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Clinical trial register · European Union · CTIS

Clinical Trials in Italy

The most recently authorised trials on the EU Clinical Trials Information System (CTIS), the single register for every trial run under the EU Clinical Trials Regulation (536/2014). CTIS holds a far larger historical archive than any one list can usefully show — this register states both numbers rather than picking one.

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Source: EMA Clinical Trials Information System (CTIS). Showing the 2500 most recently authorised of 12445 total CTIS records — a stated recency window, not the full historical archive. Synced 21 Sep 2026, 03:16 UTC
2500
Shown in this register
most recently authorised
12,445
Total on CTIS
full historical archive
745
Phase III
within the shown window
Top member states
Spain 1023 France 890 Germany 861 Italy 742 Poland 587 Netherlands 524
Narrow the registerReset
Phase
Phase I 558 Phase I/II 214 Phase II 726 Phase III 745 Phase IV 257
Lead sponsor
AstraZeneca AB 60 Assistance Publique Hopitaux De Paris 49 Merck Sharp & Dohme LLC 48 Pfizer Inc. 45 Novo Nordisk A/S 42
Member state
Spain 1023 France 890 Germany 861 Italy 742 Poland 587 Netherlands 524 Belgium 426 Czechia 327
All 28 states
238 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase II
A Phase 2, Randomized, Open-Label Study Of Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)
2025-521849-25-00Chronic Graft-Versus-Host Disease
Incyte Corp.
Immune System Diseases
Spain, Belgium, Germany, Italy
17/10/2025
Phase II
Bladder Preservation with Sacituzumab Govitecan + Zimberelimab for MuscleInvasive Bladder cancer in cisplatin-unfit and unwilling for cystectomy patients: phase II trial (preSAVE trial)
2024-516943-14-01Muscle-Invasive Bladder cancer
Fondazione IRCCS Istituto Nazionale Dei Tumori
Neoplasms
Italy
15/10/2025
Phase II
Inhibition of late sodium current (INa) to prevent coronary MICROvascular dysfunction in patients presenting with ST-Elevation myocardial infarction and multivessel disease: A multicenter, randomized, controlled and open label study (INaMICRON study)
2025-520801-12-00Acute myocardial infarction in patients presenting with STE…
Universita' Degli Studi Di Napoli Federico II
Cardiovascular Diseases
Italy
13/10/2025
Phase II
Effectiveness of CITicoline (TRAUSAN) in preventing cognitive decline After DELirium in older adults with proximal hip fracture – The CITADEL randomized controlled trial
2025-522306-21-00Cognitive profiles
Universita Degli Studi Di Milano Bicocca
Nervous System Diseases
Italy
13/10/2025
Phase II
Elacestrant and exemestane for patients with pretreated HR+/HER2- metastatic breast cancer and [18F]-FES-avid lesions (COMBINE): a proof-of-concept phase 2 clinical trial
2024-519792-25-00Metastatic hormone receptor-positive/HER2-negative breast c…
Istituto Europeo Di Oncologia S.r.l.
Neoplasms
Italy
10/10/2025
Phase II
A double-blind, randomised, placebo-controlled, parallel group, Phase IIa trial to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of BI 765423 administered intravenously with or without standard of care in patients with idiopathic pulmonary fibrosis
2025-520658-12-00Idiopathic Pulmonary Fibrosis (IPF)
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Respiratory Tract Diseases
Germany, Italy, Spain, Belgium
09/10/2025
Phase II
A Phase 2 Multicenter, Open-Label Study Evaluating the Efficacy and Safety of TYRA-300 in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer (SURF302)
2025-521277-14-00Non-muscle invasive bladder cancer (NMIBC)
Tyra Biosciences Inc.
Neoplasms
Italy, Spain, France
08/10/2025
Phase II
A Phase 2, Multicenter, Open-Label Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants with Active SLE (Including Lupus Nephritis) with Inadequate Response to Glucocorticoids and at Least 2 Immunosuppressants (Breakfree-SLE)
2024-519278-37-00Systemic Lupus Erythematosus, Lupus Nephritis
Celgene Corp.
Immune System Diseases
France, Spain, Portugal, Germany, Belgium, Poland, Italy, Denmark, Austria
06/10/2025
Phase II
A Phase 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab plus Nivolumab with or without Docetaxel versus Docetaxel Monotherapy in Second-Line Treatment of Participants with Metastatic Non-Squamous Non-Small Cell Lung Cancer (GDFATHER-NSCLC-02)
2024-516794-70-00Metastatic non-squamous non-small cell lung cancer
CatalYm GmbH
Neoplasms
Spain, Italy, Germany, Poland, Romania
06/10/2025
Phase II
A Phase 1b/2 Open-Label, Multicenter Study of RMC-9805 with or without RMC-6236, in Combination with Other Anticancer Agents, in Patients with RAS G12D-Mutated Non-Small Cell Lung Cancer (NSCLC) – Subprotocol C
2025-521147-21-00Lung Cancer
Revolution Medicines Inc.
Respiratory Tract Diseases
Germany, Austria, France, Netherlands, Czechia, Greece, Italy, Spain, Denmark
06/10/2025
Phase II
A Phase IIb, Multicenter, Double-Blind, Placebo-Controlled Induction Study with an Active Treatment Extension to Assess the Efficacy, Safety, and Pharmacokinetics of RO7837195 in Patients with Moderately to Severely Active Ulcerative Colitis
2025-520690-39-00Moderately to Severely Active Ulcerative Colitis (UC)
Genentech Inc.
Digestive System Diseases
France, Italy, Czechia, Poland, Germany
03/10/2025
Phase II
A Single-arm, Phase 2, Open-label, Multicenter Study to Evaluate NX-5948 in Adults with Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Previously Exposed to a Bruton’s Tyrosine Kinase Inhibitor (BTKi) and a B-cell Lymphoma-2 Inhibitor (BCL-2i)
