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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 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
11 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase II
A multicenter, randomized, double-blind, placebo- controlled Phase 2 study to investigate the efficacy, safety and tolerability of remibrutinib (LOU064) in adult patients with Papulopustular Rosacea (PPR)
2025-524496-23-00Papulopustular Rosacea (PPR)
Novartis Pharma AG
Skin and Connective Tissue Diseases
Bulgaria, France, Italy, Germany
14/09/2026
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 II, multicenter, open-label, single arm study to evaluate the safety and efficacy of asciminib in pediatric participants newly diagnosed or previously treated with Philadelphia positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) with or without known T315I mutation
2025-522138-29-00Philadelphia positive Chronic Myeloid leukemia in Chronic P…
Novartis Pharma AG
Neoplasms
Spain, France, Germany, Poland, Italy, Netherlands, Greece, Hungary
18/05/2026
Phase II
A randomized, double masked, placebo-controlled, multicenter, dose-range finding study to assess the efficacy and safety of FWY003 in patients with geographic atrophy secondary to age-related macular degeneration
2025-523704-77-00Geographic atrophy secondary to age-related macular degener…
Novartis Pharma AG
Eye Diseases
Bulgaria, Romania, Germany, Czechia, Spain, Poland, Italy, Hungary, France
04/05/2026
Phase II
An open-label, uncontrolled, multicenter study to assess the effect of zigakibart treatment on histologic, circulating, and excreted markers of kidney disease and dysfunction in adult patients with IgA nephropathy
2024-519699-24-00IgA nephropathy
Novartis Pharma AG
Immune System Diseases
Czechia, Germany, Spain, Italy, Poland
17/03/2026
Phase II
Exploratory Study of Ianalumab in Adults with Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) who Have Previously Benefited from Ianalumab (VAY RE-HIT)
2024-518231-11-00Immune thrombocytopenia (ITP) Warm autoimmune hemolytic an…
Novartis Pharma AG
Hemic and Lymphatic Diseases
Germany, Czechia, Belgium, Spain, Italy, Bulgaria, Romania, France, Hungary
08/12/2025
Phase II
An open-label phase II trial to evaluate the clinical efficacy, safety and tolerability of MAS825 in pediatric and adult participants with Still’s disease
2024-520208-25-00Still’s disease
Novartis Pharma AG
Immune System Diseases
Italy, Netherlands, Spain, France, Germany
28/10/2025
Phase II
EPIK-P4: A Phase II single arm study to assess the efficacy, safety and pharmacokinetics of alpelisib (BYL719) in pediatric and adult patients with PIK3CA-related overgrowth spectrum (PROS)
2024-519960-42-00PIK3CA-Related Overgrowth Spectrum (PROS)
Novartis Pharma AG
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Italy, Netherlands, Belgium, Spain, Austria, Germany, France
20/10/2025
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 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
LuMIERE: A Phase 1/2, Multicenter, Open label, Non randomized Study to Investigate Safety and Tolerability, Pharmacokinetics, Dosimetry, and Preliminary Activity of [177Lu]Lu FAP 2286 in Participants with an Advanced Solid Tumor
2023-508995-12-01Metastatic Breast Carcinoma (BC), Recurrent or metastatic n…
Novartis Pharma AG
Neoplasms
Italy, Spain, Belgium, France
26/08/2025
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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.