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A Multicenter, Open-Label Extension Study to Assess 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
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506527-28-00
Acronym
AS0014
Enrollment
568
Registered
2024-07-02
Start date
2020-06-29
Completion date
2025-10-02
Last updated
2025-03-24

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

Conditions

Axial Spondyloarthritis

Brief summary

1. Incidence of treatment-emergent adverse events (TEAEs) during the study 2. Incidence of serious adverse events (SAEs) during the study 3. Treatment-emergent adverse events (TEAEs) leading to withdrawal from the study

Detailed description

1.      Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 28, 2.      Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 52, 3.      Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 112, 4.      Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 28, 5.      Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 52, 6.      Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 112, 7.      Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 28, 8.      Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52, 9.      Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 112, 10.   Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 28, 11.   Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 52, 12.   Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 112, 13.   Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 28, 14.   Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 52, 15.   Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 112, 16.   Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 28, 17.   Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 52, 18.   Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 112, 19.   Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 28, 20.   Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52, 21.   Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 112, 22.   Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 28, 23.   Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 52, 24.   Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 112, 25.   Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 28, 26.   Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52, 27.   Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 112, 28.   Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 28, 29.   Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 52, 30.   Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 112, 31.   Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 28, 32.   Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 52, 33.   Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 112, 34.   Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 28, 35.   Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 52, 36.   Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 112

Interventions

DRUGbimekizumab

Sponsors

UCB Biopharma
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Incidence of treatment-emergent adverse events (TEAEs) during the study 2. Incidence of serious adverse events (SAEs) during the study 3. Treatment-emergent adverse events (TEAEs) leading to withdrawal from the study

Secondary

MeasureTime frame
1.      Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 28, 2.      Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 52, 3.      Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 112, 4.      Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 28, 5.      Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 52, 6.      Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 112, 7.      Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 28, 8.      Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52, 9.      Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 112, 1

Countries

Belgium, Czechia, France, Germany, Hungary, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026