A Phase 3 Study Comparing BCD-281 and Ocrelizumab for Treatment of Relapsing-Remitting Multiple Sclerosis in Adults Aged 18 to 55

What this Trial Is About

Researchers are evaluating the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-281 compared to a reference drug in adults with relapsing-remitting multiple sclerosis RRMS. This phase 3 study focuses on patients diagnosed according to the 2017 McDonald criteria, aiming to better understand how BCD-281 performs in managing RRMS symptoms and disease activity. Participants are randomly assigned to receive either BCD-281 or the reference drug Ocrelizumab, both anti-CD20 monoclonal antibodies. The dosing starts with 300 mg for the first two infusions, followed by 600 mg for subsequent infusions. The study includes a screening period of up to 28 days, a double-blind treatment phase lasting 72 weeks, an open-label phase from weeks 72 to 96, and a follow-up period from weeks 96 to 100. During the study, participants will undergo regular assessments including MRI scans to measure lesions, neurological exams using the Expanded Disability Status Scale, and performance tests like the Timed 25-Foot Walk and 9-Hole Peg Test. Quality of life is also evaluated through questionnaires. Researchers will monitor adverse reactions, antibody development, and pharmacokinetic markers throughout the 100-week period to comprehensively assess the treatments effects and safety.

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