Relapsing-remitting Multiple Sclerosis (RRMS)Phase 3MUSCATNCT07321093
A Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis
A Phase 3 study testing BCD-281 and Ocrelizumab in people with Relapsing-remitting Multiple Sclerosis (RRMS), run by Biocad at 1 site in Russia.
Trial summary
The aim of this study is to compare the efficacy, safety profile, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-281 and the reference drug in subjects with relapsing multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis (RRMS)
- What is being tested?
- BCD-281 and Ocrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2025to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Provided written ICF to participate in the study.
- Male and female subjects aged 18 to 55 years inclusive at the time of signing the ICF.
- Diagnosis of multiple sclerosis, established in accordance with the McDonald criteria for the diagnosis of multiple sclerosis (2017 revision).
- Relapsing-remitting multiple sclerosis.
- The total EDSS score 0-5.5 inclusive.
- Documentary evidence of the following at the time of signing the ICF:
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- at least one relapse within the last12 months, and/or
- 2 relapses within the last 24 months, and/or
- at least 1 T1 Gd+ lesion detected on brain MRI and 1 relapse within 24 months prior to signing the ICF.
- Presence of IgG antibodies to the Varicella-Zoster virus.
- Neurological stability for 30 days prior to signing the ICF.
- Subject's willingness to discontinue previously prescribed DMTs from the day of the first administration of the IP and throughout the study.
- The ability of the subject to follow the Protocol procedures, according to the Investigator.
- Willingness of subjects of both sexes and their sexual partners of childbearing potential to use reliable methods of contraception from the time of signing ICF, throughout the study and for 5 months after the last dose of the drug in this study.
Who cannot join
- Primary progressive or secondary progressive MS.
- MS duration of more than 10 years with EDSS score of ≤2.0 at screening.
- Malignant form of MS.
- Other medical conditions that can affect the assessment of clinical picture of the MS.
- Inability to obtain high-quality MRI images and/or the presence of contraindications to MRI and the administration of gadolinium-containing contrast agents.
- Any comorbidities requiring treatment with systemic glucocorticoids and/or immunosuppressive drugs for the duration of the study, with the exception of MS.
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- History of progressive multifocal leukoencephalopathy.
- Any acute or exacerbated chronic infections detected during screening that may have a negative impact on subject's safety during the study therapy.
- Concomitant diseases and/or conditions that may affect the assessment of the clinical picture of the underlying disease and/or significantly increase the risk of AEs during the study.
- Known alcohol or drug addiction, or current signs of alcohol/drug addiction.
- History of severe depression and/or a Beck Depression Inventory score of ≥16 at screening examination.
- History of a malignant disease within 5 years prior to screening.
- A diagnosis of HIV infection, hepatitis B or C .
- Inability to provide the subject with venous access.
- Pregnancy or breastfeeding, pregnancy planning and oocyte donation throughout the study and for 5 months after the last dose of ocrelizumab.
- A history of severe allergic or anaphylactic reactions to humanized and/or murine monoclonal antibodies.
- A history of using any prohibited medications or treatments defined in the study protocol.
- Abnormal laboratory blood values, as specified in the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Double-blind, Randomized Clinical Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis
The aim of this study is to compare the efficacy, safety profile, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-281 and the reference drug in subjects with relapsing multiple sclerosis.
Read the detailed description
The study includes the following periods:
- Screening (not more than 28 days from the date of signing the ICF).
- Double-blind period - Week 0-72.
- Open-label period - Weeks 72-96.
- Follow-up period - Weeks 96-100. The screening examination is aimed at confirming the eligibility of the subjects for the study. After confirming the eligibility, the subject will be randomized with equal probability into one of two groups (BCD-281 and the reference drug).
- Being tested
- BCD-281, Ocrelizumab
- Keywords
- Multiple Sclerosis, anti CD20, monoclonal antibody
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-281Biological
anti-CD20 monoclonal antibody
OcrelizumabBiological
anti-CD20 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| BCD-281 | Experimental | Subjects will receive 300 mg (for the first two infusions) and 600 mg via subsequent infusions. Receives: Biological: BCD-281 |
| Ocrelizumab | Active comparator | Subjects will receive 300 mg (for the first two infusions) and 600 mg via subsequent infusions. Receives: Biological: Ocrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of T1 gadolinium-enhancing (Gd+) lesions up to Week 24.
The total number of T1 Gd+ lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 12, 16, 20 and 24.
