Multiple SclerosisPhase 2NCT04056897
Comparative Study of the Efficacy and Safety of BCD-132 With Teriflunomide and Placebo in Multiple Sclerosis
A Phase 2 study testing BCD-132, 125 mg, Teriflunomide and BCD-132, 500 mg in people with Multiple Sclerosis, run by Biocad at 1 site in Russia.
Trial summary
International multicenter, randomized, double-blind, double-masked, placebo-controlled study of efficacy and safety of BCD-132 (JSC BIOСAD, Russia) using an active reference drug (teriflunomide) for the treatment of patients with 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, 125 mg, Teriflunomide and BCD-132, 500 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 271 participants
- Where
- 1 siteRussia
- Study dates
- 7 Jun 2019to 12 Jan 2022
- Phase
- Phase 2
- 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
- Signed informed consent to participate in the study;
- Men and women aged from 18 to 60 years (inclusive) on the day of signing informed consent;
- Confirmed diagnosis of relapsing-remitting multiple sclerosis (according to McDonald criteria 2017 revision);
- Documentary evidence that within the last 12 months before signing informed consent the patient had:
- At least 1 relapse, or
- 2 relapses over the past 2 years, or
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- At least 1 Gadolinium enhancing T1-weighted lesion and 1 relapse over the past 2 years (24 months) before signing informed consent;
- The patient should be neurologically stable during 30 days before signing informed consent (i.e. the patient should not have any new or aggravated neurological symptoms, as told by the patient); or the patient's condition should be completely stabilized since the last relapse, and the duration of stabilization should be at least 30 days);
- Total EDSS score of 0 to 5.5 inclusive;
- The presence of immunoglobulins G antibodies to the Varicella-Zoster virus according to the results of screening examination;
- The absence of suicidal ideation and suicidal behavior established in the screening, according to the C-SSRS score;
- The willingness of patients of both sexes and their partners with preserved reproductive function must implement reliable contraceptive methods starting from signing informed consent, throughout the study and within 48 weeks after the last dose of the drug in this study. This requirement does not apply to patients after operative sterilization. Reliable contraception methods include one barrier method in combination with one of the following: spermicides, intrauterine device/oral contraceptives;
Who cannot join
- Primary or secondary progressive MS;
- The duration of the MS for more than 10 years with EDSS ≤ 2.0;
- Other conditions (except for multiple sclerosis) that can affect the assessment of MS symptoms: to mask, aggravate, change symptoms of multiple sclerosis, result in clinical signs or laboratory instrumental findings suggesting multiple sclerosis;
- A relapse during the screening period;
- Systemic corticosteroids used within 30 days before signing informed consent;
- Diseases requiring prolonged systemic therapy with corticosteroids and / or immunosuppressive drugs, with the exception of MS;
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- Any acute infections, relapses of chronic infections or any other chronic diseases that are present on the day of signing informed consent and can, as judged by the Investigator, negatively affect the patient's safety during the study treatment;
- Congestive heart failure (Grade IV NYHA);
- A history of ischemic cerebrovascular disease or spinal cord ischemia, myelopathy, neuromyelitis optica, sarcoidosis;
- HIV, hepatitis B, hepatitis C, or syphilis;
- Metabolic abnormalities (disorders) manifesting as:
- baseline creatinine levels increased more than 2-fold vs. upper limit of normal;
- baseline urea levels increased more than 3-fold vs. upper limit of normal;
- baseline ALT (Alanine aminotransferase), AST (Aspartate Aminotransferase) or GGT (Gamma-glutamyltransferase) levels increased more than 2.5-fold vs. upper limit of normal;
- baseline bilirubin levels increased more than 1.5-fold vs. upper limit of normal;
- Baseline leukocyte counts lower than <3.0 × 109/L, platelet counts lower than <125 × 109/L or hemoglobin levels <100 g/L;
- TSH (thyroid stimulating hormone) level increased more than 2-fold vs. upper limit of normal;
- A history of severe depression, suicidal thoughts or suicide attempts ;
- Pregnancy, lactation or planned pregnancy over the entire study period;
- A history of use:
- any time before signing informed consent: anti-B cell therapy drugs (rituximab, oсrelizumab, abatacept, belimumab, ofatumumab and others);
- any time before signing informed consent: alemtuzumab, daclizumab, teriflunomide, mitoxantrone, cladribine, as well as total lymphatic irradiation (TLI), bone marrow transplantation;
- within 2 years (24 months) before signing informed consent: cyclophosphamide, cyclosporine, azathioprine; mycophenolate mofetil, fingolimod and sphingosine-1-phosphate (S1P) receptor modulator, natalizumab;
- immunoglobulin therapy within 30 days before signing informed consent.
