NCT07321093

A Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis

A Double-blind, Randomized Clinical Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 292 (estimated)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare the efficacy, safety profile, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-281 and the reference drug in subjects with relapsing multiple sclerosis.

Detailed description

The study includes the following periods: * Screening (not more than 28 days from the date of signing the ICF). * Double-blind period - Week 0-72. * Open-label period - Weeks 72-96. * Follow-up period - Weeks 96-100. The screening examination is aimed at confirming the eligibility of the subjects for the study. After confirming the eligibility, the subject will be randomized with equal probability into one of two groups (BCD-281 and the reference drug).

Conditions

• Relapsing-remitting Multiple Sclerosis (RRMS)

Interventions

Type	Name	Description
BIOLOGICAL	BCD-281	anti-CD20 monoclonal antibody
BIOLOGICAL	Ocrelizumab	anti-CD20 monoclonal antibody

Timeline

• Start date: 2025-11-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

1 site across 1 country: Russia