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
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
UCB Japan Co., Ltd.
8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo
+81-368647500
CTR-JRCT.UCBJapan@ucb.com
UCB Japan Co., Ltd.
8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo
+81-368647587
CTR_SCC_UCBJapan@UCB.com
completed
Dec. 12, 2020
30
Interventional
Multicenter, Open-label Extension study
treatment purpose
3
- 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)
- 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
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 Investigational material : 160mg administered by sc injection
control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -
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
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
- Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 112
- Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 28
- Change from Baseline in nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 52
- Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 112
- Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 28
- Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52
- Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 112
- Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 28
- Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 52
- Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 112
- Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 28
- Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 52
- Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 112
- Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 28
- Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 52
- Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 112
UCB Japan Co., Ltd.
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St.Luke's International Hospital Institutional Review Board
