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
BE MOVING
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
4 other identifiers
interventional
508
14 countries
75
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2020
Longer than P75 for phase_3
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2020
CompletedStudy Start
First participant enrolled
June 16, 2020
CompletedFirst Posted
Study publicly available on registry
June 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 7, 2026
April 24, 2026
April 1, 2026
6.1 years
June 15, 2020
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
From Baseline (Day 1) until Safety Follow-Up (up to Week 180)
Percentage of participants with serious adverse events (SAEs) during the study
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalisation or prolongation of existing hospitalisation * Is a congenital anomaly or birth defect * Is an infection that requires treatment with parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above
From Baseline (Day 1) until Safety Follow-Up (up to Week 180)
Percentage of participants with with treatment-emergent adverse Events (TEAEs) leading to withdrawal from the study
Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
From Baseline (Day 1) until Safety Follow-Up (up to Week 180)
Secondary Outcomes (36)
Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 28
Week 28
Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 52
Week 52
Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 112
Week 112
Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 28
Week 28
Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 52
Week 52
- +31 more secondary outcomes
Study Arms (1)
Bimekizumab
EXPERIMENTALSubjects will receive bimekizumab throughout the Treatment Period.
Interventions
Subjects will receive bimekizumab at prespecified time-points.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (75)
As0014 50062
Glendale, Arizona, 85306, United States
As0014 50052
Phoenix, Arizona, 85032, United States
As0014 50060
Upland, California, 91786, United States
As0014 50059
Ormond Beach, Florida, 32174, United States
As0014 50056
Sarasota, Florida, 34239, United States
As0014 50015
Hagerstown, Maryland, 21740, United States
As0014 50016
St Louis, Missouri, 63141, United States
As0014 50055
Portland, Oregon, 97239, United States
As0014 50020
Duncansville, Pennsylvania, 16635, United States
As0014 50057
Dallas, Texas, 75231, 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
Related Publications (5)
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.
PMID: 38977276RESULTRamiro 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.
PMID: 41125403RESULTMease PJ, Merola JF, Magrey M, Nash P, Poddubnyy D, Lebwohl M, Bajracharya R, Ink B, Marten A, Manente M, Peterson L, White K, Gensler LS. Bimekizumab longer-term safety profile in adult patients with axial spondyloarthritis or psoriatic arthritis: an updated analysis of six phase IIb/III clinical studies. RMD Open. 2026 Mar 10;12(1):e006174. doi: 10.1136/rmdopen-2025-006174.
PMID: 41807031DERIVEDMarzo-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.
PMID: 41314667DERIVEDMease 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.
PMID: 40194794DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273 (UCB)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2020
First Posted
June 18, 2020
Study Start
June 16, 2020
Primary Completion (Estimated)
August 7, 2026
Study Completion (Estimated)
August 7, 2026
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
- Access Criteria
- Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.