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

Study acronym: ELEFTA
StatusActive, Not Recruiting
PhasePhase 2
SponsorBiocad
Started2022-04-19
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.

Amendment history

2023-04-14
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v1
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 2 of 2 sites
2022-06-30
Original filing
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).
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