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

NCT06987851 | Completed Phase 3

• 1 other identifier: BCD-132-EXT
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 15

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

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis, relapsing multiple sclerosis, anti-CD20, DMT, divosilimab

Outcome Measures

Primary Outcomes (1)

• Annualized relapse rate

  48 and 96 weeks

Secondary Outcomes (12)

• Time to first relapse

  102 weeks

• Proportion of patients without confirmed relapses

  48 and 96 weeks

• Total number of T1 Gd+ lesions (per scan)

  48 and 100 weeks

• Proportion of patients without contrast-enhancing lesions

  48 and 100 weeks

• Proportion of patients without new or enlarging T2 lesions

  48 and 100 weeks

Study Arms (1)

BCD-132 (divozilimab)

EXPERIMENTAL

Intravenous infusion of BCD-132 every 24 weeks

Biological: Divozilimab

Interventions

Divozilimab BIOLOGICAL

Intravenous infusion of BCD-132 every 24 weeks

BCD-132 (divozilimab)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent of the subject to participate in the study has been obtained.
• The subject was in the BCD-132 500 mg group in BCD-132-2, then transferred to BCD-132-4/MIRANTIBUS and completed it according to the Protocol (completed all scheduled study visits).
• Last administration of BCD-132 in BCD-132-4/MIRANTIBUS was performed at least 22 weeks before the planned date of the first drug administration in this clinical study.

You may not qualify if:

• Heart failure (NYHA class III/IV).
• Malignancies detected after completion of study BCD-132-4/MIRANTIBUS and prior to signing the informed consent to participate in this study, as well as conditions (acute and chronic) precluding further treatment and participation in the study in the Investigator's opinion.
• Metabolic abnormalities according to blood chemistry (including increased creatinine, urea, ALT, AST) and/or blood count abnormalities (including decreased white blood cell count, absolute lymphocyte count, absolute neutrophil count, platelet count, decreased hemoglobin concentration) identified at the screening and precluding further treatment and participation in the study in the Investigator's opinion.
• Pregnancy, breastfeeding, or planned pregnancy at any time during the participation in the study and 48 weeks after the scheduled last administration of the product in this study.
• Use, between the completion of participation in BCD-132-4/MIRANTIBUS and the signing of the informed consent for this study, of the following drugs: anti-B cell therapies (e.g., rituximab, ocrelizumab, abatacept, belimumab, ofatumumab, and others); alemtuzumab, daclizumab, teriflunomide, mitoxantrone, cladribine; cyclophosphamide, cyclosporine, azathioprine; mycophenolate mofetil, fingolimod and other sphingosine-1-phosphate (S1P) receptor modulators, natalizumab.
• Known intolerance, including hypersensitivity to any component of BCD-132, premedication drugs, or conditions in which the above drugs are contraindicated in the Investigator's opinion.
• Historical evidence of progressive multifocal leukoencephalopathy (PML).
• Contraindications to MRI and the use of gadolinium-containing contrast agents, including, but not limited to, the presence of metal foreign bodies, artificial heart valves, electronic middle ear implants, pacemakers; allergies to gadolinium or gadolinium-containing contrast agents.

Sponsors & Collaborators

• Biocad: lead

Study Sites (15)

Vyacheslav Andreyevich Dudin

Kirov, Russia

Location

Dmitry Vladimirovich Pokhabov

Krasnoyarsk, Russia

Location

Ivan Aleksandrovich Shchukin

Moscow, Russia

Location

Sergey Viktorovich Kotov

Moscow, Russia

Location

Elena Vladimirovna Parshina

Nizhny Novgorod, Russia

Location

Irina Aleksandrovna Sokolova

Nizhny Novgorod, Russia

Location

Gennady Nikolayevich Mishin

Pyatigorsk, Russia

Location

Yuri Vladimirovich Trinitatsky

Rostov-on-Don, Russia

Location

Zoya Aleksandrovna Goncharova

Rostov-on-Don, Russia

Location

Leonid Grigoryevich Zaslavsky

Saint Petersburg, Russia

Location

Natalya Agafonovna Totolyan

Saint Petersburg, Russia

Location

Irina Yevgenyevna Poverennova

Samara, Russia

Location

Valentina Mikhaylovna Alifirova

Tomsk, Russia

Location

Stella Anatolyevna Sivertseva

Tyumen, Russia

Location

Irina Vladimirovna Greshnova

Ulyanovsk, Russia

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 23, 2025
• Study Start: March 22, 2022
• Primary Completion: May 16, 2024
• Study Completion: May 16, 2024
• Last Updated: May 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (15)