Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:46 AM
Study NCT ID:
NCT07321093
Status:
RECRUITING
Last Update Posted:
2026-01-06
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis
Sponsor:
Biocad
Organization:
Study Overview
Official Title:
A Double-blind, Randomized Clinical Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MUSCAT
Brief Summary:
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.
Detailed Description:
The study includes the following periods:
* Screening (not more than 28 days from the date of signing the ICF).
* Double-blind period - Week 0-72.
* Open-label period - Weeks 72-96.
* Follow-up period - Weeks 96-100. The screening examination is aimed at confirming the eligibility of the subjects for the study. After confirming the eligibility, the subject will be randomized with equal probability into one of two groups (BCD-281 and the reference drug).
* Screening (not more than 28 days from the date of signing the ICF).
* Double-blind period - Week 0-72.
* Open-label period - Weeks 72-96.
* Follow-up period - Weeks 96-100. The screening examination is aimed at confirming the eligibility of the subjects for the study. After confirming the eligibility, the subject will be randomized with equal probability into one of two groups (BCD-281 and the reference drug).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: