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

NCT05385744 | Completed Phase 3

• 1 other identifier: BCD-132-4
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Annualized relapse rate

  Annualized relapse rate at 48 weeks after the randomization of the last patient in the study

  week 48

Secondary Outcomes (10)

• Proportion of patients with persistent progression

  week 48

• Total number of T1 Gd+ lesions

  week 48

• CUA

  week 48

• Proportion of patients without contrast-enhancing lesions

  week 48

• Number of new or enlarged T2 lesions

  week 48

Study Arms (2)

BCD-132

EXPERIMENTAL

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

Biological: BCD-132

Teriflunomide, 14 mg orally

ACTIVE COMPARATOR

Teriflunomide, 14 mg orally daily, in combination with intravenous placebo infusions. The total duration of the blinded therapy is 100 weeks (a total of 5 treatment cycles with intravenous placebo infusions in combination with daily teriflunomide tablets).

Drug: Teriflunomide

Interventions

BCD-132 BIOLOGICAL

anti-CD20 monoclonal antibody

BCD-132

Teriflunomide DRUG

Teriflunomide 14 mg

Teriflunomide, 14 mg orally

Eligibility Criteria

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

You may qualify if:

• Written informed consent for participation in the study;
• Male and female subjects, 18 to 60 years of age
• Diagnosis of relapsing multiple sclerosis (according to 2017 revision to the McDonald Diagnostic Criteria for Multiple Sclerosis);
• Documentary evidence that, at the time of signing the informed consent, the subject had:
• at least 1 relapse within the last calendar year (12 months), or
• relapses within the last 2 years (24 months), or
• at least 1 T1 gadolinium-enhanced brain lesion on MRI and 1 relapse within 2 calendar years (24 months) prior to signing the informed consent;
• The subject must be neurologically stable for 30 days prior to signing the informed consent
• Total EDSS score 0 to 5.5 inclusive
• Positive anti-Varicella Zoster IgG antibodies according to screening test results;
• Absence of suicidal ideation and behavior confirmed at screening according to C-SSRS score within 1 month prior to signing the informed consent
• Willingness of both female and male patients and their sexual partners of childbearing potential to use reliable contraception

You may not qualify if:

• Primary progressive MS; Duration of multiple sclerosis for more than 10 years with EDSS ≤2.0 according to screening assessments; Other disorders (besides multiple sclerosis), which could affect the assessment of symptom severity for the primary disease A relapse during screening period ; Use of systemic corticosteroids for 30 days prior to signing the informed consent; Disorders, besides multiple sclerosis, requiring long-term systemic therapy with corticosteroids and/or immunosuppressants; Heart failure (NYHA functional class III/IV); encephalopathy, lactic acidosis, MELAS syndrome), neuromyelitis optica, sarcoidosis; Diagnosis of HIV, hepatitis B, hepatitis C, or syphilis ; Increased TTG levels at least two times the upper limit of normal on screening tests; Suicidal ideation and/or behavior History of severe depression Pregnancy, breastfeeding, or intention to become pregnant at any point throughout the study period; Prior use of anti-B cell therapies Intolerance, including hypersensitivity to any component of BCD-132/teriflunomide, premedication drugs, or conditions in which the above drugs are contraindicated in the Investigator's opinion; History of severe allergic or anaphylactic reactions to humanized and/or murine monoclonal antibodies; History of progressive multifocal leukoencephalopathy Known alcohol or drug addiction or signs of current alcohol/drug addiction Inability to follow the procedures specified in the Protocol, as assessed by the Investigator;
• Contraindications to MRI and administration of gadolinium-based contrast agents:
• Any current or prior malignancies, except for successfully treated basal cell carcinoma and cervical carcinoma in situ Vaccination within 6 weeks prior to signing the informed consent

Sponsors & Collaborators

• Biocad: lead

Study Sites (1)

State Budgetary Healthcare Institution of the Moscow Region M.F. Vladimirsky Moscow Regional Research and Clinical Institute

Moscow, 129110, 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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 23, 2022
• Study Start: April 5, 2021
• Primary Completion: September 9, 2022
• Study Completion: September 29, 2023
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

RU (1)