Clinical trial register · European Union · CTIS

Clinical Trials in Italy, 2026

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 2557 most recently authorised of 12788 total CTIS records — a stated recency window, not the full historical archive. Synced 08 Nov 2026, 03:17 UTC

2557

Shown in this register

most recently authorised

12,788

Total on CTIS

full historical archive

789

Phase III

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Top member states

Spain 1074 France 933 Germany 893 Italy 777 Poland 614 Netherlands 544

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All 28 states

Trials with a site in Italy

Phase

Study

Lead sponsor

Area

Member states

Decision

Phase II

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, 52-Week Study Evaluating the Efficacy and Safety of Apitegromab in Participants With Facioscapulohumeral Muscular Dystrophy (FORGE)

2026-525204-10-00Facioscapulohumeral Muscular Dystrophy

DrugApitegromab

Scholar Rock Inc.

Musculoskeletal Diseases

Italy, Spain

05/11/2026

Phase II

A Phase 2, Multicenter, Randomized, Parallel Treatment Arms, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CP-012B in Participants with Parkinson’s Disease with Early Morning OFF Episodes

2026-526634-46-00Parkinson’s Disease With Early Morning OFF Episodes

Contera Pharma A/S

Nervous System Diseases

Italy, Spain

05/11/2026

Phase II

A Phase IIb multicenter, randomized, double-blind, placebo-controlled, dose-range study to assess the efficacy and safety of GIA632 in participants with moderate to severe cutaneous lichen planus, followed by an extension period

2025-522300-25-00Cutaneous lichen planus

DrugGIA632

Novartis Pharma AG

Immune System Diseases

Italy, Germany, Spain, France

02/11/2026

Phase II

PHASE II RANDOMISED CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PAPAVERINE IN PREVENTING ARTERIAL VASOSPASM AND REDUCING POSTOPERATIVE HYPOPARATHYROIDISM IN ADULT PATIENTS UNDERGOING TOTAL THYROIDECTOMY – PPPTH trial

2026-527270-37-00Patients affected by benign or malignant thyroid disease

DrugPapaverine

Azienda Provinciale Per I Servizi Sanitari

Hormonal diseases

Italy

02/11/2026

Phase II

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of ALN-CIDEB in Adults with Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)

2026-525916-33-00Metabolic Dysfunction-Associated Steatohepatitis (MASH)

DrugAln-Cideb

Regeneron Pharmaceuticals Inc.

Nutritional and Metabolic Diseases

Spain, Italy

30/10/2026

Phase II

Multicenter, open-label, randomized Phase 2 study evaluating continuous weekly dosing of ficerafusp alfa (BCA101) in combination with pembrolizumab versus an alternative dosing regimen for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma

2026-526741-10-00Recurrent or Metastatic Head and Neck Squamous Cell Carcino…

DrugsFicerafusp alfa·Pembrolizumab

Bicara Therapeutics Inc.

Neoplasms

Netherlands, Spain, France, Italy, Belgium, Poland, Germany

30/10/2026

Phase II

(VVD-133214-02 / 23236) A Phase 2, Randomized, Open-label Study of VVD-133214 in Combination with Pembrolizumab compared to Pembrolizumab Monotherapy in Participants with Advanced Colorectal Adenocarcinoma (CRC) Harboring Microsatellite Instability (MSI) and/or Deficient Mismatch Repair (DMMR)

2026-525507-26-00Advanced colorectal adenocarcinoma

DrugsVVD-133214·Pembrolizumab

Vividion Therapeutics Inc.

Neoplasms

Greece, Portugal, Italy, France, Belgium, Germany, Spain

30/10/2026

Phase II

A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, in Patients with Previously Treated, Advanced KRAS G12D-Mutated Non-Small Cell Lung Cancer (TARGET-D 202)

2026-526472-23-00Non-Small Cell Lung Cancer

Verastem Inc.

Neoplasms

France, Spain, Germany, Italy, Belgium

27/10/2026

Phase II

A Phase 2, Double-blind, Randomized, Placebo-controlled, Multicenter Trial to Assess the Efficacy, Safety, and Tolerability of AGMB-447 in Participants with Idiopathic Pulmonary Fibrosis

2026-526404-71-00Idiopathic Pulmonary Fibrosis

DrugSalbutamol

Agomab Spain S.L.U.

Respiratory Tract Diseases

Poland, France, Belgium, Italy, Spain, Portugal, Netherlands, Germany

27/10/2026

Phase II

A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF RO7568282 IN PARTICIPANTS WITH EARLY SYMPTOMATIC ALZHEIMER’S DISEASE

2026-526158-14-00Early Symptomatic Alzheimer’s Disease (AD)

DrugRO7568282

F. Hoffmann-La Roche AG

Nervous System Diseases

Spain, Belgium, Denmark, France, Poland, Italy, Germany, Ireland

27/10/2026

Phase II

Effects of Anti-IL33 (Tozorakimab) Upon Airway Inflammation, Remodelling and Response to Exacerbation Triggers in COPD (The MAB Trial)

2025-522359-24-00COPD

DrugTozorakimab

University Of Leicester

Respiratory Tract Diseases

Spain, Netherlands, Italy, Denmark

22/10/2026

Phase II

Aspire-202: A Phase 2 Multi-center, Randomized, Open-label Study to Assess the Efficacy and Safety of AHB-137 in Nucleos(t)ide Analogue-treated Participants with Chronic Hepatitis B in the North America and Europe Regions

2025-524159-30-00Chronic Hepatitis B

DrugAHB-137

Ausperbio Therapeutics Inc.

Virus Diseases

France, Italy, Spain

22/10/2026

Phase II

"PREVENTAMI-FX — PREvention of VENtricular Thrombosis in Acute Myocardial Infarction with FondaparinuX"

2025-524664-38-00Acute anterior myocardial infarction with systolic dysfunct…

DrugsPrasugrel·Acetylsalicylic acid·Ticagrelor·Clopidogrel

Azienda Unita' Sanitaria Locale Toscana Sud Est

Cardiovascular Diseases

Italy

21/10/2026

Phase II

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of RO7568282 in Participants with Early-Stage Parkinson’s Disease

2025-524064-37-00Parkinson’s Disease (PD)

DrugRO7568282

F. Hoffmann-La Roche AG

Nervous System Diseases

Germany, Italy, Netherlands, Poland, France, Ireland, Spain, Austria

21/10/2026

Phase II

A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, With and Without an Anti-EGFR Antibody, and With an Anti-EGFR Antibody and Chemotherapy, in Patients With Metastatic KRAS G12D-Mutated Colorectal Adenocarcinoma (TARGET-D 203)

2026-526473-42-00Metastatic KRAS G12D-Mutated Colorectal Adenocarcinoma

DrugsPanitumumab·Erbitux·Fluorouracil·Oxaliplatin

Verastem Inc.

Neoplasms

Italy, Spain, France, Germany, Belgium

20/10/2026

Phase II

RELIEVE (RandomizEd triaL of Intravesical xEomin for incontinence via the VibE system) - a randomized, prospective, multicenter, double blind, placebo and sham controlled study to assess the safety and efficacy of NT 201 intravesical administration using Vibe System in the treatment of female participants suffering from idiopathic overactive bladder

2026-526512-36-00Idiopathic Overactive Bladder (OAB)

Vensica Medical Ltd.

Female Urogenital Diseases and Pregnancy Complications

Portugal, Italy, Czechia, Poland

20/10/2026

Phase II

An open-label, phase 2 pilot study on the efficacy and safety of Piclidenoson in patients with Lowe syndrome

2026-525495-26-00Lowe Syndrome

Can-Fite Biopharma Ltd.

Nutritional and Metabolic Diseases

Italy

19/10/2026

Phase II

PET-Guided Navigation with Electromagnetic Tracking during PSMA-RadioGuided Surgery: Innovative Bimodal Detection of Nodal Metastases in Prostate Cancer Patients

2026-526915-12-00Prostate Cancer

Ospedale San Raffaele S.r.l.

Male Urogenital Diseases

Italy

19/10/2026

Phase II

EORTC-2456-LCG-BTG: A randomized phase II study evaluating upfront SRT to all brain metastases followed by ivonescimab plus chemotherapy versus upfront ivonescimab plus chemotherapy in patients with asymptomatic active brain metastases from NSCLC.

2025-522985-60-00Non-small cell lung cancer

DrugsIvonescimab·Paclitaxel·Carboplatin

European Organisation For Research And Treatment Of Cancer

Neoplasms

Slovenia, Spain, Germany, France, Austria, Netherlands, Italy, Greece

19/10/2026

Phase II

A Pragmatic Phase II Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2− Early Breast Cancer Using Oncotype DX and Abemaciclib - VIOLET trial

2026-525457-37-00HER2-negative, stage II–IIIB, neoadjuvant chemotherapy, est…

DrugsAbemaciclib·Paclitaxel

Istituto Di Ricerche Farmacologiche Mario Negri

Neoplasms

Italy

16/10/2026

Phase II

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Finding Trial to Evaluate the Efficacy and Safety of Orally Administered NS-863 in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)

2025-525115-16-00Pulmonary Hypertension Associated with Interstitial Lung Di…

DrugNS-863

Ns Pharma Inc.

Respiratory Tract Diseases

Italy, Greece, Portugal, France, Belgium, Germany, Spain

16/10/2026

Phase II

A Phase 2, Open-label, Multicenter Study to Determine the Safety, Tolerability, and Efficacy of MK- 1045 in Participants with Hematologic Malignancies

2025-522242-49-00CLL/SLL

DrugsMK-1045·Tocilizumab

Merck Sharp & Dohme LLC

Neoplasms

Spain, Italy

15/10/2026

Phase II

A randomized, parallel-group, open-label, Phase IIb pilot trial to evaluate the effectiveness in reducing systemic disease activity with methotrexate compared with hydroxychloroquine in adult male and female participants with moderate-to-severe primary Sjögren’s disease (MOSAIC STUDY)

2026-526767-38-00Sjogren's disease

DrugHydroxychloroquine

Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon

Immune System Diseases

Italy

15/10/2026

Phase II

A randomized, double-blind, placebo-controlled, multicenter Phase 2a/b study assessing the efficacy, safety and tolerability of DDY391 in participants with Sjögren's Disease

2025-524513-92-00Sjögren's Disease

Novartis Pharma AG

Immune System Diseases

Portugal, Bulgaria, Belgium, Spain, Denmark, France, Slovakia, Poland, Hungary, Italy, Netherlands, Germany, Austria

15/10/2026

Phase II

A Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab Compared to Placebo in Adult Participants with Graves’ Disease

2026-526482-19-00Graves’ Disease

DrugFelzartamab

Biogen Idec Research Limited

Nutritional and Metabolic Diseases

Italy, Spain

15/10/2026

Phase II

Semaglutide for the treatment of visceral obesity in people with HIV with body mass index <30 kg/m2 and without diabetes: a randomized clinical trial to explore immune metabolism, systemic and vascular inflammation assessed with Positron Emission Tomography

2026-526738-18-00Adult subjects with HIV infection on stable antiretroviral …

DrugSemaglutide

Azienda Ospedaliero Universitaria Di Modena

Virus Diseases

Italy

12/10/2026

Phase II

A Dose-finding, Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of Treatment with Efimosfermin Alfa in Adult Participants with Alcohol-related Liver Disease (ALD)

2026-526391-23-00Liver Diseases, Alcoholic

Glaxosmithkline Research & Development Limited

Digestive System Diseases

Spain, Denmark, Italy, Poland, France, Germany, Greece

12/10/2026

Phase II

An open label, multi-center alpelisib roll-over study to assess long-term safety in participants who have completed a Novartis sponsored alpelisib (BYL719) study and are judged by the Investigator to benefit from continued treatment with alpelisib.

