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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 12445 total CTIS records — a stated recency window, not the full historical archive. Synced 20 Sep 2026, 03:17 UTC
2500
Shown in this register
most recently authorised
12,445
Total on CTIS
full historical archive
745
Phase III
within the shown window
Top member states
Spain 1023 France 890 Germany 861 Italy 742 Poland 581 Netherlands 524
Narrow the registerReset
Phase
Phase I 558 Phase I/II 214 Phase II 726 Phase III 745 Phase IV 257
Lead sponsor
AstraZeneca AB 60 Assistance Publique Hopitaux De Paris 49 Merck Sharp & Dohme LLC 48 Pfizer Inc. 45 Novo Nordisk A/S 42
Member state
Spain 1023 France 890 Germany 861 Italy 742 Poland 581 Netherlands 524 Belgium 426 Czechia 327
All 28 states
581 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase I
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
2025-525113-22-00Rheumatoid Arthritis
Neurocrine Biosciences Inc.
Immune System Diseases
Poland, Romania
29/05/2026
Phase I/II
Prospective, multicentre, two-arms, I/II phase study to Optimise and Personalise Immunological Therapy of relapsed chronic lymphocytic leukaemia patients (OPTIC)
2024-513917-11-01Adult patients with chronic lymphocytic leukemia/small lymp…
Uniwersytet Medyczny W Lublinie
Hemic and Lymphatic Diseases
Poland
29/05/2026
Phase I/II
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
2025-523005-15-00Non-Hodgkin Lymphoma
Merck Sharp & Dohme LLC
Neoplasms
Poland, Italy, France, Germany, Spain
28/05/2026
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)
F. Hoffmann-La Roche AG
Immune System Diseases
Italy, Spain, Germany, France, Denmark, Poland, Belgium
27/05/2026
Phase III
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
2025-521590-13-00Moderately to Severely Active Crohn’s Disease
Janssen Cilag International
Immune System Diseases
Slovakia, Germany, Denmark, France, Spain, Italy, Netherlands, Belgium, Poland, Sweden, Austria, Czechia, Hungary
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 III
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
2025-523576-23-00Unresectable Stage III non-small cell lung cancer without p…
Bristol-Myers Squibb Services Unlimited Company
Neoplasms
France, Ireland, Germany, Greece, Bulgaria, Spain, Netherlands, Italy, Sweden, Romania, Hungary, Belgium, Austria, Poland
22/05/2026
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)
Eikon Therapeutics Inc.
Neoplasms
Germany, Spain, Netherlands, Romania, Greece, Italy, Austria, Belgium, Bulgaria, France, Hungary, Poland
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 III
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
2025-524078-40-00Chronic Spontaneous Urticaria
Novartis Pharma AG
Skin and Connective Tissue Diseases
Germany, Spain, France, Poland, Bulgaria, Czechia
20/05/2026
Phase III
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
2025-523259-72-00Hidradenitis Suppurativa (HS)
Novartis Pharma AG
Immune System Diseases
Portugal, Greece, Germany, Hungary, France, Spain, Bulgaria, Slovakia, Poland, Czechia, Belgium, Italy
20/05/2026
Phase III
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
2025-523087-20-00Duchenne muscular dystrophy
Avidity Biosciences Inc.
Musculoskeletal Diseases
Italy, Germany, France, Spain, Belgium, Poland, Netherlands
20/05/2026
Phase II
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)
2025-524005-32-00Rheumatoid arthritis
Elevara Medicines Limited
Immune System Diseases
Czechia, Bulgaria, Hungary, Netherlands, Poland, Spain
19/05/2026
Phase I
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
2025-524060-38-00Active Ulcerative Colitis (UC)
F. Hoffmann-La Roche AG
Digestive System Diseases
Germany, Poland, Belgium
19/05/2026
Phase II
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
2025-523464-20-00Moderate to Severe Atopic Dermatitis
Janssen Cilag International
Immune System Diseases
Germany, Poland
19/05/2026
Phase III
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)
2025-521632-12-00Patients on Factor Xa inhibitor treatment needing an urgent…
VarmX B.V.
Hemic and Lymphatic Diseases
Belgium, Germany, Italy, France, Czechia, Bulgaria, Hungary, Spain, Netherlands, Poland, Austria, Estonia, Romania, Portugal, Lithuania
19/05/2026
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 III
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
2025-523735-19-00Metastatic Microsatellite Stable Colorectal Cancer
Incyte Corp.
Neoplasms
Poland, France, Denmark, Norway, Spain, Germany, Belgium, Netherlands, Austria, Italy
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.
2025-521816-20-00​​Exocrine Pancreatic Insufficiency​
Aimmune Nestle Health Science US R&D LLC
Nutritional and Metabolic Diseases
Poland, Hungary, Spain, Bulgaria, Italy
18/05/2026
Phase III
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis
2025-524316-11-00Primary Progressive Multiple Sclerosis (PPMS)
Zenas Biopharma (USA) LLC
Nervous System Diseases
Italy, Finland, Bulgaria, Greece, Belgium, Estonia, Portugal, Spain, Germany, France, Czechia, Slovakia, Romania, Croatia, Poland, Austria, Netherlands, Denmark, Sweden, Hungary
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 IV
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.
2025-524289-56-00Asthma
Chiesi Farmaceutici S.p.A.
Respiratory Tract Diseases
Germany, Romania, Italy, Bulgaria, Poland, Slovakia, Spain, France
18/05/2026
Phase III
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%
2025-523586-18-00Non-Small Cell Lung Cancer
Bristol-Myers Squibb Services Unlimited Company
Neoplasms
Portugal, Norway, Sweden, Bulgaria, France, Belgium, Austria, Germany, Finland, Poland, Romania, Netherlands, Spain, Italy, Hungary, Czechia
15/05/2026
Phase I/II
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
2025-525127-27-00Generalized Myasthenia Gravis
Aurinia Pharmaceuticals Inc.
Immune System Diseases
Poland
15/05/2026
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Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 20 September 2026. https://priyalifescience.com/clinical-trials-europe/country/poland

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Listing here is informational and not medical advice; eligibility is determined by each study team. Looking for Irish sites? See the Ireland, UK or USA registers. For approved medicines, see the EMA Approvals Tracker.