NCT04009499CompletedPhase 3
A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
This is a study to assess the long-term safety, long-term efficacy and tolerability of bimekizumab administered subcutaneously (sc) in adult subjects with psoriatic arthritis (PsA).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1131 (actual)
- First submitted
- 2 Jul 2019
- Start date
- 13 Aug 2019
- Primary completion date
- 26 May 2026
- Lead sponsor
- UCB Biopharma SRL
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT04009499
- EU CT number
- 2023-506528-95-00
- EudraCT number
- 2018-004725-86
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 1131
- From 13 Aug 2019 to the primary completion date, 26 May 2026
- 114 sites in 14 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
- Subjects who meet any withdrawal criteria in PA0010 or PA0011. For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder studies, the Medical Monitor must be consulted prior to the subject's entry into PA0012, although the decision to enroll the subject remains with the Investigator
Other
- Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP)
- Subject has a positive or 2 indeterminate interferon gamma release assays (IGRAs) in one of the feeder studies, unless appropriately evaluated and treated
Who the study is looking for
- In the opinion of the Investigator, the subject is expected to benefit from participation in this Open-Label Extension study
- Subject completed PA0010 \[NCT03895203\] or PA0011 \[NCT03896581\] without meeting any withdrawal criteria
- Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (114)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pa0012 30005 Coordinator of this site? Confirm its status | Camberwell | Australia | Unknown status |
| Pa0012 30002 Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Pa0012 30008 Coordinator of this site? Confirm its status | Hobart | Australia | Unknown status |
| Pa0012 30003 Coordinator of this site? Confirm its status | Maroochydore | Australia | Unknown status |
| Pa0012 30007 Coordinator of this site? Confirm its status | Victoria Park | Australia | Unknown status |
| Pa0012 30006 Coordinator of this site? Confirm its status | Woodville South | Australia | Unknown status |
| ReumaClinic Coordinator of this site? Confirm its status | Genk | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| CHU Helora Coordinator of this site? Confirm its status | Mons | Belgium | Completed |
| Pa0012 50041 Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Pa0012 50042 Coordinator of this site? Confirm its status | Rimouski | Canada | Unknown status |
| Pa0012 50043 Coordinator of this site? Confirm its status | Sydney | Canada | Unknown status |
| Pa0012 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 |
| Pratia Pardubice a.s. Coordinator of this site? Confirm its status | Pardubice I | Czechia | Completed |
| Affidea Praha s.r.o. Coordinator of this site? Confirm its status | Prague 11 | Czechia | Completed |
| Pratia Prague s.r.o. Coordinator of this site? Confirm its status | Prague 3 | Czechia | Completed |
| PV Medical S R O Coordinator of this site? Confirm its status | Zlín | Czechia | Completed |
| Prof. Dr. med. Gunther Neeck MVZ GmbH Coordinator of this site? Confirm its status | Bad Doberan | Germany | Completed |
| Rheumatologische Schwerpunktpraxis Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Praxis Mario Sutowicz Coordinator of this site? Confirm its status | Cottbus | Germany | Completed |
| Universitaetsklinikum Erlangen AöR Coordinator of this site? Confirm its status | Erlangen | Germany | Completed |
| Centrum fuer innovative Diagnostik und Therapie Rheumatologie/Immunologie c i r i GmbH Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Completed |
| Praxis fur Klinische Studien und Praxis fur Orthopadie Coordinator of this site? Confirm its status | Hamburg | 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 |
| Universitaetsklinikum Leipzig Aor Coordinator of this site? Confirm its status | Leipzig | Germany | Completed |
| Rheumazentrum Ratingen Coordinator of this site? Confirm its status | Ratingen | Germany | Completed |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Completed |
| Hospital General Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | 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 |
| University Hospital Virgen Del Rocio S.L. 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 |
| Complexo Hospitalario Universitario De Vigo Coordinator of this site? Confirm its status | Vigo | Spain | Completed |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Chambray Les Tours | France | Completed |
| University Hospitals Pitie Salpetriere - Charles Foix Coordinator of this site? Confirm its status | Paris | France | Completed |
| Pa0012 40109 Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Pa0012 40116 Coordinator of this site? Confirm its status | Peterborough | United Kingdom | Unknown status |
| Pa0012 40107 Coordinator of this site? Confirm its status | Wolverhampton | United Kingdom | Unknown status |
| Central Hospital Of Northern Pest Military Hospital Coordinator of this site? Confirm its status | Budapest VI | Hungary | Completed |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Completed |
| Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz Coordinator of this site? Confirm its status | Szentes | Hungary | Completed |
| Azienda USL IRCCS di Reggio Emilia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Completed |
| Pa0012 20035 Coordinator of this site? Confirm its status | Bunkyō City | Japan | Unknown status |
