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 (ELEFTA)

NCT05445076 Phase 2 ACTIVE_NOT_RECRUITING

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).

Details

Lead sponsor	Biocad
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	250
Start date	2022-04-19
Completion	2027-06

Conditions

• Axial Spondyloarthritis

Interventions

• anti-TRBV9 monoclonal antibody, low dose
• anti-TRBV9 monoclonal antibody, high dose
• placebo

Primary outcomes

• Proportion of subjects who achieved ASAS40 — week 24
  Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 40% or more

Countries

Russia