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