NCT07321093 A Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis
| NCT ID | NCT07321093 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Biocad |
| Condition | Relapsing-remitting Multiple Sclerosis (RRMS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 292 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 292 participants in total. It began in 2025-11-01 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07321093 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Relapsing-remitting Multiple Sclerosis (RRMS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07321093 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 292 participants.
Is NCT07321093 currently recruiting?
Yes, NCT07321093 is actively recruiting participants. Contact the research team at krasnovam@biocad.ru for enrollment information.
Where is the NCT07321093 trial being conducted?
This trial is being conducted at Nizhny Novgorod, Russia.
Who is sponsoring the NCT07321093 clinical trial?
NCT07321093 is sponsored by Biocad. The trial plans to enroll 292 participants.
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