Clinical Trials in Poland 2026 - 121 Recent EU Authorisations

📍 France · Bulgaria · Romania · Slovakia · Norway · Denmark · Greece · Italy · Austria · Poland · Netherlands · Czechia · Germany · Belgium · Spain · Hungary · Portugal

2026-525923-26-00 on CTIS ↗

Phase I/II Skin and Connective Tissue Diseases Authorised 29/07/2026

A Phase I/II, randomized, placebo-controlled, multi-arm, dose-finding study to evaluate the safety, efficacy and immunogenicity of an Acne mRNA vaccine candidate in adults with moderate to severe acne 18 to 45 years of age

Acne
Sanofi Pasteur Inc. · 189 participants

📍 Spain · Germany · Poland

2025-521740-38-00 on CTIS ↗

Phase IV Mental Disorders Authorised 29/07/2026

Effectiveness of Trazodone on Emotional Blunting in Patients with Major Depressive: a Phase IV, Open-label, clinical study

Major depressive disorder (MDD)
Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Enunciabile Anche Angelini Pharma Italia S.p.A. Angelini Pharma S.p.A. A.C.R.A.F. S.p.A. Acraf S.p.A. Angelini S.p.A. aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. · 120 participants

📍 Bulgaria · Poland · Hungary

2025-523267-38-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 29/07/2026

A Phase III, Randomized, Double-blind, Parallel-group, Placebo controlled, Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Cardiovascular Outcomes in Participants with HFpEF and HFmrEF (Elevate-HF)

Heart failure with preserved ejection fraction (HFpEF) and heart failure with mildly reduced ejection fraction (HFmrEF); on background SGLT2i.
AstraZeneca AB · 2343 participants

📍 Spain · Hungary · Germany · Poland · Italy · Bulgaria · Netherlands · Austria · Romania · Sweden · France · Greece · Slovakia · Czechia

2026-526304-79-00 on CTIS ↗

Phase II Neoplasms Authorised 28/07/2026

A Phase 2 Study of Alisertib in Combination with Paclitaxel in Patients with Small Cell Lung Cancer

Small Cell Lung Cancer (SCLC)
Puma Biotechnology Inc. · 30 participants

📍 France · Poland · Spain

2026-525382-47-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 27/07/2026

A clinical study to compare efficacy and safety of two different doses of CagriSema and semaglutide in participants with obesity with or without type 2 diabetes

Participants with obesity with or without type 2 diabetes
Novo Nordisk A/S · 1140 participants

📍 Greece · Portugal · France · Slovakia · Bulgaria · Netherlands · Romania · Italy · Austria · Poland · Hungary · Spain · Czechia · Belgium

2025-522488-14-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 27/07/2026

A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Master Protocol to Evaluate the Efficacy and Safety of Elecoglipron in Participants with Obesity or Overweight with or without Type 2 Diabetes Mellitus (Embold)

Participants Living with Obesity or Overweight with at least 1 comorbidity with or without Type 2 Diabetes Mellitus
AstraZeneca AB · 1010 participants

📍 Spain · Germany · Italy · Poland

2025-524688-19-00 on CTIS ↗

Phase III Neoplasms Authorised 27/07/2026

An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients with Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease

Advanced or Metastatic HR+/HER2- Breast Cancer
BeOne Medicines I GmbH · 233 participants

📍 Poland · Italy · Germany · France · Spain

2025-523960-19-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 24/07/2026

An Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Salanersen (BIIB115) in Participants Aged 15-60 Years With Spinal Muscular Atrophy Who Are Either Treatment-Naïve or Have Previously Been Treated With Risdiplam

Spinal Muscular Atrophy
Biogen Idec Research Limited · 40 participants

📍 Finland · Spain · Italy · Poland · Ireland · Germany · France

2025-524054-34-00 on CTIS ↗

Phase II Cardiovascular Diseases Authorised 24/07/2026

A randomised active-controlled trial to assess the safety and pharmacodynamics of two blinded doses of vortosiran and open-label apixaban in patients with non-valvular atrial fibrillation

non-valvular atrial fibrillation
Ribocure Pharmaceuticals AB · 150 participants

📍 Norway · Denmark · Poland · Sweden

2026-525417-31-00 on CTIS ↗

Phase I Diagnosis Authorised 24/07/2026

161Tb-labeled Gastrin Analogue - A Novel Tool for Precision Treatment of Advanced Medullary Thyroid Cancer

Thyroid cancer
Uniwersytet Jagiellonski Collegium Medicum · 30 participants

📍 Poland

2025-524951-30-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 24/07/2026

A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Renal Outcomes and Mortality in Participants with Chronic Kidney Disease (Elevate-CKD)

Chronic kidney disease (CKD) in adults, with specified ranges of eGFR and albuminuria (UACR), irrespective of T2DM status; background SGLT2i dapagliflozin 10 mg as GDMT.
AstraZeneca AB · 1600 participants

📍 Czechia · Italy · Hungary · Romania · Bulgaria · Sweden · Denmark · Poland · Spain · Norway · Finland · Greece · France · Germany

2025-523994-41-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 23/07/2026

Phase 3 Randomized Study of Teclistamab and Talquetamab (Tec-Tal) Versus Daratumumab and Lenalidomide (DR) in Minimal Residual Disease (MRD) Positive Patients With Newly Diagnosed Multiple Myeloma After Autologous Hematopoietic Stem Cell Transplantation (TiTan)

Multiple myeloma
Polish Myeloma Consortium · 248 participants

📍 Poland

2025-525097-11-00 on CTIS ↗

Phase III Not possible to specify Authorised 23/07/2026

Prospective, multicentre, open-label, single arm trial on contraceptive efficacy, safety and tolerability of LPRI-CF113 (Drospirenone 4 mg + 2.8 mg) during 13 cycles.

