drugset / Trial / NCT05445076
Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis
RandomizedParallel-groupDouble-blindTreatment
Summary
The aim of the study is to evaluate the efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics of two doses of study drug (BCD-180) in comparison with placebo in patients with active radiographic axial spondyloarthritis (axSpA). The study will include HLA-B27+ patients with radiographic axSpA who had no response to prior therapy with Non-steroidal anti-inflammatory drugs (NSAIDs), have not received biologic therapy or targeted Disease-modifying antirheumatic drugs (DMARDs).
Timeline
- Start
- 2022-04-19
- Primary completion
- 2025-12
- Completion
- 2027-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BCD-180 | Monoclonal antibody | — | Other |