NCT06624228CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis
A Multicenter, Randomized, Double-Blind, Risankizumab-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
The purpose of the study is to compare the efficacy of bimekizumab versus risankizumab after 16 weeks of treatment in study participants with active psoriatic arthritis (PsA).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 553 (actual)
- First submitted
- 30 Sept 2024
- Start date
- 21 Oct 2024
- Primary completion date
- 6 Feb 2026
- Lead sponsor
- UCB Biopharma SRL
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT06624228
- EU CT number
- 2024-511738-11-00
- EudraCT number
- 2024-511738-11
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 553
- From 21 Oct 2024 to the primary completion date, 6 Feb 2026
- 133 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant has a history of chronic alcohol or drug abuse within 6 months prior to Screening.
- Study participants taking psoriatic arthritis (PsA) medications other than MTX, SSZ, apremilast, hydroxychloroquine (HCQ), LEF, nonsteroidal anti-inflammatory drug (NSAIDs)/ cyclooxygenase-2 (COX-2) inhibitors, oral corticosteroids, and analgesics as outlined in the Inclusion criteria.
- Study participant is taking or has taken prohibited PsA or PSO medications without meeting the mandatory wash-out period relative to the Baseline Visit or is taking or has taken weight management medications without meeting the mandatory dose stability period/washout period relative to the Baseline Visit.
- Study participant is taking or has taken janus kinase (JAK) inhibitor.
- Study participant is taking or has taken bDMARDs, including bimekizumab or risankizumab, with the exception of having received 1 prior TNFα inhibitor.
- Study participant previously participated in another study of a medical device under investigation within the 4 weeks prior to the Screening Visit or is currently participating in another study of a medical device under investigation.
Other illness
- Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study.
- Participant has an active infection or a history of recent serious infections.
- Participant has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection.
- Study participant has a diagnosis of inflammatory conditions other than PSO or PsA including, but not limited to, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, reactive arthritis, and axial spondyloarthritis.
- Study participants with a history of anterior uveitis are allowed if they have no active symptoms at Screening or Baseline. Study participants with a diagnosis of Crohn's disease or ulcerative colitis are allowed if they have no active symptomatic disease at Screening or Baseline.
- Participant has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer.
Other
- Female participants who are breastfeeding, pregnant, or plan to become pregnant during the study.
- Study participants with fibromyalgia or osteoarthritis symptoms that in the Investigator's opinion would have potential to interfere with efficacy assessments.
Who the study is looking for
- Study participants must have a documented diagnosis of adult-onset PsA classified by and that meets the CASPAR classification criteria for at least 6 months prior to Screening with active PsA (despite previous csDMARD or apremilast therapy) and must have at Baseline tender joint count (TJC) ≥3 out of 68 joints and swollen joint count (SJC) ≥3 out of 66 joints (dactylitis of a digit counts as 1 joint each).
- Study participant must have at least 1 active psoriatic lesion(s) and/or a documented history of chronic plaque-type psoriasis (PSO).
- Study participants may currently be on conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy and must have previously been treated with at least 1 csDMARD (methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ)). Study participants must have had an inadequate response to therapy or discontinued due to intolerance. (Inadequate response is determined by the Investigator and is defined as not achieving the minimal response after 12 weeks of therapy.)
