised 07/07/2026

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

Multiple Myeloma
F. Hoffmann-La Roche AG
133 participants planned
France · Germany · Italy · Greece · Denmark · Czechia · Spain · Poland
2025-524028-23-00 on CTIS ↗
Phase III 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 planned
Portugal · Spain · France · Italy · Germany · Austria
2025-522563-15-00 on CTIS ↗
Phase III Respiratory Tract Diseases Authorised 06/07/2026

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

Respiratory tract diseases
Sanofi-Aventis Recherche & Developpement
613 participants planned
Denmark · Sweden · Poland · Estonia · Portugal · Latvia · Spain · Hungary · Germany · Finland · Italy · Belgium · France
2024-518016-39-00 on CTIS ↗
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 planned
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
156 participants planned
Netherlands · Greece · Germany · Italy · Austria · Spain
2025-521929-32-01 on CTIS ↗
Phase III Neoplasms Authorised 01/07/2026

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

Relapsed or Refractory Multiple Myeloma
Janssen Cilag International
206 participants planned
Poland · Spain · Czechia · France · Italy · Germany · Greece
2025-523815-12-00 on CTIS ↗
Phase 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 planned
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
257 participants planned
Finland · Belgium · Hungary · France · Denmark · Austria · Germany · Italy · Spain · Czechia · Norway · Poland
2025-522167-15-00 on CTIS ↗
Phase III Respiratory Tract Diseases 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 planned
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 planned
Greece · France · Italy · Belgium · Denmark · Germany · Poland · Czechia · Portugal · Austria · Spain · Romania
2025-521769-29-00 on CTIS ↗
Phase III Skin and Connective Tissue Diseases Authorised 29/06/2026

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

Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease
Merck Healthcare KGaA
57 participants planned
Germany · Romania · France · Bulgaria · Belgium · Spain · Poland · Greece · Italy · Czechia
2025-524855-30-00 on CTIS ↗
Phase III Immune System Diseases Authorised 29/06/2026

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

Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease
Merck Healthcare KGaA
54 participants planned
Spain · Belgium · France · Germany · Slovakia · Romania · Bulgaria · Italy · Poland · Greece
2025-523871-44-00 on CTIS ↗
Phase 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 planned
France · Italy · Spain
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.
252 participants planned
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 planned
Netherlands · Romania · Poland · France · Italy · Spain
2025-523288-39-00 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 planned
Italy
2026-526113-28-00 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 planned
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 planned
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 planned
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
486 participants planned
Germany · Bulgaria · Netherlands · Sweden · Portugal · Croatia · Italy · Austria · Spain · Poland · France · Denmark · Hungary · Romania · Estonia · Slovakia · Belgium · Czechia · Norway · Lithuania · Greece
2025-524322-18-00 on CTIS ↗
Phase II 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 planned
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 planned
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 planned
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 planned
Spain · Italy · France
2025-522587-33-00 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 planned
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.
37 participants planned
Spain · Germany · France · Italy · Belgium
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 planned
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 planned
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 planned
Finland · Portugal · Hungary · Ireland · Poland · Greece · France · Belgium · Denmark · Italy · Spain · Netherlands · Austria · Germany
2025-522373-10-00 on CTIS ↗
Phase II Skin and Connective Tissue Diseases Authorised 17/06/2026

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

Systemic sclerosis
Galderma S.A.
56 participants planned
Poland · Italy · Bulgaria · France · Greece · Spain · Croatia
2025-522294-11-00 on CTIS ↗
Phase 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 planned
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 planned
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 planned
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 planned
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 planned
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 planned
Greece · Poland · Italy · Hungary · Germany · Netherlands · France · Spain
2025-522643-18-00 on CTIS ↗
Phase II Digestive System Diseases Authorised 16/06/2026

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

Ulcerative colitis (Inflammatory Bowel Disease)
Spyre Therapeutics Inc.
228 participants planned
Croatia · Poland · Austria · Czechia · Italy · Slovakia · Bulgaria · Greece · Belgium · Spain · Hungary · Germany · Lithuania · France · Romania
2025-524640-35-00 on CTIS ↗
Phase III Musculoskeletal Diseases Authorised 15/06/2026

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 planned
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)

C3 Glomerulopathy (C3G), Primary Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
Swedish Orphan Biovitrum AB (publ)
82 participants planned
France · Italy · Spain · Germany · Belgium
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 planned
Italy · Netherlands · France · Germany · Spain · Poland · Greece
2025-522038-29-00 on CTIS ↗
Phase III Neoplasms Authorised 12/06/2026

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

​Relapsed/refractory B-cell Acute Lymphoblastic Leukemia​
Merck Sharp & Dohme LLC
109 participants planned
Greece · Netherlands · Sweden · France · Italy · Spain · Denmark
2025-522267-15-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 12/06/2026

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

Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Glaxosmithkline Research & Development Limited
210 participants planned
Greece · Germany · Belgium · Netherlands · Poland · Italy · France · Spain · Bulgaria · Austria
2025-523674-16-00 on CTIS ↗
Phase 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 planned
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 planned
Italy · Germany · Hungary · Poland · Belgium
2025-524112-11-00 on CTIS ↗
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Priya Life Science (2026). EU Clinical Trials Tracker. Available at: https://priyalifescience.com/clinical-trials-europe/country/italy (Accessed: 11 September 2026).

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Source: Clinical Trials Information System (CTIS), European Medicines Agency - trials authorised under the EU Clinical Trials Regulation (Regulation 536/2014), showing the most recent EU authorisation decisions, refreshed daily. Listing here is informational and not medical advice; eligibility is determined by each study team. Looking for Irish sites? See our Ireland Clinical Trials Tracker. For approved medicines, see the EMA Approvals Tracker. See who's running these trials in our Company Directory, or compare pay across these markets in the EU Salary Guide.