NCT04056897 - Comparative Study of the Efficacy and Safety of BCD-132 With Teriflunomide and Placebo in Multiple Sclerosis | Biotech Hunter

Enrollment

271

Participants

Timeline

Start Date

June 7, 2019

Primary Completion Date

July 13, 2020

Study Completion Date

January 12, 2022

Conditions

Multiple Sclerosis

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)

Trial Locations (1)

Unknown

"State Budgetary Healthcare Institution of Nizhny Novgorod region Regional Clinical Hospital N.A. Semashko, Nizhny Novgorod", Nizhny Novgorod