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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 20 Sep 2026, 03:17 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 581 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 581 Netherlands 524 Belgium 426 Czechia 327
All 28 states
742 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase III
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
2024-518016-39-00Respiratory tract diseases
Sanofi-Aventis Recherche & Developpement
Respiratory Tract Diseases
Denmark, Sweden, Poland, Estonia, Portugal, Latvia, Spain, Hungary, Germany, Finland, Italy, Belgium, France
06/07/2026
Phase II
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
2024-517799-40-00Advanced squamous non-small cell lung cancer
G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica
Neoplasms
Italy
03/07/2026
Phase III
AugmENtation witH cAnnabidiol iN first episode psyChosis: a doublE blind randomised controlled trial (STEP-ENHANCE Trial)
2025-521929-32-01First Episode Psychosis (FEP)
University Of Oxford
Mental Disorders
Netherlands, Greece, Germany, Italy, Austria, Spain
01/07/2026
Phase III
"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"
2025-523815-12-00Relapsed or Refractory Multiple Myeloma
Janssen Cilag International
Neoplasms
Poland, Spain, Czechia, France, Italy, Germany, Greece
01/07/2026
Phase I
A Study to Evaluate Targeted Therapies for Patients with Rheumatoid Arthritis
2025-523127-21-00Rheumatoid Arthritis
AbbVie Deutschland GmbH & Co. KG
Immune System Diseases
Belgium, Netherlands, Spain, Germany, Italy
01/07/2026
Phase III
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)
2025-522167-15-00Ovarian Cancer Platinum-Sensitive Ovarian Cancer (PSOC)
Genmab A/S
Neoplasms
Finland, Belgium, Hungary, France, Denmark, Austria, Germany, Italy, Spain, Czechia, Norway, Poland
01/07/2026
Phase III
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
2025-521971-29-00Non Small Cell Lung Cancer (NSCLC)
Nuvation Bio Inc.
Respiratory Tract Diseases
Spain, Belgium, France, Italy, Germany
30/06/2026
Phase III
A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease
2025-521769-29-00Pulmonary Hypertension Associated with Interstitial Lung Di…
Insmed Inc.
Respiratory Tract Diseases
Greece, France, Italy, Belgium, Denmark, Germany, Poland, Czechia, Portugal, Austria, Spain, Romania
30/06/2026
Phase III
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
2025-524855-30-00Cutaneous Manifestations of Lupus Erythematosus With or Wit…
Merck Healthcare KGaA
Skin and Connective Tissue Diseases
Germany, Romania, France, Bulgaria, Belgium, Spain, Poland, Greece, Italy, Czechia
29/06/2026
Phase III
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
2025-523871-44-00Cutaneous Manifestations of Lupus Erythematosus With or Wit…
Merck Healthcare KGaA
Immune System Diseases
Spain, Belgium, France, Germany, Slovakia, Romania, Bulgaria, Italy, Poland, Greece
29/06/2026
Phase II
C6461014 - A Phase 2 Interventional Study of PF-08634404 in Combination with Chemotherapy in Participants with Previously Untreated Transformed Small Cell Lung Cancer
2025-524686-24-00Small Cell Lung Cancer
Pfizer Inc.
Neoplasms
France, Italy, Spain
29/06/2026
Phase I/II
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
2025-524623-50-00Solid Tumors
Revolution Medicines Inc.
Neoplasms
France, Poland, Ireland, Spain, Greece, Germany, Italy, Sweden, Belgium
29/06/2026
Phase II
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)
2025-523288-39-00Diffuse Cutaneous Systemic Sclerosis (dcSSc)
Mediar Therapeutics Inc.
Immune System Diseases
Netherlands, Romania, Poland, France, Italy, Spain
29/06/2026
Phase III
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)
2025-525009-18-00Pancreatic Ductal Adenocarcinoma
Incyte Corp.
Neoplasms
Poland, Italy, Netherlands, Sweden, Denmark, Finland, Spain, France, Germany, Belgium, Norway, Austria
26/06/2026
Phase IV
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.
2026-526113-28-00Advanced thyroid carcinoma. Post-thyroidectomy hypothyroidi…
Ceinge Biotecnologie Avanzate Franco Salvatore S.c.a.r.l.
Hormonal diseases
Italy
26/06/2026
Phase III
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
2025-523726-40-00Multiple Sclerosis
F. Hoffmann-La Roche AG
Immune System Diseases
Spain, France, Poland, Italy
24/06/2026
Phase III
SERENDIPITY: phase III multicentric randomized study assessing the reduction of chronic prostate inflammation with Permixon®
2025-525123-27-00Benign prostatic hypertrophy
Azienda Ospedaliero Universitaria Careggi, University Of Florence
Male Urogenital Diseases
Italy
23/06/2026
Phase III
A Phase 3 Extension Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema
2025-521353-16-00Hereditary Angioedema
Adarx Pharmaceuticals Inc.
Immune System Diseases
Poland, Italy, Hungary, France, Austria, Czechia, Belgium, Spain, Bulgaria, Germany, Croatia
22/06/2026
Phase III
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-Active Secondary Progressive Multiple Sclerosis
2025-524322-18-00Non-active Secondary Progressive Multiple Sclerosis (SPMS)
Zenas Biopharma (USA) LLC
Nervous System Diseases
Germany, Bulgaria, Netherlands, Sweden, Portugal, Croatia, Italy, Austria, Spain, Poland, France, Denmark, Hungary, Romania, Estonia, Slovakia, Belgium, Czechia, Norway, Lithuania, Greece, Slovenia
22/06/2026
Phase II
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).
2025-524488-18-00Muscle-invasive Bladder Cancer
Astellas Pharma Global Development Inc.
Neoplasms
Germany, France, Poland, Italy, Spain
22/06/2026
Phase II
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
2025-523479-49-00Colitis ulcerative
Merck Sharp & Dohme LLC
Digestive System Diseases
Italy, Greece, Netherlands, Poland, Germany, France
22/06/2026
Phase IV
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
2025-522275-28-00Metachromatic leukodystrophy
Orchard Therapeutics (Europe) Limited
Musculoskeletal Diseases
Netherlands, Germany, Italy, Sweden, France
22/06/2026
Phase II
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)
2025-522587-33-00Narcolepsy with Cataplexy (NT1)
Takeda Development Center Americas Inc.
Nervous System Diseases
Spain, Italy, France
22/06/2026
Phase III
Effects of bempedoic acid/ezetimibe/high-intensity statin on plaque regression and stabilisation of coronary atherosclerosis among patients without cardiovascular events
2025-524625-41-00Coronary atherosclerosis
Daiichi Sankyo Europe GmbH
Cardiovascular Diseases
Italy, Spain, Germany
22/06/2026
Phase III
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)
2025-524337-11-00Systemic Sclerosis
Celgene Corp.
Immune System Diseases
Spain, Germany, France, Italy, Belgium
19/06/2026
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Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 20 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.