No medical condition
Chemo Research S.L. · 1550 participants

📍 Sweden · Czechia · Spain · Hungary · Poland · Finland · Romania

2026-525727-24-00 on CTIS ↗

Phase I/II Immune System Diseases Authorised 22/07/2026

A Phase 1/2a, Open-label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of BMS-986528 in Participants with Refractory Rheumatoid Arthritis

Refractory, difficult-to-treat Rheumatoid Arthritis
Bristol-Myers Squibb Services Unlimited Company · 21 participants

📍 Poland · Italy · Spain · Germany

2025-520666-22-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 22/07/2026

A Randomized, Open-label, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared with Oral Semaglutide in Adults with Type 2 Diabetes Mellitus (Eluminate-2)

type 2 diabetes mellitus
AstraZeneca AB · 335 participants

📍 Poland · Hungary · Italy · Bulgaria · Germany

2025-523933-24-00 on CTIS ↗

Phase III Digestive System Diseases Authorised 21/07/2026

A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis

Primary Sclerosing Cholangitis
Ipsen Bioscience Inc. · 127 participants

📍 Spain · Sweden · Germany · Romania · Finland · Portugal · Austria · Italy · Denmark · Czechia · France · Netherlands · Poland · Belgium · Norway

2026-525242-29-00 on CTIS ↗

Phase III Virus Diseases Authorised 21/07/2026

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to a Regimen of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination with Capsid Inhibitor Lenacapavir Twice Yearly in Virologically Suppressed Adults with HIV-1 Infection on Stable Oral Treatment Regimens

HIV-1
Gilead Sciences Inc. · 183 participants

📍 Poland · Italy · France · Spain · Germany · Netherlands

2025-524336-19-00 on CTIS ↗

Phase III Virus Diseases Authorised 21/07/2026

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to Long-acting Antiretroviral Therapy of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination With the Capsid Inhibitor Lenacapavir Twice-Yearly Versus Cabotegravir and Rilpivirine Every 8 Weeks in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy

HIV-1
Gilead Sciences Inc. · 183 participants

📍 Netherlands · Poland · Germany · France · Spain · Italy

2025-524335-39-00 on CTIS ↗

Phase III Skin and Connective Tissue Diseases Authorised 21/07/2026

A Phase 3, Double-blinded, Vehicle-controlled Trial to Investigate the Efficacy and Safety of Twice-daily Delgocitinib Cream in Adult Participants with Lichen Sclerosus During a 12-Week Initial Treatment Period Followed by a 40-Week Continuation Treatment Period

Lichen Sclerosus
Leo Pharma A/S · 205 participants

📍 Italy · France · Spain · Poland · Germany

2025-524873-17-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 20/07/2026

A randomized, placebo-controlled, double-blind Phase 3 study to evaluate the efficacy, safety and tolerability of votoplam in participants with Huntington’s Disease

Huntington’s Disease
Novartis Pharma AG · 368 participants

📍 Norway · Poland · Spain · Sweden · Bulgaria · Netherlands · Finland · Portugal · Austria · Italy · Greece · Ireland · Czechia · France · Romania · Belgium · Germany · Denmark · Slovakia · Hungary

2025-522227-99-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 20/07/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

Narcolepsy Type 1
Alkermes Inc. · 116 participants

📍 Sweden · Finland · Belgium · Spain · Austria · Netherlands · France · Norway · Germany · Italy · Poland

2025-524711-36-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 20/07/2026

Phase 3 Single-Arm Open-Label Study to Evaluate the Efficacy and Safety of Zodasiran in Adolescent Subjects (age 12 to <18 years) with Homozygous Familial Hypercholesterolemia (SPRUCE)

Homozygous Familial Hypercholesterolemia (HoFH)
Arrowhead Pharmaceuticals Inc. · 9 participants

📍 Netherlands · Denmark · Norway · Sweden · Poland

2025-523662-24-00 on CTIS ↗

Phase I Mental Disorders Authorised 20/07/2026

A study comparing the new drugs PG511/PG521/PG531 produced by Celon Pharma SA with the drug PG203 in healthy volunteers.

Treatment of psychotic disorders like schizophrenia Treatment of levodopa-induced dyskinesia in Parkinson's disease
Celon Pharma S.A. · 68 participants

📍 Poland

2025-524936-20-00 on CTIS ↗

Phase II Cardiovascular Diseases Authorised 17/07/2026

An Open-Label Study to Assess the Hemodynamic Effect and the Safety of TX000045 After 16 Weeks of Treatment in Participants With Pulmonary Hypertension due to Interstitial Lung Disease

Pulmonary hypertension secondary to interstitial lung disease
Tectonic Operating Company Inc. · 9 participants

📍 Poland · Romania · Spain

2026-525810-80-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 16/07/2026

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

Ulcerative Colitis
Microbial Resource Management Health · 109 participants

📍 Czechia · Poland · Italy

2025-524682-24-00 on CTIS ↗

Phase III Neoplasms Authorised 15/07/2026

A Phase 3, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants with Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy

Relapsed or refractory large B-cell lymphoma (r/r LBCL)
Kite Pharma Inc. · 192 participants

📍 Belgium · Germany · Poland · Czechia · Netherlands · Spain · Italy · France

2025-524403-80-00 on CTIS ↗

Phase III Neoplasms Authorised 14/07/2026

A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan with or Without Bevacizumab Compared to Trifluridine/Tipiracil plus Bevacizumab in Participants with Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)

Metastatic colorectal cancer
Merck Healthcare KGaA · 323 participants

📍 Belgium · Germany · France · Denmark · Poland · Spain · Netherlands · Italy · Austria

2025-524648-37-00 on CTIS ↗

Phase III Female Urogenital Diseases and Pregnancy Complications Authorised 14/07/2026

