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Clinical trial register · European Union · CTIS

Clinical Trials in Poland

The most recently authorised trials on the EU Clinical Trials Information System (CTIS), the single register for every trial run under the EU Clinical Trials Regulation (536/2014). CTIS holds a far larger historical archive than any one list can usefully show — this register states both numbers rather than picking one.

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Source: EMA Clinical Trials Information System (CTIS). Showing the 2500 most recently authorised of 12467 total CTIS records — a stated recency window, not the full historical archive. Synced 22 Sep 2026, 03:17 UTC
2500
Shown in this register
most recently authorised
12,467
Total on CTIS
full historical archive
744
Phase III
within the shown window
Top member states
Spain 1018 France 887 Germany 856 Italy 735 Poland 580 Netherlands 527
Narrow the registerReset
Phase
Phase I 557 Phase I/II 211 Phase II 727 Phase III 744 Phase IV 261
Lead sponsor
AstraZeneca AB 62 Assistance Publique Hopitaux De Paris 49 Merck Sharp & Dohme LLC 47 Pfizer Inc. 44 Novo Nordisk A/S 43
Member state
Spain 1018 France 887 Germany 856 Italy 735 Poland 580 Netherlands 527 Belgium 424 Czechia 329
All 28 states
580 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase II
RENAISSANCE 2: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of SPN-817 in Adults with Focal Onset Seizures
2025-520587-18-00Focal Onset Seizures
Supernus Pharmaceuticals Inc.
Nervous System Diseases
Poland, Hungary, Bulgaria
20/10/2025
Phase III
IZABRIGHT-Breast01: A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) versus Treatment of Physician’s Choice in Patients with Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer (TNBC) or ER-low, HER2-negative BC who are Ineligible for Anti-PD1/PD-L1 Treatment
2024-519871-24-00Breast cancer, Triple-negative breast cancer
Bristol-Myers Squibb Services Unlimited Company
Neoplasms
France, Portugal, Romania, Greece, Italy, Spain, Sweden, Austria, Poland, Germany
17/10/2025
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 III
Low dose corticosteroids adjacent to enzyme replacement therapy or chaperon therapy in patients with cardiac manifestation of Fabry disease – prospective randomized controlled phase III trial
2025-521408-24-00Fabry disease
Medical University Of Lodz
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Poland
17/10/2025
Phase III
B7981027 - A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF RITLECITINIB IN PEDIATRIC PARTICIPANTS 6 TO LESS THAN 12 YEARS OF AGE WITH SEVERE ALOPECIA AREATA
2024-515438-33-00Alopecia areata
Pfizer Inc.
Immune System Diseases
Spain, France, Czechia, Italy, Poland
14/10/2025
Phase III
TRITON-CM: A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nucresiran in Patients with Transthyretin-Mediated Amyloidosis with Cardiomyopathy (ATTR amyloidosis with cardiomyopathy)
2024-519917-72-00Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloid…
Alnylam Pharmaceuticals Inc.
Cardiovascular Diseases
France, Germany, Italy, Greece, Belgium, Portugal, Netherlands, Austria, Sweden, Denmark, Spain, Czechia, Hungary, Ireland, Romania, Norway, Poland, Slovakia
14/10/2025
Phase III
B7981028 - A LONG-TERM, DOUBLE-BLIND EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN PARTICIPANTS WITH SEVERE ALOPECIA AREATA WHO PREVIOUSLY COMPLETED STUDIES B7981027 OR B7981031
2024-515439-31-00Alopecia areata
Pfizer Inc.
Immune System Diseases
Italy, France, Czechia, Poland, Spain
14/10/2025
Phase III
J2O-MC-EKBG: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Muvalaplin on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) Who Have Had a Prior Atherosclerotic Cardiovascular Event or Are at Risk for a First Atherosclerotic Cardiovascular Event - MOVE-Lp(a)
2025-521067-13-00Elevated Lp(a), Atherosclerotic Cardiovascular Disease (ASC…
Eli Lilly & Co.