2026-525890-38-00• PROS (PIK3CA‑Related Overgrowth Spectrum) and, • Breast N…

DrugsAlpelisib·Fulvestrant

Novartis Pharma AG

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

France, Italy, Bulgaria, Slovakia, Finland, Spain

12/10/2026

Phase II

2025-525114-38-00Pulmonary Arterial Hypertension (PAH)

DrugNS-863

Ns Pharma Inc.

Respiratory Tract Diseases

France, Germany, Poland, Italy, Belgium, Spain, Greece

08/10/2026

Phase II

An Exploratory Phase II, Randomized, Open-Label, Proof-of-Concept Trial Evaluating Add-on Polyunsaturated Fatty Acid Ethyl Esters on Pain and Minimal Disease Activity in Psoriatic Arthritis Patients Starting TNF-alpha Inhibitors

2026-526768-20-00Psoriatic arthritis

DrugsCertolizumab Pegol·Golimumab·Etanercept·Infliximab

Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon

Immune System Diseases

Italy

06/10/2026

Phase II

A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of ARGX-121 SC in Adult Participants With Primary IgA Nephropathy

2026-525638-43-00Immunoglobulin A nephropathy (IgAN)

Argenx

Not possible to specify

Spain, Poland, Czechia, Belgium, Italy

05/10/2026

Phase II

LIGHTBEAM-U01 Substudy 01E: A Phase 2 Substudy to Evaluate the Safety and Efficacy of Belzutifan in Participants With Solid Tumors

2025-524515-37-00Neoplasm malignant

DrugBelzutifan

Merck Sharp & Dohme LLC

Neoplasms

Belgium, Spain, Denmark, Italy, France

05/10/2026

Phase II

PHOENIX - ECP: A Phase 2, Randomized, Controlled, Open-label, Multicenter Study to Evaluate the Efficacy and Safety/Tolerability of Extracorporeal Photopheresis (ECP) Versus Best Available Therapy (BAT) for the Treatment of Immune-related Colitis and/or Hepatitis with Inadequate Response to Corticosteroids in Participants with Unresectable or Metastatic Melanoma Treated with Immune Checkpoint Inhibitors (ICI)

2026-526261-14-00Immune-related Colitis or Hepatitis with Inadequate Respons…

DrugsAzathioprine·Vedolizumab·Infliximab

Therakos Europe Limited

Neoplasms

Austria, Spain, Italy, Germany, Netherlands

30/09/2026

Phase II

A Randomized, Double-Blind, Placebo-controlled, Parallel Arm, 52-week Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Two Doses of EXPD-101 in Participants with COPD

2026-525216-34-00Chronic Obstructive Pulmonary Disease (COPD) exacerbations

Expedition Therapeutics Inc.

Respiratory Tract Diseases

Italy, Germany, Spain, Poland, Czechia, Romania, Hungary, Denmark, Bulgaria

29/09/2026

Phase II

Use of the Checkpoint inhibitor DOstarlimab in the endOmetrial cancer fertility-Sparing trEatment: CHOOSE study.

2023-509535-11-00Newly diagnosed endometrial carcinomas of the MMR-deficient…

DrugDostarlimab

UZ Leuven

Neoplasms

Italy, Belgium

23/09/2026

Phase II

A Phase 2b, Randomized, Placebo-controlled, Double-blind, Dose-ranging Trial to Assess the Efficacy and Safety of Ontunisertib in Patients with Fibrostenosing Crohn’s Disease

2026-525197-19-00Fibrostenosing Crohn’s Disease

DrugOntunisertib

Agomab Spain S.L.U.

Digestive System Diseases

France, Germany, Poland, Spain, Czechia, Denmark, Austria, Italy, Belgium, Netherlands

21/09/2026

Phase II

Randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of 2 dose levels of the oral ghrelin receptor agonist AC01 over 12 weeks in patients with chronic advanced heart failure with reduced ejection fraction (HFrEF)

2025-524469-25-00chronic advanced heart failure with reduced ejection fracti…

AnaCardio AB

Cardiovascular Diseases

Czechia, Slovakia, Spain, Bulgaria, Netherlands, Italy, Poland, Germany, Sweden, Hungary

21/09/2026

Phase II

A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Moderate to Severe Atopic Dermatitis (SIERRA1)

2025-524384-20-00Atopic dermatitis (AD)

DrugSoquelitinib

Corvus Pharmaceuticals Inc.

Skin and Connective Tissue Diseases

Italy, Czechia, Germany, Poland, Spain, Bulgaria

18/09/2026

Phase II

Prevention of venous thromboembolism in cirrhotic patients with hepatocellular carcinoma

2026-526857-33-00liver cirrhosis and hepatocellular carcinoma

DrugTinzaparin

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Neoplasms

Italy

17/09/2026

Phase II

Interventional, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose trial of Lu AF28996 in adults with Parkinson’s disease experiencing motor fluctuations.

2025-524655-30-00Parkinson’s disease

H. Lundbeck A/S

Nervous System Diseases

Czechia, France, Spain, Poland, Italy, Germany, Sweden

15/09/2026

Phase II

Optimization of De-EscalatiON strategies in early breast cancer

2026-527524-27-00breast cancer

DrugsTrastuzumab emtansine·Exemestane·Anastrozole·Ribociclib

Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS

Neoplasms

Italy

14/09/2026

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, Spain, France, Italy, Germany

14/09/2026

Phase II

A Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long Term Safety and Tolerability of KT-621 in Participants With Asthma Previously Enrolled in a KT-621 Asthma Study

2026-526241-98-00Uncontrolled Moderate to Severe Eosinophilic Asthma

DrugKT-621

Kymera Therapeutics Inc.

Immune System Diseases

Austria, Germany, Belgium, Romania, Italy, Slovakia, Poland, Spain

09/09/2026

Phase II

A Phase 2, Randomized, Open-label, Study Assessing the Safety, Tolerability and Efficacy of Imzokitug in Combination with Pumitamig and Platinum-Doublet Chemotherapy (PDCT) versus Pumitamig and PDCT as First-line Treatment for Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

2026-525170-19-00Locally Advanced or Metastatic Non-Small Cell Lung Cancer (…

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Italy, Spain, Romania, Germany, France

07/09/2026

Phase II

Hyperthermic Intraperitoneal Chemotherapy and Regional Adrenalectomy in the management of Stage II & III Adrenocortical Carcinoma

2026-525406-36-00Adrenocortical Carcinoma

DrugsSodium Thiosulfate·Doxorubicin·Cisplatin

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Neoplasms

Italy

02/09/2026

Phase II

Randomized, Multicenter, Vehicle-Controlled, Double-Masked Study to Evaluate the Efficacy and Safety of Intranasal Cenegermin (Recombinant Human Nerve Growth Factor [rhNGF]) in Adult Participants with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)

2025-524748-37-00Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)

DrugCenegermin

Dompe' Farmaceutici S.p.A.

Eye Diseases

Denmark, Italy, Germany, Hungary, Netherlands, Spain, Belgium, France, Portugal

01/09/2026

Phase II

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE-791 in Subjects with Idiopathic Pulmonary Fibrosis

2025-521901-42-00Idiopathic Pulmonary Fibrosis (IPF)

Contineum Therapeutics Inc.

Respiratory Tract Diseases

Italy, Belgium, Denmark, Austria, Greece, Germany, France, Netherlands, Portugal, Poland, Spain

26/08/2026

Phase II

C6461010 - An Interventional, Open-Label, Phase 2 Study to Investigate the Safety and Efficacy of PF-08634404 Monotherapy or in Combination in Adult Participants with Early-Stage Resectable or Locally Advanced Unresectable Non-Small Cell Lung Cancer

2025-524825-42-00Early-Stage Resectable or Locally Advanced Unresectable Non…

Pfizer Inc.

Neoplasms

Spain, France, Italy, Ireland, Germany, Poland

26/08/2026

Phase II

A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina S) in Participants With Advanced Gastrointestinal (GI) Cancers

2025-524130-26-00Gastrointestinal Cancers

Genmab A/S

Neoplasms

Italy, Belgium, France, Spain, Denmark, Netherlands, Germany

26/08/2026

Phase II

Solid tumor Study for Long term Treatment of Cancer Patients Who Have Participated in BMS-Parent Studies Investigating Adagrasib (BMS-986503)

2025-524905-34-00Solid tumor

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Greece, Hungary, Poland, Belgium, Spain, Netherlands, Germany, France, Portugal, Italy, Romania

25/08/2026

Phase II

A Phase II, Randomized, Open-label, Multi-center Study of AK104 in Combination with Lenvatinib versus Lenvatinib in Participants with Advanced Hepatocellular Carcinoma Who Have Progressed on Atezolizumab and Bevacizumab

2025-524591-30-00Hepatocellular Carcinoma

Akeso Biopharma Co. Ltd.

Neoplasms

Poland, France, Spain, Italy

18/08/2026

Phase II

A phase IIa open-label dose-finding study with lead-in phase evaluating the safety, pharmacokinetics, and attenuating effects of trazodone on the consciousness-altering effects of psilocybin in individuals with Treatment-Resistant Depression

2025-523346-27-00Treatment-Resistant Depression

Universita' Degli Studi G. D'Annunzio Di Chieti

Mental Disorders

Italy

14/08/2026

Phase II

Denosumab or Zoledronic acid for erosive hand osteoarthritis (EHOA) in patients with osteoporosis a randomized controlled trial (ZODIAC trial)

2026-526828-41-00Erosive hand osteoarthritis (EHOA)

DrugsZoledronic Acid·Denosumab

Azienda Ospedaliera Universitaria Integrata Verona

Musculoskeletal Diseases

Italy

14/08/2026

Phase II

A Phase 2, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of CRD-4730 in patients with heart failure with reduced ejection fraction (HFREF) (CALIBRATE-HF)

2025-525033-31-00heart failure

DrugCRD-4730

Cardurion Pharmaceuticals Inc.

