NCT04056897

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

International Multicenter, Randomized, Double-blind, Double-masked, Placebo-controlled Study of the Efficacy and Safety of BCD-132 Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 271 (actual)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

• Multiple Sclerosis

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2019-06-07
• Primary completion: 2020-07-13
• Completion: 2022-01-12
• First posted: 2019-08-14
• Last updated: 2025-02-21

Locations

1 site across 1 country: Russia