Cardiovascular Diseases
Italy, Poland, Germany, Austria, Romania, Spain, Czechia, France, Denmark, Greece, Hungary, Slovakia, Belgium, Netherlands
13/10/2025
Phase III
A Phase 3, Multicenter, Randomized, Open-Label, Study to Evaluate REGN7508, A Factor XI Monoclonal Antibody, Versus Apixaban and Enoxaparin for Prophylaxis of Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-APEX).
2025-520478-20-00Thromboembolic disease
Regeneron Pharmaceuticals Inc.
Hemic and Lymphatic Diseases
Bulgaria, Lithuania, Poland, Hungary, Latvia, Romania
08/10/2025
Phase II
C4921003 - A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Oral Branched-Chain Ketoacid Dehydrogenase Kinase Inhibitor, PF-07328948 in Adults with Heart Failure (BRANCH-HF)
2024-518438-94-00Heart failure
Pfizer Inc.
Cardiovascular Diseases
France, Spain, Bulgaria, Poland, Hungary, Czechia
08/10/2025
Phase III
A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Deucravacitinib in Adolescent Subjects (12 years to less than 18 years) with Moderate to Severe Plaque Psoriasis
2023-506296-97-00Moderate to Severe Plaque Psoriasis
Bristol-Myers Squibb Services Unlimited Company
Immune System Diseases
Germany, Romania, Italy, Belgium, Poland, Hungary, Spain
08/10/2025
Phase III
Efficacy and safety of cagrilintide for weight management in participants with overweight or obesity
2024-519530-24-00Overweight and obesity
Novo Nordisk A/S
Nutritional and Metabolic Diseases
Norway, France, Italy, Germany, Poland
07/10/2025
Phase III
A multi-center, open-label, single-arm study to evaluate the efficacy and safety of oral rilzabrutinib in adults with immune thrombocytopenia (ITP) who failed first-line treatment
2025-522070-36-00immune thrombocytopenia (ITP)
Sanofi-Aventis Recherche & Developpement
Immune System Diseases
France, Spain, Italy, Germany, Czechia, Poland, Hungary, Austria, Norway
07/10/2025
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)
2024-519278-37-00Systemic Lupus Erythematosus, Lupus Nephritis
Celgene Corp.
Immune System Diseases
France, Spain, Portugal, Germany, Belgium, Poland, Italy, Denmark, Austria
06/10/2025
Phase III
Open Label Extension Clinical Trial of Vormatrigine in Adult Patients with Epilepsy.
2025-521640-38-00Focal onset seizures or primary generalized tonic-clonic se…
Praxis Precision Medicines Inc.
Nervous System Diseases
Germany, Spain, Poland, Italy
06/10/2025
Phase III
A Phase 3b open-label, randomised study of IPX203 in subjects with advanced Parkinson’s disease and motor fluctuations - ADIP study
2025-521772-57-00Motor fluctuations in advanced Parkinson’s disease
Zambon Biotech S.A.
Nervous System Diseases
Spain, Italy, Poland
06/10/2025
Phase III
A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Phase 3 Study of Zipalertinib Plus Adjuvant Chemotherapy Versus Placebo Plus Adjuvant Chemotherapy in Stage IB-IIIA NSCLC Patients with Uncommon EGFR Mutations Following Complete Tumor Resection (REZILIENT4)
2025-521775-31-00Stage IB-IIIA NSCLC Patients with uncommon EGFR Mutations
Taiho Oncology Inc.
Neoplasms
Germany, Poland, Spain, France, Belgium, Italy, Greece, Romania, Netherlands
06/10/2025
Phase III
A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (FORTIFI-HN01).
2024-519654-37-00Recurrent or Metastatic Head and Neck Squamous Cell Carcino…
Bicara Therapeutics Inc.
Neoplasms
Belgium, Austria, Italy, Poland, Spain, Germany, Czechia, Ireland, Greece, France, Portugal
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
Phase II
A Phase 2a double blind, randomized, parallel arm, placebo-controlled trial to investigate the effects of two dose levels of CIT-013 on disease activity in patients with Hidradenitis Suppurativa (HS)
2025-521684-12-00Hidradenitis Suppurativa
Citryll B.V.
