Multiple SclerosisPhase 3NCT06987851
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
A Phase 3 study testing Divozilimab in people with Multiple Sclerosis, run by Biocad at 15 sites in Russia.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Divozilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 15 sitesRussia
- Study dates
- 22 Mar 2022to 16 May 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Russia15 sites
Vyacheslav Andreyevich Dudin
Kirov
Dmitry Vladimirovich Pokhabov
Krasnoyarsk
Ivan Aleksandrovich Shchukin
Moscow
Sergey Viktorovich Kotov
Moscow
Elena Vladimirovna Parshina
Nizhny Novgorod
Irina Aleksandrovna Sokolova
Nizhny Novgorod
Gennady Nikolayevich Mishin
Pyatigorsk
Yuri Vladimirovich Trinitatsky
Rostov-on-Don
Zoya Aleksandrovna Goncharova
Rostov-on-Don
Leonid Grigoryevich Zaslavsky
Saint Petersburg
Natalya Agafonovna Totolyan
Saint Petersburg
Irina Yevgenyevna Poverennova
Samara
Valentina Mikhaylovna Alifirova
Tomsk
Stella Anatolyevna Sivertseva
Tyumen
Irina Vladimirovna Greshnova
Ulyanovsk
About this study
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
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
Read the 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
- Being tested
- Divozilimab
- Keywords
- multiple sclerosis, relapsing multiple sclerosis, anti-CD20, DMT, divosilimab
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DivozilimabBiological
Intravenous infusion of BCD-132 every 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| BCD-132 (divozilimab) | Experimental | Intravenous infusion of BCD-132 every 24 weeks Receives: Biological: Divozilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized relapse rate
Measured: 48 and 96 weeks
Secondary outcomes (12)
Time to first relapse
Measured: 102 weeks
Proportion of patients without confirmed relapses
Measured: 48 and 96 weeks
Total number of T1 Gd+ lesions (per scan)
Measured: 48 and 100 weeks
Proportion of patients without contrast-enhancing lesions
Measured: 48 and 100 weeks
Proportion of patients without new or enlarging T2 lesions
Measured: 48 and 100 weeks
Number of new or enlarged T2 lesions
Measured: 48 and 100 weeks
Number of CUA (Combined Unique Active) lesions
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)
Measured: 48 and 100 weeks
Changes over time in neurological deficit parameters according to the Expanded Disability Status Scale (EDSS)
Measured: 102 weeks
Changes over time in Timed 25-Foot Walk Test
Measured: 102 weeks
Changes over time in 9-Hole Peg Test
Measured: 102 weeks
Changes over time in Symbol Digit Modalities Test (SDMT)
Measured: 102 weeks
Changes over time in quality of life indicators assessed with the SF-36 questionnaire
Measured: 102 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start22 Mar 2022
- Primary completion16 May 2024
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiocadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987851
- Sponsor's protocol ID
- BCD-132-EXT
- Status last verified
- Apr 2025
- First submitted
- 16 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06987851
- Acronym / sponsor ID
- BCD-132-EXT
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, relapsing multiple sclerosis, anti-CD20, DMT, divosilimab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCD-132 (divozilimab) | Experimental | Biological: DivozilimabIntravenous infusion of BCD-132 every 24 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DivozilimabIntravenous infusion of BCD-132 every 24 weeks | Biological | BCD-132 (divozilimab) |
Primary outcome
Annualized relapse rate
Time frame: 48 and 96 weeks
12 secondary outcomes
Time to first relapse
Time frame: 102 weeks
Proportion of patients without confirmed relapses
Time frame: 48 and 96 weeks
Total number of T1 Gd+ lesions (per scan)
Time frame: 48 and 100 weeks
Proportion of patients without contrast-enhancing lesions
Time frame: 48 and 100 weeks
Proportion of patients without new or enlarging T2 lesions
Time frame: 48 and 100 weeks
Number of new or enlarged T2 lesions
Time frame: 48 and 100 weeks
Number of CUA (Combined Unique Active) lesions
Time frame: 48 and 100 weeks
Changes over time in neurological deficit parameters according to the Expanded Disability Status Scale (EDSS)
Time frame: 102 weeks
Changes over time in Timed 25-Foot Walk Test
Time frame: 102 weeks
Changes over time in 9-Hole Peg Test
Time frame: 102 weeks
Changes over time in Symbol Digit Modalities Test (SDMT)
Time frame: 102 weeks
Changes over time in quality of life indicators assessed with the SF-36 questionnaire
Time frame: 102 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Divozilimab in people with Multiple Sclerosis, run by Biocad at 15 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized relapse rate (time frame: 48 and 96 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.