- Intolerance, including hypersensitivity to any of the components of BCD-132 / teriflunomide, premedication, as well as conditions that, as judged by the Investigator, are a contraindication to the appointment of the above drugs;
- The history of severe allergic or anaphylactic reactions;
- Progressive multifocal leukoencephalopathy (PML);
- Known alcoholic or drug dependency or signs of present alcoholic/drug dependence that, in the Investigator's opinion, can be contraindications for study therapy of MS with anti-CD20 Mab or limit treatment compliance;
- Inability to follow the Protocol procedures (in the Investigator's opinion);
- Contraindications to MRI or use of gadolinium-containing contrast agents:
- Metal foreign objects in the body: magnetic implants, ferromagnetic clips for cerebral vessels, artificial heart valves, electronic middle ear implants, pacemakers;
- A history of allergy to gadolinium or gadolinium-containing contrast agents;
- Fear of cramped spaces; d) Kidney function impairment with a risk of delayed gadolinium elimination (creatinine level increased to more than 2 x upper limit of normal); d) Documented diagnosis of sickle cell or hemolytic anemia, hemoglobinopathy;
- Any malignancies or a history of malignancies, except for cured basal cell carcinoma or cervical cancer in situ;
- Vaccination within 4 weeks before signing informed consent (as told by the patient);
- Participation in other clinical studies within 90 months before signing informed consent.
Trial locations and contacts
1 site in 1 country.
Russia1 site
State Budgetary Healthcare Institution of Nizhny Novgorod region "Regional Clinical Hospital N.A. Semashko, Nizhny Novgorod"
Nizhny Novgorod
About this study
Official title: International Multicenter, Randomized, Double-blind, Double-masked, Placebo-controlled Study of the Efficacy and Safety of BCD-132 Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis
International multicenter, randomized, double-blind, double-masked, placebo-controlled study of efficacy and safety of BCD-132 (JSC BIOСAD, Russia) using an active reference drug (teriflunomide) for the treatment of patients with multiple sclerosis
- Conditions
- Multiple Sclerosis
- Being tested
- BCD-132, 125 mg, Teriflunomide, Placebo, BCD-132, 500 mg
- 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-132, 125 mgBiological
IV infusion every 24 weeks in combination with placebo tablet daily. The total duration of blinded therapy is 100 weeks (a total of 5 cycles of therapy BCD-132 in combination with a daily placebo)
TeriflunomideDrug
14 mg teriflunomide tablet. Per os. Daily in combination with IV placebo. The total duration of blinded therapy is 100 weeks (a total of 5 cycles of placebo IV therapy in combination with daily administration of teriflunomide)
PlaceboDrug
intravenous infusion in combination with placebo tablet daily. The total duration of blinded therapy is 100 weeks
BCD-132, 500 mgBiological
IV infusion every 24 weeks in combination with placebo tablet daily. The total duration of blinded therapy is 100 weeks (a total of 5 cycles of therapy BCD-132 in combination with a daily placebo)
| Study group | Role | What they receive |
|---|---|---|
| BCD-132, 125 mg | Experimental | 72 patients Receives: Biological: BCD-132, 125 mg |
| BCD-132, 500 mg | Experimental | 72 patients Receives: Biological: BCD-132, 500 mg |
| Teriflunomide | Active comparator | 72 patients Receives: Drug: Teriflunomide |
| Placebo | Placebo comparator | 54 patients Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of T1 Gd+ Lesions (per scan)
The number of T1 gadolinium enhancing (T1 Gd+) lesions
Measured: week 24
Secondary outcomes (25)
CUA
The number of combined unique active (CUA) lesions. Changes in MRI (magnetic resonance imaging) markers
Measured: week 24, week 100
Proportion of Patients Without Contrast-enhancing Lesions
Changes in MRI markers
Measured: week 24, week 100
Number of New or Enlarging T2-weighted Lesions
Changes in MRI markers
Measured: week 24, week 100
Number of Patients Without New or Enlarging T2-weighted Lesions
Changes in MRI markers
Measured: week 24, week 100
Changes in T2-weighted Lesion Volume
Changes in MRI markers
Measured: week 24, week 100
Changes in Hypointense T1-weighted Lesion Volume
Changes in MRI markers
Measured: week 24, week 100
Whole-brain Volume Change according MRI
Changes in MRI markers
Measured: week 24, week 100
Annual Average Frequency of Relapses
Number of relapses during the year
Measured: week 24, week 100
Time to First Relapse
Relapse-related variables
Measured: week 24, week 100
Number of Relapse-free Patients
Relapse-related variables
Measured: week 24, week 100
Number of Patients With Sustained Disability Progression
Relapse-related variables
Measured: week 24, week 100
Expanded Disability Status Scale (EDSS)
EDSS is a scale for assessing neurologic impairment in MS. It consists of eight functional systems (FS) which are used to derive the EDSS steps (score) ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's score is determined between 0 to 10. A positive change from baseline indicates improvement
Measured: week 24, week 100
Timed 25-Foot Walk
Quantitative mobility and leg function performance test based on a timed 25-walk.