A Sequential Phase 2/3, Single-Arm, Open-Label Study in Adults Followed by a Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults and Adolescents with Focal Segmental Glomerulosclerosis

Focal segmental glomerulosclerosis (FSGS)
Apellis Pharmaceuticals Inc. · 97 participants

📍 France · Portugal · Spain · Slovakia · Italy · Germany · Poland

2025-524448-36-00 on CTIS ↗

Phase III Digestive System Diseases Authorised 14/07/2026

RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients with Metastatic Pancreatic Adenocarcinoma

Metastatic Pancreatic Adenocarcinoma
Revolution Medicines Inc. · 337 participants

📍 Poland · Belgium · Norway · Sweden · Austria · Germany · Denmark · Netherlands · France · Italy · Spain

2025-525088-34-00 on CTIS ↗

Phase II Immune System Diseases Authorised 13/07/2026

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

Antibody-mediated Kidney Disease
AstraZeneca AB · 17 participants

📍 France · Germany · Italy · Belgium · Poland · Spain

2025-524139-38-00 on CTIS ↗

Phase II Hemic and Lymphatic Diseases Authorised 13/07/2026

Phase II, Multicenter, Randomized Study to Evaluate Safety and Efficacy of MRD-guided Therapy with Reduced versus Standard Dose of Belantamab Mafodotin in Combination with Pomalidomide and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma (REBEL)

Relapsed/refractory Multiple myeloma
Polish Myeloma Consortium · 228 participants

📍 Poland

2025-525096-83-00 on CTIS ↗

Phase I/II Neoplasms Authorised 13/07/2026

A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor Surzetoclax (ABBV-453) given as Monotherapy or in Combination with Antimyeloma Regimens in Subjects with Multiple Myeloma

Multiple Myeloma (MM), Multiple Myeloma (MM)
AbbVie Deutschland GmbH & Co. KG · 88 participants

📍 Germany · Poland · Czechia · Belgium · France · Greece · Sweden · Portugal · Italy

2025-525105-20-00 on CTIS ↗

Phase II Immune System Diseases Authorised 08/07/2026

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

AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis, MG, gMG
Argenx · 29 participants

📍 Greece · Italy · Germany · Belgium · Netherlands · Spain · Poland

2025-522939-33-00 on CTIS ↗

Phase III Neoplasms Authorised 08/07/2026

Fight Osteosarcoma Through European Research evolving study platform from diagnosis to relapse (FOSTER evolving study platform)

Osteosarcoma
Institut Gustave Roussy · 508 participants

📍 Sweden · Poland · Denmark · Finland · Netherlands · Italy · France · Spain

2023-505575-69-01 on CTIS ↗

Phase III Nervous System Diseases Authorised 07/07/2026

An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Xembify versus Gamunex-C in Participants with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
Grifols Therapeutics LLC · 20 participants

📍 Romania · Czechia · Poland

2025-522165-30-00 on CTIS ↗

Phase III Eye Diseases Authorised 07/07/2026

Multicenter, randomized, double-blind, parallel-group clinical study comparing RD03/2016 (levoFloxacin and ketorolac trometAmol) eye drops vs Leviosa® (levofloxacin and dexamethaSone 21-phosphaTe) eye drops for 7 days for the prevention and treatment of inflammation and prevention of infection associated with cataract surgery in adults. (FAST 7)

Cataract
Ntc S.r.l. · 536 participants

📍 Spain · Poland · Greece · Sweden · Italy

2026-525594-39-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 07/07/2026

A study to evaluate the dose-exposure, safety, and exploratory efficacy of nerandomilast in children and adolescents from 2 years to less than 18 years of age with fibrosing interstitial lung disease (Part A: double-blind, placebo-controlled in children from 6 to less than 18 years of age and open-label active treatment in children from 2 to less than 6 years of age), followed by an open-label phase with active treatment (Part B)

Fibrosing interstitial lung disease
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 20 participants

📍 Belgium · Greece · Germany · France · Finland · Spain · Czechia · Poland · Italy · Netherlands · Denmark · Portugal

2025-523369-32-00 on CTIS ↗

Phase III Neoplasms Authorised 07/07/2026

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Cevostamab in Combination with Pomalidomide and Dexamethasone Versus Standard of Care in Patients with Multiple Myeloma who Have Received One to Three Prior Lines of Therapy

Multiple Myeloma
F. Hoffmann-La Roche AG · 133 participants

📍 France · Germany · Italy · Greece · Denmark · Czechia · Spain · Poland

2025-524028-23-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 06/07/2026

A Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multicenter study, to investigate the efficacy and safety of lunsekimig in adult participants with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype

Respiratory tract diseases
Sanofi-Aventis Recherche & Developpement · 613 participants

📍 Denmark · Sweden · Poland · Estonia · Portugal · Latvia · Spain · Hungary · Germany · Finland · Italy · Belgium · France

2024-518016-39-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 06/07/2026

A Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multicenter study, to investigate the efficacy and safety of lunsekimig in adult participants with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype

Respiratory tract diseases
Sanofi-Aventis Recherche & Developpement · 550 participants

📍 Germany · Romania · Greece · Norway · Netherlands · Poland · Lithuania · Czechia · Slovakia · Spain

2024-518213-25-00 on CTIS ↗

Phase III Neoplasms Authorised 01/07/2026

"A Phase 3 Randomized Study Comparing JNJ-79635322 versus Teclistamab in Participants with Relapsed or Refractory Multiple Myeloma after 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Antibody and Lenalidomide"

Relapsed or Refractory Multiple Myeloma
Janssen Cilag International · 206 participants

📍 Poland · Spain · Czechia · France · Italy · Germany · Greece

2025-523815-12-00 on CTIS ↗

Phase II Respiratory Tract Diseases Authorised 01/07/2026

A Phase II, Randomized, Double-blind, 3-Period Cross-over, Dose‑ranging Study to Assess the Efficacy and Safety of Glycopyrronium (GP) versus Placebo in Participants of 4 to Less than 12 Years of Age with Asthma Receiving Background Budesonide and Formoterol Fumarate (BFF) (FAROS)

