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Comparative Study of the Efficacy and Safety of BCD-132 With Teriflunomide and Placebo in Multiple Sclerosis

NCT04056897 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 271

Last updated 2025-02-21

No results posted yet for this study

Summary

International multicenter, randomized, double-blind, double-masked, placebo-controlled study of efficacy and safety of BCD-132 (JSC BIOСAD, Russia) using an active reference drug (teriflunomide) for the treatment of patients with multiple sclerosis

Conditions

Interventions

BIOLOGICAL

BCD-132, 125 mg

IV infusion every 24 weeks in combination with placebo tablet daily. The total duration of blinded therapy is 100 weeks (a total of 5 cycles of therapy BCD-132 in combination with a daily placebo)

DRUG

Teriflunomide

14 mg teriflunomide tablet. Per os. Daily in combination with IV placebo. The total duration of blinded therapy is 100 weeks (a total of 5 cycles of placebo IV therapy in combination with daily administration of teriflunomide)

DRUG

Placebo

intravenous infusion in combination with placebo tablet daily. The total duration of blinded therapy is 100 weeks

BIOLOGICAL

BCD-132, 500 mg

IV infusion every 24 weeks in combination with placebo tablet daily. The total duration of blinded therapy is 100 weeks (a total of 5 cycles of therapy BCD-132 in combination with a daily placebo)

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Roman Ivanov, PhD · JSC BIOCAD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-06-07
Primary Completion
2020-07-13
Completion
2022-01-12

Countries

  • Russia

Study Locations

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Entities

Drugs
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 NCT04056897 on ClinicalTrials.gov