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

StatusActive, Not Recruiting
PhasePhase 3
SponsorBiocad
Started2023-12-25
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 3, 2024 (before its estimated December 2024 completion). Its status may not reflect the trial's current state.

Amendment history

2024-05-31
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v2
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 32 of 32 sites
2024-05-02
Study Status, Contacts/Locations v1
Study sites4→32
2024-03-20
Original filing
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.
Trial Details
NCT Number NCT06333210
Lead Sponsor Biocad
Conditions Axial Spondyloarthritis
Enrollment 421 participants
Start Date 2023-12-25
Primary Completion 2024-12 (estimated)
Study Completion 2028-02 (estimated)
Updated on ClinicalTrials.gov 2024-06-03