Multiple SclerosisPhase 3MIRANTIBUSNCT05385744
An International, Multicenter, Randomized, Double-Blind, Double-Masked Study of the Efficacy and Safety of BCD-132 (JSC BIOCAD, Russia) Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis
A Phase 3 study testing BCD-132 and Teriflunomide in people with Multiple Sclerosis, run by Biocad at 1 site in Russia.
Trial summary
Clinical study BCD-132-4/MIRANTIBUS is an international, multicenter, randomized, double-blind, double-masked study using an active reference drug (teriflunomide). The goal of the study is to evaluate the efficacy and safety of BCD-132 in the treatment of patients with relapsing multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- BCD-132 and Teriflunomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteRussia
- Study dates
- 5 Apr 2021to 29 Sep 2023
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent for participation in the study;
- Male and female subjects, 18 to 60 years of age
- Diagnosis of relapsing multiple sclerosis (according to 2017 revision to the McDonald Diagnostic Criteria for Multiple Sclerosis);
- Documentary evidence that, at the time of signing the informed consent, the subject had:
- at least 1 relapse within the last calendar year (12 months), or
- 2 relapses within the last 2 years (24 months), or
Show all 12Show fewer
- at least 1 T1 gadolinium-enhanced brain lesion on MRI and 1 relapse within 2 calendar years (24 months) prior to signing the informed consent;
- The subject must be neurologically stable for 30 days prior to signing the informed consent
- Total EDSS score 0 to 5.5 inclusive
- Positive anti-Varicella Zoster IgG antibodies according to screening test results;
- Absence of suicidal ideation and behavior confirmed at screening according to C-SSRS score within 1 month prior to signing the informed consent
- Willingness of both female and male patients and their sexual partners of childbearing potential to use reliable contraception
Who cannot join
- Primary progressive MS; Duration of multiple sclerosis for more than 10 years with EDSS ≤2.0 according to screening assessments; Other disorders (besides multiple sclerosis), which could affect the assessment of symptom severity for the primary disease A relapse during screening period ; Use of systemic corticosteroids for 30 days prior to signing the informed consent; Disorders, besides multiple sclerosis, requiring long-term systemic therapy with corticosteroids and/or immunosuppressants; Heart failure (NYHA functional class III/IV); encephalopathy, lactic acidosis, MELAS syndrome), neuromyelitis optica, sarcoidosis; Diagnosis of HIV, hepatitis B, hepatitis C, or syphilis ; Increased TTG levels at least two times the upper limit of normal on screening tests; Suicidal ideation and/or behavior History of severe depression Pregnancy, breastfeeding, or intention to become pregnant at any point throughout the study period; Prior use of anti-B cell therapies Intolerance, including hypersensitivity to any component of BCD-132/teriflunomide, premedication drugs, or conditions in which the above drugs are contraindicated in the Investigator's opinion; History of severe allergic or anaphylactic reactions to humanized and/or murine monoclonal antibodies; History of progressive multifocal leukoencephalopathy Known alcohol or drug addiction or signs of current alcohol/drug addiction Inability to follow the procedures specified in the Protocol, as assessed by the Investigator;
- Contraindications to MRI and administration of gadolinium-based contrast agents:
- Any current or prior malignancies, except for successfully treated basal cell carcinoma and cervical carcinoma in situ Vaccination within 6 weeks prior to signing the informed consent
- -
Trial locations and contacts
1 site in 1 country.
Russia1 site
State Budgetary Healthcare Institution of the Moscow Region M.F. Vladimirsky Moscow Regional Research and Clinical Institute
Moscow, 129110
About this study
Clinical study BCD-132-4/MIRANTIBUS is an international, multicenter, randomized, double-blind, double-masked study using an active reference drug (teriflunomide). The goal of the study is to evaluate the efficacy and safety of BCD-132 in the treatment of patients with relapsing multiple sclerosis.
Read the detailed description
Clinical study No. BCD-132-4/MIRANTIBUS is an international, multicenter, randomized, double-blind, double-masked study using an active reference drug (teriflunomide). The goal of the study is to evaluate the efficacy and safety of BCD-132 in the treatment of patients with relapsing multiple sclerosis.