- Study participants can either be biological disease-modifying antirheumatic drug (bDMARD)-naïve or have received not more than 1 prior tumor necrosis factor alpha (TNFα) inhibitor. Study participants who have been on a TNFα inhibitor previously must not have discontinued the TNFα inhibitor due to financial or health insurance reasons and must have either:
- experienced an inadequate response to previous treatment given at an approved dose for at least 3 months, or
- been intolerant to administration (eg, had a side-effect/adverse event (AE) that led to discontinuation).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (133)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pa0016 30002 Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Pa0016 30034 Coordinator of this site? Confirm its status | Footscray | Australia | Unknown status |
| Pa0016 30033 Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Pa0016 30003 Coordinator of this site? Confirm its status | Maroochydore | Australia | Unknown status |
| Pa0016 30032 Coordinator of this site? Confirm its status | Parramatta | Australia | Unknown status |
| Pa0016 30009 Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| Medical Center Medconsult Pleven OOD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Completed |
| University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd. Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Completed |
| Outpatient Clinic For Individual Practice For Specialized Medical Assistance In Rheumatology Dr. Gergana Rumenova Avramova EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Completed |
| University Multiprofile Hospital For Active Treatment Kaspela EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Completed |
| Medical center "Artmed" LTD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Completed |
| Medical Center Teodora EOOD Coordinator of this site? Confirm its status | Ruse | Bulgaria | Completed |
| Dkc 1 Ruse EOOD Coordinator of this site? Confirm its status | Ruse | Bulgaria | Completed |
| Medical Center Excelsior OOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Dkc Fokus-5 Lzip OOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Diagnostic Consulting Center XVII Sofia Ltd. Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Medical Center Hera EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Diagnostic-Consultative Center Alexandrovska EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Pa0016 50041 Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Pa0016 50044 Coordinator of this site? Confirm its status | Trois-Rivières | Canada | Unknown status |
| Revmatologie s.r.o. Coordinator of this site? Confirm its status | Brno-Sever | Czechia | Completed |
| CCR Ostrava s.r.o. Coordinator of this site? Confirm its status | Moravska Ostrava A Privoz | Czechia | Completed |
| Vesalion s.r.o. Coordinator of this site? Confirm its status | Moravska Ostrava A Privoz | Czechia | Completed |
| Revmatologicky Ustav Coordinator of this site? Confirm its status | Prague 2 | Czechia | Completed |
| MUDr. Zuzana Stejfova Coordinator of this site? Confirm its status | Praha 4 | Czechia | Completed |
| MEDICAL PLUS s.r.o. Coordinator of this site? Confirm its status | Uherské Hradiště | Czechia | Completed |
| PV Medical Services s.r.o. Coordinator of this site? Confirm its status | Zlín | Czechia | Completed |
| Kerckhoff-Klinik GmbH Coordinator of this site? Confirm its status | Bad Nauheim | Germany | Completed |
| Rheumatologische Schwerpunktpraxis Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Completed |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Completed |
| Fraunhofer Institute For Translational Medicine And Pharmacology ITMP Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Completed |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Completed |
| MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Completed |
| St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Coordinator of this site? Confirm its status | Herne | Germany | Completed |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Completed |
| Studienambulanz Rheumazentrum Ratingen GbR Coordinator of this site? Confirm its status | Ratingen | Germany | Completed |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Completed |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Completed |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Completed |
| Hospital Universitario Basurto Coordinator of this site? Confirm its status | Bilbao | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| Parc Tauli Hospital Universitari Coordinator of this site? Confirm its status | Sabadell | Spain | Completed |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Completed |
| Hospital Quironsalud Infanta Luisa Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Pa0016 40833 Coordinator of this site? Confirm its status | Barnet | United Kingdom | Unknown status |
| Pa0016 40281 Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| Pa0016 40827 Coordinator of this site? Confirm its status | Luton | United Kingdom | Unknown status |
| Pa0016 40237 Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Pa0016 40306 Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| Pa0016 40828 Coordinator of this site? Confirm its status | Reading | United Kingdom | Unknown status |
| Pa0016 40108 Coordinator of this site? Confirm its status | Salford | United Kingdom | Unknown status |
| Qualiclinic Kft. Coordinator of this site? Confirm its status | Budapest | Hungary | Completed |
| Revita Kft. Coordinator of this site? Confirm its status | Budapest II | Hungary | Completed |
| Vasarhelyi Sarkanyfu Kft. Coordinator of this site? Confirm its status | Hódmezővásárhely | Hungary | Completed |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Completed |
| Pa0016 20035 Coordinator of this site? Confirm its status | Bunkyō City | Japan | Unknown status |
