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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 โ€” 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 โ€” a stated recency window, not the full historical archive. Synced 19 Sep 2026, 04:26 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 Clear sponsor filter
Member state
Spain 1023 France 890 Germany 861 Italy 742 Poland 581 Netherlands 524 Belgium 426 Czechia 327
All 28 states
16 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase III
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).
2025-524014-29-00Newly Diagnosed Multiple Myeloma
AstraZeneca AB
Neoplasms
Poland, Italy, Denmark, France, Sweden, Germany, Spain
01/09/2026
Phase III
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
2025-523444-12-00Breast Cancer
AstraZeneca AB
Neoplasms
Poland, Spain, France, Germany, Italy
13/08/2026
Phase III
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
2025-523307-29-00Eosinophilic Granulomatosis with Polyangiitis (EGPA), Hyperโ€ฆ
AstraZeneca AB
Respiratory Tract Diseases
Denmark, Belgium, France, Italy, Netherlands, Austria, Poland
04/08/2026
Phase III
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)
2026-526304-79-00Heart failure with preserved ejection fraction (HFpEF) and โ€ฆ
AstraZeneca AB
Cardiovascular Diseases
Spain, Hungary, Germany, Poland, Italy, Bulgaria, Netherlands, Austria, Romania, Sweden, France, Greece, Slovakia, Czechia
29/07/2026
Phase III
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)
2025-524688-19-00Participants Living with Obesity or Overweight with at leasโ€ฆ
AstraZeneca AB
Nutritional and Metabolic Diseases
Spain, Germany, Italy, Poland
27/07/2026
Phase III
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)
2025-523994-41-00Chronic kidney disease (CKD) in adults, with specified rangโ€ฆ
AstraZeneca AB
Cardiovascular Diseases
Czechia, Italy, Hungary, Romania, Bulgaria, Sweden, Denmark, Poland, Spain, Norway, Finland, Greece, France, Germany
24/07/2026
Phase III
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)
2025-523933-24-00type 2 diabetes mellitus
AstraZeneca AB
Nutritional and Metabolic Diseases
Poland, Hungary, Italy, Bulgaria, Germany
22/07/2026
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, Eโ€ฆ
AstraZeneca AB
Neoplasms
France, Italy, Spain, Hungary, Poland, Belgium, Germany, Netherlands
16/06/2026
Phase III
Multinational, Interventional, 52-week, Open-label, Single-arm Study to Evaluate the Treatment Outcomes of Anifrolumab 120 mg Subcutaneous Once Weekly in Immunosuppressant-naรฏve and Biologic-naรฏve Systemic Lupus Erythematosus (SUNFLOWER)
2025-523670-17-00Systemic lupus erythematosus
AstraZeneca AB
Immune System Diseases
Poland, Germany, Italy, France, Spain
02/06/2026
Phase III
A Phase III Open-label, Randomised, Multicentre Study Comparing AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19, versus Standard Regimens in Participants with Relapsed Refractory Multiple Myeloma (DURGA-4)
2025-523285-25-00Relapsed or Refractory Multiple Myeloma
AstraZeneca AB
Neoplasms
Norway, Poland, Spain, Germany, France, Italy
30/04/2026
Phase III
Randomised, Open-label, Phase III Study of AZD5335 Versus Mirvetuximab Soravtansine in FRฮฑ-high and AZD5335 Versus Investigatorโ€™s Choice Chemotherapy in FRฮฑ-low Expressing High-grade Platinum-resistant Epithelial Ovarian Cancer Patients (TREVI-OC-01)
2025-520466-22-00Advanced Platinum-resistant Epithelial Ovarian Cancer
AstraZeneca AB
Pathological Conditions, Signs and Symptoms
Ireland, Greece, Czechia, France, Sweden, Belgium, Denmark, Spain, Italy, Germany
27/03/2026
Phase III
Phase III, Randomized, Open-label, Global, Multicenter Study of Rilvegostomig or Durvalumab in Combination With Chemotherapy as a First-line Treatment for Patients With Advanced Biliary Tract Cancer (ARTEMIDE-Biliary02).
2025-523085-24-00Biliary Tract Cancer
AstraZeneca AB
Neoplasms
Germany, Poland, Italy, Belgium, France, Netherlands, Spain
23/03/2026
Phase III
A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)
2024-520101-39-00TROP2 NMR-positive advanced or metastatic non-squamous non-โ€ฆ
AstraZeneca AB
Neoplasms
Spain, Poland, Hungary, Italy, Germany, France, Belgium, Austria
26/02/2026
Phase III
A Phase III, Randomized, Open-Label, Multicenter, Global Study of Puxitatug Samrotecan (AZD8205) Monotherapy versus Physicianโ€™s Choice of Chemotherapy in Participants with B7-H4-Selected Advanced/Metastatic Endometrial Cancer Who Progressed On or After Platinum-Based Chemotherapy and Anti-PD-1/Anti-PD-L1 Therapy (Bluestar-Endometrial01)
2024-518777-34-00B7-H4-Selected Advanced/Metastatic Endometrial Cancer.
AstraZeneca AB
Neoplasms
Italy, Netherlands, Lithuania, Finland, Greece, Austria, Belgium, Hungary, Spain, Poland, Czechia, Germany, France, Denmark, Slovenia
17/11/2025
Phase III
A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients with BRCAm Localised High-risk Prostate Cancer Receiving Radiotherapy with Androgen Deprivation Therapy (EvoPAR-Prostate02)
2024-513586-39-00Prostate Cancer
AstraZeneca AB
Male Urogenital Diseases
Austria, Sweden, Spain, France, Netherlands, Germany, Belgium, Finland, Hungary, Poland, Italy
12/11/2025
Phase III
A Phase III, Randomised, Open-Label, Sponsor-Blinded, Multicenter Study of Rilvegostomig in Combination with Bevacizumab with or without Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma (ARTEMIDE-HCC01)
2024-518210-81-00Advanced Hepatocellular Carcinoma
AstraZeneca AB
Neoplasms
Italy, Germany, France, Poland, Spain, Netherlands
30/09/2025
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Cite this view

Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 19 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.