Cardiovascular Diseases

Latvia, Slovakia, Lithuania, Hungary, Italy, Netherlands, Spain, Poland, Bulgaria, Czechia

14/08/2026

Phase II

A TWO-STAGE, SINGLE-ARM, PHASE II STUDY OF ZONGERTINIB PLUS FULVESTRANT IN PARTICIPANTS WITH HORMONE RECEPTOR-POSITIVE/HER2-NEGATIVE ADVANCED BREAST CANCER HARBORING HER2 MUTATIONS (AGATHA)

2026-525328-10-00HR-positive/HER2-negative advanced breast cancer

DrugsZongertinib·Goserelin·Fulvestrant

Medica Scientia Innovation Research S.L.

Neoplasms

Spain, Italy, Germany

13/08/2026

Phase II

AN OPEN LABEL, SINGLE ARM, EXPLORATIVE TRIAL TO EVALUATE EFFICACY AND SAFETY OF BEROTRALSTAT IN PREVENTING ANGIOEDEMA ATTACKS IN SUBJECTS WITH ACQUIRED ANGIOEDEMA DUE TO C1 INHIBITOR DEFICIENCY (AAE)

2025-524747-13-00Acquired angioedema due to C1 inhibitor deficiency

Policlinico San Donato S.p.A.

Genetic Phenomena

Italy

12/08/2026

Phase II

A RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, CLINICAL TRIAL OF COLCHICINE IN AMYOTROPHIC LATERAL SCLEROSIS (CO-ALS II)

2026-526460-20-00AMYOTROPHIC LATERAL SCLEROSIS

Azienda Ospedaliero Universitaria Di Modena

Musculoskeletal Diseases

Italy

12/08/2026

Phase II

Valproic acid and lenvatinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma

2026-525733-24-00Recurrent and/or Metastatic Adenoid Cystic Carcinom

DrugsSodium valproate·Lenvatinib

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Neoplasms

Italy

11/08/2026

Phase II

[22961] A placebo-controlled, parallel-group, double blind, randomized, multi-cohort Phase 2 study to investigate efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of BAY 3670549 in adult participants with atrial fibrillation.

2025-523807-31-00Atrial fibrillation

Bayer AG

Cardiovascular Diseases

Belgium, Netherlands, Germany, Poland, Italy, Hungary, Bulgaria

06/08/2026

Phase II

A Phase IIb Study to Evaluate the Efficacy, Safety, and Tolerability of AZD8965 in Participants with Idiopathic Pulmonary Fibrosis (IPF)) (ARGiNAUT)

2025-525016-41-00Idiopathic Pulmonary Fibrosis

AstraZeneca AB

Respiratory Tract Diseases

Poland, Hungary, Netherlands, Germany, Spain, Greece, Bulgaria, Italy, France, Denmark

04/08/2026

Phase II

Immune dynamics and biomarkers of anti-tumor response in BMS-986340 (anti-CCR8) and nivolumab (anti-PD-1) co-treatment of metastatic tumors

2025-524125-40-01Metastatic solid tumors, with the following specific indica…

DrugNivolumab

Humanitas Mirasole S.p.A., Fondazione Humanitas Per La Ricerca Ets

Neoplasms

Italy

23/07/2026

Phase II

A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of SIR9900 in Patients with VEXAS Syndrome (SIVEX)

2025-524918-28-00VEXAS Syndrome

Sironax USA Inc.

Immune System Diseases

Italy

23/07/2026

Phase II

A Phase 2, Multicenter, Randomized, Double-blind, Placebocontrolled Study, to Evaluate Efficacy, Safety, Tolerability, and Pharmacodynamics of Intrathecally Administered Mivelsiran in Adult Participants with Early-Stage Down Syndrome-Associated Alzheimer’s Disease (DS-AD)

2025-523390-42-00Early-Stage Down Syndrome-Associated Alzheimer’s Disease (D…

DrugMivelsiran

Alnylam Pharmaceuticals Inc.

Nervous System Diseases

Italy, Netherlands, Spain, Germany, Ireland

22/07/2026

Phase II

A Phase 2, open-label, randomized, dose optimization study evaluating the efficacy and safety of belantamab mafodotin administered in combination with cyclophosphamide, bortezomib, and dexamethasone in adult participants with newly diagnosed amyloid light chain amyloidosis (ALANIS)

2025-522803-60-00newly diagnosed amyloid light chain amyloidosis

DrugsEndoxan·Velcade·Bortezomib

Glaxosmithkline Research & Development Limited

Immune System Diseases

Italy, Greece, Spain

21/07/2026

Phase II

J2J-MC-JZLL - preEMBER: A Phase 2, Open-label Study Evaluating Imlunestrant in Premenopausal Women with Estrogen Receptor-Positive, HER2-Negative Breast Cancer.

2025-523258-15-00Breast Neoplasms

DrugsGoserelin·Tamoxifen

Eli Lilly & Co.

Neoplasms

Belgium, France, Italy, Germany, Ireland

21/07/2026

Phase II

A Phase IIb, randomised, double-blind, placebo-controlled, multicentre study to evaluate the efficacy and safety of concomitant use of eplontersen and ALXN2220 compared with eplontersen and placebo in adult participants with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM).

2025-523908-75-00Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

AstraZeneca AB

Cardiovascular Diseases

Germany, Italy, Spain, France, Sweden

20/07/2026

Phase II

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Confirm Efficacy and Safety of MH002 and to Assess the Effect of Dose in Patients With Mild-to-Moderate Ulcerative Colitis Insufficiently Controlled With 5-Aminosalicylic Acid

2025-524682-24-00Ulcerative Colitis

Microbial Resource Management Health

Digestive System Diseases

Czechia, Poland, Italy

16/07/2026

Phase II

A Phase II, Open-Label, Single-Arm, Multicentre Study of Immunotherapy and non-invasive response evaluation in cutaneous squamous cell carcinoma as an organ preservation strategy: a proof of concept clinical study and translational correlates - INCEPT

2025-523633-25-00cutaneous squamous cell carcinoma

DrugCemiplimab

Fondazione GONO Plus

Neoplasms

Italy

14/07/2026

Phase II

A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surovatamig in Adults with Antibody-mediated Kidney Disease

2025-524139-38-00Antibody-mediated Kidney Disease

DrugSurovatamig

AstraZeneca AB

Immune System Diseases

France, Germany, Italy, Belgium, Poland, Spain

13/07/2026

Phase II

Master Protocol Full Title- A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis. ISA 2 to Master Protocol ARGX-999-2-MG-2000 – an Exploratory, Phase 2a, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis

2025-522939-33-00AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthe…

DrugEmpasiprubart

Argenx

Immune System Diseases

Greece, Italy, Germany, Belgium, Netherlands, Spain, Poland

08/07/2026

Phase II

A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of E2086 in Adults with Narcolepsy

2025-523503-30-00Narcolepsy

Eisai Limited

Nervous System Diseases

Belgium, Italy, Spain, Germany

08/07/2026

Phase II

A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination with Other Agents in Participants with Advanced and/or Metastatic Solid Tumors with Homozygous MTAP Deletion

2025-524285-18-00Advanced and/or Metastatic Solid Tumors with Homozygous MTA…

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Belgium, Ireland, Germany, Norway, Italy, France, Spain

07/07/2026

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

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

DrugCemiplimab

G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica

Neoplasms

Italy

03/07/2026

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

DrugsPF-08634404·Etoposide·Carboplatin

Pfizer Inc.

Neoplasms

France, Italy, Spain

29/06/2026

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 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 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

DrugPrasinezumab

Universitaetsklinikum Tuebingen AöR

Nervous System Diseases

Spain, Germany, Italy, Sweden, France, Luxembourg

18/06/2026

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 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

DrugsENTR-601-44·ENTR-601-45

Entrada Therapeutics Inc.

Musculoskeletal Diseases

Belgium, Italy, Netherlands, 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)

DrugsSPYPBO-101·SPY001·SPY002·SPY003

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 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…

DrugsTremelimumab·Durvalumab·Lenvatinib

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…

DrugMirikizumab

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, Acti…

Eli Lilly & Co.

Digestive System Diseases

Latvia, Portugal, Greece, France, Czechia, Italy, Poland, Slovakia, Hungary, Croatia, Lithuania

10/06/2026

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 II

Radium223 dichloride (223RaCl) in the treatment of symptomatic bone metastases from breast cancer.

2025-524208-31-00Symptomatic bone metastases from breast cancer

DrugsExemestane·Anastrozole·Letrozole

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Neoplasms

Italy

08/06/2026

Phase II

C4531031 - AN INTERVENTIONAL PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, THIRD PARTY-UNBLINDED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF PF-07275315 IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

2024-518587-12-00MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (C…

Pfizer Inc.

Respiratory Tract Diseases

Spain, Germany, Poland, Czechia, Greece, Italy, Bulgaria, France, Hungary

08/06/2026

Phase II

Leveraging the neural mechanisms of social reward for drug relapse prevention

2023-504518-31-01substance use disorder

DrugOxytocin

Fondazione Santa Lucia IRCCS

Mental Disorders

Italy

29/05/2026

Phase II

A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX‑828/Deutivacaftor With and Without Tezacaftor in Subjects Aged 18 Years and Older With Cystic Fibrosis

2025-523400-72-00Cystic fibrosis

Vertex Pharmaceuticals Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Spain, Sweden, Germany, Italy, Belgium, Czechia, Ireland, Portugal, Netherlands, France, Denmark

29/05/2026

Phase II

An Extension Study to Evaluate the Long-Term Safety and Efficacy of Afimkibart (RO7790121) in Patients with Rheumatoid Arthritis who Participated in Previous Afimkibart Clinical Trials

2025-523579-47-00moderate to severe rheumatoid arthritis (RA)

DrugAfimkibart

F. Hoffmann-La Roche AG

Immune System Phenomena

Italy, Spain, Germany, France, Denmark, Poland, Belgium

27/05/2026

Phase II

An Open-Label Study to Assess the Long-Term Safety and Tolerability of ML-007C-MA in Adult Participants with Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis

2025-521757-16-00Hallucinations and Delusions Associated with Alzheimer’s Di…

Maplight Therapeutics Inc.

Mental Disorders

Italy, Poland, Czechia, Portugal, Bulgaria, France, Slovakia, Romania, Hungary

27/05/2026

Phase II

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma (r/r MM)

2025-524181-26-00relapsed/refractory multiple myeloma

C4 Therapeutics Inc.

Hemic and Lymphatic Diseases

Italy, France, Spain, Poland

25/05/2026

Phase II

A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Participants with Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008).

2025-525013-23-00Stage 4 (IV) Non-Small Cell Lung Cancer (NSCLC)

DrugPembrolizumab

Eikon Therapeutics Inc.

Neoplasms

Germany, Spain, Netherlands, Romania, Greece, Italy, Austria, Belgium, Bulgaria, France, Hungary, Poland

21/05/2026

Phase II

An open-label, single-arm extension study to evaluate the long-term safety, tolerability, and efficacy of KL1333 (napazimone) in patients with primary mitochondrial disease

2025-524367-20-00Adult patients with primary mitochondrial disease

Pharming Technologies B.V.

