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

Axial Spondyloarthritis Clinical Trial

Official title:
An International, Multicenter, Double-Blind, Randomized Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis

Clinical Trial 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).

Clinical Trial Description

Subjects meeting the eligibility criteria will be randomized in 3 groups to receive one of two studied doses of BCD-180 or placebo. After the primary endpoint assessment subjects in placebo group will be switched to BCD-180 in minimal studied dose. After the completion of the main period of the study in each of the BCD-180 groups subjects who meet the criterion of non-active radiographic axSpA (ASDAS-CRP <1.3 at two subsequent visits) will be subjected to repeated randomization in two groups for the use of two different dosing regimens. Subjects of the Placebo group will continue to receive BCD-180 infusions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05445076
Study type Interventional
Source Biocad
Contact
Status Active, not recruiting
Phase Phase 2
Start date April 19, 2022
Completion date June 2027
View Details
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