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
Part of paid clinical trials in Glendale, Arizona.
- Sponsor
- UCB Biopharma SRL
- Study ID
- NCT04436640
- Phase
- PHASE3
- Status
- Active Not Recruiting
Conditions
- Ankylosing Spondylitis
- Axial Spondyloarthritis
- Nr-axSpa
- r-axSpa
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bimekizumab — DRUGSubjects will receive bimekizumab at prespecified time-points.
Study Details
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).
Key Dates
- Start date
- Jun 16, 2020
- Status verified
- May 2026
- Primary completion
- Aug 7, 2026
- Completion
- Aug 7, 2026
Study Design
- Enrollment
- 508 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: BimekizumabSubjects will receive bimekizumab throughout the Treatment Period.
Primary Outcome Measure
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study [ Time Frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 180) ]
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| As0014 50062 | Glendale | Arizona | 85306 | - |
| As0014 50052 | Phoenix | Arizona | 85032 | - |
| As0014 50060 | Upland | California | 91786 | - |
| As0014 50059 | Ormond Beach | Florida | 32174 | - |
| As0014 50056 | Sarasota | Florida | 34239 | - |
| As0014 50015 | Hagerstown | Maryland | 21740 | - |
| As0014 50016 | St Louis | Missouri | 63141 | - |
| As0014 50055 | Portland | Oregon | 97239 | - |
| As0014 50020 | Duncansville | Pennsylvania | 16635 | - |
| As0014 50057 | Dallas | Texas | 75231 | - |
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