The study includes adults with relapsing-remitting multiple sclerosis (according to 2017 revision to the McDonald Diagnostic Criteria for Multiple Sclerosis) and EDSS disability score up to 5.5.
Some of the subjects in this study will be patients rolled over from ongoing phase II clinical study No. BCD-132-2; treatment group, individual product kit number (IPKN), stratification factors, order of procedures and timeframes for blinded therapy with a duration of up to 100 weeks will remain the same.
- Conditions
- Multiple Sclerosis
- Being tested
- BCD-132, Teriflunomide
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-132Biological
anti-CD20 monoclonal antibody
TeriflunomideDrug
Teriflunomide 14 mg
| Study group | Role | What they receive |
|---|---|---|
| BCD-132 | Experimental | IV infusion every 24 weeks in combination with daily placebo tablets. The total duration of the blinded therapy is 100 weeks (a total of 5 treatment cycles with BCD-132 in combination with the daily placebo tablets) Receives: Biological: BCD-132 |
| Teriflunomide, 14 mg orally | Active comparator | Teriflunomide, 14 mg orally daily, in combination with intravenous placebo infusions. The total duration of the blinded therapy is 100 weeks (a total of 5 treatment cycles with intravenous placebo infusions in combination with daily teriflunomide tablets). Receives: Drug: Teriflunomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized relapse rate
Annualized relapse rate at 48 weeks after the randomization of the last patient in the study
Measured: week 48
Secondary outcomes (10)
Proportion of patients with persistent progression
Persistent progression is defined as an increase in the EDSS score from Visit 1 by at least 1.0 in patients with a score >0 and ≤5.5 at the first visit and by at least 1.5 in patients with a score of 0 at the first visit
Measured: week 48
Total number of T1 Gd+ lesions
Total number of T1 Gd+ lesions (per scan) detected on brain MRI;
Measured: week 48
CUA
Combined unique active lesions
Measured: week 48
Proportion of patients without contrast-enhancing lesions
Proportion of patients without contrast-enhancing lesions
Measured: week 48
Number of new or enlarged T2 lesions
Number of new or enlarged T2 lesions
Measured: week 48
Proportion of patients without new or enlarged T2 lesions
Proportion of patients without new or enlarged T2 lesions
Measured: week 48
Changes in the neurologic deficit according to EDSS score
Changes in the neurologic deficit according to Expanded Disability Status Scale
Measured: week 48
Annualized relapse rate
Mean annualized relapse rate
Measured: week 48
Proportion of patients with adverse reactions
Measured: week 48
Proportion of patients with serious adverse reactions
Measured: week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start5 Apr 2021
- Primary completion9 Sep 2022
- Study completion29 Sep 2023
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385744
- Sponsor's protocol ID
- BCD-132-4
- Acronym
- MIRANTIBUS
- Status last verified
- Nov 2024
- First submitted
- 18 May 2022
- Last updated
- 25 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multicenter, Randomized, Double-Blind, Double-Masked Study of the Efficacy and Safety of BCD-132 (JSC BIOCAD, Russia) Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05385744
- Acronym / sponsor ID
- MIRANTIBUS / BCD-132-4
- Conditions
- Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 23 May 2022 (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.
Clinical study BCD-132-4/MIRANTIBUS is an international, multicenter, randomized, double-blind, double-masked study using an active reference drug (teriflunomide). The goal of the study is to evaluate the efficacy and safety of BCD-132 in the treatment of patients with relapsing multiple sclerosis.
Detailed description
Clinical study No. BCD-132-4/MIRANTIBUS is an international, multicenter, randomized, double-blind, double-masked study using an active reference drug (teriflunomide). The goal of the study is to evaluate the efficacy and safety of BCD-132 in the treatment of patients with relapsing multiple sclerosis.
The study includes adults with relapsing-remitting multiple sclerosis (according to 2017 revision to the McDonald Diagnostic Criteria for Multiple Sclerosis) and EDSS disability score up to 5.5.