Asthma
AstraZeneca AB · 35 participants

📍 Czechia · Poland · Hungary

2025-524914-26-00 on CTIS ↗

Phase III Neoplasms Authorised 01/07/2026

A Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment After 2L PlatinumBased Doublet Chemotherapy in Participants With Recurrent Platinum-Sensitive Ovarian Cancer (PSOC)

Ovarian Cancer Platinum-Sensitive Ovarian Cancer (PSOC)
Genmab A/S · 257 participants

📍 Finland · Belgium · Hungary · France · Denmark · Austria · Germany · Italy · Spain · Czechia · Norway · Poland

2025-522167-15-00 on CTIS ↗

Phase III Immune System Diseases Authorised 30/06/2026

Phase III, Open-label Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, Efficacy, and Immunogenicity of Benralizumab in Children with Eosinophilic Disease (CLIPS)

Eosinophilic Disease
AstraZeneca AB · 7 participants

📍 Poland · Netherlands · France

2023-508533-14-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 30/06/2026

A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease

Pulmonary Hypertension Associated with Interstitial Lung Disease
Insmed Inc. · 165 participants

📍 Greece · France · Italy · Belgium · Denmark · Germany · Poland · Czechia · Portugal · Austria · Spain · Romania

2025-521769-29-00 on CTIS ↗

Phase III Skin and Connective Tissue Diseases Authorised 29/06/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants with Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care

Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease
Merck Healthcare KGaA · 57 participants

📍 Germany · Romania · France · Bulgaria · Belgium · Spain · Poland · Greece · Italy · Czechia

2025-524855-30-00 on CTIS ↗

Phase III Immune System Diseases Authorised 29/06/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants with Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care

Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease
Merck Healthcare KGaA · 54 participants

📍 Spain · Belgium · France · Germany · Slovakia · Romania · Bulgaria · Italy · Poland · Greece

2025-523871-44-00 on CTIS ↗

Phase I/II Neoplasms Authorised 29/06/2026

A Phase 1/2 Open-Label, Multicenter Study of RAS(ON) inhibitors in Combination with Ivonescimab with or without Other Anti-Cancer Agents in Patients with Solid Tumors

Solid Tumors
Revolution Medicines Inc. · 252 participants

📍 France · Poland · Ireland · Spain · Greece · Germany · Italy · Sweden · Belgium

2025-524623-50-00 on CTIS ↗

Phase II Immune System Diseases Authorised 29/06/2026

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)

Diffuse Cutaneous Systemic Sclerosis (dcSSc)
Mediar Therapeutics Inc. · 36 participants

📍 Netherlands · Romania · Poland · France · Italy · Spain

2025-523288-39-00 on CTIS ↗

Phase III Neoplasms Authorised 26/06/2026

A Randomized, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303)

Pancreatic Ductal Adenocarcinoma
Incyte Corp. · 239 participants

📍 Poland · Italy · Netherlands · Sweden · Denmark · Finland · Spain · France · Germany · Belgium · Norway · Austria

2025-525009-18-00 on CTIS ↗

Phase IV Hemic and Lymphatic Diseases Authorised 26/06/2026

Phase IV study evaluating the efficacy and safety of the venetoclax + rituximab (VR) regimen in patients with relapsed chronic lymphocytic leukemia in Polish clinical practice

Adult with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL)
Uniwersytet Medyczny W Lublinie · 36 participants

📍 Poland

2025-524795-35-00 on CTIS ↗

Phase III Immune System Diseases Authorised 24/06/2026

A PHASE III, OPEN-LABEL, SINGLE-ARM, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND USE OF AN ON-BODY DELIVERY SYSTEM FOR THE SUBCUTANEOUS HOME ADMINISTRATION OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS

Multiple Sclerosis
F. Hoffmann-La Roche AG · 54 participants

📍 Spain · France · Poland · Italy

2025-523726-40-00 on CTIS ↗

Phase II Respiratory Tract Diseases Authorised 23/06/2026

A Randomized, Double-blinded, Placebo-controlled, Parallel Group, Phase 2a Study to Assess the Activity, Safety, and Tolerability of SAR445399 in Adult Participants with Non-Cystic Fibrosis Bronchiectasis (NCFB).

Non-cystic fibrosis bronchiectasis
Sanofi-Aventis Recherche & Developpement · 41 participants

📍 Poland · Spain · France · Netherlands · Germany

2025-523403-29-00 on CTIS ↗

Phase III Musculoskeletal Diseases Authorised 23/06/2026

Multicenter Interventional Study Somatrogon Impact on Outcomes in Naive Small for Gestational Age or Idiopathic Short Stature paediatric patients compared with daily growth hormone

Small for gestational age (SGA) and idiopathic short stature (ISS)
Schneider Children's Medical Center Of Israel · 95 participants

📍 Greece · Poland · France · Czechia

2025-523832-38-00 on CTIS ↗

Phase II Nervous System Diseases Authorised 23/06/2026

An Open-Label Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis (RRMS)
F. Hoffmann-La Roche AG · 9 participants

📍 Poland · Germany · France

2025-524164-37-00 on CTIS ↗

Phase III Immune System Diseases Authorised 22/06/2026

A Phase 3 Extension Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema

Hereditary Angioedema
Adarx Pharmaceuticals Inc. · 45 participants

📍 Poland · Italy · Hungary · France · Austria · Czechia · Belgium · Spain · Bulgaria · Germany · Croatia

2025-521353-16-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 22/06/2026

A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-Active Secondary Progressive Multiple Sclerosis

Non-active Secondary Progressive Multiple Sclerosis (SPMS)
Zenas Biopharma (USA) LLC · 467 participants

📍 Germany · Bulgaria · Netherlands · Sweden · Portugal · Croatia · Italy · Austria · Spain · Poland · France · Denmark · Hungary · Romania · Estonia · Slovakia · Belgium · Czechia · Norway · Lithuania · Greece

2025-524322-18-00 on CTIS ↗

Phase II Neoplasms Authorised 22/06/2026

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).

