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.
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