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
- Conditions
- Nonradiographic axial spondyloarthritis / Ankylosing spondylitis
- Registration Number
- jRCT2080225318
- Lead Sponsor
- UCB Japan Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 30
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Multicenter, Open-label Extension study
- Primary Outcome Measures
Name Time Method Percentage of participants with treatment-emergent adverse events (TEAEs) during the study 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 serious adverse events (SAEs) during the study
Percentage of participants with treatment-emergent adverse Events (TEAEs) leading to withdrawal from the study Percentage of participants with treatment-emergent adverse Events (TEAEs) leading to withdrawal from the study
- Secondary Outcome Measures
Name Time Method ASAS40 response Week 28, Week 52, Week 112 Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response
ASAS20 response Week 28, Week 52, Week 112 Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response
BASDAI change Week 28, Week 52, Week 112 Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
ASAS-PR Week 28, Week 52, Week 112 Assessment of SpondyloArthritis International Society partial remission (ASAS-PR)
ASDAS-CRP Week 28, Week 52, Week 112 Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP)
ASAS 5/6 response Week 28, Week 52, Week 112 Assessment of SpondyloArthritis International Society (ASAS) 5/6 response
BASFI change Week 28, Week 52, Week 112 Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
Nocturnal Spinal Pain NRS change Week 28, Week 52, Week 112 Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS)
ASQoL change Week 28, Week 52, Week 112 Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL)
SF-36 PCS change Week 28, Week 52, Week 112 Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS)
BASMI change Week 28, Week 52, Week 112 Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI)
MASES Index change Week 28, Week 52, Week 112 Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index
Trial Locations
- Locations (1)
Japan/Asia except Japan/North America/Europe
Location not specified
Japan/Asia except Japan/North America/Europe