NCT05445076

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Axial Spondyloarthritis

Interventions

Type	Name	Description
BIOLOGICAL	anti-TRBV9 monoclonal antibody, low dose	infusion
BIOLOGICAL	anti-TRBV9 monoclonal antibody, high dose	infusion
OTHER	placebo	infusion

Timeline

• Start date: 2022-04-19
• Primary completion: 2025-12-01
• Completion: 2027-06-01
• First posted: 2022-07-06
• Last updated: 2023-04-18

Locations

2 sites across 1 country: Russia