Muscle-invasive Bladder Cancer
Astellas Pharma Global Development Inc. · 88 participants

📍 Germany · France · Poland · Italy · Spain

2025-524488-18-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 22/06/2026

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

Colitis ulcerative
Merck Sharp & Dohme LLC · 44 participants

📍 Italy · Greece · Netherlands · Poland · Germany · France

2025-523479-49-00 on CTIS ↗

Phase I Skin and Connective Tissue Diseases Authorised 18/06/2026

A Study to Learn How Different Amounts of the Study Intervention Called PF-07832837 are Tolerated and Act in the Body in Healthy Adults and Patients

Atopic Dermatitis
Pfizer Inc. · 19 participants

📍 Poland

2025-524150-34-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 17/06/2026

IM0271016: An Open-label, Multi-center, Long-term Extension Study to Evaluate the Long-term Safety and Tolerability of Admilparant in Participants with Pulmonary Fibrosis

Progressive pulmonary fibrosis and Idiopathic pulmonary fibrosis
Bristol-Myers Squibb Services Unlimited Company · 318 participants

📍 Finland · Portugal · Hungary · Ireland · Poland · Greece · France · Belgium · Denmark · Italy · Spain · Netherlands · Austria · Germany

2025-522373-10-00 on CTIS ↗

Phase II Skin and Connective Tissue Diseases Authorised 17/06/2026

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

Systemic sclerosis
Galderma S.A. · 56 participants

📍 Poland · Italy · Bulgaria · France · Greece · Spain · Croatia

2025-522294-11-00 on CTIS ↗

Phase III Neoplasms Authorised 16/06/2026

A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug vedotin in Combination with Capecitabine with or without Rilvegostomig in First-line Claudin18.2-positive, HER2-negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)

Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Cancer Expressing Claudin18.2
AstraZeneca AB · 516 participants

📍 France · Italy · Spain · Hungary · Poland · Belgium · Germany · Netherlands

2024-519787-40-00 on CTIS ↗

Phase I/II Neoplasms Authorised 16/06/2026

A Phase I/II Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6621, a T Cell-engaging Antibody That Targets STEAP2, CD3, and CD8 in Adult Participants With Metastatic Prostate Cancer (ACTIVATED-4-PC)

Metastatic Prostate Cancer
AstraZeneca AB · 45 participants

📍 Belgium · Spain · Poland · Italy · Netherlands

2025-520626-37-00 on CTIS ↗

Phase III Neoplasms Authorised 16/06/2026

A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014)

Stage I NSCLC
Merck Sharp & Dohme LLC · 283 participants

📍 Greece · Poland · Italy · Hungary · Germany · Netherlands · France · Spain

2025-522643-18-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 16/06/2026

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

Ulcerative colitis (Inflammatory Bowel Disease)
Spyre Therapeutics Inc. · 228 participants

📍 Croatia · Poland · Austria · Czechia · Italy · Slovakia · Bulgaria · Greece · Belgium · Spain · Hungary · Germany · Lithuania · France · Romania

2025-524640-35-00 on CTIS ↗

Phase III Neoplasms Authorised 12/06/2026

A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Study of MK-1084 Plus Durvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platinum-Based Chemoradiotherapy (KANDLELIT-015)

Locally advanced, unresected (unresectable or medically inoperable or refuse surgery) Stage II-III NSCLC with KRAS G12C mutation
Merck Sharp & Dohme LLC · 88 participants

📍 Italy · Netherlands · France · Germany · Spain · Poland · Greece

2025-522038-29-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 12/06/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)

Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Glaxosmithkline Research & Development Limited · 210 participants

📍 Greece · Germany · Belgium · Netherlands · Poland · Italy · France · Spain · Bulgaria · Austria

2025-523674-16-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 11/06/2026

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

J6Z-MC-IIBD - Colitis, Ulcerative Crohn Disease J6Z-MC-CD01 - Crohn Disease
Eli Lilly & Co. · 37 participants

📍 Italy · Germany · Hungary · Poland · Belgium

2025-524112-11-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 10/06/2026

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)

Ulcerative Colitis, Active Severe, Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
Eli Lilly & Co. · 104 participants

📍 Latvia · Portugal · Greece · France · Czechia · Italy · Poland · Slovakia · Hungary · Croatia · Lithuania

2025-524404-29-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 08/06/2026

A Phase 2b/3, Randomized, Double-Blinded, Placebo Controlled Study ChecKing the Efficacy and Safety of ATAciguat to Slow the Progression of VaLvular DYsfunction in Participants with Moderate Calcific Aortic Valve STenosis (KATALYST-AV)

Moderate Calcific Aortic Valve Stenosis (CAVS)
Kardigan Inc. · 496 participants

📍 Norway · Czechia · Portugal · Austria · Poland · France · Spain

2025-522176-86-01 on CTIS ↗

Phase I/II Neoplasms Authorised 08/06/2026

A Phase 1b/2 Open-label Study Evaluating different MK-6070 and Ifinatamab Deruxtecan (MK-2400)-based regimens in First-line Extensive Stage Small Cell Lung Cancer

Small cell lung cancer extensive stage
Merck Sharp & Dohme LLC · 79 participants

📍 Germany · Poland · Greece · Italy · France · Spain

2025-521032-11-00 on CTIS ↗

Phase II Immune System Diseases Authorised 08/06/2026

J5D-MC-FPAC: A Phase 2a, Randomized, Multicenter, Double-Blind, Placebo-Controlled Proof of Concept Study to Investigate Efficacy and Safety of LY4005130 in Adult Participants With Severe Alopecia Areata

