A Double-blind, Randomized Clinical Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
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• 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

⁃ 2 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.

Locations
Other Locations
Russian Federation
LLC Medis
RECRUITING
Nizhny Novgorod
Contact Information
Primary
Marina Krasnova
krasnovam@biocad.ru
+7 (812) 380 49 33
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2028-12
Participants
Target number of participants: 292
Treatments
Experimental: BCD-281
Subjects will receive 300 mg (for the first two infusions) and 600 mg via subsequent infusions.
Active_comparator: Ocrelizumab
Subjects will receive 300 mg (for the first two infusions) and 600 mg via subsequent infusions.
Sponsors
Leads: Biocad

This content was sourced from clinicaltrials.gov