Measured: week 24, week 100
9-Hole Peg Test (9 HPT)
9HPT is a brief, standardized, quantitative test of upper extremity function
Measured: week 24, week 100
Symbol Digit Modalities Test (SDMT)
SDMT it is neuropsychological test detecting not only the presence of brain damage, but also changes in cognitive functioning over time and in response to treatment.
Measured: week 24, week 100
36-Item Short Form Survey (SF-36)
SF-36 it is a 36-item, patient-reported survey of patient health.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability
Measured: week 24, week 100
EQ-5D Questionnaire
EQ-5D - European Quality of Life Questionnaire. It has two components: health state description and evaluation. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3.
Measured: week 24, week 100
MSQOL-54 Questionnaire
MSQOL - Multiple Sclerosis Quality of Life-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores.
MSQoL-54 has 0-100 scales. Higher values indicate better quality of life.
Measured: week 24, week 100
Number of Patients Who Developed AEs That, in the Investigator's Opinion, Are Related to Treatment
The Proportion of Patients Who Developed AEs That, in the Investigator's Opinion, Are Related to Treatment
Measured: week 24, week 100
The Number of Patients Who Developed SAEs That, in the Investigator's Opinion, Are Related to Treatment
SAE- Serious adverse event
Measured: week 24, week 100
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
The Proportion of Patients, in Each Group, Who Developed СТСАЕ v. 5.0 Grade 3-4 AEs That, in the Investigator's Opinion, Are Related to Treatment CTCAE - Common Terminology Criteria for Adverse Events
Measured: week 24, week 100
The Number of Patients, in Each Group, Who Discontinued the Study Due to AEs/SAEs
AE- adverse event, SAE - serious adverse event
Measured: week 24, week 100
Number of patients with binding and neutralizing antibodies
The Proportion of binding and neutralizing positive patients
Measured: week 24, week 100
Beck Depression Inventory
Beck Depression Inventory is a 21-item self-reporting questionnaire for evaluating the severity of depression. Minimum score -0, maximum score - 63.
Higher total scores indicate more severe depressive symptoms.
Measured: week 24, week 100
C-SSRS
The Columbia Suicide Severity Rating Scale, or C-SSRS, is a suicidal ideation and behavior rating scale.
C-SSRS - Columbia-Suicide Severity Rating Scale. Suicidal Ideation Score: The maximum suicidal ideation category (1-5 on the CSSRS) present at the assessment. Assign a score of 0 if no ideation is present.
Measured: week 24, week 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start7 Jun 2019
- Primary completion13 Jul 2020
- Study completion12 Jan 2022
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roman Ivanov, PhD, Study chair, JSC BIOCAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056897
- Sponsor's protocol ID
- BCD-132-2
- Status last verified
- Sep 2021
- First submitted
- 12 Aug 2019
- Last updated
- 21 Feb 2025
- 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 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multicenter, Randomized, Double-blind, Double-masked, Placebo-controlled Study of the Efficacy and Safety of BCD-132 Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04056897
- Acronym / sponsor ID
- BCD-132-2
- Conditions
- Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 13 Jul 2020 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 14 Aug 2019 (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.