Measured: up to Week 24
Secondary outcomes (33)
Annualized relapse rate (ARR).
ARR was protocol-defined and calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of exposure to that treatment.
Measured: up to Week 100
Time to first relapse.
Measured: up to Week 100
Proportion of subjects without confirmed relapses.
Measured: up to Week 100
Total number of T1 Gd+ lesions at Weeks 48, 72, 100.
Measured: up to Week 100
Total number of new or enlarged T2 lesions.
Measured: up to Week 100
Proportion of subjects without contrast-enhancing lesions.
Measured: up to Week 100
Proportion of subjects without new or enlarged T2 lesions.
Measured: up to Week 100
Total number of new hypointense T1 lesions.
Measured: up to Week 100
Change in the volume of hypointense T1 lesions.
Measured: up to Week 100
Change in the volume of T2 lesions.
Measured: up to Week 100
Combined unique active (CUA).
The total number of new T1 Gd+ lesions and new or enlarging T2 lesions, without double counting
Measured: up to Week 100
Changes over time in the neurologic deficit according to the Expanded Disability Status Scale (EDSS).
Changes in the neurologic deficit according to EEDSS to measure disability and disease progression (from 0 to 10). An increase in the EDSS score signifies worsening disability.
Measured: up to Week 100
Changes over time in Timed 25-Foot (7.62 meters) Walk Test performance.
Measured: up to Week 100
Changes over time in 9-Hole Peg Test (9HPT) performance.
Measured: up to Week 100
Changes over time in Symbol Digit Modalities Test (SDMT) performance.
Measured: up to Week 100
Change in quality of life using SF-36 questionnaire (36-Item Short Form Health Survey)
Change in the quality of life parameters using a SF-36 questionnaire. SF-36 (Short Form-36) questionnaire includes a total of 36 questions. Higher scores (0-100) mean better health.
Measured: up to Week 100
Change in quality of life using EQ-5D questionnaire (EuroQol Five Dimensions)
A positive change in the Index score or a higher score generally means improvement in health.
A negative change in the Index or a lower score means deterioration.
Measured: up to Week 100
Proportion of subjects with confirmed disability progression (CDP).
Measured: up to Week 100
Proportion of subjects with confirmed disability worsening (CDW).
Measured: up to Week 100
The proportion of subjects with confirmed overall disability worsening.
Measured: up to Week 100
Proportion of patients with adverse reactions
Measured: up to Week 100
Proportion of patients with serious adverse reactions
Measured: up to Week 100
AUC 168-336.
Area under the drug concentration-time curve for the time interval from the measurable concentration on Day 169 to the measurable concentration on Day 337 (before the fourth administration of the investigational products).
Measured: up to Week 100
Cmax.
Maximum observed drug concentration.
Measured: up to Week 100
Tmax.
Time to maximum plasma concentration.
Measured: up to Week 100
T1/2.
Terminal Elimination Half-life (T1/2) of IP.
Measured: up to Week 100
Kel.
The elimination rate constant.
Measured: up to Week 100
Ceoi.
Measured: up to Week 100
Ctrough.
Trough Concentration (Ctrough) of IP.
Measured: up to Week 100
Pharmacodynamic endpoints.
PD will be evaluated based on the determination of CD19+ B-cell levels in subjects' blood.
Measured: up to Week 100
Proportion of subjects with binding antibodies (BAbs).
Measured: up to Week 100
Proportion of subjects with neutralizing antibodies (NAbs).
Measured: up to Week 100
Time to BAb/NAb positivity.
Measured: up to Week 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Nov 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-remitting Multiple Sclerosis (RRMS)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321093
- Sponsor's protocol ID
- BCD-281-2/MUSCAT
- Acronym
- MUSCAT
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 6 Jan 2026
- 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 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized Clinical Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07321093
- Acronym / sponsor ID
- MUSCAT / BCD-281-2/MUSCAT
- Keywords
- Multiple Sclerosis, anti CD20, monoclonal antibody
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Jan 2026 (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 study is to compare the efficacy, safety profile, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-281 and the reference drug in subjects with relapsing multiple sclerosis.
Detailed description
The study includes the following periods:
- Screening (not more than 28 days from the date of signing the ICF).
- Double-blind period - Week 0-72.
- Open-label period - Weeks 72-96.
- Follow-up period - Weeks 96-100. The screening examination is aimed at confirming the eligibility of the subjects for the study. After confirming the eligibility, the subject will be randomized with equal probability into one of two groups (BCD-281 and the reference drug).
