This record was last updated June 3, 2024 (before its estimated December 2024 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History
2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-03-20; most recent amendment 2024-05-31.
Status change: Recruiting → Active, Not Recruiting2024-05-31