Skin and Connective Tissue Diseases
Netherlands, Germany, Poland, Spain
06/10/2025
Phase III
A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination with Pembrolizumab Versus Platinum-based Chemotherapy in Combination with Pembrolizumab, as First-line Therapy in Participants with Locally Advanced Unresectable or Metastatic HER2-overexpressing and PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer. (DESTINY-Lung06)
2024-515658-26-00Unresectable or Metastatic HER2 overexpressing and PD-L1 TP…
Daiichi Sankyo Inc.
Neoplasms
France, Belgium, Germany, Portugal, Italy, Greece, Romania, Spain, Poland
06/10/2025
Phase III
C4951063: An interventional efficacy and safety, Phase 3, double-blind, parallel group study to investigate intermittent prevention of Menstrual Migraine with Rimegepant compared with placebo in women participants 18 to 45 years of age
2024-517121-10-00Menstrual Migraine
Pfizer Inc.
Nervous System Diseases
Netherlands, Italy, Poland, Denmark, Germany, Spain
06/10/2025
Phase III
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impactof Maridebart Cafraglutide on Cardiovascular Outcomes in Participants with Atherosclerotic Cardiovascular Disease and Overweight or Obesity (MARITIME-CV)
2024-516652-18-00Atherosclerotic cardiovascular disease (ASCVD) and obesity …
Amgen Inc.
Cardiovascular Diseases
Slovakia, Denmark, Portugal, Czechia, Poland, Greece, Bulgaria, France, Spain, Sweden, Finland, Belgium, Romania, Germany, Hungary, Netherlands, Italy, Austria
06/10/2025
Phase I
EAST-1 (ERAP-inhibition in Axial Spondyloarthritis Trial-1)
2025-521315-39-00Axial spondyloarthritis
Grey Wolf Therapeutics Limited
Hemic and Lymphatic Diseases
Belgium, Germany, Netherlands, Spain, Poland
06/10/2025
Phase II
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Efficacy of Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Patients with Idiopathic Pulmonary Fibrosis (RENEW)
2025-520715-13-00Idiopathic Pulmonary Fibrosis
Rein Therapeutics Inc.
Cardiovascular Diseases
Germany, Poland
06/10/2025
Phase I/II
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
2024-517140-65-00Multiple Myeloma (MM).
AbbVie Deutschland GmbH & Co. KG
Neoplasms
Belgium, Portugal, Sweden, Italy, France, Poland, Germany
06/10/2025
Phase II
A Phase IIb, Multicenter, Double-Blind, Placebo-Controlled Induction Study with an Active Treatment Extension to Assess the Efficacy, Safety, and Pharmacokinetics of RO7837195 in Patients with Moderately to Severely Active Ulcerative Colitis
2025-520690-39-00Moderately to Severely Active Ulcerative Colitis (UC)
Genentech Inc.
Digestive System Diseases
France, Italy, Czechia, Poland, Germany
03/10/2025
Phase II
A Single-arm, Phase 2, Open-label, Multicenter Study to Evaluate NX-5948 in Adults with Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Previously Exposed to a Bruton’s Tyrosine Kinase Inhibitor (BTKi) and a B-cell Lymphoma-2 Inhibitor (BCL-2i)
2025-521088-10-00Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL…
Nurix Therapeutics Inc.
Neoplasms
France, Italy, Hungary, Poland
02/10/2025
Phase I
A first-in-human, dose finding study to evaluate the safety, tolerability and pharmacokinetics of EGL-003 in healthy volunteers followed by adults with autoimmune disease.
