Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-01-31 @ 10:19 AM
Study NCT ID:
NCT06987851
Status:
COMPLETED
Last Update Posted:
2025-05-23
First Post:
2025-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Extension Clinical Study of the Efficacy and Safety of BCD-132 in Patients With Multiple Sclerosis Who Previously Received Therapy in Clinical Studies of JSC BIOCAD
Sponsor:
Biocad
Organization:
Study Overview
Official Title:
An Extension, Multicenter, Open-Label, Non-Comparative Clinical Study of the Efficacy and Safety of Long-Term Use of BCD-132 (JSC BIOCAD) in Patients With Multiple Sclerosis Who Previously Received Therapy in Clinical Studies of JSC BIOCAD
Status:
COMPLETED
Status Verified Date:
2025-04
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:
None
Brief Summary:
The aim of this clinical study is to assess the long-term efficacy and safety of BCD-132 (divozilimab) in patients with multiple sclerosis who previously participaded in BCD-132-2 and BCD-132-4/MIRANTIBUS studies
Detailed Description:
Clinical study BCD-132-EXT is a Phase III study extension conducted after completion of BCD-132 500 mg therapy by subjects of clinical studies BCD-132-2 and BCD-132-4/MIRANTIBUS.
The study is designed as a multicenter, open-label, non-randomized, non-comparative, single-arm clinical study.
The study consists of a screening period (14 days), a treatment period (96 weeks) and a follow-up period (4 weeks). During treatment period, the subjects will receive the investigational product BCD-132 (divozilimab).
The duration of participation for each subject will be approximately 102 weeks.
The study is designed as a multicenter, open-label, non-randomized, non-comparative, single-arm clinical study.
The study consists of a screening period (14 days), a treatment period (96 weeks) and a follow-up period (4 weeks). During treatment period, the subjects will receive the investigational product BCD-132 (divozilimab).
The duration of participation for each subject will be approximately 102 weeks.
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?: