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

Axial Spondyloarthritis Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis

• NCT number: NCT06333210
• Study type: Interventional
• Source: Biocad
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 25, 2023
• Completion date: February 2028