Alopecia Areata
Eli Lilly & Co. · 14 participants

📍 Poland · Netherlands

2025-524727-41-00 on CTIS ↗

Phase III Neoplasms Authorised 08/06/2026

A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody Drug Conjugate (ADC), Compared to Investigator’s Choice Therapy in Participants with Relapsed Small Cell Lung Cancer

Small Cell Lung Cancer (SCLC)
Zai Lab (US) LLC · 234 participants

📍 Belgium · Czechia · Germany · Denmark · Greece · Netherlands · Poland · Spain · Austria · Italy · France

2025-522818-23-00 on CTIS ↗

Phase II Respiratory Tract Diseases Authorised 08/06/2026

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)

MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Pfizer Inc. · 318 participants

📍 Spain · Germany · Poland · Czechia · Greece · Italy · Bulgaria · France · Hungary

2024-518587-12-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 08/06/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa in Participants With Biopsy-Confirmed F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-1)

Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Glaxosmithkline Research & Development Limited · 173 participants

📍 Belgium · Greece · Poland · France · Spain · Bulgaria · Italy · Germany · Austria · Netherlands

2025-523675-39-00 on CTIS ↗

Phase IV Nutritional and Metabolic Diseases Authorised 05/06/2026

A randomised, double-blind, three parallel-group, placebo controlled superiority trial assessing the effect of intravenous versus oral iron supplementation on physical performance, quality of life and cognitive function in iron deficient FRAIL elderly IndiviDuals with cardiovascular disease (FRAIL-ID trial)

Frailty with Iron Deficiency in Elderly Patients with Cardiovascular Disease
Wroclaw Medical University · 396 participants

📍 Poland

2025-521570-34-00 on CTIS ↗

Phase I/II Nervous System Diseases Authorised 03/06/2026

A Phase 1b/2 Study to Evaluate NB-4746 in Participants with Amyotrophic Lateral Sclerosis.

Amyotrofic Lateral Sclerosis (ALS)
Nura Bio Inc. · 46 participants

📍 Poland · Netherlands · Italy · Spain

2025-523939-18-00 on CTIS ↗

Phase III Eye Diseases Authorised 03/06/2026

A randomized double-masked, multicenter, 3-arm, pivotal Phase 2/3 study to evaluate the efficacy and safety of intravitreal (IVT) EYE201/MK-8748 compared to aflibercept (2 mg) in participants with neovascular age-related macular degeneration (NVAMD)

Neovascular age-related macular degeneration (NVAMD)
Eyebiotech Limited · 130 participants

📍 Spain · Poland · Estonia · Latvia · Germany

2025-524575-22-00 on CTIS ↗

Phase III Immune System Diseases Authorised 02/06/2026

Multinational, Interventional, 52-week, Open-label, Single-arm Study to Evaluate the Treatment Outcomes of Anifrolumab 120 mg Subcutaneous Once Weekly in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus (SUNFLOWER)

Systemic lupus erythematosus
AstraZeneca AB · 113 participants

📍 Poland · Germany · Italy · France · Spain

2025-523670-17-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 01/06/2026

A MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF NXT007 PROPHYLAXIS VERSUS FACTOR VIII PROPHYLAXIS IN PEOPLE WITH HEMOPHILIA A WITHOUT INHIBITORS

Hemophilia A Without Inhibitors
F. Hoffmann-La Roche AG · 42 participants

📍 France · Austria · Poland · Netherlands · Spain · Denmark · Italy · Germany · Hungary

2025-522434-32-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 01/06/2026

A double-dummy, double-blind, randomized, active controlled, two-way cross-over study with 12-week treatment duration per period, to evaluate the efficacy and safety of QVM149 (indacaterol acetate / glycopyrronium bromide / mometasone furoate) compared to salmeterol xinafoate/fluticasone propionate in children from 12 years to less than 18 years of age with asthma.

Asthma
Novartis Pharma AG · 68 participants

📍 Poland · France · Slovakia · Spain · Hungary · Germany · Romania

2022-502365-26-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 01/06/2026

A MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF NXT007 PROPHYLAXIS VERSUS EMICIZUMAB PROPHYLAXIS IN PEOPLE WITH HEMOPHILIA A

Hemophilia A
F. Hoffmann-La Roche AG · 124 participants

📍 Hungary · Spain · Ireland · Poland · Austria · Germany · Denmark · Belgium · Netherlands · Italy · France

2025-522435-33-00 on CTIS ↗

Phase III Neoplasms Authorised 01/06/2026

Use of DOTATOC labeled with V-Cu64 in PET-CT imaging of neuroendocrine tumors

Neoplasms
Voxel S.A. · 80 participants

📍 Poland

2025-524050-34-01 on CTIS ↗

Phase III Neoplasms Authorised 01/06/2026

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination with Rituximab and Bendamustine (BR) vs. BR in Subjects with Treatment-Naїve Mantle Cell Lymphoma

Treatment-naїve mantle cell lymphoma (MCL)
Innocare Pharma Inc. · 102 participants

📍 Poland · France · Czechia · Spain · Romania

2025-524241-27-00 on CTIS ↗

Phase III Neoplasms Authorised 29/05/2026

A Phase 3, Randomized, Double-Blind, Active-Control Study of Pelabresib (DAK539) and Ruxolitinib vs. Placebo and Ruxolitinib in Adult Patients with Myelofibrosis who are JAK inhibitor naive

Myelofibrosis
Novartis Pharma AG · 173 participants

📍 Belgium · Germany · Austria · Poland · Spain · Italy · Netherlands · Czechia · France