2025-521658-40-00Atopic dermatitis
Egle Therapeutics
Skin and Connective Tissue Diseases
Germany, Bulgaria, Poland
01/10/2025
Phase II
A randomised, double-masked, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of oral BI 1815368 in participants with centre-involved diabetic macular edema for 48 weeks of treatment (THULITE)
2024-520384-14-00Centre-involved diabetic macular edema
Boehringer Ingelheim International GmbH
Eye Diseases
Germany, Slovakia, Poland, Hungary, Czechia
30/09/2025
Phase III
A Phase III, Randomised, Open-Label, Sponsor-Blinded, Multicenter Study of Rilvegostomig in Combination with Bevacizumab with or without Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma (ARTEMIDE-HCC01)
2024-518210-81-00Advanced Hepatocellular Carcinoma
AstraZeneca AB
Neoplasms
Italy, Germany, France, Poland, Spain, Netherlands
30/09/2025
Phase IV
A randomized, double-blind, placebo-controlled study to evaluate the effect of dupilumab on airway inflammation through assessments of mucus plugging and other lung imaging parameters in patients with chronic obstructive pulmonary disease (AEOLUS)
2025-521268-37-00Respiratory tract diseases
Sanofi-Aventis Recherche & Developpement
Respiratory Tract Diseases
Netherlands, Hungary, France, Germany, Austria, Spain, Poland, Sweden, Italy, Denmark
29/09/2025
Phase III
An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy versus Treatment of Physician’s Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04)
2025-520582-51-00Hormone receptor positive breast cancer
Merck Sharp & Dohme LLC
Neoplasms
Greece, Poland, France, Italy, Spain, Hungary, Germany
29/09/2025
Phase III
Phase 3, Multicenter, Randomized, Open-label Clinical Study of GSK5764227, a B7-H3 Antibody Drug Conjugate (ADC), compared with Topotecan in Participants with Relapsed Small Cell Lung Cancer (SCLC)
2025-521627-78-00Neoplasms, Lung
Glaxosmithkline Research & Development Limited
Neoplasms
Hungary, France, Portugal, Greece, Sweden, Ireland, Poland, Bulgaria, Romania, Finland, Italy, Germany, Spain
29/09/2025
Phase III
A Phase 3b Extension Study to Evaluate the Long-Term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease
2023-508804-39-00Ulcerative Colitis or Crohn’s Disease
Takeda Development Center Americas Inc.
Digestive System Diseases
Spain, Ireland, Portugal, Poland, Belgium, Netherlands, Bulgaria, Romania, Italy, Denmark
29/09/2025
Phase II
A randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, and tolerability of SAR444336 in participants with microscopic colitis in clinical remission with budesonide.
2024-519495-83-00Digestive system diseases
Sanofi-Aventis Recherche & Developpement
Digestive System Diseases
Italy, Sweden, Germany, France, Poland, Denmark, Belgium, Hungary
29/09/2025
Phase II
A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose Range-finding, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ALXN2420, a Growth Hormone Receptor Antagonist, Administered Subcutaneously in Combination with Somatostatin Analogs in Adult Participants with Acromegaly
2025-521243-20-00Acromegaly
Alexion Pharmaceuticals Inc.
Hormonal diseases
Lithuania, Romania, Denmark, Italy, Hungary, Poland, Netherlands
29/09/2025
Phase II
Clinical Randomised Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation.
2025-521377-14-00Atrial fibrillation
Acesion Pharma ApS
Cardiovascular Diseases
Hungary, Italy, Denmark, Bulgaria, Poland, Netherlands, Germany
29/09/2025
Phase II
A Phase 2b, Multicenter, Randomized, Double-blind, Parallel group, Placebo-controlled, Dose Range Finding Study to Evaluate the Efficacy, Safety, and Tolerability of Nebulized CSL787 in Adults (18 to 85 years) with Non-cystic Fibrosis Bronchiectasis
2024-518821-13-00Non-cystic Fibrosis Bronchiectasis
CSL Behring LLC
Respiratory Tract Diseases
Spain, Belgium, Germany, Greece, Denmark, Netherlands, Hungary, Italy, France, Poland
26/09/2025
Phase III
A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
2024-517131-52-00Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymp…
BeOne Medicines AG
Neoplasms
France, Sweden, Czechia, Austria, Belgium, Germany, Denmark, Spain, Netherlands, Italy, Ireland, Poland
26/09/2025
Phase I
A Study to Test How Safe, Effective and How the Body Responds to the Combination of Mosunetuzumab and Pirtobrutinib Together to Treat Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
2024-514152-32-00Relapsed or Refractory Chronic Lymphocytic Leukemia (R/R CL…
F. Hoffmann-La Roche AG
Neoplasms
France, Spain, Poland
25/09/2025
Phase II
A Study Evaluating Monthly (Every 4 Weeks) Dosing of Atacicept in Patients with IgAN
2025-521519-37-00IgA Nephropathy (IgAN); Berger Disease; Renal and Urinary D…
Vera Therapeutics Inc.