2025-521088-10-00Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL…
Nurix Therapeutics Inc.
Neoplasms
France, Italy, Hungary, Poland
02/10/2025
Phase II
Upfront trastuzumab-deruxtecan plus capecitabine and bevacizumab for patients with HER2 positive metastatic colorectal cancer: the CHIMERA trial
2024-519479-24-00metastatic colorectal cancer
Fondazione GONO G.I.
Neoplasms
Germany, France, Italy, Spain
02/10/2025
Phase II
Phase II study of lurbinectedin and irinotecan in adult and young adult patients with advanced desmoplastic small round cell tumor (DSRCT)
2024-519261-21-00Desmoplastic small round cell tumor
Italian Sarcoma Group
Neoplasms
Spain, Italy
30/09/2025
Phase II
A randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, and tolerability of SAR444336 in participants with microscopic colitis in clinical remission with budesonide.
2024-519495-83-00Digestive system diseases
Sanofi-Aventis Recherche & Developpement
Digestive System Diseases
Italy, Sweden, Germany, France, Poland, Denmark, Belgium, Hungary
29/09/2025
Phase II
A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose Range-finding, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ALXN2420, a Growth Hormone Receptor Antagonist, Administered Subcutaneously in Combination with Somatostatin Analogs in Adult Participants with Acromegaly
2025-521243-20-00Acromegaly
Alexion Pharmaceuticals Inc.
Hormonal diseases
Lithuania, Romania, Denmark, Italy, Hungary, Poland, Netherlands
29/09/2025
Phase II
Clinical Randomised Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation.
2025-521377-14-00Atrial fibrillation
Acesion Pharma ApS
Cardiovascular Diseases
Hungary, Italy, Denmark, Bulgaria, Poland, Netherlands, Germany
29/09/2025
Phase II
A Phase 2b, Multicenter, Randomized, Double-blind, Parallel group, Placebo-controlled, Dose Range Finding Study to Evaluate the Efficacy, Safety, and Tolerability of Nebulized CSL787 in Adults (18 to 85 years) with Non-cystic Fibrosis Bronchiectasis
2024-518821-13-00Non-cystic Fibrosis Bronchiectasis
CSL Behring LLC
Respiratory Tract Diseases
Spain, Belgium, Germany, Greece, Denmark, Netherlands, Hungary, Italy, France, Poland
26/09/2025
Phase II
A Randomized, Double-Blind, Active-Controlled Multicenter Phase 2 Study Evaluating the Efficacy and Safety of ALG-000184 Compared with Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg-Negative Adult Subjects with Chronic Hepatitis B Virus Infection (B-SUPREME)
2025-521178-33-00Chronic Hepatitis B Virus Infection
Aligos Therapeutics Inc.
Virus Diseases
Spain, Italy, Bulgaria, Romania, France
24/09/2025
Phase II
A multicenter, randomized, double-blind, placebo-controlled, Phase II platform study to assess the efficacy and safety of investigational compound(s) in patients with moderate to severe atopic dermatitis
2024-519081-49-00Moderate to severe atopic dermatitis
Novartis Pharma AG
Skin and Connective Tissue Diseases
Czechia, Netherlands, Poland, Germany, Spain, Hungary, France, Italy, Slovakia
22/09/2025
Phase II
A Multicentre, Parallel-group, Phase IIb, Randomised, Double blind, Placebo-controlled, 3-Arm, 24-Week Study to Evaluate the Efficacy and Safety of AZD6793 Tablets in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PRESTO).
2025-520473-40-00Moderate to Very Severe Chronic Obstructive Pulmonary Disea…
AstraZeneca AB
Respiratory Tract Diseases
Spain, Greece, Bulgaria, Germany, Denmark, Hungary, Italy, Poland
22/09/2025
Phase II
A Phase 2, Open-Label, Multicenter Study of Zoldonrasib(RMC-9805) in Previously Treated Patients with RAS G12DMutant Non-Small Cell Lung Cancer (NSCLC) – Subprotocol D
2025-521681-10-00Lung Cancer
Revolution Medicines Inc.
Respiratory Tract Diseases
Germany, Greece, Netherlands, Czechia, France, Austria, Denmark, Spain, Italy
22/09/2025
Phase II
A Phase II, randomized, open-label, multi-center study of JSB462 in combination with lutetium (177Lu) vipivotide tetraxetan in adult male patients with PSMA-positive metastatic castration resistant prostate cancer (mCRPC)
2024-520155-24-00Metastatic castration resistant prostate cancer (mCRPC)
Novartis Pharma AG
Neoplasms
Netherlands, Austria, Germany, Italy, France, Czechia, Spain
17/09/2025
Phase II
A Phase 2b, non-randomized, controlled, open-label, extension study to evaluate the persistence of immune response of the adjuvanted RSVPreF3 vaccine and the safety and immunogenicity following revaccination in lung and kidney transplant recipients (≥18 years of age)
2024-519730-23-00Respiratory Syncytial Virus Infections
GlaxoSmithKline Biologicals
Respiratory Tract Diseases
Italy, Germany, Spain
16/09/2025
Phase II
Combining Loncastuximab Tesirine and Epcoritamab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
2023-509861-19-01Diffuse large B-cell lymphoma (DLBCL), High-grade B-cell ly…
Universitaet Muenster
Neoplasms
Germany, Italy
15/09/2025
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Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 21 September 2026. https://priyalifescience.com/clinical-trials-europe/country/italy

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Listing here is informational and not medical advice; eligibility is determined by each study team. Looking for Irish sites? See the Ireland, UK or USA registers. For approved medicines, see the EMA Approvals Tracker.