NCT04436640CompletedPhase 3
A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Subjects With Active Axial Spondyloarthritis Including Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis
A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
The purpose of the study is to demonstrate the long-term safety, tolerability and efficacy of bimekizumab in patients with active axial spondyloarthritis (axSpA, also known as radiographic axSpa (r-axSpA)) including ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpa).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 508 (actual)
- First submitted
- 15 Jun 2020
- Start date
- 16 Jun 2020
- Primary completion date
- 9 Aug 2026
- Lead sponsor
- UCB Biopharma SRL
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT04436640
- EU CT number
- 2023-506527-28-00
- EudraCT number
- 2019-004163-47
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 508
- From 16 Jun 2020 to the primary completion date, 9 Aug 2026
- 71 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
- Study participants who meet any withdrawal criteria in AS0010 or AS0011. For any study participant with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder study, the Medical Monitor must be consulted prior to the study participant's entry into AS0014
Other
- Female study participants who plan to become pregnant during the study or within 20 weeks following final dose of Investigational Medicinal Product (IMP). Male study participants who are planning a partner pregnancy during the study or within 20 weeks following the final dose
- Study participant has a positive or indeterminate interferon gamma release assay (IGRA) in AS0010 or AS0011, unless appropriately evaluated and treated
Who the study is looking for
- Study participant is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgement of the Investigator
- In the opinion of the Investigator, the study participant is expected to benefit from participation in this extension study
- Study participant completed AS0010 (NCT03928704) or AS0011 (NCT03928743)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (71)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ReumaClinic Coordinator of this site? Confirm its status | Genk | Belgium | Completed |
| As0014 40006 Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Unknown status |
| As0014 40007 Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Unknown status |
| As0014 40008 Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| As0014 40005 Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| As0014 20040 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| As0014 20021 Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| As0014 20019 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| As0014 20034 Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| As0014 20024 Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| As0014 20018 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| As0014 20026 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| As0014 20020 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| As0014 20025 Coordinator of this site? Confirm its status | Wenzhou | China | 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 |
| Revmatologicky Ustav Coordinator of this site? Confirm its status | Prague 2 | Czechia | Completed |
| Pratia Prague s.r.o. Coordinator of this site? Confirm its status | Prague 3 | Czechia | Completed |
| MUDR. Zuzana URBANOVA Coordinator of this site? Confirm its status | Prague 4 | Czechia | Completed |
| MEDICAL PLUS s.r.o. Coordinator of this site? Confirm its status | Uherské Hradiště | Czechia | Completed |
| PV Medical S R O Coordinator of this site? Confirm its status | Zlín | Czechia | Completed |
| Rheumatologische Schwerpunktpraxis Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Completed |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | 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 |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Completed |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hôpital Ambroise-Paré Coordinator of this site? Confirm its status | Boulogne-Billancourt | France | Completed |
| Polyclinique De Limoges Coordinator of this site? Confirm its status | Limoges Cedex I | France | Completed |
| As0014 40057 Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| As0014 40056 Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| As0014 40055 Coordinator of this site? Confirm its status | Norwich | United Kingdom | Unknown status |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Completed |
| Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Coordinator of this site? Confirm its status | Szekesfehervar | Hungary | Completed |
| As0014 20035 Coordinator of this site? Confirm its status | Bunkyō City | Japan | Unknown status |
| As0014 20030 Coordinator of this site? Confirm its status | Chūōku | Japan | Unknown status |
| As0014 20039 Coordinator of this site? Confirm its status | Iruma-gun | Japan | Unknown status |
| As0014 20036 Coordinator of this site? Confirm its status | Kawachi-Nagano | Japan | Unknown status |
| As0014 20045 Coordinator of this site? Confirm its status | Kita-gun | Japan | Unknown status |
| As0014 20065 Coordinator of this site? Confirm its status | Kitakyushu | Japan | Unknown status |
| As0014 20037 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| As0014 20084 Coordinator of this site? Confirm its status | Saga | Japan | Unknown status |
| As0014 20048 Coordinator of this site? Confirm its status | Saitama | Japan | Unknown status |
| As0014 20031 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| As0014 20032 Coordinator of this site? Confirm its status | Suita | Japan | Unknown status |
| As0014 40034 Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Reumed Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Medyczne Centrum Hetmańska Piotr Leszczyński Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Torun | Poland | Completed |
| Futuremeds Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | 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 |
| As0014 50057 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| As0014 50020 Coordinator of this site? Confirm its status | Duncansville | United States | Unknown status |
| As0014 50062 Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| As0014 50015 Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| As0014 50059 Coordinator of this site? Confirm its status | Ormond Beach | United States | Unknown status |
| As0014 50052 Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| As0014 50055 Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| As0014 50056 Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
| As0014 50016 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| As0014 50060 Coordinator of this site? Confirm its status | Upland | United States | Unknown status |
| As0014 40053 Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| As0014 40052 Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| As0014 40050 Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.