Pathological Conditions, Signs and Symptoms
Spain, Poland
24/09/2025
Phase III
EASi-PROTKT™ - A Phase III double-blind, randomised, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral vicadrostat (BI 690517) and empagliflozin compared with placebo and empagliflozin in participants with type 2 diabetes, hypertension and established cardiovascular disease
2025-521188-11-00hypertension, cardiovascular disease, Type 2 diabetes
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Cardiovascular Diseases
Lithuania, Netherlands, Ireland, Romania, France, Hungary, Finland, Latvia, Austria, Germany, Greece, Italy, Sweden, Denmark, Czechia, Belgium, Slovakia, Croatia, Spain, Norway, Bulgaria, Poland, Portugal
24/09/2025
Phase III
ARGX-113-2409: A Multicenter, Randomized, Double-blinded, Parallel-Arm, Placebo- Controlled, Pharmacokinetic and Pharmacodynamic Study Followed by an Open-Label Arm to Evaluate Efgartigimod IV in Pediatric Participants from 12 Years to Less Than 18 Years of Age with Chronic ITP
2025-521055-23-00Chronic Idiopathic thrombocytopenic purpura
Argenx
Immune System Diseases
Lithuania, Romania, Hungary, France, Italy, Spain, Poland, Germany
24/09/2025
Phase II
A Phase 2b, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants with Moderate-to-Severe Atopic Dermatitis
2024-520117-50-00Atopic Dermatitis
Inmagene LLC
Immune System Diseases
Czechia, Spain, Germany, Hungary, Poland
24/09/2025
Phase III
OPTIMA YOUNG : Optimal Personalized Treatment of early breast cancer using Multi-parameter Analysis : focus on YOUNGer women
2024-519655-28-00Premenopausal patients with high-risk HR-positive/HER2-nega…
Unicancer
Neoplasms
Poland, France, Italy, Greece, Spain, Ireland, Belgium
23/09/2025
Phase I/II
A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies
2024-516234-35-00Relapsed or Refractory B-Cell Malignancies
BeOne Medicines AG
Neoplasms
Italy, Germany, Poland
23/09/2025
Phase III
A MULTICENTER, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFECTS OF TASIMELTEON VS. PLACEBO IN TREATING PEDIATRIC INSOMNIA
2024-516411-24-00Insomnia Disorder
Vanda Pharmaceuticals Netherlands B.V., Vanda Pharmaceuticals Inc.
Nervous System Diseases
Poland, Germany
23/09/2025
Phase III
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Felzartamab in Adults with IgA Nephropathy (299IG301 / PREVAIL)
2024-519345-30-00IgA nephropathy
Biogen Idec Research Limited
Immune System Diseases
Greece, Portugal, Spain, Croatia, Czechia, Belgium, Bulgaria, Germany, Italy, Poland, France
23/09/2025
Phase III
A randomized, multicenter, multiple-dose, double-blind, placebo-controlled, parallel-group design, clinical endpoint bioequivalence study to evaluate the therapeutic equivalence and safety of fluticasone furoate and vilanterol inhalation powder 100 mcg/25 mcg (Sandoz) and BREO® ELLIPTA® (fluticasone furoate and vilanterol inhalation powder) 100 mcg/25 mcg (GlaxoSmithKline) in adult participants with asthma
2025-521565-27-00Asthma
Sandoz Private Limited
Respiratory Tract Diseases
Poland
22/09/2025
Phase I
A research study looking at how different doses of study medicine (Inno8) work in the body of people with haemophilia A
2025-520490-38-00Haemophilia A with or without inhibitors. Proposed indicati…
Novo Nordisk A/S
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Poland, Spain, Austria, Italy, Germany, Belgium, France, Portugal, Sweden
22/09/2025
Phase II
A multicenter, randomized, double-blind, placebo-controlled, Phase II platform study to assess the efficacy and safety of investigational compound(s) in patients with moderate to severe atopic dermatitis
2024-519081-49-00Moderate to severe atopic dermatitis
Novartis Pharma AG
Skin and Connective Tissue Diseases
Czechia, Netherlands, Poland, Germany, Spain, Hungary, France, Italy, Slovakia
22/09/2025
Phase II
A Multicentre, Parallel-group, Phase IIb, Randomised, Double blind, Placebo-controlled, 3-Arm, 24-Week Study to Evaluate the Efficacy and Safety of AZD6793 Tablets in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PRESTO).