Some of the subjects in this study will be patients rolled over from ongoing phase II clinical study No. BCD-132-2; treatment group, individual product kit number (IPKN), stratification factors, order of procedures and timeframes for blinded therapy with a duration of up to 100 weeks will remain the same.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCD-132 | Experimental | Biological: BCD-132IV infusion every 24 weeks in combination with daily placebo tablets. The total duration of the blinded therapy is 100 weeks (a total of 5 treatment cycles with BCD-132 in combination with the daily placebo tablets) |
| Teriflunomide, 14 mg orally | Active comparator | Drug: TeriflunomideTeriflunomide, 14 mg orally daily, in combination with intravenous placebo infusions. The total duration of the blinded therapy is 100 weeks (a total of 5 treatment cycles with intravenous placebo infusions in combination with daily teriflunomide tablets). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Written informed consent for participation in the study;
- Male and female subjects, 18 to 60 years of age
- Diagnosis of relapsing multiple sclerosis (according to 2017 revision to the McDonald Diagnostic Criteria for Multiple Sclerosis);
- Documentary evidence that, at the time of signing the informed consent, the subject had:
- The subject must be neurologically stable for 30 days prior to signing the informed consent
Key exclusion criteria (4 listed)
- Primary progressive MS; Duration of multiple sclerosis for more than 10 years with EDSS ≤2.0 according to screening assessments; Other disorders (besides multiple sclerosis), which could affect the assessment of symptom severity for the primary disease A relapse during screening period ; Use of systemic corticosteroids for 30 days prior to signing the informed consent; Disorders, besides multiple sclerosis, requiring long-term systemic therapy with corticosteroids and/or immunosuppressants; Heart failure (NYHA functional class III/IV); encephalopathy, lactic acidosis, MELAS syndrome), neuromyelitis optica, sarcoidosis; Diagnosis of HIV, hepatitis B, hepatitis C, or syphilis ; Increased TTG levels at least two times the upper limit of normal on screening tests; Suicidal ideation and/or behavior History of severe depression Pregnancy, breastfeeding, or intention to become pregnant at any point throughout the study period; Prior use of anti-B cell therapies Intolerance, including hypersensitivity to any component of BCD-132/teriflunomide, premedication drugs, or conditions in which the above drugs are contraindicated in the Investigator's opinion; History of severe allergic or anaphylactic reactions to humanized and/or murine monoclonal antibodies; History of progressive multifocal leukoencephalopathy Known alcohol or drug addiction or signs of current alcohol/drug addiction Inability to follow the procedures specified in the Protocol, as assessed by the Investigator;
- Any current or prior malignancies, except for successfully treated basal cell carcinoma and cervical carcinoma in situ Vaccination within 6 weeks prior to signing the informed consent
- -
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 |
|---|---|---|
| BCD-132anti-CD20 monoclonal antibody | Biological | BCD-132 |
| TeriflunomideTeriflunomide 14 mg | Drug | Teriflunomide, 14 mg orally |
Primary outcome
Annualized relapse rate
Time frame: week 48
Annualized relapse rate at 48 weeks after the randomization of the last patient in the study
10 secondary outcomes
Proportion of patients with persistent progression
Time frame: week 48
Total number of T1 Gd+ lesions
Time frame: week 48
CUA
Time frame: week 48
Proportion of patients without contrast-enhancing lesions
Time frame: week 48
Number of new or enlarged T2 lesions
Time frame: week 48
Proportion of patients without new or enlarged T2 lesions
Time frame: week 48
Changes in the neurologic deficit according to EDSS score
Time frame: week 48
Annualized relapse rate
Time frame: week 48
Proportion of patients with adverse reactions
Time frame: week 48
Proportion of patients with serious adverse reactions
Time frame: week 48
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 25 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BCD-132 and Teriflunomide in people with Multiple Sclerosis, run by Biocad at 1 site 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 12 inclusion and 4 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 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: week 48). 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 25 Nov 2024; AzTrials last refreshed its copy on 31 Oct 2026.