New MS drug trial aims to reduce brain lesions and relapses
NCT ID NCT07321093
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new medicine called BCD-281 in people with relapsing-remitting multiple sclerosis (RRMS). The goal is to see if it reduces brain lesions and relapse rates better than the current standard drug. About 292 adults aged 18-55 with mild to moderate disability are being recruited. Participants will receive either BCD-281 or the reference drug, and researchers will monitor their safety and disease activity over time.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 292 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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: 1. at least one relapse within the last12 months, and/or 2. 2 relapses within the last 24 months, and/or 3. 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. Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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LLC "Medis"
RECRUITINGNizhny Novgorod, Russia
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