International multicenter, randomized, double-blind, double-masked, placebo-controlled study of efficacy and safety of BCD-132 (JSC BIOСAD, Russia) using an active reference drug (teriflunomide) for the treatment of patients with multiple sclerosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BCD-132, 125 mg | Experimental | Biological: BCD-132, 125 mg72 patients |
| BCD-132, 500 mg | Experimental | Biological: BCD-132, 500 mg72 patients |
| Teriflunomide | Active comparator | Drug: Teriflunomide72 patients |
| Placebo | Placebo comparator | Drug: Placebo54 patients |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Signed informed consent to participate in the study;
- Men and women aged from 18 to 60 years (inclusive) on the day of signing informed consent;
- Confirmed diagnosis of relapsing-remitting multiple sclerosis (according to McDonald criteria 2017 revision);
- Documentary evidence that within the last 12 months before signing informed consent the patient had:
- The patient should be neurologically stable during 30 days before signing informed consent (i.e. the patient should not have any new or aggravated neurological symptoms, as told by the patient); or the patient's condition should be completely stabilized since the last relapse, and the duration of stabilization should be at least 30 days);
Key exclusion criteria (36 listed)
- Primary or secondary progressive MS;
- The duration of the MS for more than 10 years with EDSS ≤ 2.0;
- Other conditions (except for multiple sclerosis) that can affect the assessment of MS symptoms: to mask, aggravate, change symptoms of multiple sclerosis, result in clinical signs or laboratory instrumental findings suggesting multiple sclerosis;
- A relapse during the screening period;
- Systemic corticosteroids used within 30 days before signing 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-132, 125 mgIV infusion every 24 weeks in combination with placebo tablet daily. The total duration of blinded therapy is 100 weeks (a total of 5 cycles of therapy BCD-132 in combination with a daily placebo) | Biological | BCD-132, 125 mg |
| Teriflunomide14 mg teriflunomide tablet. Per os. Daily in combination with IV placebo. The total duration of blinded therapy is 100 weeks (a total of 5 cycles of placebo IV therapy in combination with daily administration of teriflunomide) | Drug | Teriflunomide |
| Placebointravenous infusion in combination with placebo tablet daily. The total duration of blinded therapy is 100 weeks | Drug | Placebo |
| BCD-132, 500 mgIV infusion every 24 weeks in combination with placebo tablet daily. The total duration of blinded therapy is 100 weeks (a total of 5 cycles of therapy BCD-132 in combination with a daily placebo) | Biological | BCD-132, 500 mg |
Primary outcome
Number of T1 Gd+ Lesions (per scan)
Time frame: week 24
The number of T1 gadolinium enhancing (T1 Gd+) lesions
25 secondary outcomes
CUA
Time frame: week 24, week 100
Proportion of Patients Without Contrast-enhancing Lesions
Time frame: week 24, week 100
Number of New or Enlarging T2-weighted Lesions
Time frame: week 24, week 100
Number of Patients Without New or Enlarging T2-weighted Lesions
Time frame: week 24, week 100
Changes in T2-weighted Lesion Volume
Time frame: week 24, week 100
Changes in Hypointense T1-weighted Lesion Volume
Time frame: week 24, week 100
Whole-brain Volume Change according MRI
Time frame: week 24, week 100
Annual Average Frequency of Relapses
Time frame: week 24, week 100
Time to First Relapse
Time frame: week 24, week 100
Number of Relapse-free Patients
Time frame: week 24, week 100
Number of Patients With Sustained Disability Progression
Time frame: week 24, week 100
Expanded Disability Status Scale (EDSS)
Time frame: week 24, week 100
Timed 25-Foot Walk
Time frame: week 24, week 100
9-Hole Peg Test (9 HPT)
Time frame: week 24, week 100
Symbol Digit Modalities Test (SDMT)
Time frame: week 24, week 100
36-Item Short Form Survey (SF-36)
Time frame: week 24, week 100
EQ-5D Questionnaire
Time frame: week 24, week 100
MSQOL-54 Questionnaire
Time frame: week 24, week 100
Number of Patients Who Developed AEs That, in the Investigator's Opinion, Are Related to Treatment
Time frame: week 24, week 100
The Number of Patients Who Developed SAEs That, in the Investigator's Opinion, Are Related to Treatment
Time frame: week 24, week 100
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: week 24, week 100
The Number of Patients, in Each Group, Who Discontinued the Study Due to AEs/SAEs
Time frame: week 24, week 100
Number of patients with binding and neutralizing antibodies
Time frame: week 24, week 100
Beck Depression Inventory
Time frame: week 24, week 100
C-SSRS
Time frame: week 24, week 100
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 21 Feb 2025.
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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.
Roman Ivanov, PhD study chair
JSC BIOCAD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BCD-132, 125 mg, Teriflunomide and BCD-132, 500 mg 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 36 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 21 Feb 2025. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of T1 Gd+ Lesions (per scan) (time frame: week 24). 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 21 Feb 2025.