A Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis

NCT07321093 | Recruiting Phase 3

• 1 other identifier: BCD-281-2/MUSCAT
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the efficacy, safety profile, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-281 and the reference drug in subjects with relapsing multiple sclerosis.

Conditions

Relapsing-remitting Multiple Sclerosis (RRMS)

Keywords

Multiple Sclerosis; anti CD20; monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• Total number of T1 gadolinium-enhancing (Gd+) lesions up to Week 24.

  The total number of T1 Gd+ lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 12, 16, 20 and 24.

  up to Week 24

Secondary Outcomes (33)

• Annualized relapse rate (ARR).

  up to Week 100

• Time to first relapse.

  up to Week 100

• Proportion of subjects without confirmed relapses.

  up to Week 100

• Total number of T1 Gd+ lesions at Weeks 48, 72, 100.

  up to Week 100

• Total number of new or enlarged T2 lesions.

  up to Week 100

Study Arms (2)

BCD-281

EXPERIMENTAL

Subjects will receive 300 mg (for the first two infusions) and 600 mg via subsequent infusions.

Biological: BCD-281

Ocrelizumab

ACTIVE COMPARATOR

Subjects will receive 300 mg (for the first two infusions) and 600 mg via subsequent infusions.

Biological: Ocrelizumab

Interventions

BCD-281 BIOLOGICAL

anti-CD20 monoclonal antibody

BCD-281

Ocrelizumab BIOLOGICAL

anti-CD20 monoclonal antibody

Ocrelizumab

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Provided written ICF to participate in the study.
• Male and female subjects aged 18 to 55 years inclusive at the time of signing the ICF.
• Diagnosis of multiple sclerosis, established in accordance with the McDonald criteria for the diagnosis of multiple sclerosis (2017 revision).
• Relapsing-remitting multiple sclerosis.
• The total EDSS score 0-5.5 inclusive.
• Documentary evidence of the following at the time of signing the ICF:
• at least one relapse within the last12 months, and/or
• relapses within the last 24 months, and/or
• at least 1 T1 Gd+ lesion detected on brain MRI and 1 relapse within 24 months prior to signing the ICF.
• Presence of IgG antibodies to the Varicella-Zoster virus.
• Neurological stability for 30 days prior to signing the ICF.
• Subject's willingness to discontinue previously prescribed DMTs from the day of the first administration of the IP and throughout the study.
• The ability of the subject to follow the Protocol procedures, according to the Investigator.
• Willingness of subjects of both sexes and their sexual partners of childbearing potential to use reliable methods of contraception from the time of signing ICF, throughout the study and for 5 months after the last dose of the drug in this study.

You may not qualify if:

• Primary progressive or secondary progressive MS.
• MS duration of more than 10 years with EDSS score of ≤2.0 at screening.
• Malignant form of MS.
• Other medical conditions that can affect the assessment of clinical picture of the MS.
• Inability to obtain high-quality MRI images and/or the presence of contraindications to MRI and the administration of gadolinium-containing contrast agents.
• Any comorbidities requiring treatment with systemic glucocorticoids and/or immunosuppressive drugs for the duration of the study, with the exception of MS.
• History of progressive multifocal leukoencephalopathy.
• Any acute or exacerbated chronic infections detected during screening that may have a negative impact on subject's safety during the study therapy.
• Concomitant diseases and/or conditions that may affect the assessment of the clinical picture of the underlying disease and/or significantly increase the risk of AEs during the study.
• Known alcohol or drug addiction, or current signs of alcohol/drug addiction.
• History of severe depression and/or a Beck Depression Inventory score of ≥16 at screening examination.
• History of a malignant disease within 5 years prior to screening.
• A diagnosis of HIV infection, hepatitis B or C .
• Inability to provide the subject with venous access.
• Pregnancy or breastfeeding, pregnancy planning and oocyte donation throughout the study and for 5 months after the last dose of ocrelizumab.

Sponsors & Collaborators

• Biocad: lead

Study Sites (1)

LLC "Medis"

Nizhny Novgorod, Russia

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Marina Krasnova

CONTACT

+7 (812) 380 49 33; krasnovam@biocad.ru

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: November 17, 2025
• First Posted: January 6, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)