NCT06333210

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

A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Efficacy and Safety of BCD-180 in Patients With Active Axial Spondyloarthritis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 421 (estimated)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subjects meeting the eligibility criteria will be randomized in 2 groups:bDMARDs and/or tsDMARD naive subjects and bDMARDs and/or tsDMARD experienced subjects will be randomized independently of each other. bDMARDs and tsDMARD-naive subjects (naïve) will be randomized into 3 groups: * BCD-180 (naïve); * Placebo (naïve); * Adalimumab. bDMARDs and/or tsDMARD experienced subjects (exp) will be randomized into 2 groups: * BCD-180 (exp); * Placebo (exp). After the primary endpoint assessment all subjects will be switched to BCD-180.

Conditions

• Axial Spondyloarthritis

Interventions

Type	Name	Description
BIOLOGICAL	anti-TRBV9 monoclonal antibody infusions	infusions
OTHER	Placebo infusions	infusions
DRUG	Adalimumab subcutaneous injection	subcutaneous injection
OTHER	Placebo subcutaneous injection	subcutaneous injection

Timeline

• Start date: 2023-12-25
• Primary completion: 2024-12-01
• Completion: 2028-02-01
• First posted: 2024-03-27
• Last updated: 2024-06-03

Locations

32 sites across 2 countries: Belarus, Russia