2025-520473-40-00Moderate to Very Severe Chronic Obstructive Pulmonary Disea…
AstraZeneca AB
Respiratory Tract Diseases
Spain, Greece, Bulgaria, Germany, Denmark, Hungary, Italy, Poland
22/09/2025
Phase III
A Double-blind, Randomized,Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants with Elevated Lipoprotein(a)
2025-520554-11-00Cardiovascular Disease
Amgen Inc.
Cardiovascular Diseases
Spain, Hungary, Portugal, Greece, Germany, Italy, Austria, Ireland, Romania, Slovakia, Netherlands, Czechia, Bulgaria, Denmark, France, Poland, Belgium
22/09/2025
Phase III
ADVANCE: A Phase III Multi-Centre, Randomised, Double-Blind, Double-Dummy Clinical Trial Comparing Essentiale® Liquid vs. Capsules for MASLD/MASH, Alcoholic Liver Disease, and Chronic Viral Hepatitis B
2025-521678-32-00Alcoholic Liver Disease, MASLD (Metabolic Dysfunction-Assoc…
Opella Healthcare Group S.A.S.
Digestive System Diseases
Bulgaria, Germany, Poland
22/09/2025
Phase III
INCB018424-316: A Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Children and Adolescents (6 to < 18 Years Old) With Moderate Atopic Dermatitis
2024-518156-24-00Atopic Dermatitis
Incyte Corp.
Skin and Connective Tissue Diseases
France, Germany, Spain, Belgium, Italy, Hungary, Poland
18/09/2025
Phase III
A Multicenter, Open-label, Randomized Phase 3 Study Evaluating THIO Sequenced with Cemiplimab (LIBTAYO®) vs Investigator Choice of Single-agent Chemotherapy as Third-line Treatment in Subjects with Advanced / Metastatic Non-Small Cell Lung Cancer (NSCLC)
2024-520164-33-00Non-Small Cell Lung Cancer
Maia Biotechnology Inc.
Neoplasms
Poland, Hungary, Romania, Spain, Portugal
18/09/2025
Phase III
A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012).
2024-517232-22-00KRAS G12C-mutant, Locally Advanced Unresectable or Metastat…
Merck Sharp & Dohme LLC
Neoplasms
Poland, Spain, Netherlands, Italy, Finland, Romania, France, Germany, Hungary
17/09/2025
Phase III
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate Efficacy and Safety of Mezagitamab (TAK-079) in Study Participants with Primary IgA Nephropathy in Combination with Stable Background Therapy
2025-520825-19-00IgAN is Primary Immunoglobulin A Nephropathy (IgAN) (also k…
Takeda Development Center Americas Inc.
Immune System Diseases
Spain, Czechia, Austria, Hungary, Germany, Norway, Slovenia, France, Sweden, Netherlands, Poland, Italy
16/09/2025
Phase III
NBI-1065845-MDD3027: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance of Effect of NBI 1065845 as an Adjunctive Treatment in Subjects with Major Depressive Disorder (MDD)
2025-520541-72-00Major Depressive Disorder
Neurocrine Biosciences Inc.
Mental Disorders
Bulgaria, Estonia, Poland, Italy, Spain
16/09/2025
Phase I/II
A Phase 1/2, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Assess the Safety, Pharmacokinetics, and Efficacy of AMG 732 in Healthy Subjects and Subjects with Moderate-to-Severe Active Thyroid Eye Disease
2024-514110-12-00Thyroid Eye Disease
Amgen Inc.
