Compares BCD-281 with ocrelizumab in relapsing multiple sclerosis

Trial details

Who runs it

Biocad

Trial code

NCT07321093

Record updated

6 January 2026

Original description

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.Read full original descriptionShow less

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.

Inclusion: 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.

Exclusion: Any comorbidities requiring treatment with systemic glucocorticoids and/or immunosuppressive drugs for the duration of the study, with the exception of MS; 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 a malignant disease within 5 years prior to screening; Malignant form of MS; Other medical conditions that can affect the assessment of clinical picture of the 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; History of severe depression and/or a Beck Depression Inventory score of ≥16 at screening examination; A diagnosis of HIV infection, hepatitis B or C ; A history of severe allergic or anaphylactic reactions to humanized and/or murine monoclonal antibodies; A history of using any prohibited medications or treatments defined in the study protocol; Abnormal laboratory blood values, as specified in the study protocol; Primary progressive or secondary progressive MS; MS duration of more than 10 years with EDSS score of ≤2.0 at screening; Inability to obtain high-quality MRI images and/or the presence of contraindications to MRI and the administration of gadolinium-containing contrast agents; 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.

ClinicalTrials.gov NCT07321093