MedTrace Logo

An International, Multicenter, Randomized, Double-Blind, Double-Masked Study of the Efficacy and Safety of BCD-132 (JSC BIOCAD, Russia) Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis

NCT05385744 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2024-11-25

No results posted yet for this study

Summary

Clinical study BCD-132-4/MIRANTIBUS is an international, multicenter, randomized, double-blind, double-masked study using an active reference drug (teriflunomide). The goal of the study is to evaluate the efficacy and safety of BCD-132 in the treatment of patients with relapsing multiple sclerosis.

Conditions

Interventions

BIOLOGICAL

BCD-132

anti-CD20 monoclonal antibody

DRUG

Teriflunomide

Teriflunomide 14 mg

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-04-05
Primary Completion
2022-09-09
Completion
2023-09-29

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

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 NCT05385744 on ClinicalTrials.gov