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

NCT07321093 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2026-01-06

No results posted yet for this study

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.

Conditions

  • Relapsing-remitting Multiple Sclerosis (RRMS)

Interventions

BIOLOGICAL

BCD-281

anti-CD20 monoclonal antibody

BIOLOGICAL

Ocrelizumab

anti-CD20 monoclonal antibody

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07321093 on ClinicalTrials.gov