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

Official 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.

Eligibility Requirements

• Minimum Age: 18 Years
• Maximum Age: 60 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: TRIPLE
• Enrollment: 336 participants

Study Arms

• 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)
• 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).

Interventions

• BIOLOGICAL: BCD-132 — anti-CD20 monoclonal antibody
• DRUG: Teriflunomide — Teriflunomide 14 mg

Primary Outcomes

• Annualized relapse rate (week 48)

Secondary Outcomes

• 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)

Eligibility Criteria

Inclusion Criteria:

1. Written informed consent for participation in the study;
2. Male and female subjects, 18 to 60 years of age
3. Diagnosis of relapsing multiple sclerosis (according to 2017 revision to the McDonald Diagnostic Criteria for Multiple Sclerosis);
4. Documentary evidence that, at the time of signing the informed consent, the subject had:

   1. at least 1 relapse within the last calendar year (12 months), or
   2. 2 relapses within the last 2 years (24 months), or
   3. 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;
5. The subject must be neurologically stable for 30 days prior to signing the informed consent
6. Total EDSS score 0 to 5.5 inclusive
7. Positive anti-Varicella Zoster IgG antibodies according to screening test results;
8. Absence of suicidal ideation and behavior confirmed at screening according to C-SSRS score within 1 month prior to signing the informed consent
9. Willingness of both female and male patients and their sexual partners of childbearing potential to use reliable contraception

Exclusion Criteria:

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

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Trial Locations

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

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