2025-523555-66-00 on CTIS ↗

Phase II Immune System Diseases Authorised 29/05/2026

J5D-MC-FPAD: A Phase 2a, Randomized, 24-Week, Multicenter, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Investigate Efficacy and Safety of LY4005130 in Adult Participants with Non-Segmental Vitiligo

Non-Segmental Vitiligo (NSV), Vitiligo
Eli Lilly & Co. · 14 participants

📍 Poland · Belgium

2025-524726-18-00 on CTIS ↗

Phase III Neoplasms Authorised 29/05/2026

Efficacy and Tolerability of N-AVD compared to BrECADD in patients with advanced Hodgkin Lymphoma (N-BRAVE)

Hodgkin lymphoma
Polska Grupa Badawcza Chloniakow · 370 participants

📍 Poland

2026-525263-41-00 on CTIS ↗

Phase II Nervous System Diseases Authorised 29/05/2026

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a Long-term Extension of Povetacicept in Adults with Generalized Myasthenia Gravis

Generalized Myasthenia Gravis
Vertex Pharmaceuticals Inc. · 5 participants

📍 Poland

2025-523950-15-01 on CTIS ↗

Phase I Immune System Diseases Authorised 29/05/2026

A First-in-Human, Open-label, Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of NBIM-1008 in Patients with Rheumatoid Arthritis

Rheumatoid Arthritis
Neurocrine Biosciences Inc. · 15 participants

📍 Poland · Romania

2025-525113-22-00 on CTIS ↗

Phase I/II Hemic and Lymphatic Diseases Authorised 29/05/2026

Prospective, multicentre, two-arms, I/II phase study to Optimise and Personalise Immunological Therapy of relapsed chronic lymphocytic leukaemia patients (OPTIC)

Adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (PBL) with an indication to start treatment of relapsed disease according to IWCLL recommendations.
Uniwersytet Medyczny W Lublinie · 36 participants

📍 Poland

2024-513917-11-01 on CTIS ↗

Phase I/II Neoplasms Authorised 28/05/2026

A Phase 1b/2 Study to Evaluate the Safety and Efficacy of MK‑1045 Monotherapy or in Combination with Other Anticancer Agents in Participants with Non-Hodgkin Lymphoma

Non-Hodgkin Lymphoma
Merck Sharp & Dohme LLC · 73 participants

📍 Poland · Italy · France · Germany · Spain

2025-523005-15-00 on CTIS ↗

Phase II Immune System Phenomena Authorised 27/05/2026

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

moderate to severe rheumatoid arthritis (RA)
F. Hoffmann-La Roche AG · 46 participants

📍 Italy · Spain · Germany · France · Denmark · Poland · Belgium

2025-523579-47-00 on CTIS ↗

Phase III Immune System Diseases Authorised 27/05/2026

A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab versus Risankizumab in the Treatment of Participants with Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
Janssen Cilag International · 302 participants

📍 Slovakia · Germany · Denmark · France · Spain · Italy · Netherlands · Belgium · Poland · Sweden · Austria · Czechia · Hungary

2025-521590-13-00 on CTIS ↗

Phase II Mental Disorders Authorised 27/05/2026

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

Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis
Maplight Therapeutics Inc. · 85 participants

📍 Italy · Poland · Czechia · Portugal · Bulgaria · France · Slovakia · Romania · Hungary

2025-521757-16-00 on CTIS ↗

Phase II Hemic and Lymphatic Diseases Authorised 25/05/2026

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)

relapsed/refractory multiple myeloma
C4 Therapeutics Inc. · 43 participants

📍 Italy · France · Spain · Poland

2025-524181-26-00 on CTIS ↗

Phase III Neoplasms Authorised 22/05/2026

ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 study of Pumitamig Monotherapy Compared to Durvalumab in Participants with Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy

Unresectable Stage III non-small cell lung cancer without progression
Bristol-Myers Squibb Services Unlimited Company · 279 participants

📍 France · Ireland · Germany · Greece · Bulgaria · Spain · Netherlands · Italy · Sweden · Romania · Hungary · Belgium · Austria · Poland

2025-523576-23-00 on CTIS ↗

Phase II Eye Diseases Authorised 20/05/2026

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

Thyroid Eye Disease
Amgen Inc. · 8 participants

📍 Spain · Poland · France · Italy

2025-523280-38-00 on CTIS ↗

Phase III Skin and Connective Tissue Diseases Authorised 20/05/2026

An open-label, multi-center protocol for patients who have completed a previous Novartis sponsored remibrutinib study and are judged by the investigator to benefit from continued treatment with remibrutinib

Chronic Spontaneous Urticaria
Novartis Pharma AG · 154 participants

📍 Germany · Spain · France · Poland · Bulgaria · Czechia

2025-524078-40-00 on CTIS ↗

Phase III Immune System Diseases Authorised 20/05/2026

A double-blind, double-dummy, parallel group, multicenter Phase 3 extension study evaluating the long-term safety and efficacy of 2 doses of remibrutinib in adult participants with moderate to severe hidradenitis suppurativa

Hidradenitis Suppurativa (HS)
Novartis Pharma AG · 307 participants

📍 Portugal · Greece · Germany · Hungary · France · Spain · Bulgaria · Slovakia · Poland · Czechia · Belgium · Italy

2025-523259-72-00 on CTIS ↗

Phase III Musculoskeletal Diseases Authorised 20/05/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Global Study with an Open-Label Extension to Evaluate the Efficacy and Safety of Intravenous AOC 1044 (delpacibart zotadirsen) for the Treatment of DMD with Gene Mutations Amenable to Exon 44 Skipping

Duchenne muscular dystrophy
Avidity Biosciences Inc. · 42 participants

📍 Italy · Germany · France · Spain · Belgium · Poland · Netherlands

2025-523087-20-00 on CTIS ↗

Phase II Immune System Diseases Authorised 19/05/2026

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of ELV001 as Add-on Therapy in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)

