drugset / Trial / NCT05445076

Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis

NCT05445076

Phase 2 Active not recruiting 250 enrolled Biocad
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

EvaluationDrugModalityDoseRoute
Subject BCD-180 Monoclonal antibody Other

Indications