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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
742 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase III
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
2025-524048-36-00Advanced HER2-negative and PD-L1 positive gastroesophageal …
Fondazione GONO G.I.
Neoplasms
Spain, Germany, Italy
18/06/2026
Phase II
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)
2024-513496-40-00PARKINSON’S DISEASE
Universitaetsklinikum Tuebingen AöR
Nervous System Diseases
Spain, Germany, Italy, Sweden, France, Luxembourg
18/06/2026
Phase III
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
2025-522373-10-00Progressive pulmonary fibrosis and Idiopathic pulmonary fib…
Bristol-Myers Squibb Services Unlimited Company
Respiratory Tract Diseases
Finland, Portugal, Hungary, Ireland, Poland, Greece, France, Belgium, Denmark, Italy, Spain, Netherlands, Austria, Germany
17/06/2026
Phase II
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
2025-522294-11-00Systemic sclerosis
Galderma S.A.
Skin and Connective Tissue Diseases
Poland, Italy, Bulgaria, France, Greece, Spain, Croatia
17/06/2026
Phase I
Open-label study of BBO-11818 in adult subjects with KRAS mutant cancer
2025-524690-16-00Solid Tumors
Theras Inc.
Neoplasms
Spain, Italy, France
16/06/2026
Phase II
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)
2025-525124-10-00Duchenne Muscular Dystrophy
Entrada Therapeutics Inc.
Musculoskeletal Diseases
Belgium, Italy, Netherlands, Spain
16/06/2026
Phase I
A Phase 1, Open-Label, Multicenter Study of INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies
2025-523130-11-00Hematological malignancies, Advanced solid tumors
Incyte Corp.
Neoplasms
Italy, Belgium, Denmark
16/06/2026
Phase III
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)
2024-519787-40-00Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, E…
AstraZeneca AB
Neoplasms
France, Italy, Spain, Hungary, Poland, Belgium, Germany, Netherlands
16/06/2026
Phase I/II
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)
2025-520626-37-00Metastatic Prostate Cancer
AstraZeneca AB
Neoplasms
Belgium, Spain, Poland, Italy, Netherlands
16/06/2026
Phase III
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)
2025-522643-18-00Stage I NSCLC
Merck Sharp & Dohme LLC
Neoplasms
Greece, Poland, Italy, Hungary, Germany, Netherlands, France, Spain
16/06/2026
Phase II
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
2025-524640-35-00Ulcerative colitis (Inflammatory Bowel Disease)
Spyre Therapeutics Inc.
Digestive System Diseases
Croatia, Poland, Austria, Czechia, Italy, Slovakia, Bulgaria, Greece, Belgium, Spain, Hungary, Germany, Lithuania, France, Romania
16/06/2026
Phase III
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)
2025-524371-23-00Limb Girdle Muscular Dystrophy (LGMD) Type 2I
ML Bio Solutions Inc.
Musculoskeletal Diseases
Germany, Denmark, Netherlands, Italy, Norway
15/06/2026
Phase IV
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)
2025-524487-37-00C3 Glomerulopathy (C3G), Primary Immune Complex Membranopro…
Swedish Orphan Biovitrum AB (publ)
Immune System Diseases
France, Italy, Spain, Germany, Belgium
15/06/2026
Phase III
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)
2025-522038-29-00Locally advanced, unresected (unresectable or medically ino…
Merck Sharp & Dohme LLC
Neoplasms
Italy, Netherlands, France, Germany, Spain, Poland, Greece
12/06/2026
Phase III
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)
2025-522267-15-00​Relapsed/refractory B-cell Acute Lymphoblastic Leukemia​
Merck Sharp & Dohme LLC
Neoplasms
Greece, Netherlands, Sweden, France, Italy, Spain, Denmark
12/06/2026
Phase III
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)
2025-523674-16-00Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Glaxosmithkline Research & Development Limited
Nutritional and Metabolic Diseases
Greece, Germany, Belgium, Netherlands, Poland, Italy, France, Spain, Bulgaria, Austria
12/06/2026
Phase II
A PHASE 2 STUDY OF STRIDE (durvalumab + tremelimumab) With Lenvatinib Versus STRIDE Alone in Patients With Unresectable Hepatocellular Carcinoma (SLIDE-HCC) - HE.2
2025-521608-23-00patients with unrestectable hepatocellular carcinoma (SLIDE…
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Neoplasms
Italy
12/06/2026
Phase II
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
2025-524112-11-00J6Z-MC-IIBD - Colitis, Ulcerative Crohn Disease J6Z-MC-CD…
Eli Lilly & Co.
Digestive System Diseases
Italy, Germany, Hungary, Poland, Belgium
11/06/2026
Phase II
J6E-MC-KWAM: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Development Program to Evaluate the Efficacy and Safety of LY4268989 (MORF-057) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis (EMERALD-3)
2025-524404-29-00Ulcerative Colitis, Active Severe, Ulcerative Colitis (UC),…
Eli Lilly & Co.
Digestive System Diseases
Latvia, Portugal, Greece, France, Czechia, Italy, Poland, Slovakia, Hungary, Croatia, Lithuania
10/06/2026
Phase III
A Phase 2/3 randomized, open-label study of MK-1045 in combination with rituximab in patients with 1L follicular lymphoma.
2025-522777-10-00Follicular Lymphoma
Merck Sharp & Dohme LLC
Neoplasms
France, Spain, Germany, Greece, Italy, Poland
09/06/2026
Phase I/II
A Phase 1/2, Open-label Study of VS-7375, a KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and in Combination, in Patients with Advanced KRAS G12D-Mutant Solid Tumors
2025-523432-39-01Advanced KRAS G12D-Mutant Solid Tumors
Verastem Inc.
Neoplasms
Italy, France, Germany, Belgium, Spain, Netherlands
09/06/2026
Phase I/II
A Phase 1b/2 Open-label Study Evaluating different MK-6070 and Ifinatamab Deruxtecan (MK-2400)-based regimens in First-line Extensive Stage Small Cell Lung Cancer
2025-521032-11-00Small cell lung cancer extensive stage
Merck Sharp & Dohme LLC
Neoplasms
Germany, Poland, Greece, Italy, France, Spain
08/06/2026
Phase II
A multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase IIb study to assess the efficacy and safety of GIA632 in adult participants with non-segmental vitiligo followed by an extension period
2025-522301-37-00Nonsegmental vitiligo
Novartis Pharma AG
Skin and Connective Tissue Diseases
Germany, Spain, Netherlands, France, Italy
08/06/2026
Phase II
A Phase 2, Open Label, Multicenter, Randomized Study, to Evaluate the Efficacy and Safety of Denikitug Monotherapy and Denikitug-based Combinations in Participants With Advanced Microsatellite Stable (MSS) Colorectal Cancer (CRC).
2025-523984-39-00Advanced Microsatellite Stable (MSS) Colorectal Cancer (CRC)
Gilead Sciences Inc.
Neoplasms
Spain, Italy, France
08/06/2026
Phase III
A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody Drug Conjugate (ADC), Compared to Investigator’s Choice Therapy in Participants with Relapsed Small Cell Lung Cancer
2025-522818-23-00Small Cell Lung Cancer (SCLC)
Zai Lab (US) LLC
Neoplasms
Belgium, Czechia, Germany, Denmark, Greece, Netherlands, Poland, Spain, Austria, Italy, France
08/06/2026
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Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 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.