Multiple Sclerosis
Conditions
Keywords
multiple sclerosis, relapsing multiple sclerosis, anti-CD20, DMT, divosilimab
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.
Interventions
BIOLOGICALDivozilimab
Intravenous infusion of BCD-132 every 24 weeks
Sponsors
Biocad
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized relapse rate | 48 and 96 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Number of new or enlarged T2 lesions | 48 and 100 weeks | — |
| Time to first relapse | 102 weeks | — |
| Changes over time in neurological deficit parameters according to the Expanded Disability Status Scale (EDSS) | 102 weeks | — |
| Changes over time in Timed 25-Foot Walk Test | 102 weeks | — |
| Changes over time in 9-Hole Peg Test | 102 weeks | — |
| Changes over time in Symbol Digit Modalities Test (SDMT) | 102 weeks | — |
| Changes over time in quality of life indicators assessed with the SF-36 questionnaire | 102 weeks | — |
| Number of CUA (Combined Unique Active) lesions | 48 and 100 weeks | Total number of new contrast-enhancing T1 lesions and new T2 lesions or enlarged T2-weighted lesions without double counting on MRI (Combined Unique Active) |
Countries
Russia
Outcome results
None listed