| Pa0016 20045 Coordinator of this site? Confirm its status | Kita-gun | Japan | Unknown status |
| Pa0016 20049 Coordinator of this site? Confirm its status | Kitakyushu | Japan | Unknown status |
| Pa0016 20069 Coordinator of this site? Confirm its status | Meguro-ku | Japan | Unknown status |
| Pa0016 20336 Coordinator of this site? Confirm its status | Mitaka-shi | Japan | Unknown status |
| Pa0016 20046 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Pa0016 20041 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Pa0016 20031 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Pa0016 20043 Coordinator of this site? Confirm its status | tabashi City | Japan | Unknown status |
| Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p. Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| Clinicmed Daniluk Nowak Sp. k. Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| Osteo Medic s.c. Artur Racewicz Jerzy Supronik Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Centrum Medyczne All-Med Badania Kliniczne Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Malopolskie Badania Kliniczne Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p. Coordinator of this site? Confirm its status | Elblag | Poland | Completed |
| Provita Sp z o o Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| Reumed Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| NZOZ Lecznica MAK MED S C Coordinator of this site? Confirm its status | Nadarzyn | Poland | Completed |
| Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Nowa Sol | Poland | Completed |
| Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A. Coordinator of this site? Confirm its status | Olsztyn | Poland | Completed |
| NOVAMED ROBERT KOTERAS Coordinator of this site? Confirm its status | Opole | Poland | Completed |
| Ortopedyczno - Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Medyczne Centrum Hetmańska Piotr Leszczyński Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Ai Centrum Medyczne Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| RCMed Oddzial Sochaczew Coordinator of this site? Confirm its status | Sochaczew | Poland | Completed |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Torun | Poland | Completed |
| Rheuma Medicus Sp z o o Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Etg Warszawa Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Klinika Reuma Park Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| REUMA CENTRUM Specjalistyczna Praktyka Lekarska Dr n.med. Jakub Trefler Coordinator of this site? Confirm its status | Warszawa | Poland | Completed |
| Centrum Medyczne Oporow Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| WroMedica I Bielicka A Strzalkowska s c Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| Pa0016 50653 Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Pa0016 50666 Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| Pa0016 50630 Coordinator of this site? Confirm its status | Clearwater | United States | Unknown status |
| Pa0016 50654 Coordinator of this site? Confirm its status | Covina | United States | Unknown status |
| Pa0016 50679 Coordinator of this site? Confirm its status | Cutler Bay | United States | Unknown status |
| Pa0016 50652 Coordinator of this site? Confirm its status | Duncansville | United States | Unknown status |
| Pa0016 50689 Coordinator of this site? Confirm its status | Eagan | United States | Unknown status |
| Pa0016 50685 Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Pa0016 50673 Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Pa0016 50662 Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
| Pa0016 50062 Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Pa0016 50674 Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Pa0016 50686 Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Pa0016 50001 Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Pa0016 50682 Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Pa0016 50048 Coordinator of this site? Confirm its status | Katy | United States | Unknown status |
| Pa0016 50665 Coordinator of this site? Confirm its status | Lansing | United States | Unknown status |
| Pa0016 50657 Coordinator of this site? Confirm its status | Lubbock | United States | Unknown status |
| Pa0016 50664 Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Pa0016 50059 Coordinator of this site? Confirm its status | Ormond Beach | United States | Unknown status |
| Pa0016 50058 Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Pa0016 50324 Coordinator of this site? Confirm its status | Plantation | United States | Unknown status |
| Pa0016 50551 Coordinator of this site? Confirm its status | Saint Clair Shores | United States | Unknown status |
| Pa0016 50663 Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Pa0016 50672 Coordinator of this site? Confirm its status | Santa Monica | United States | Unknown status |
| Pa0016 50651 Coordinator of this site? Confirm its status | Skokie | United States | Unknown status |
| Pa0016 50061 Coordinator of this site? Confirm its status | Spokane Valley | United States | Unknown status |
| Pa0016 50016 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Pa0016 50131 Coordinator of this site? Confirm its status | Sun City | United States | Unknown status |
| Pa0016 50655 Coordinator of this site? Confirm its status | Tomball | United States | Unknown status |
| Pa0016 50680 Coordinator of this site? Confirm its status | Vandalia | United States | Unknown status |
| Pa0016 50650 Coordinator of this site? Confirm its status | Willowbrook | United States | Unknown status |
| Pa0016 50006 Coordinator of this site? Confirm its status | Wyomissing | United States | Unknown status |
| Pa0016 50678 Coordinator of this site? Confirm its status | Zephyrhills | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.