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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 — MIRANTIBUS  

Multiple Sclerosis Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

Clinical study No. 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. The study includes adults with relapsing-remitting multiple sclerosis (according to 2017 revision to the McDonald Diagnostic Criteria for Multiple Sclerosis) and EDSS disability score up to 5.5. Some of the subjects in this study will be patients rolled over from ongoing phase II clinical study No. BCD-132-2; treatment group, individual product kit number (IPKN), stratification factors, order of procedures and timeframes for blinded therapy with a duration of up to 100 weeks will remain the same. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05385744
Study type Interventional
Source Biocad
Contact Daria Bolsun
Phone 7 (812) 380 49 33
Email bolsun@biocad.ru
Status Recruiting
Phase Phase 3
Start date April 5, 2021
Completion date March 2024
View Details
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