Actively Recruiting
A 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
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 consent
- Multiple sclerosis diagnosis according to the 2017 McDonald criteria
- Relapsing-remitting multiple sclerosis
- Expanded Disability Status Scale (EDSS) score between 0 and 5.5 inclusive
- Evidence of at least one relapse within the last 12 months, or two relapses within the last 24 months, or at least one T1 gadolinium-enhancing lesion on brain MRI and one relapse within 24 months prior to signing consent
- Presence of IgG antibodies to Varicella-Zoster virus
- Neurological stability for at least 30 days prior to signing consent
- Willingness to discontinue previously prescribed disease-modifying therapies from the first study drug administration and throughout the study
- Ability to follow study procedures as assessed by the investigator
- Willingness of subjects and their sexual partners of childbearing potential to use reliable contraception from signing consent through 5 months after 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 images 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
- Any acute or worsening chronic infections at screening that could affect safety
- Conditions increasing risk of adverse events or affecting disease assessment
- Known alcohol or drug addiction or current signs of addiction
- History of severe depression or Beck Depression Inventory score of 16 or higher at screening
- History of malignant disease within 5 years prior to screening
- Diagnosis of HIV, hepatitis B, or hepatitis C
- Inability to provide venous access
- Pregnancy, breastfeeding, pregnancy planning, or oocyte donation during study and for 5 months after last dose
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- Use of prohibited medications or treatments as defined by the study protocol
- Abnormal laboratory blood values as specified in the study protocol
AI-Screening
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Trial Site Locations
Total: 1 location
1
LLC "Medis"
Nizhny Novgorod, Russia
Actively Recruiting
Research Team
M
Marina Krasnova
CONTACT
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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