RecruitingPhase 3NCT07321093

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


Sponsor

Biocad

Enrollment

292 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called BCD-281 for people with relapsing-remitting multiple sclerosis (RRMS) — a form of MS where symptoms come and go in episodes called relapses. Researchers want to find out if BCD-281 is safe and effective at reducing relapses and new brain lesions. **You may be eligible if...** - You are 18–55 years old - You have been diagnosed with relapsing-remitting MS - You have had at least 1 relapse in the last 12 months, or 2 relapses in the last 2 years, or had a recent active brain lesion on MRI - Your MS disability score is mild to moderate (EDSS 0–5.5) - You have immunity to chickenpox (varicella-zoster virus) - You are willing to stop your current MS medications **You may NOT be eligible if...** - You have primary or secondary progressive MS - You have had MS for over 10 years with only very mild disability - You have a serious infection or immune-suppressing condition - You cannot get an MRI - You are pregnant or unwilling to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBCD-281

anti-CD20 monoclonal antibody

BIOLOGICALOcrelizumab

anti-CD20 monoclonal antibody


Locations(1)

LLC "Medis"

Nizhny Novgorod, Russia

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NCT07321093


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