| Pa0012 20030 Coordinator of this site? Confirm its status | Chūōku | Japan | Unknown status |
| Pa0012 20036 Coordinator of this site? Confirm its status | Kawachi-Nagano | Japan | Unknown status |
| Pa0012 20045 Coordinator of this site? Confirm its status | Kita-gun | Japan | Unknown status |
| Pa0012 20049 Coordinator of this site? Confirm its status | Kitakyushu | Japan | Unknown status |
| Pa0012 20044 Coordinator of this site? Confirm its status | Minatoku | Japan | Unknown status |
| Pa0012 20033 Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Pa0012 20046 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Pa0012 20041 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Pa0012 20048 Coordinator of this site? Confirm its status | Saitama | Japan | Unknown status |
| Pa0012 20031 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Pa0012 20042 Coordinator of this site? Confirm its status | Sasebo | Japan | Unknown status |
| Pa0012 20032 Coordinator of this site? Confirm its status | Suita | Japan | Unknown status |
| Pa0012 20043 Coordinator of this site? Confirm its status | tabashi City | Japan | Unknown status |
| Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p. Coordinator of this site? Confirm its status | Elblag | Poland | Completed |
| Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Nowa Sol | Poland | Completed |
| Medicover Integrated Clinical Services 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 |
| Centrum Medyczne Amed Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | 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 |
| Pa0012 20002 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Pa0012 20010 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Pa0012 20005 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Pa0012 20017 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Pa0012 20013 Coordinator of this site? Confirm its status | Petrozavodsk | Russia | Unknown status |
| Pa0012 20012 Coordinator of this site? Confirm its status | Ryazan | Russia | Unknown status |
| Pa0012 20016 Coordinator of this site? Confirm its status | Ryazan | Russia | Unknown status |
| Pa0012 20083 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Pa0012 20009 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Pa0012 20001 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Pa0012 20004 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Pa0012 20003 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Pa0012 20007 Coordinator of this site? Confirm its status | Saratov | Russia | Unknown status |
| Pa0012 20014 Coordinator of this site? Confirm its status | Ulyanovsk | Russia | Unknown status |
| Pa0012 20006 Coordinator of this site? Confirm its status | Vladimir | Russia | Unknown status |
| Pa0012 20015 Coordinator of this site? Confirm its status | Yaroslavl | Russia | Unknown status |
| Pa0012 20008 Coordinator of this site? Confirm its status | Yaroslavl | Russia | Unknown status |
| Pa0012 50029 Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Pa0012 50039 Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Pa0012 50002 Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Pa0012 50023 Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| Pa0012 50050 Coordinator of this site? Confirm its status | Beckley | United States | Unknown status |
| Pa0012 50024 Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| Pa0012 50047 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Pa0012 50010 Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| Pa0012 50125 Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Pa0012 50049 Coordinator of this site? Confirm its status | Corpus Christi | United States | Unknown status |
| Pa0012 50020 Coordinator of this site? Confirm its status | Duncansville | United States | Unknown status |
| Pa0012 50005 Coordinator of this site? Confirm its status | Freehold | United States | Unknown status |
| Pa0012 50015 Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Pa0012 50001 Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Pa0012 50008 Coordinator of this site? Confirm its status | Johnston | United States | Unknown status |
| Pa0012 50019 Coordinator of this site? Confirm its status | Lansing | United States | Unknown status |
| Pa0012 50028 Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Pa0012 50012 Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Pa0012 50036 Coordinator of this site? Confirm its status | Mesquite | United States | Unknown status |
| Pa0012 50011 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Pa0012 50007 Coordinator of this site? Confirm its status | Orangeburg | United States | Unknown status |
| Pa0012 50033 Coordinator of this site? Confirm its status | Palm Harbor | United States | Unknown status |
| Pa0012 50017 Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Pa0012 50034 Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Pa0012 50035 Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Pa0012 50016 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Pa0012 50037 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Pa0012 50040 Coordinator of this site? Confirm its status | Vandalia | United States | Unknown status |
| Pa0012 50009 Coordinator of this site? Confirm its status | Waco | United States | Unknown status |
| Pa0012 50031 Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
| Pa0012 50006 Coordinator of this site? Confirm its status | Wyomissing | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.