Metabolism

Belgium, Germany, Czechia, Spain, Denmark, Italy, France, Netherlands

21/05/2026

Phase II

An Open-Label, Rollover Study for Participants With Thyroid Eye Disease Previously Enrolled in Amgen-Sponsored AMG 732 Studies and are Primary Proptosis Non-responders or who Relapsed During the Safety Follow-up

2025-523280-38-00Thyroid Eye Disease

Amgen Inc.

Eye Diseases

Spain, Poland, France, Italy, Greece

20/05/2026

Phase II

PODOMOUNT-Basket, a Phase II, multicentre, randomised, 2-arm parallel-group, double-blind, placebo-controlled basket trial to assess safety, tolerability, PK, and efficacy of BI 764198 in four proteinuric kidney diseases

2025-523425-17-00Proteinuric kidney diseases

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Nutritional and Metabolic Diseases

Portugal, Greece, Italy, Poland, Estonia, Slovakia, Sweden, Denmark, Belgium, Norway, Romania, France, Spain, Germany, Netherlands, Croatia

19/05/2026

Phase II

An Open-label, Single-arm, Global Study of Perioperative Durvalumab With Cisplatin-based Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer (NIAGARA-2)

2024-519246-75-01Patients With Muscle-Invasive Bladder Cancer

AstraZeneca AB

Neoplasms

Italy, Spain, France, Netherlands

19/05/2026

Phase II

A Phase II, Open-Label Randomized Study of Intravenous Tambiciclib in Combination with the Standard of care Venetoclax and Azacitidine in Patients with Newly Diagnosed AML Who Failed to Achieve at Least MLFS After the First Two Cycles of Treatment with Venetoclax and Azacitidine Alone

2025-524308-31-00Acute myeloid leukemia

DrugsAzacitidine·Venetoclax

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l., IIS La Fe

Neoplasms

Italy, Spain

19/05/2026

Phase II

A Phase 2a, Randomized, Open-Label, Active-Controlled, Crossover Study to Evaluate Safety and Explore Efficacy of Different Doses of New Lipase NHS7108 Administered Orally in Participants with Exocrine Pancreatic Insufficiency.

2025-521816-20-00Exocrine Pancreatic Insufficiency

DrugZenpep

Aimmune Nestle Health Science US R&D LLC

Nutritional and Metabolic Diseases

Poland, Hungary, Spain, Bulgaria, Italy

18/05/2026

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 Phase 2, Open-label Study of JNJ-79635322 in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) who Have Received at least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti-CD38 Antibody

2025-521976-80-00Relapsed or Refractory Multiple Myeloma (RRMM)

Janssen Cilag International

Neoplasms

Poland, Italy

14/05/2026

Phase II

Maintenance AVElumab after SECond line platinum-based chemotherapy for metastatic urothelial carcinoma: AVESEC trial - GOIRC-02-2025

2025-524077-16-00metastatic urothelial carcinoma

DrugAvelumab

G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica

Neoplasms

Italy

12/05/2026

Phase II

A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors

2025-523895-22-00Non-small cell lung cancer (NSCLC), Cervical cancer (CC), M…

DrugsBNT324·Pumitamig

Dualitybio Inc.

Neoplasms

Italy, Poland, France, Spain, Germany

12/05/2026

Phase II

A prospective, multinational, multicenter, randomized, sequential, double-blind, placebo-controlled, phase 2a clinical study to assess the safety and pharmacokinetics (PK) of OMN6 in hospital-acquired bacterial pneumonia (HABP) or ventilated-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC).

2025-524200-29-00Hospital-acquired bacterial pneumonia or ventilated-associa…

Omnix Medical Ltd.

Respiratory Tract Diseases

Italy, Hungary, Greece

06/05/2026

Phase II

A Master Protocol of an Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)

2025-524843-11-00Non-Small Cell Lung Cancer

AstraZeneca AB

Neoplasms

France, Italy, Spain

06/05/2026

Phase II

A Phase II, Multi-Center, Master Protocol to Evaluate the Efficacy and Safety of Volrustomig as Monotherapy or in Combination with Anti-cancer Agents in Participants with Advanced/Metastatic Solid Tumors (eVOLVE-02)

2025-523947-36-00Sub-study 4: Esophageal Squamous Cell Carcinoma (Volrustomi…

AstraZeneca AB

Neoplasms

Italy, Germany

05/05/2026

Phase II

A Long-Term Extension Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Patients With Graves' Disease

2025-524001-33-00Graves’ Disease

Immunovant Sciences GmbH

Immune System Diseases

Italy, Greece, Germany, Hungary, Poland, Czechia, Netherlands, Spain, Belgium, Bulgaria, Latvia

05/05/2026

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

Efficacy of cell therapy with allo-MSCs in patients with gvhd resistant to ruxolitinib second line therapy: a Phase IIB Clinical Trial - MSC-GRR2 Study

2025-523448-10-00Gvhd Resistant to ruxolitinib and steroids

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Hemic and Lymphatic Diseases

Italy

28/04/2026

Phase II

A Phase 2 Study of [68Ga]BED003 for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

2025-521983-36-00Colorectal cancer (CRC), gastric cancer (GC), pancreatic du…

Blue Earth Diagnostics Ireland Limited

Neoplasms

Netherlands, Italy

28/04/2026

Phase II

Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety of Anumigilimab (CSL324) in Adults with Sickle Cell Disease

2025-521154-42-00Sickle Cell Disease

CSL Behring LLC

Hemic and Lymphatic Diseases

Belgium, Netherlands, France, Italy

28/04/2026

Phase II

A Phase IIb, multicentre, randomised, doubleblind, placebocontrolled, three-arm parallel-group study to evaluate the efficacy, safety, and tolerability at Week 24 of 2 doses of CHF10067 (zampilimab) in participants with idiopathic pulmonary fibrosis

2024-514246-37-00Idiopathic pulmonary fibrosis (IPF)

Chiesi Farmaceutici S.p.A.

Respiratory Tract Diseases

Belgium, Germany, Italy, Czechia, Bulgaria, Netherlands, France, Portugal, Poland, Spain, Romania

27/04/2026

Phase II

The MAVRiC Study: A Phase II Study of Disease Risk Mutation-guided Finite Duration Acalabrutinib plus Venetoclax for Relapse in CLL/SLL after First-line Finite covalent BTKi plus BCL2i combination, with or without Obinutuzumab

2024-518858-17-00Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CL…

DrugsAcalabrutinib·Venetoclax

AstraZeneca AB

Neoplasms

Italy, Austria, Spain, Ireland, Czechia, Poland

27/04/2026

Phase II

Colchicine to Quench the Inflammatory Response after Deep Vein Thrombosis: The CONQUER-DVT Randomized Controlled Trial

2025-521836-12-00deep vein thrombosis

Universita' Degli Studi G. D'Annunzio Di Chieti

Hemic and Lymphatic Diseases

Italy

23/04/2026

Phase II

A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study of the Efficacy and Safety of Vamifeport in Adult Subjects with HFE-related Hereditary Hemochromatosis (FERROCLEAR Study)

2025-523793-16-00Homeostatic iron regulator gene-related hereditary hemochro…

CSL Behring LLC

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Austria, Poland, Spain, Germany, France, Ireland, Romania, Belgium, Italy, Czechia, Netherlands

20/04/2026

Phase II

A Multicentre, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of MaaT013 in Ruxolitinib-Refractory or Intolerant Paediatric and Adolescent participants with Gastrointestinal Acute Graft-versus-Host Disease

2025-524302-15-00Gastrointestinal Acute Graft-versus-Host Disease (GI-aGvHD)

DrugVancomycin

MaaT PHARMA

Digestive System Diseases

Netherlands, Italy, France, Spain

17/04/2026

Phase II

Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group, Adaptive Proof-of-concept, Dose-selecting Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Intranasal Cenegermin (recombinant human Nerve Growth Factor [rhNGF]) in Adult Participants with subacute moderate to severe Traumatic Brain Injury (TBI).

2025-522692-29-00Subacute Moderate to Severe Traumatic Brain Injury (TBI)

DrugCenegermin

Dompe' Farmaceutici S.p.A.

Nervous System Diseases

Italy, Denmark, Finland, France, Germany, Spain, Sweden, Poland

14/04/2026

Phase II

A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina-S) in Participants with Non-Small Cell Lung Cancer

2025-522107-18-00Locally advanced or metastatic Non-Small Cell Lung Cancer

DrugPegfilgrastim

Genmab A/S

Neoplasms

Germany, Hungary, Netherlands, France, Italy, Belgium, Spain, Poland

14/04/2026

Phase II

Teclistamab plus autologous lymphocytes infusion for the treatment of relapsed/refractory Multiple Myeloma (TALIM). MM0125

2025-521827-61-00refractory/relapsed multiple myeloma

DrugTeclistamab

Fondazione G.I.M.Em.A Franco Mandelli Ets

Hemic and Lymphatic Diseases

Italy

14/04/2026

Phase II

A phase II, multicenter study of GlOfitamab in patients with mantle cell Lymphoma and inaDequate response or relapse following CAR T-cell therapy (GOLD)

2025-523428-39-00Mantle Cell Lymphoma

Fondazione Italiana Linfomi Ets

Hemic and Lymphatic Diseases

Italy

14/04/2026

Phase II

A Phase 2b, Randomized, Double blind, Placebo controlled, Parallel group, Multicenter, Dose ranging Study Investigating the Efficacy and Safety Profile of KT-621 Administered Orally to Adult Participants with Uncontrolled Moderate to Severe Eosinophilic Asthma

2025-523180-38-00Uncontrolled Moderate to Severe Eosinophilic Asthma

Kymera Therapeutics Inc.

Immune System Diseases

Spain, Romania, Slovakia, Poland, Germany, Italy, Belgium, Austria

10/04/2026

Phase II

A Phase 2 Study to Investigate the Safety and Efficacy of Petosemtamab in Adults with Non-Small Cell Lung Cancer in Combination with Pembrolizumab.

2025-522867-13-00Non Small Cell Lung Cancer

Merus B.V.

Not possible to specify

Spain, Belgium, Netherlands, Poland, Italy, France

09/04/2026

Phase II

ETOP 29-25 START-lung: A multicentre phase II trial of tarlatamab in patients with pretreated extensive-stage small cell lung cancer (ES-SCLC) and ECOG PS 2.

2025-522288-13-00Patients with pretreated extensive-stage small cell lung ca…

ETOP IBCSG Partners Foundation

Neoplasms

France, Greece, Spain, Italy

08/04/2026

Phase II

Efficacy and safety of a novel dual pH-dependent delayed-release ColeseveLam for the trEatment of bile Acid diarrhoea: a Randomized, double-blind, parallel-group, placebo-controlled clinical trial - CLEAR

2025-523868-20-00Bile acid diarrhoea

Monteresearch S.r.l.

