Clinical Trial

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

Study acronym: ELEFTA
Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated April 18, 2023 (before its estimated December 2025 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 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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2022-06-30.
Status change: Recruiting → Active, Not Recruiting 2023-04-14
Trial Details
NCT Number NCT05445076
Lead Sponsor Biocad
Conditions Axial Spondyloarthritis
Enrollment 250 participants
Start Date 2022-04-19
Primary Completion 2025-12 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2023-04-18