Rheumatoid arthritis
Elevara Medicines Limited · 95 participants

📍 Czechia · Bulgaria · Hungary · Netherlands · Poland · Spain

2025-524005-32-00 on CTIS ↗

Phase I Digestive System Diseases Authorised 19/05/2026

An Early-Stage Study in Multiple Clinics of how Afimkibart May Affect the Body’s Processing of Medicines that Rely on Cytochrome P450 Enzymes in Patients with Ulcerative Colitis

Active Ulcerative Colitis (UC)
F. Hoffmann-La Roche AG · 19 participants

📍 Germany · Poland · Belgium

2025-524060-38-00 on CTIS ↗

Phase II Immune System Diseases Authorised 19/05/2026

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-95597528 for the Treatment of Adult Participants with Moderate to Severe Atopic Dermatitis

Moderate to Severe Atopic Dermatitis
Janssen Cilag International · 14 participants

📍 Germany · Poland

2025-523464-20-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 19/05/2026

A Phase 3 prospective randomised clinical trial of VMX-C001 vs usual pharmacological care in patients receiving a FXa direct oral anticoagulant (FXa DOAC) who require urgent surgery or other invasive procedure that is associated with a high risk of bleeding, with or without planned administration of heparin (EQUILIBRIX-S)

Patients on Factor Xa inhibitor treatment needing an urgent intervention associated with a high risk of bleeding
VarmX B.V. · 443 participants

📍 Belgium · Germany · Italy · France · Czechia · Bulgaria · Hungary · Spain · Netherlands · Poland · Austria · Estonia · Romania · Portugal · Lithuania

2025-521632-12-00 on CTIS ↗

Phase II Nutritional and Metabolic Diseases Authorised 19/05/2026

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

Proteinuric kidney diseases
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 66 participants

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

2025-523425-17-00 on CTIS ↗

Phase III Neoplasms Authorised 19/05/2026

A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer

Metastatic Microsatellite Stable Colorectal Cancer
Incyte Corp. · 292 participants

📍 Poland · France · Denmark · Norway · Spain · Germany · Belgium · Netherlands · Austria · Italy

2025-523735-19-00 on CTIS ↗

Phase II Nutritional and Metabolic Diseases Authorised 18/05/2026

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.

Exocrine Pancreatic Insufficiency
Aimmune Nestle Health Science US R&D LLC · 29 participants

📍 Poland · Hungary · Spain · Bulgaria · Italy

2025-521816-20-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 18/05/2026

A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis

Primary Progressive Multiple Sclerosis (PPMS)
Zenas Biopharma (USA) LLC · 398 participants

📍 Italy · Finland · Bulgaria · Greece · Belgium · Estonia · Portugal · Spain · Germany · France · Czechia · Slovakia · Romania · Croatia · Poland · Austria · Netherlands · Denmark · Sweden · Hungary

2025-524316-11-00 on CTIS ↗

Phase II Neoplasms Authorised 18/05/2026

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

Philadelphia positive Chronic Myeloid leukemia in Chronic Phase with newly diagnosed and resistant/intolerant to previous TKIs, with or without the T315I mutation
Novartis Pharma AG · 15 participants

📍 Spain · France · Germany · Poland · Italy · Netherlands · Greece

2025-522138-29-00 on CTIS ↗

Phase IV Respiratory Tract Diseases Authorised 18/05/2026

A pragmatic, phase IV, randomized, open-label, multinational, multicentre, 2-arm parallel group, prospective study comparing efficacy and safety of Single Inhaler ICS/LABA/LAMA (beclometasone/formoterol fumarate/glycopyrronium bromide [87/5/9 pMDI {BD/FF/GB - 100/6/12.5 µg}]) vs Single Inhaler ICS/LABA (beclometasone dipropionate plus formoterol fumarate [200/6 pMDI {BD/FF - 200/6 µg}]) in asthma subjects.

Asthma
Chiesi Farmaceutici S.p.A. · 606 participants

📍 Germany · Romania · Italy · Bulgaria · Poland · Slovakia · Spain · France

2025-524289-56-00 on CTIS ↗

Phase III Neoplasms Authorised 15/05/2026

ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with PD-L1 ≥ 50%

Non-Small Cell Lung Cancer
Bristol-Myers Squibb Services Unlimited Company · 265 participants

📍 Portugal · Norway · Sweden · Bulgaria · France · Belgium · Austria · Germany · Finland · Poland · Romania · Netherlands · Spain · Italy · Hungary · Czechia

2025-523586-18-00 on CTIS ↗

Phase I/II Immune System Diseases Authorised 15/05/2026

A Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety and Efficacy of Aritinercept, a Dual BAFF/APRIL Inhibitor, in Patients with Generalized Myasthenia Gravis

Generalized Myasthenia Gravis
Aurinia Pharmaceuticals Inc. · 28 participants

📍 Poland

2025-525127-27-00 on CTIS ↗

Phase I/II Neoplasms Authorised 15/05/2026

A Multicenter, Multi-Part, Phase 1/2 Study of EIK1005 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors, including Checkpoint Inhibitor Naïve Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors

Advanced Solid Tumors
Eikon Therapeutics Inc. · 63 participants

📍 France · Spain · Norway · Italy · Germany · Austria · Poland · Finland · Portugal

2026-525248-13-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 15/05/2026

Efficacy and safety of NNC0487-0111 s.c. once-weekly compared to semaglutide s.c. once-weekly in participants with overweight or obesity, and type 2 diabetes (AMAZE 8)

Participants with overweight or obesity, and type 2 diabetes
Novo Nordisk A/S · 440 participants

📍 Germany · Croatia · Portugal · Hungary · Bulgaria · Romania · Poland

2024-520446-31-00 on CTIS ↗