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

NCT04056897 | Completed Phase 2

• 1 other identifier: BCD-132-2
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of T1 Gd+ Lesions (per scan)

  The number of T1 gadolinium enhancing (T1 Gd+) lesions

  week 24

Secondary Outcomes (25)

• CUA

  week 24, week 100

• Proportion of Patients Without Contrast-enhancing Lesions

  week 24, week 100

• Number of New or Enlarging T2-weighted Lesions

  week 24, week 100

• Number of Patients Without New or Enlarging T2-weighted Lesions

  week 24, week 100

• Changes in T2-weighted Lesion Volume

  week 24, week 100

Study Arms (4)

BCD-132, 125 mg

EXPERIMENTAL

72 patients

Biological: BCD-132, 125 mg

BCD-132, 500 mg

EXPERIMENTAL

72 patients

Biological: BCD-132, 500 mg

Teriflunomide

ACTIVE COMPARATOR

72 patients

Drug: Teriflunomide

Placebo

PLACEBO COMPARATOR

54 patients

Drug: Placebo

Interventions

BCD-132, 125 mg BIOLOGICAL

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)

BCD-132, 125 mg

Teriflunomide DRUG

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)

Teriflunomide

Placebo DRUG

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

Placebo

BCD-132, 500 mg BIOLOGICAL

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)

BCD-132, 500 mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent to participate in the study;
• Men and women aged from 18 to 60 years (inclusive) on the day of signing informed consent;
• Confirmed diagnosis of relapsing-remitting multiple sclerosis (according to McDonald criteria 2017 revision);
• Documentary evidence that within the last 12 months before signing informed consent the patient had:
• At least 1 relapse, or
• relapses over the past 2 years, or
• At least 1 Gadolinium enhancing T1-weighted lesion and 1 relapse over the past 2 years (24 months) before signing informed consent;
• The patient should be neurologically stable during 30 days before signing informed consent (i.e. the patient should not have any new or aggravated neurological symptoms, as told by the patient); or the patient's condition should be completely stabilized since the last relapse, and the duration of stabilization should be at least 30 days);
• Total EDSS score of 0 to 5.5 inclusive;
• The presence of immunoglobulins G antibodies to the Varicella-Zoster virus according to the results of screening examination;
• The absence of suicidal ideation and suicidal behavior established in the screening, according to the C-SSRS score;
• The willingness of patients of both sexes and their partners with preserved reproductive function must implement reliable contraceptive methods starting from signing informed consent, throughout the study and within 48 weeks after the last dose of the drug in this study. This requirement does not apply to patients after operative sterilization. Reliable contraception methods include one barrier method in combination with one of the following: spermicides, intrauterine device/oral contraceptives;

You may not qualify if:

• Primary or secondary progressive MS;
• The duration of the MS for more than 10 years with EDSS ≤ 2.0;
• Other conditions (except for multiple sclerosis) that can affect the assessment of MS symptoms: to mask, aggravate, change symptoms of multiple sclerosis, result in clinical signs or laboratory instrumental findings suggesting multiple sclerosis;
• A relapse during the screening period;
• Systemic corticosteroids used within 30 days before signing informed consent;
• Diseases requiring prolonged systemic therapy with corticosteroids and / or immunosuppressive drugs, with the exception of MS;
• Any acute infections, relapses of chronic infections or any other chronic diseases that are present on the day of signing informed consent and can, as judged by the Investigator, negatively affect the patient's safety during the study treatment;
• Congestive heart failure (Grade IV NYHA);
• A history of ischemic cerebrovascular disease or spinal cord ischemia, myelopathy, neuromyelitis optica, sarcoidosis;
• HIV, hepatitis B, hepatitis C, or syphilis;
• Metabolic abnormalities (disorders) manifesting as:
• baseline creatinine levels increased more than 2-fold vs. upper limit of normal;
• baseline urea levels increased more than 3-fold vs. upper limit of normal;
• baseline ALT (Alanine aminotransferase), AST (Aspartate Aminotransferase) or GGT (Gamma-glutamyltransferase) levels increased more than 2.5-fold vs. upper limit of normal;
• baseline bilirubin levels increased more than 1.5-fold vs. upper limit of normal;

Sponsors & Collaborators

• Biocad: lead

Study Sites (1)

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

Nizhny Novgorod, Russia

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

teriflunomide

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Roman Ivanov, PhD

  JSC BIOCAD

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 14, 2019
• Study Start: June 7, 2019
• Primary Completion: July 13, 2020
• Study Completion: January 12, 2022
• Last Updated: February 21, 2025

Record last verified: 2021-09

Locations

RU (1)