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

Recruiting Phase 3 Interventional Study
Relapsing-remitting Multiple Sclerosis (RRMS)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 55
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
292 (estimated)
Sponsor
Biocad · Industry
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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 revi…
Contacts

Marina Krasnova

+7 (812) 380 49 33

krasnovam@biocad.ru

CONTACT