Digestive System Diseases

Italy

02/04/2026

Phase II

A multicenter, multicohort, phase 2 platform trial to personalize second-line treatment intensity and targeting in HR-positive, HER2-negative metastatic breast cancer through an integrated liquid biopsy algorithm.

2025-523460-21-00Metastatic breast cancer

DrugsCapivasertib·Elacestrant·Trastuzumab deruxtecan·Fulvestrant

Centro Di Riferimento Oncologico Di Aviano

Neoplasms

Italy

31/03/2026

Phase II

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Proof of Concept (POC) Study Evaluating the Safety, Tolerability, and Efficacy of Nintedanib Solution for Inhalation (AP02) in Participants with Idiopathic Pulmonary Fibrosis (IPF) (AURA-IPF)

2025-523431-19-00Idiopathic Pulmonary Fibrosis (IPF)

Avalyn Pharma Inc.

Respiratory Tract Diseases

Germany, Italy, Spain, Ireland

26/03/2026

Phase II

An Open-label, Multi-center, Global Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects with Advanced Non-small Cell Lung Cancer (NSCLC)

2025-523803-31-00Advanced non-small cell lung cancer (NSCLC)

Shanghai Henlius Biotech Inc.

Therapeutics

Italy, Romania, Poland, Spain, France

25/03/2026

Phase II

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of V940 in Combination With Pembrolizumab and Chemotherapy as First-Line Treatment for Participants With Metastatic Squamous NSCLC (INTerpath-013)

2025-520902-37-00Non-small cell lung cancer stage IV

Merck Sharp & Dohme LLC

Neoplasms

Italy, Spain, Poland, France

23/03/2026

Phase II

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib plus Ribociclib plus Fulvestrant Versus Placebo plus Ribociclib plus Fulvestrant in Patients with Endocrine-Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer with Chromosome 8P Loss and Without a PIK3CA Mutation

2025-523013-28-00Endocrine-Resistant Hormone-Receptor-Positive, HER2-Negativ…

F. Hoffmann-La Roche AG

Neoplasms

France, Italy, Poland, Germany, Spain

23/03/2026

Phase II

A Phase 2 Study of ACR-368 Therapy in Subjects with Endometrial Cancer

2025-524542-10-00Endometrial cancer

Acrivon Therapeutics Inc.

Neoplasms

Italy, Germany, Spain, France

23/03/2026

Phase II

A Phase 2 Posology Study with Long-Term Extension in Participants with Well‑Controlled Recurrent Pericarditis to Evaluate the Efficacy and Safety of Transition Regimens to KPL-387 Monotherapy from Standard Therapies

2025-523234-66-00Well-Controlled Recurrent Pericarditis

Kiniksa Pharmaceuticals GmbH

Therapeutics

Spain, Greece, Germany, France, Italy, Poland

19/03/2026

Phase II

SEZanne: A Phase 2 Randomized, Open label, Multicenter Study to Evaluate the Optimal Dose, Safety, and Efficacy of ABBV-706 in Combination with Atezolizumab versus Standard of Care as First-Line Treatment in Subjects with Previously Untreated Extensive Stage Small Cell Lung Cancer (ES-SCLC)

2024-517490-24-00Small Cell Lung Cancer

AbbVie Deutschland GmbH & Co. KG

Neoplasms

Spain, Germany, Italy, Poland, Belgium

18/03/2026

Phase II

J6E-MC-KWAN: A Phase 2, Multicenter, Randomized, Double-Blind, Active-Controlled Study of LY4268989 (MORF-057) Co-Administered with Mirikizumab in Adults with Moderately to Severely Active Ulcerative Colitis

2025-522338-30-00Ulcerative Colitis

Eli Lilly & Co.

Digestive System Diseases

Hungary, Spain, Denmark, Netherlands, Poland, Romania, Germany, Italy, Austria

18/03/2026

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

A Phase 2, Randomized, Masked, Placebo-Controlled Study of Subcutaneously Administered ADX-038 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

2025-521779-30-00Geographic atrophy secondary to age-related macular degener…

Adarx Pharmaceuticals Inc.

Eye Diseases

Germany, Portugal, Italy, Spain

17/03/2026

Phase II

An Open-Label Extension Study to Evaluate the Long-term Safety and Efficacy of Weekly Intravenous Infusions of BMN 351 in Participants with Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping

2024-511656-41-00Duchenne Muscular Dystrophy

Biomarin Pharmaceutical Inc.

Musculoskeletal Diseases

Spain, Italy, Netherlands

16/03/2026

Phase II

A Phase 2 Study of Emavusertib in Combination with an Approved Bruton Tyrosine Kinase Inhibitor in Patients with Chronic Lymphocytic Leukemia and Other B-cell Malignancies

2025-523600-68-00Chronic Lymphocytic Leukemia and Other B-cell Malignancies

Curis Inc.

Neoplasms

Spain, Italy

16/03/2026

Phase II

A phase 2b, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of Usnoflast administered to adult subjects with Amyotrophic Lateral Sclerosis (ALS)

2025-522580-15-00Amyotrophic Lateral Sclerosis (ALS)

Zydus Therapeutics Inc.

Nervous System Diseases

Spain, Germany, Sweden, Ireland, Poland, Italy, Belgium, France, Netherlands

12/03/2026

Phase II

A Phase 2a Multicenter Platform Study of Investigational Products for the Treatment of Adult Subjects with Idiopathic Pulmonary Fibrosis

2024-518013-25-00Idiopathic Pulmonary Fibrosis

AbbVie Deutschland GmbH & Co. KG

Respiratory Tract Diseases

Greece, Italy, Sweden, Germany, Portugal, Spain, France, Hungary, Poland, Bulgaria, Romania

10/03/2026

Phase II

A Phase II, Randomized, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of the Combination of Inavolisib Plus Enzalutamide Versus Physician's Choice of ARPI or Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer

2025-521327-67-00Metastatic Castration-Resistant Prostate Cancer

F. Hoffmann-La Roche AG

Neoplasms

Germany, France, Italy, Spain

06/03/2026

Phase II

A multinational, multicenter extension study to investigate the long-term safety, tolerability and efficacy of balinatunfib in adults with Crohn’s disease or ulcerative colitis

2025-522511-42-00Colitis Ulcerative, Crohn's disease

Sanofi-Aventis Recherche & Developpement

Digestive System Diseases

Belgium, Germany, Czechia, Netherlands, Spain, Austria, Italy, Greece, Croatia, Bulgaria, Poland, France, Romania, Hungary

06/03/2026

Phase II

A Phase 2, Multi-center, Randomized, Dose-Ranging, Placebo-Controlled, Double-blind Study of the Relaxin Agonist R2R01 in Patients at High Risk for Cardiac Surgery Associated - Acute Kidney Injury.

2025-523037-25-00Patients at high risk for Cardiac Surgery Associated – Acut…

River 2 Renal Corp.

Pathological Conditions, Signs and Symptoms

Italy, Germany

04/03/2026

Phase II

A Phase 2 Study to Assess ADX-038 in Participants With Complement-Mediated Kidney Disease

2025-521752-26-00Complement-Mediated Kidney Disease

Adarx Pharmaceuticals Inc.

Male Urogenital Diseases

Spain, Italy

02/03/2026

Phase II

An open label extension study to evaluate the long-term safety and efficacy of subcutaneous lunsekimig in adult participants with asthma who participated in study DRI16762 or ACT18301. AIRPHRODITE

2025-522896-27-00Asthma

Sanofi-Aventis Recherche & Developpement

Respiratory Tract Diseases

Poland, Italy, Belgium, Sweden, Hungary, France, Germany, Spain, Denmark

02/03/2026

Phase II

A randomized, double-blind, placebo-controlled, Phase 2, dose-finding study to investigate the efficacy and safety of SAR445399 in participants with moderate to severe hidradenitis suppurativa

2025-522695-83-00Hidradenitis suppurativa

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

Hungary, Spain, France, Belgium, Sweden, Germany, Italy

02/03/2026

Phase II

C5041018 - A Phase 2 Open-Label, Single Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

2025-523100-77-00Ulcerative Colitis

Pfizer Inc.

Digestive System Diseases

Finland, Poland, France, Germany, Italy, Slovakia

27/02/2026

Phase II

A Phase 2a, Open-Label Pilot Study to Evaluate the Safety/Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of VTX2735 in Participants with Recurrent Pericarditis

2025-524784-20-00Recurrent Pericarditis

Zomagen Biosciences Limited

Cardiovascular Diseases

Belgium, France, Greece, Spain, Italy

27/02/2026

Phase II

PirtobrUtinib as frontline Therapy for elderly unfit/frail patient with MAntle cell lymphoma: a phase II study of the Fondazione Italiana Linfomi (FIL)

2025-521666-10-01Mantle Cell Lymphoma

Fondazione Italiana Linfomi Ets

Hemic and Lymphatic Diseases

Italy

26/02/2026

Phase II

A Phase 2, Multicenter, Randomized, Double-blind Study of Safety and Efficacy of EL219 (Turletricin) versus Liposomal Amphotericin B or Voriconazole for Early Antifungal Therapy of Invasive Mould Infections (TREAT-1)

2025-522835-32-00Suspected Invasive Mould Infection

Elion Therapeutics Inc.

Bacterial Infections and Mycoses

Belgium, France, Spain, Italy

26/02/2026

Phase II

Open-label, Uncontrolled, Multicenter Trial to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Children From 2 Years to Less Than 18 Years of Age with Immunoglobulin G4 related Disease (IgG4-RD)

2025-520988-41-00Immunoglobulin G4 related Disease (IgG4-RD)

DrugInebilizumab

Amgen Inc.

Immune System Diseases

Greece, Poland, Italy, Spain

25/02/2026

Phase II

KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

2025-521939-36-00Participants with KRAS G12C-Mutant, Advanced or Metastatic …

Merck Sharp & Dohme LLC

Neoplasms

Italy, Poland, Spain, Finland, Netherlands, Greece

24/02/2026

Phase II

J2R-MC-YAAD: A Phase 2, Double-blind, Placebo-Controlled Study to Evaluate LY3537021 for the Treatment of Chemotherapy-Induced Nausea and Vomiting in Adult Participants With Malignant Disease

2025-522204-24-00Neoplasms, Drug-Related Side Effects and Adverse Reactions,…

Eli Lilly & Co.

Neoplasms

Romania, Spain, France, Italy

23/02/2026

Phase II

Obinutuzumab Treatment in Frequently Relapsing and Rituximab-Dependent Idiopathic Nephrotic Syndrome in Adults: a fully academic, single-arm, open, prospective, intervention trial

2025-523306-33-00Idiopathic Nephrotic Syndrome

Istituto Di Ricerche Farmacologiche Mario Negri

Immune System Diseases

Italy

23/02/2026

Phase II

Master Protocol Full Title: A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis. ISA 1 Full Title: An ISA to Master Protocol ARGX-999-2-MG-2000 for an Exploratory, Phase 2a, Proof-of-Concept Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV as Add-On Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod.

