NCT06987851

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Biocad · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	Divozilimab	Intravenous infusion of BCD-132 every 24 weeks

Timeline

• Start date: 2022-03-22
• Primary completion: 2024-05-16
• Completion: 2024-05-16
• First posted: 2025-05-23
• Last updated: 2025-05-23

Locations

15 sites across 1 country: Russia