A Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBiocad
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- BCD-281
- Ocrelizumab
Treatment groups
292 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov