Actively Recruiting
A Double-blind, Randomized Clinical Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis
Led by Biocad · Updated on 2026-01-06
292
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-281 compared to a reference drug in adults with relapsing-remitting multiple sclerosis (RRMS). This phase 3 study focuses on patients diagnosed according to the 2017 McDonald criteria, aiming to better understand how BCD-281 performs in managing RRMS symptoms and disease activity. Participants are randomly assigned to receive either BCD-281 or the reference drug Ocrelizumab, both anti-CD20 monoclonal antibodies. The dosing starts with 300 mg for the first two infusions, followed by 600 mg for subsequent infusions. The study includes a screening period of up to 28 days, a double-blind treatment phase lasting 72 weeks, an open-label phase from weeks 72 to 96, and a follow-up period from weeks 96 to 100. During the study, participants will undergo regular assessments including MRI scans to measure lesions, neurological exams using the Expanded Disability Status Scale, and performance tests like the Timed 25-Foot Walk and 9-Hole Peg Test. Quality of life is also evaluated through questionnaires. Researchers will monitor adverse reactions, antibody development, and pharmacokinetic markers throughout the 100-week period to comprehensively assess the treatments' effects and safety.
CONDITIONS
Brief Title
A Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent to participate in the study.
- Male and female subjects aged 18 to 55 years inclusive at the time of signing the consent.
- Diagnosis of multiple sclerosis according to the McDonald criteria (2017 revision).
- Relapsing-remitting multiple sclerosis.
- Expanded Disability Status Scale (EDSS) score between 0 and 5.5 inclusive.
- Documented evidence of at least one relapse in the last 12 months, or two relapses in the last 24 months, or at least one T1 gadolinium-enhancing lesion on brain MRI and one relapse within 24 months prior to consent.
- Presence of IgG antibodies to Varicella-Zoster virus.
- Neurological stability for at least 30 days prior to signing the consent.
- Willingness to discontinue previously prescribed disease-modifying therapies from the first administration of investigational product and throughout the study.
- Ability to follow the study procedures as assessed by the investigator.
- Willingness of subjects and their sexual partners of childbearing potential to use reliable contraception from consent until 5 months after the last dose.
You will not qualify if you...
- Primary progressive or secondary progressive multiple sclerosis.
- Multiple sclerosis duration over 10 years with EDSS score of 2.0 or less at screening.
- Malignant form of multiple sclerosis.
- Other medical conditions affecting clinical assessment of multiple sclerosis.
- Inability to obtain high-quality MRI or contraindications to MRI or gadolinium contrast.
- Comorbidities requiring systemic glucocorticoids or immunosuppressive drugs during the study, except for multiple sclerosis.
- History of progressive multifocal leukoencephalopathy.
- Acute or worsened chronic infections detected during screening.
- Concomitant diseases increasing risk of adverse events or complicating assessment.
- Known alcohol or drug addiction or current signs of addiction.
- History of severe depression or Beck Depression Inventory score of 16 or higher.
- History of malignant disease within 5 years prior to screening.
- Diagnosis of HIV, hepatitis B, or hepatitis C infection.
- Inability to provide venous access.
- Pregnancy, breastfeeding, pregnancy planning, or oocyte donation during study and 5 months after last dose.
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
- Use of any prohibited medications or treatments as defined by the study protocol.
- Abnormal laboratory blood values as specified in the protocol.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - Up to 28 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 72 weeks
Participants receive infusions of either BCD-281 or the reference drug under double-blind conditions.
Regular visits during Weeks 0 to 72 for infusions and assessments
Duration - Weeks 72 to 96
Participants receive open-label treatment with study medication.
Visits for infusions and assessments during Weeks 72 to 96
Duration - Weeks 96 to 100
Participants are monitored for safety and efficacy after treatment completion.
Follow-up visits during Weeks 96 to 100
Trial Site Locations
Total: 1 location
1
LLC "Medis"
Nizhny Novgorod, Russia
Actively Recruiting
Research Team
M
Marina Krasnova
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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