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A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Efficacy and Safety of BCD-180 in Patients With Active Axial Spondyloarthritis
The aim of the study is to evaluate the efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics of a fixed dose of study drug (BCD-180) in comparison with placebo in patients with active axial spondyloarthritis (axSpA). The study will include HLA-B27+ patients with radiographic (r-axSpA) and non-radiographic (nr-axSpA) who had no response to prior therapy with non-steroidal anti-rheumatic drugs (NSAIDs), have not received biologic disease-modifying anti-rheumatic drugs (bDMARDs) or targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), and subjects with insufficient efficacy and/or loss of efficacy on bDMARDs and/or tsDMARDs.
Details
| Lead sponsor | Biocad |
|---|---|
| Phase | Phase 3 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 421 |
| Start date | 2023-12-25 |
| Completion | 2028-02 |
Conditions
- Axial Spondyloarthritis
Interventions
- anti-TRBV9 monoclonal antibody infusions
- Placebo infusions
- Adalimumab subcutaneous injection
- Placebo subcutaneous injection
Primary outcomes
- Proportion of subjects who achieved ASAS40 among bDMARDs and tsDMARD-naive subjects — [Time Frame: week 24]
Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 40% or more - Proportion of subjects who achieved ASAS40 among bDMARDs and/or tsDMARD-experienced subjects — [Time Frame: week 24]
Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 40% or more
Countries
Belarus, Russia