2025-522492-28-00AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthe…

Argenx

Immune System Diseases

Spain, Poland, Germany, Netherlands, Greece, Italy, Belgium

18/02/2026

Phase II

Prevention of Ribociclib-related hepatotoxicity in breast cancer patients: a phase II, multicentre, open label, single arm trial of Silimarin.

2025-521651-22-00hormone receptor positive, HER2-negative breast cancer

DrugRibociclib

Fondazione Oncotech Impresa Sociale

Not possible to specify

Italy

17/02/2026

Phase II

Revumenib Treatment in Combination with FLA Chemotherapy in Paediatric Refractory/Relapsed KMT2A-r, NUP98-r or NPM1-mut Acute Myeloid Leukemia (AML)

2025-521390-14-00Acute Myeloid Leukemia

DrugsRevumenib·Cytarabine·Fludarabine

Pediatric Research International GmbH

Neoplasms

Denmark, Italy, Czechia, Sweden, Poland, Netherlands, Germany, Austria

16/02/2026

Phase II

A Phase IIb, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AZD5148 for Prevention of Recurrence of Clostridioides difficile Infection in Individuals 18 Years of Age and Above

2025-521416-19-00Recurrence of Clostridioides difficile Infection

AstraZeneca AB

Bacterial Infections and Mycoses

Greece, Spain, France, Germany, Italy, Hungary, Denmark, Sweden

16/02/2026

Phase II

Inavolisib for PIK3CA mutated advanced endometrial cancer:a multicentric, phase II, MITO END-4 trial

2025-522981-61-00endometrial cancer

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Female Urogenital Diseases and Pregnancy Complications

Italy

12/02/2026

Phase II

A Phase 2 study of intratumoral administration of L19IL2/L19TNF in locally advanced Cutaneous Squamous Cell Carcinoma patients progressing on or intolerant to systemic treatment.

2025-523231-19-00Cutaneous Squamous Cell Carcinoma

Philogen S.p.A.

Neoplasms

Italy, Germany, Greece, Spain, Austria, France, Netherlands

10/02/2026

Phase II

A Phase 2 controlled randomized study of the efficacy of L19IL2 or L19TNF or L19IL2/L19TNF intralesional injections for the treatment of locally advanced basal cell carcinoma patients.

2025-523229-16-00locally advanced basal cell carcinoma patients

Philogen S.p.A.

Neoplasms

Greece, Italy, Germany, Spain, Netherlands, Austria, France

10/02/2026

Phase II

A Phase 2 study of intratumoral administration of L19IL2/L19TNF in locally advanced Basal Cell Carcinoma patients progressed on or intolerant to systemic treatment.

2025-523230-77-00Patients with locally advanced Basal Cell Carcinoma (LaBCC)…

Philogen S.p.A.

Neoplasms

Germany, Italy, Greece, Spain, Austria, France

10/02/2026

Phase II

Hyperprogression upon cemiplimab alone or with chemotherapy in PD-L1 ≥ 50% NSCLC: a biomarker guided phase 2 trial – HYPERBOLIC study

2025-521583-35-00non-small cell lung cancer (NSCLC)

DrugsCemiplimab·Pemetrexed·Paclitaxel·Cisplatin

Universita' Vita-salute S. Raffaele

Neoplasms

Italy

10/02/2026

Phase II

A Phase 2 Open-label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children From 2 Years to less than 18 Years of age With Generalized Myasthenia Gravis (gMG)

2025-520993-20-00Generalized Myasthenia Gravis

DrugInebilizumab

Amgen Inc.

Nervous System Diseases

Spain, Italy, Poland, France

09/02/2026

Phase II

A Phase 2 randomized, double-blind, placebo-controlled study to investigate efficacy, safety, immunogenicity, and pharmacokinetics, of GSK3862995B in participants with bronchiectasis

2025-522892-27-00Bronchiectasis

GSK PLC

Respiratory Tract Diseases

Denmark, France, Spain, Italy, Germany, Poland

09/02/2026

Phase II

A Phase IIb, Monocentric, Non-Profit, Open-label Trial for the Intrathecal Administration of AAV9/AP4M1 for Hereditary Spastic Paraplegia Type 50 (SPG50)

2025-522603-15-00Hereditary Spastic Paraplegia Type 50 (SPG50)

Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Italy

06/02/2026

Phase II

Phase II study of Cemiplimab before and after standard chemoradiotherapy for patients with locally advanced cervical carcinoma. CADILLACC TRIAL

2025-521839-36-00locally advanced cervical carcinoma

Fondazione IRCCS Istituto Nazionale Dei Tumori

Female Urogenital Diseases and Pregnancy Complications

Italy

06/02/2026

Phase II

A Phase 2, Randomised, Double-masked, Placebo-controlled, Parallel-group, Multi-centre Study to Evaluate K1-70 in Patients with Active Thyroid Eye Disease in Europe

2024-519292-26-00Graves’ disease and active thyroid eye disease

Av7 Limited

Eye Diseases

Spain, Italy

05/02/2026

Phase II

An Open-Label Extension, Multi-centered, Phase 2 Trial to Describe the Safety and Efficacy of TEV-56286 (Emrusolmin) in Participants with Multiple System Atrophy

2025-521642-14-00Multiple System Atrophy

Teva Branded Pharmaceutical Products R&D LLC

Nervous System Diseases

France, Germany, Italy, Spain

04/02/2026

Phase II

An Open-label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Induction Treatment with Melphalan/HDS Followed by Consolidation Treatment with Eribulin or Vinorelbine or Capecitabine Versus Eribulin or Vinorelbine or Capecitabine Alone in Patients with Metastatic Breast Cancer with Liver Dominant Disease

2025-521966-91-00Refractory Metastatic Breast Cancer with Liver Dominant Dis…

Delcath Systems Inc.

Neoplasms

Italy, Spain, Sweden, France, Germany

04/02/2026

Phase II

A Phase 2b, Randomised, Double-Blind, Placebo-Controlled, Parallel-Arm Dose Finding Study Evaluating the Efficacy and Safety of SAB-142 for Delaying the Progression of Type 1 Diabetes (T1D) in Patients with Stage 3 New Onset of Type 1 Diabetes (NOT1D)

2025-521560-36-00Type 1 Diabetes

Sab Biotherapeutics Inc.

Nutritional and Metabolic Diseases

Austria, Germany, Poland, Italy, Denmark, Spain, Belgium, Finland, France, Lithuania, Slovenia

02/02/2026

Phase II

A Multi-Center, Double-Blind, Placebo-Controlled, Phase II Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489, A Monoacylglycerol Lipase Inhibitor, as Add-On Therapy to Ocrelizumab, in Participants with Progressive Forms of Multiple Sclerosis

2025-521636-10-00Progressive Forms of Multiple Sclerosis (PMS)

F. Hoffmann-La Roche AG

Nervous System Diseases

Germany, Spain, France, Hungary, Italy, Poland, Portugal

28/01/2026

Phase II

PASSION (olaParib mAintenance in chemotherapy-Sensitive metaStatic pancreatIc adenOcarciNoma - mPDAC): a phase II, proof of principle, study

2025-522530-31-01Patients with metastatic PDAC, who have not progressed foll…

Universita' Degli Studi Di Verona

Neoplasms

Italy

26/01/2026

Phase II

Master Protocol: A Phase 1b / 2, Multicenter, Multi Arm Study of Evorpacept in Combination with Anti-cancer Therapies in Advanced / Metastatic Malignancies (ASPEN-09) Substudy Protocol: A Single-arm Phase 2 Multicenter Study of Evorpacept in Combination with Trastuzumab and Chemotherapy in Participants with Metastatic HER2-Positive Breast Cancer (ASPEN-09-03)

2025-522012-16-00Breast Cancer

Alx Oncology Holdings Inc.

Neoplasms

Spain, Italy, France

23/01/2026

Phase II

A Phase 2b Randomized, Open-Label Active Controlled Study Evaluating the Safety and Efficacy of oral VH4524184 Coadministered with Emtricitabine and Tenofovir Alafenamide in Treatment Naïve Viremic Persons with HIV-1.( INNOVATE Study)

2025-521918-26-00HIV Infections

Viiv Healthcare UK Limited

Virus Diseases

Spain, Belgium, France, Germany, Italy, Portugal, Poland

23/01/2026

Phase II

A phase II, open label, multicenter trial investigating Irinotecan plus cetuximab rechallenge compared with trifluridine/tipiracil plus bevacizumab as third line treatment in circulating tumor DNA molecularly selected metastatic colorectal cancer: the ROMANCE-GOIM trial

2025-521319-38-00metastatic colorectal cancer

Gruppo Oncologico Dell'Italia Meridionale

Neoplasms

Italy

19/01/2026

Phase II

A phase 2, three-arm, randomized study of the efficacy of intratumorally administered L19IL2 or L19TNF or L19IL2/L19TNF, all in combination with systemic anti-PD1 pembrolizumab, in stage III and IV unresectable melanoma patients with resistance to or progressing upon anti-PD1 checkpoint inhibitors and with presence of injectable metastases

2024-519326-20-00Patients with diagnosis of unresectable clinical stage III …

Philogen S.p.A.

Neoplasms

Italy, Germany

14/01/2026

Phase II

A Phase IIa, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Assess the Efficacy, Safety, and Tolerability of AZD4144 in Participants with Sepsis-associated Acute Kidney Injury (SERENIA)

2025-522232-13-00Sepsis-associated acute kidney injury (AKI)

DrugAZD4144

AstraZeneca AB

Not possible to specify

Germany, France, Spain, Italy, Belgium, Czechia, Greece, Denmark, Hungary

14/01/2026

Phase II

Evaluation of the Pharmacokinetics of Subcutaneous Administration of Piperacillin/Tazobactam: An Open-Label, Multicentric, Non-Inferiority Randomized Clinical Trial (STUPITA01)

2024-519663-17-01Infectious disease

Azienda Sanitaria Universitaria Friuli Centrale

Bacterial Infections and Mycoses

Italy

09/01/2026

Phase II

A Phase 2b, Randomized, Blinded Trial Investigating the Efficacy and Safety of Visugromab in combination with Nivolumab and Lenvatinib compared to Double Placebo and Lenvatinib in Participants with Unresectable or Metastatic Hepatocellular Carcinoma and Compensated Liver Function (Child-Pugh A) after Failure of First-Line Treatment that Included an Anti-PD-(L)1 Compound (GDFATHER-HCC-01)

2025-520675-86-00Unresectable or Metastatic Hepatocellular Carcinoma and Com…

CatalYm GmbH

Neoplasms

Germany, France, Italy, Spain

23/12/2025

Phase II

PHASE II STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CAMIZESTRANT PLUS RIBOCICLIB IN PATIENTS WITH HORMONE RECEPTOR-POSITIVE (HR+) BREAST CANCER (THE CADILLAC STUDY)

2024-520027-88-00Patients with hormone receptor-positive (HR+) breast cancer

DrugsCamizestrant·Ribociclib

Medica Scientia Innovation Research S.L.