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-281 | Experimental | Biological: BCD-281Subjects will receive 300 mg (for the first two infusions) and 600 mg via subsequent infusions. |
| Ocrelizumab | Active comparator | Biological: OcrelizumabSubjects will receive 300 mg (for the first two infusions) and 600 mg via subsequent infusions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Provided written ICF to participate in the study.
- Male and female subjects aged 18 to 55 years inclusive at the time of signing the ICF.
- Diagnosis of multiple sclerosis, established in accordance with the McDonald criteria for the diagnosis of multiple sclerosis (2017 revision).
- Relapsing-remitting multiple sclerosis.
- The total EDSS score 0-5.5 inclusive.
Key exclusion criteria (18 listed)
- Primary progressive or secondary progressive MS.
- MS duration of more than 10 years with EDSS score of ≤2.0 at screening.
- Malignant form of MS.
- Other medical conditions that can affect the assessment of clinical picture of the MS.
- Inability to obtain high-quality MRI images and/or the presence of contraindications to MRI and the administration of gadolinium-containing contrast agents.
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-281anti-CD20 monoclonal antibody | Biological | BCD-281 |
| Ocrelizumabanti-CD20 monoclonal antibody | Biological | Ocrelizumab |
Primary outcome
Total number of T1 gadolinium-enhancing (Gd+) lesions up to Week 24.
Time frame: up to Week 24
The total number of T1 Gd+ lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 12, 16, 20 and 24.
33 secondary outcomes
Annualized relapse rate (ARR).
Time frame: up to Week 100
Time to first relapse.
Time frame: up to Week 100
Proportion of subjects without confirmed relapses.
Time frame: up to Week 100
Total number of T1 Gd+ lesions at Weeks 48, 72, 100.
Time frame: up to Week 100
Total number of new or enlarged T2 lesions.
Time frame: up to Week 100
Proportion of subjects without contrast-enhancing lesions.
Time frame: up to Week 100
Proportion of subjects without new or enlarged T2 lesions.
Time frame: up to Week 100
Total number of new hypointense T1 lesions.
Time frame: up to Week 100
Change in the volume of hypointense T1 lesions.
Time frame: up to Week 100
Change in the volume of T2 lesions.
Time frame: up to Week 100
Combined unique active (CUA).
Time frame: up to Week 100
Changes over time in the neurologic deficit according to the Expanded Disability Status Scale (EDSS).
Time frame: up to Week 100
Changes over time in Timed 25-Foot (7.62 meters) Walk Test performance.
Time frame: up to Week 100
Changes over time in 9-Hole Peg Test (9HPT) performance.
Time frame: up to Week 100
Changes over time in Symbol Digit Modalities Test (SDMT) performance.
Time frame: up to Week 100
Change in quality of life using SF-36 questionnaire (36-Item Short Form Health Survey)
Time frame: up to Week 100
Change in quality of life using EQ-5D questionnaire (EuroQol Five Dimensions)
Time frame: up to Week 100
Proportion of subjects with confirmed disability progression (CDP).
Time frame: up to Week 100
Proportion of subjects with confirmed disability worsening (CDW).
Time frame: up to Week 100
The proportion of subjects with confirmed overall disability worsening.
Time frame: up to Week 100
Proportion of patients with adverse reactions
Time frame: up to Week 100
Proportion of patients with serious adverse reactions
Time frame: up to Week 100
AUC 168-336.
Time frame: up to Week 100
Cmax.
Time frame: up to Week 100
Tmax.
Time frame: up to Week 100
T1/2.
Time frame: up to Week 100
Kel.
Time frame: up to Week 100
Ceoi.
Time frame: up to Week 100
Ctrough.
Time frame: up to Week 100
Pharmacodynamic endpoints.
Time frame: up to Week 100
Proportion of subjects with binding antibodies (BAbs).
Time frame: up to Week 100
Proportion of subjects with neutralizing antibodies (NAbs).
Time frame: up to Week 100
Time to BAb/NAb positivity.
Time frame: up to Week 100
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- 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.
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-281 and Ocrelizumab in people with Relapsing-remitting Multiple Sclerosis (RRMS), 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 14 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 6 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marina Krasnova (+7 (812) 380 49 33, krasnovam@biocad.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of T1 gadolinium-enhancing (Gd+) lesions up to Week 24. (time frame: up to 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 6 Jan 2026.