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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225318

Enrollment

Registered

2020-08-18

Start date

2020-12-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonradiographic axial spondyloarthritis / Ankylosing spondylitis

Interventions

investigational material(s) Generic name etc : UCB4940 INN of investigational material : bimekizumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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)

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
safety -Percentage of participants with treatment-emergent adverse events (TEAEs) during the study -Percentage of participants with serious adverse events (SAEs) during the study -Percentage of participants with treatment-emergent adverse Events (TEAEs) leading to withdrawal from the study	—

Secondary

Measure	Time frame
safety efficacy - Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 28 - Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 52 - Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 112 - Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 28 - Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 52 - Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 112 - Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 28 - Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52 - Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 112 - Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 28 - Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 52 - Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 112 - Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 28 - Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 52 - Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 112 - Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 28 - Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 52 - Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 112 - Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 28 - Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52 - Chang	—

Measure

Time frame

safety efficacy - Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 28 - Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 52 - Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 112 - Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 28 - Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 52 - Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 112 - Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 28 - Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52 - Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 112 - Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 28 - Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 52 - Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 112 - Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 28 - Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 52 - Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 112 - Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 28 - Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 52 - Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 112 - Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 28 - Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52 - Chang

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Countries

Asia except Japan, Europe, Japan, North America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026