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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


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

See also
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