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
NCT ID: NCT04436640
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
508 participants
INTERVENTIONAL
2020-06-16
2026-08-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis
NCT03928704
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis
NCT03928743
A Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing Spondylitis
NCT02963506
A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis
NCT03355573
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
NCT07290036
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bimekizumab
Subjects will receive bimekizumab throughout the Treatment Period.
Bimekizumab
Subjects will receive bimekizumab at prespecified time-points.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bimekizumab
Subjects will receive bimekizumab at prespecified time-points.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
Exclusion Criteria
* 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
* Study participant has a positive or indeterminate interferon gamma release assay (IGRA) in AS0010 or AS0011, unless appropriately evaluated and treated
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
UCB Biopharma SRL
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273 (UCB)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
As0014 50062
Glendale, Arizona, United States
As0014 50052
Phoenix, Arizona, United States
As0014 50060
Upland, California, United States
As0014 50059
Ormond Beach, Florida, United States
As0014 50056
Sarasota, Florida, United States
As0014 50015
Hagerstown, Maryland, United States
As0014 50016
St Louis, Missouri, United States
As0014 50055
Portland, Oregon, United States
As0014 50020
Duncansville, Pennsylvania, United States
As0014 50057
Dallas, Texas, United States
As0014 40004
Brussels, , Belgium
As0014 40003
Genk, , Belgium
As0014 40001
Ghent, , Belgium
As0014 40006
Plovdiv, , Bulgaria
As0014 40007
Plovdiv, , Bulgaria
As0014 40005
Sofia, , Bulgaria
As0014 40008
Sofia, , Bulgaria
As0014 20040
Beijing, , China
As0014 20021
Chengdu, , China
As0014 20019
Guangzhou, , China
As0014 20034
Hefei, , China
As0014 20024
Nanjing, , China
As0014 20018
Shanghai, , China
As0014 20020
Shanghai, , China
As0014 20026
Shanghai, , China
As0014 20025
Wenzhou, , China
As0014 40011
Brno, , Czechia
As0014 40009
Pardubice, , Czechia
As0014 40013
Prague, , Czechia
As0014 40014
Prague, , Czechia
As0014 40015
Prague, , Czechia
As0014 40016
Prague, , Czechia
As0014 40010
Uherské Hradiště, , Czechia
As0014 40012
Zlín, , Czechia
As0014 40018
Boulogne-Billancourt, , France
As0014 40022
Limoges, , France
As0014 40025
Berlin, , Germany
As0014 40029
Hamburg, , Germany
As0014 40024
Hanover, , Germany
As0014 40027
Herne, , Germany
As0014 40078
Leipzig, , Germany
As0014 40026
Ratingen, , Germany
As0014 40032
Debrecen, , Hungary
As0014 40031
Szeged, , Hungary
As0014 40033
Székesfehérvár, , Hungary
As0014 20035
Bunkyō City, , Japan
As0014 20030
Chūōku, , Japan
As0014 20039
Iruma-gun, , Japan
As0014 20036
Kawachi-Nagano, , Japan
As0014 20045
Kita-gun, , Japan
As0014 20065
Kitakyushu, , Japan
As0014 20037
Osaka, , Japan
As0014 20084
Saga, , Japan
As0014 20048
Saitama, , Japan
As0014 20031
Sapporo, , Japan
As0014 20032
Suita, , Japan
As0014 40034
Amsterdam, , Netherlands
As0014 40038
Elblag, , Poland
As0014 40042
Krakow, , Poland
As0014 40037
Lublin, , Poland
As0014 40044
Poznan, , Poland
As0014 40040
Torun, , Poland
As0014 40041
Warsaw, , Poland
As0014 40039
Wroclaw, , Poland
As0014 40043
Wroclaw, , Poland
As0014 40045
A Coruña, , Spain
As0014 40046
Córdoba, , Spain
As0014 40048
Santiago de Compostela, , Spain
As0014 40049
Seville, , Spain
As0014 40052
Ankara, , Turkey (Türkiye)
As0014 40053
Ankara, , Turkey (Türkiye)
As0014 40050
Istanbul, , Turkey (Türkiye)
As0014 40057
Edinburgh, , United Kingdom
As0014 40056
Leeds, , United Kingdom
As0014 40055
Norwich, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Brown MA, Rudwaleit M, van Gaalen FA, Haroon N, Gensler LS, Fleurinck C, Marten A, Massow U, de Peyrecave N, Vaux T, White K, Deodhar A, van der Horst-Bruinsma I. Low uveitis rates in patients with axial spondyloarthritis treated with bimekizumab: pooled results from phase 2b/3 trials. Ann Rheum Dis. 2024 Nov 14;83(12):1722-1730. doi: 10.1136/ard-2024-225933.
Ramiro S, Poddubnyy D, Mease PJ, Lopez-Medina C, Kim M, Massow U, Taieb V, Kragstrup TW, McGonagle D. Sustained resolution of enthesitis and peripheral arthritis over 104 weeks with bimekizumab in axial spondyloarthritis. RMD Open. 2025 Oct 22;11(4):e005969. doi: 10.1136/rmdopen-2025-005969.
Marzo-Ortega H, Navarro-Compan V, Dubreuil M, Mease PJ, Magrey M, Rudwaleit M, D'Agostino MA, Gaffney K, Kay J, de la Loge C, Massow U, Taieb V, Vaux T, Deodhar A. Sustained improvements in spinal pain, morning stiffness, fatigue, sleep, physical function and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: 2-year results from two phase 3 studies. RMD Open. 2025 Nov 28;11(4):e006013. doi: 10.1136/rmdopen-2025-006013.
Mease PJ, Gensler LS, Orbai AM, Warren RB, Bajracharya R, Ink B, Marten A, Massow U, Shende V, Manente M, Peterson L, White K, Landewe R, Poddubnyy D. Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies. RMD Open. 2025 Apr 6;11(2):e005026. doi: 10.1136/rmdopen-2024-005026.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-004163-47
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-506527-28
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1304-6865
Identifier Type: OTHER
Identifier Source: secondary_id
AS0014
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.