Eye Diseases
France, Spain, Italy, Poland, Germany, Greece
15/09/2025
Phase III
A Phase 3, randomized, parallel-group, double-blind, multicenter study investigating the safety and efficacy of NT 201 compared with placebo in adult participants with moderate to severe platysma prominence in Europe
2025-520499-24-00Moderate to Severe Platysma Prominence
Merz Aesthetics GmbH
Not possible to specify
Germany, Poland, France, Spain
12/09/2025
Phase II
A Phase 2, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects with Moderately to Severely Active Rheumatoid Arthritis.
2025-520721-21-00Rheumatoid Arthritis
AbbVie Deutschland GmbH & Co. KG
Immune System Diseases
Germany, Czechia, Hungary, Spain, Poland, Slovakia
12/09/2025
Phase II
A phase 2, multi-center study consisting of a randomized, placebo-controlled period, followed by an open-label extension period to assess the efficacy, safety, and tolerability of tibulizumab in adults with hidradenitis suppurativa
2024-519736-17-00Hidradenitis Suppurativa
Zura Bio Inc.
Immune System Diseases
Poland, Germany, Spain, Hungary
10/09/2025
Phase II
A Phase 2b Randomized, Double-blind, Placebo-controlled, Parallel-Group Study to Assess Efficacy and Safety of Verekitug (UPB-101) in Participants with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
2025-520488-42-00Moderate-to-Severe Chronic Obstructive Pulmonary Disease (C…
Upstream Bio Inc.
Respiratory Tract Diseases
Romania, Lithuania, Hungary, Spain, Bulgaria, Ireland, Germany, Latvia, Czechia, Poland, Slovakia
09/09/2025
Phase II
A Phase 2 Study to Evaluate the Safety and Efficacy of Atacicept in Multiple Autoimmune Glomerular Diseases (PIONEER)
2024-518465-10-00Multiple Autoimmune Glomerular Diseases
Vera Therapeutics Inc.
Pathological Conditions, Signs and Symptoms
Germany, France, Italy, Spain, Poland, Belgium
08/09/2025
Phase II
A Phase 2, Randomized, Double-Blind, Four-Arm, Placebo-Controlled, Multicenter Study Assessing the Efficacy, Safety and Tolerability of three doses of orally administered BMS-986368, a FAAH/MAGL Inhibitor, for the treatment of Spasticity in Participants with Multiple Sclerosis (BALANCE-MSS-1)
2024-517745-14-00Multiple Sclerosis Spasticity
Celgene Corp.
Immune System Diseases
Germany, Czechia, Poland
08/09/2025
Phase III
An Evaluation of Bemnifosbuvir-Ruzasvir (BEM/RZR) Versus Sofosbuvir-Velpatasvir (SOF/VEL) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection in a Phase 3 Randomized, Controlled, Open-label Study
2025-521096-31-00Chronic Hepatitis C Virus (HCV) Infection
Atea Pharmaceuticals Inc.
Virus Diseases
Romania, France, Germany, Greece, Poland, Spain
08/09/2025
Phase III
A prospective, controlled, randomized, double blind, 2-arms, parallel-group, multicentre, phase 3 study to investigate effectiveness of Actisoufre nasal spray in a pressurized container compared to placebo in female and male adult and paediatric population over 6 years old with acute rhinitis, rhinopharyngitis and rhinosinusitis not requiring antibiotic therapy.
2024-516284-90-00rhinosinusitis not requiring antibiotic therapy, rhinophary…
Laboratoires Grimberg
Respiratory Tract Diseases
Poland
08/09/2025
Phase III
Comparing high and lOw-dose asPirin with dual anTIplatelet therapy for three Months using prasUgrel and aSpirin following Coronary Artery Bypass Grafting. (OPTIMUS-CABG trial).
2025-521892-30-00Primary isolated CABG patients with stable coronary artery …
Dolnoslaskie Centrum Chorob Serca Im. Prof. Zbigniewa Religi Medinet Sp. z o.o.
