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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
BCD-281
Biological/Vaccineanti-CD20 monoclonal antibody
Ocrelizumab
Biological/Vaccineanti-CD20 monoclonal antibody
Treatment groups
292 Participants
are divided into 2 treatment groupsGroup A: BCD-281Experimental treatment 1 intervention
Group B: OcrelizumabActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total number of T1 gadolinium-enhancing (Gd+) lesions up to Week 24.
The total number of T1 Gd+ lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 12, 16, 20 and 24.
Time frame
up to Week 24Secondary outcomes
1
Annualized relapse rate (ARR).
ARR was protocol-defined and calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of exposure to that treatment.
Time frame
up to Week 1002
Time to first relapse.
Time frame
up to Week 1003
Proportion of subjects without confirmed relapses.
Time frame
up to Week 1004
Total number of T1 Gd+ lesions at Weeks 48, 72, 100.
Time frame
up to Week 100 Source ClinicalTrials.gov