Neoplasms

Spain, Germany, Italy

23/12/2025

Phase II

A randomized, double-blind, placebo-controlled, dose-ranging Phase 2 study of brivekimig followed by a maintenance period in participants with moderate to severe hidradenitis suppurativa

2025-522333-61-00Hidradenitis suppurativa

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

Poland, Hungary, Netherlands, Germany, Czechia, Spain, France, Italy, Greece

22/12/2025

Phase II

A Phase 2, randomized, multicenter, open-label neoadjuvant study evaluating zanidatamab in combination with chemotherapy in participants with HER2-positive breast cancer

2025-523204-68-00HER2-positive breast cancer

Jazz Pharmaceuticals Ireland Limited

Neoplasms

Italy, Spain, Germany

22/12/2025

Phase II

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Zasocitinib in Participants with Nonsegmental Vitiligo.

2025-522309-40-00Non-segmental vitiligo

Takeda Development Center Americas Inc.

Skin and Connective Tissue Diseases

Poland, Italy, Spain, France

19/12/2025

Phase II

A Phase 1/2 Study to Evaluate STK-012 as a Single Agent and in Combination Therapy in Subjects with Front-line Advanced NSCLC and Other Selected Indications

2025-522632-14-00Non-small cell lung cancer (NSCLC)

Synthekine Inc.

Neoplasms

Ireland, Poland, Spain, Italy

19/12/2025

Phase II

A single arm, open label, multicenter, single-dose, phase 2b clinical study evaluating efficacy and safety of gene therapy using autologous CD34+ hematopoietic stem cells transduced with the GLOBE lentiviral vector using an improved transduction protocol in subjects with transfusion-dependent beta-thalassemia.

2025-522160-32-00transfusion-dependent beta-thalassemia

Fondazione Telethon Ets, San Raffaele Hospital

Hemic and Lymphatic Diseases

Italy

18/12/2025

Phase II

Targeting inflammation to reduce 90-day and 1-year postoperative severe morbidity in patients with unfavorable inflammatory profile undergoing oncologic surgery (POST CARE Trial)

2024-515333-14-03Patients scheduled for major surgery for oncologic indicati…

Fondazione IRCCS Istituto Nazionale Dei Tumori

Neoplasms

Italy

17/12/2025

Phase II

A multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 2a trial to evaluate the efficacy and safety of BP1.4979 in adult participants with obsessive compulsive disorder

2025-522026-13-00Obsessive compulsive disorder

Bioprojet Pharma

Mental Disorders

Portugal, Spain, Italy, Poland

16/12/2025

Phase II

Randomized, Double-Blinded, Vehicle-Controlled, Crossover Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intranasal Cenegermin (Recombinant Human Nerve Growth Factor [rhNGF]) in Pediatric Participants with Spastic Cerebral Palsy (CP).

2025-522786-29-00Spastic Cerebral Palsy

Dompe' Farmaceutici S.p.A.

Nervous System Diseases

Italy

11/12/2025

Phase II

A Phase 2, Open-label, Basket Study Investigating the Safety and Efficacy of GTX-102 in Adult and Pediatric Subjects with Deletion- or Nondeletion-type Angelman Syndrome

2024-519393-39-00Angelman Syndrome

Ultragenyx Pharmaceutical Inc.

Nervous System Diseases

Portugal, Italy, France

11/12/2025

Phase II

ZANUBRUTINIB, A SECOND GENERATION BTK INHIBITOR, IN ANTI-MAG ANTIBODY NEUROPATHY: A PHASE II ITALIAN MULTICENTER CLINICAL TRIAL (MAZINGA)

2025-523091-23-00Peripheral anti-MAG neuropathy, waldenstrom macroglobulinem…

Azienda Ospedaliera di Padova

Nervous System Diseases

Italy

10/12/2025

Phase II

An Open-Label, Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PTX-100 Monotherapy in Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma.

2025-521852-45-00Cutaneous T-Cell Lymphoma

Prescient Therapeutics Limited

Neoplasms

Italy, France

08/12/2025

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

(22419) A randomized, double-blind, placebo-controlled, parallel group Phase 2a study with an extension phase to evaluate the efficacy and safety of BAY 3401016 in participants aged 18 to 45 with Alport syndrome

2024-516471-33-00Chronic kidney disease, Alport Syndrome

Bayer AG

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Spain, Italy, Poland, Czechia, Germany, Portugal, France

05/12/2025

Phase II

A Phase II, Randomized, Open-Label, Parallel Group, Multicenter Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Patients with Multiple Sclerosis

2024-517980-22-00Multiple Sclerosis (MS)

F. Hoffmann-La Roche AG

Immune System Diseases

Poland, Italy, France, Spain, Germany

05/12/2025

Phase II

A PHASE 2A, OPEN-LABEL SINGLE ARM MULTICENTER EXPLORATORY STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF ORAL DOSES OF ROC-101 IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) AND PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE (ILD-PH)

2025-522074-37-00Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertensi…

Allrock Bio Inc.

Cardiovascular Diseases

Spain, Italy, Poland, France, Latvia, Germany

04/12/2025

Phase II

C5001004 - A Phase 2, Open-Label Extension Study to Investigate the Safety and Efficacy of PF-07868489 Administered to Adult Participants With Pulmonary Arterial Hypertension

2025-521155-23-00Pulmonary Arterial Hypertension

Pfizer Inc.

Cardiovascular Diseases

Italy, Czechia, Germany, Greece, Spain, Belgium, France

02/12/2025

Phase II

A phase 2, multicenter, randomized, placebo-controlled, double-blind study to investigate the safety, pharmacodynamics, and preliminary efficacy of S-606001 as an add-on to enzyme replacement therapy in patients with late-onset Pompe disease.

2025-522146-40-00Late-onset Pompe disease.

Shionogi B.V.

Nutritional and Metabolic Diseases

Belgium, Germany, Denmark, France, Italy, Spain, Netherlands

01/12/2025

Phase II

A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-407 in Subjects with Autosomal Dominant Polycystic Kidney Disease Who Have a Subset of PKD1 Gene Variants

2024-517393-13-00Autosomal Dominant Polycystic Kidney Disease (ADPKD)

DrugVX-407

Vertex Pharmaceuticals Inc.

Genetic Phenomena

France, Germany, Italy, Belgium, Spain, Netherlands

28/11/2025

Phase II

A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination with Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination with Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

2025-520730-28-00Common EGFR-Mutated Locally Advanced or Metastatic Non-Smal…

Janssen Cilag International

Neoplasms

Germany, Spain, Finland, Greece, Portugal, Italy, Belgium, Poland, France

27/11/2025

Phase II

A Phase 2, multicenter, open-label study of lifileucel (tumor-infiltrating lymphocytes [TIL]) in participants with previously treated advanced melanoma

2025-522054-40-00Previously treated advanced melanoma

Iovance Biotherapeutics Inc.

Skin and Connective Tissue Diseases

France, Italy, Germany, Spain

26/11/2025

Phase II

“A phase 2 multi-center study investigating the efficacy, safety and tolerability of pioglitazone in adult participants with non-segmental vitiligo”

2025-523266-24-00Vitiligo

DrugPioglitazone

I.F.O. Istituti Fisioterapici Ospitalieri

Skin and Connective Tissue Diseases

Italy

26/11/2025

Phase II

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants with Primary Sjogren’s Disease with Moderate to Severe Systemic Disease Activity

2025-520831-18-00Primary Sjogren’s Disease

Immunovant Sciences GmbH

Immune System Diseases

Germany, Greece, Romania, Spain, Poland, Italy, Hungary

24/11/2025

Phase II

A Phase II, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of RO7790121 in Patients with Moderate to Severe Rheumatoid Arthritis who have an Inadequate Response or Intolerance to TNF and/or JAK Inhibitors

2025-521034-28-00Moderate to Severe Rheumatoid Arthritis (RA)

DrugAfimkibart

F. Hoffmann-La Roche AG

Immune System Phenomena

Italy, Denmark, France, Poland, Germany, Spain, Belgium

23/11/2025

Phase II

A Phase 2, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of 2 doses of vipoglanstat in patients with moderate to severe endometriosis-related pain – the NOVA trial

2025-522452-16-00Endometriosis related pain

Gesynta Pharma AB

Female Urogenital Diseases and Pregnancy Complications

Italy, Hungary, Poland, Czechia, Bulgaria, Romania

21/11/2025

Phase II

A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of ALXN1920 in Adult Participants with PMN (Primary Membranous Nephropathy) who are at a High Risk for Disease Progression (AUTUMN)

2025-520780-40-00Primary Mebranous Nephropathy (PMN)

Alexion Pharmaceuticals Inc.

Immune System Diseases

Spain, France, Italy

20/11/2025

Phase II

A Global Phase 2b, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients with Symptomatic Non Obstructive Hypertrophic Cardiomyopathy – FORTITUDE-HCM

2024-515125-28-00Non-obstructive hypertrophic cardiomyopathy

Imbria Pharmaceuticals Inc.

Cardiovascular Diseases

Austria, Germany, Belgium, France, Portugal, Spain, Netherlands, Italy, Poland

20/11/2025

Phase II

Phase 2, Randomized, Double-Blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Tarperprumig in Adult Participants with Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

2025-521706-17-00Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasc…

Alexion Pharmaceuticals Inc.

Hemic and Lymphatic Diseases

Spain, France, Italy, Germany, Poland

17/11/2025

Phase II

A phase 2, multicentric study to assess the efficacy and safety of maribavir treatment in hematopoietic stem cell transplant (HSCT) recipients with cytomegalovirus (CMV) infection with a medical condition that contraindicate the administration of ganciclovir, valganciclovir or foscarnet and in those who discontinued first line preemptive therapy with ganciclovir, valganciclovir or foscarnet due to toxicity or intolerance.

2025-521074-34-00Allogeneic peripheral hematopoietic stem cell transplant, C…

Gruppo Italiano Per Il Trapianto Di Midollo Osseo Cellule Staminali Emopoietiche E Terapia Cellulare

Hemic and Lymphatic Diseases

Italy

17/11/2025

Phase II

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER, PHASE 2B TRIAL TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF AEF0217 FOR 24 WEEKS IN ADULTS AND OLDER ADOLESCENTS WITH DOWN SYNDROME

2025-521013-10-00Treatment of behavioural and cognitive impairments in Down …

Aelis Farma

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Spain, Italy, France

17/11/2025

Phase II

A Randomized, Double-Blinded, Placebo-Controlled, Dose-Finding, Adaptive Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants with Narcolepsy without Cataplexy (NT2)

2024-517711-70-01Narcolepsy without Cataplexy (NT2)

Takeda Development Center Americas Inc.

Nervous System Diseases

Spain, Italy, France

14/11/2025

Phase II

An Extension Study to Evaluate the Long-Term Safety and Efficacy of Afimkibart (RO7790121) in Patients with Atopic Dermatitis who Participated in Previous Afimkibart Clinical Trials

2025-520771-59-00Atopic Dermatitis

F. Hoffmann-La Roche AG

Skin and Connective Tissue Diseases

Italy, Poland, Germany, Spain, France

13/11/2025

Phase II

A Phase 2, open-label, multicenter study to evaluate efficacy and safety of zanidatamab for the treatment of participants with previously treated HER2-expressing solid tumors (DiscovHER PAN-206)

2024-516551-41-00Patients with HER2-expressing solid tumors

Jazz Pharmaceuticals Ireland Limited

Neoplasms

Spain, France, Italy

13/11/2025

Phase II

A Phase 2, Open-Label, Multicenter, Tumor-agnostic Study of MK-1084 as Monotherapy and in Combination with Cetuximab, in Participants with KRAS G12C-Mutant, Advanced Solid Tumors (KANDLELIT-014)

2025-521737-91-00Neoplasm malignant with KRAS G12C mutation

Merck Sharp & Dohme LLC

Neoplasms

Norway, Spain, Sweden, Italy, Denmark, France, Poland, Germany, Greece

12/11/2025

Phase II

Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis

2025-521242-26-00Moderately to Severely Active Ulcerative Colitis

DrugsSPYPBO-101·SPY001·SPY002·SPY003

Spyre Therapeutics Inc.

Digestive System Diseases

Belgium, Hungary, Lithuania, Netherlands, Croatia, Czechia, Bulgaria, Romania, Spain, France, Austria, Italy, Greece, Poland, Germany, Slovakia

10/11/2025

Phase II

An Open-label, Multinational Study Assessing the Efficacy and Safety of Dato-DXd Treatment in Patients With HR-positive, HER2 IHC 0, Locally Advanced Inoperable or Metastatic Breast Cancer Refractory to Endocrine Therapy (TROPION-Breast06)

2025-521904-23-00Locally Advanced Inoperable or Metastatic Breast Cancer Ref…

AstraZeneca AB

Neoplasms

Spain, France, Italy

05/11/2025

Phase II

PROBHE: Prehabilitation with Botulinum Toxin A in complex hernia: an Italian prospective study on predictive scores of myofascial release.

2025-522451-25-00Large hernia width, chronically retracted lateral abdominal…

Azienda Socio Sanitaria Territoriale Ovest Milanese

Surgical Procedures, Operative

Italy

04/11/2025

Phase II

Efficacy and safety assessment of T1695 ophthalmic suspension, versus Ciclosporin ophthalmic emulsion, in participants with moderate to severe Vernal Keratoconjunctivitis (VKC)

2025-521567-12-00Vernal Keratoconjunctivitis (VKC)

DrugCiclosporin

Laboratoires Thea

Eye Diseases

Spain, Italy, Bulgaria, France, Greece

04/11/2025

Phase II

A Seamless Phase 2a/2b, Randomized, Double-Blind, Placebo- and Active-Controlled, Multiple-Arm, Multiple-Stage, Adaptive Study Evaluating the Efficacy and Safety of LAD191 in Adults With Moderate-to-Severe Hidradenitis Suppurativa

2025-521293-34-00Moderate-to-severe hidradenitis suppurativa

Almirall S.A.

Skin and Connective Tissue Diseases

Germany, Italy, Ireland, Poland, Spain, France

03/11/2025

Phase II

A Phase IIb Randomized, Double-blind, Placebo-controlled, Parallel, Multidose Study to Evaluate the Efficacy, Safety, and PK of AZD0292 in Participants 12 years of Age and Older With Bronchiectasis and Chronic Pseudomonas aeruginosa Colonization

2025-523009-14-00Bronchiectasis with chronic pseudomonas aeruginosa coloniza…

AstraZeneca AB

Respiratory Tract Diseases

Netherlands, Italy, Greece, Denmark, Belgium, Spain, France, Germany

31/10/2025

Phase II

A Double-Blind, Placebo-Controlled, Phase 2, Efficacy and Safety Study of ACP-204 in Adults with Lewy Body Dementia Psychosis (LBDP)

2025-521710-25-00Lewy Body Dementia Psychosis (LBDP)

Acadia Pharmaceuticals Inc.

Nervous System Diseases

Bulgaria, Czechia, Italy, France

29/10/2025

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

A Phase 2b, Multi-center, Randomized, Double-blind, Placebo controlled Study of IMVT-1402 Treatment in Adult Participants with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

2024-517614-14-00Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Immunovant Sciences GmbH

Immune System Diseases

Austria, Hungary, Slovenia, Greece, Denmark, Ireland, Finland, Estonia, Spain, Slovakia, Netherlands, Poland, Norway, Italy, Portugal, Belgium, Germany, Romania, Bulgaria

28/10/2025

Phase II

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis

2024-519820-26-00Hallucinations and Delusions Associated with Alzheimer’s Di…

Maplight Therapeutics Inc.

Nervous System Diseases

France, Czechia, Slovakia, Hungary, Portugal, Romania, Bulgaria, Italy, Poland

27/10/2025

Phase II

CAT-VHL - Exploring the role of Carbonic Anhydrase IX as diagnostic and Theranostic target in Von-Hippel Lindau disease

2024-515679-36-01Von-Hippel Lindau (VHL) Disease

Ospedale San Raffaele S.r.l.

Therapeutics

Italy

24/10/2025

Phase II

Randomized Multicentric Proof-of-Concept Phase 2 Trial Doravirine in the Early Outpatient Management of West Nile Virus Infection in Patients at Risk of Progression - DORICO Trial

2025-521677-14-00West Nile Virus Infection

DrugDoravirine

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Virus Diseases

Italy

24/10/2025

Phase II

LUSPARA - A basket phase II clinical trial evaluating Luspatercept in patients affected with rare inherited anemias

2024-520200-26-00Inherited anemias

Eurobloodnet Association

Hemic and Lymphatic Diseases

Italy, France

24/10/2025

Phase II

A Multi-Center, Single Arm, Open-Label Extension Study to Evaluate the Long-term Safety and Efficacy of GSK4527226 [AL101] in Participants with Early Alzheimer’s Disease.

2025-521107-42-00Alzheimer's Disease

Glaxosmithkline Research & Development Limited

Nervous System Diseases

Sweden, Norway, Italy, France, Spain, Finland, Netherlands, Germany

23/10/2025

Phase II

A Phase 2, Open-label, Multi-cohort Study to Assess the Efficacy and Safety of ASP5541 in Participants with Advanced Prostate Cancer

2024-517653-27-00Prostate Cancer

Astellas Pharma Global Development Inc.

Neoplasms

Italy, Poland, Spain, France, Germany

22/10/2025

Phase II

A Phase 2, Double-Blind Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of Apitegromab in Subjects <2 Years Old With Spinal Muscular Atrophy (SMA) (OPAL)

2024-520130-29-00Spinal Muscular Atrophy

Scholar Rock Inc.

Musculoskeletal and Neural Physiological Phenomena

Belgium, France, Italy, Spain, Netherlands

21/10/2025

Phase II

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Vosoritide in Infants and Young Children with Hypochondroplasia, Aged 0 to < 36 Months

2024-512261-14-00Hypochondroplasia

Biomarin Pharmaceutical Inc.

Genetic Phenomena

Germany, Italy, France

20/10/2025

Phase II

Phase II randomized trial of XELOX plus DoSTARlimab versus XELOX alone as Consolidation Treatment after Standard Chemoradiation in pMMR/MSS or MSI-Low Locally Advanced Rectal Cancer (LARC) Patients – IMMUNOSTAR Trial - GOIRC-02-2024

2024-519798-20-00pMMR/MSS or MSI-Low Locally Advanced Rectal Cancer (LARC)

G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica

Neoplasms

Italy

20/10/2025

Phase II

A Phase 2, Multi-Center, Platform Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics with Multiple Therapies in Participants with Active Crohn’s Disease or Active Ulcerative Colitis (ASCEND-IBD)

2025-522001-38-00Crohn’s Disease, Ulcerative Colitis

DrugMT-201

Mirador Therapeutics Inc.

Digestive System Diseases

Poland, Bulgaria, Croatia, Germany, Belgium, Slovakia, Czechia, Italy

20/10/2025

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

EFfIcacy and Tolerability of FIXed duration teclistamab and talquetamab FOR FRAIL patients with newly diagnosed multiple myeloma (2 cohort study) - the EMN 37 FITFIX FOR FRAIL trial

2024-520433-76-00Newly Diagnosed Multiple Myeloma

DrugsTalquetamab·Teclistamab·Daratumumab

European Myeloma Network B.V., Emn Trial Office S.r.l. Impresa Sociale

Neoplasms

Norway, Italy, Spain, Netherlands

20/10/2025

Phase II

A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease

2025-521920-31-00Graves’ Disease

Immunovant Sciences GmbH

Immune System Diseases

Italy, Poland, Greece, Germany, Netherlands, Czechia, Spain, Latvia, Bulgaria

17/10/2025

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

DrugsZimberelimab·Sacituzumab Govitecan

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)

2024-519278-37-00Lupus Nephritis, Systemic Lupus Erythematosus

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

Cite this view

Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 8 November 2026. https://priyalifescience.com/clinical-trials-europe/country/italy

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About this register

This register is built from the EU Clinical Trials Information System (CTIS), run by the European Medicines Agency: the single register for every trial authorised under the EU Clinical Trials Regulation (536/2014). CTIS held 12,788 trial records at the last sync on 08 Nov 2026, 03:17 UTC; this register shows the 2,557 most recently authorised of them, a stated recency window rather than the full archive. The list can be downloaded as CSV or JSON.

This page shows the 246 of those trials with a site in Italy that also match the filters currently applied.

How many recently authorised EU trials have a site in Italy?

246 of the 2,557 most recently authorised trials in this register list a site in Italy and match the filters applied; 0 of them are Phase III. Trials are counted by authorisation on CTIS, not by recruitment status, which CTIS does not publish in the same form as ClinicalTrials.gov.

Summary by phase

Trials by phase (Italy), 246 trials
Phase	Trials	Share
Phase II	246	100%

Most active sponsors

Lead sponsors with the most trials (Italy)
Lead sponsor	Trials
AstraZeneca AB	11
Novartis Pharma AG	11
F. Hoffmann-La Roche AG	9
Merck Sharp & Dohme LLC	6
Eli Lilly & Co.	5
Pfizer Inc.	5
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia	4
Immunovant Sciences GmbH	4
Philogen S.p.A.	4
Sanofi-Aventis Recherche & Developpement	4

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.