Cardiovascular Diseases
Poland
08/09/2025
Phase II
A Randomized, Double-Blind, Placebo- and Open-Label Active Comparator- Controlled, Parallel-Group, Multi-Center Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Daily RO7795081 Administered for 30 Weeks to Participants with Type 2 Diabetes Mellitus
2024-520322-11-00Type 2 Diabetes Mellitus (T2D)
F. Hoffmann-La Roche AG
Nutritional and Metabolic Diseases
Poland, Spain, Hungary
05/09/2025
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease
2024-518296-56-00Crohn’s Disease
Merck Sharp & Dohme LLC
Digestive System Diseases
Spain, Austria, Lithuania, France, Belgium, Germany, Sweden, Czechia, Finland, Croatia, Latvia, Portugal, Netherlands, Italy, Denmark, Slovakia, Romania, Poland, Ireland, Hungary, Greece
03/09/2025
Phase II
A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ATI-045 in Patients with Moderate-to-Severe Atopic Dermatitis
2024-520302-19-00Atopic dermatitis
Aclaris Therapeutics Inc.
Skin and Connective Tissue Diseases
Poland, Czechia, Germany
02/09/2025
Phase III
A Phase III Long-Term Extension Trial with Optional Additional Doses of CYB003 to Assess the Safety and Long-term Efficacy in Participants with Major Depressive Disorder (EXTEND)
2024-516805-22-00Major Depressive Disorder
Cybin IRL Limited
Mental Disorders
Greece, Poland, Ireland, Germany, Czechia
02/09/2025
Phase III
A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in combination with Durvalumab, Carboplatin and Etoposide versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)
2024-520050-38-00Extensive stage small cell lung cancer (ES-SCLC). …
Amgen Inc.
Neoplasms
Portugal, Germany, Spain, Italy, Denmark, Netherlands, France, Austria, Greece, Belgium, Hungary, Poland, Romania
01/09/2025
Phase III
A Phase 3, randomized, double-blind, placebo-controlled, multicenter, clinical trial with extension period to evaluate the efficacy and safety of Xeomin® injections for the prevention of chronic migraine (MINT-C)
2024-515682-34-00Chronic migraine
Merz Therapeutics GmbH
Nervous System Diseases
Spain, Denmark, France, Germany, Slovakia, Austria, Italy, Poland, Czechia
01/09/2025
Phase III
A phase 3, randomised, multi-center, open label trial to evaluate the safety and efficacy of intravesical nadofaragene firadenovec alone or in combination with chemotherapy (gemcitabine and docetaxel) or immunotherapy (pembrolizumab) in subjects with high-grade Bacillus Calmette-Guerin therapy (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC)
2024-512177-27-01High-risk Bacillus Calmette-Guerin (BCG)-unresponsive non-m…
Ferring Pharmaceuticals A/S
Male Urogenital Diseases
Spain, Denmark, Poland, Czechia, France
01/09/2025
Phase III
A Phase 3, randomized, double-blind, placebo-controlled, multicenter, clinical trial with extension period to evaluate the efficacy and safety of Xeomin® injections for the prevention of episodic migraine (MINT-E)
2024-515715-22-00Episodic migraine
Merz Therapeutics GmbH
Nervous System Diseases
Italy, Austria, Poland, Germany, France, Spain, Slovakia, Denmark, Czechia
01/09/2025
Phase III
A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with moderate to severe hidradenitis suppurativa
2025-520564-17-00Hidradenitis suppurativa (HS)
MoonLake Immunotherapeutics AG
Skin and Connective Tissue Diseases
Norway, Hungary, Spain, France, Germany, Poland, Czechia, Slovakia, Bulgaria, Netherlands, Italy, Portugal, Belgium
29/08/2025
Phase III
A Double-Blind, Randomized, Active Controlled, Parallel-group, Phase 1/3 Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination with Lenalidomide and Dexamethasone in Patients with Refractory or Relapsed Multiple Myeloma
2024-518588-36-00Refractory or Relapsed Multiple Myeloma
Celltrion Inc.
Neoplasms
Spain, Poland
29/08/2025
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Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 22 September 2026. https://priyalifescience.com/clinical-trials-europe/country/poland?page=6

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