BridgeMD
Tests treatment safety and results for Relapsing-remitting Multiple Sclerosis (RRMS)
Official title A Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis
ClinicalTrials.gov ID: NCT07321093
What this study is testing
What is BCD-281?
BCD-281 is an investigational medicine, being studied as a potential treatment for relapsing-remitting multiple sclerosis (rrms).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- Provided written ICF to participate in the study.
- Male and female people 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.
You likely can't join if
- 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...
- Any comorbidities requiring treatment with systemic glucocorticoids and/or immunosuppressive drugs for the duration of the study, with the exception...
See the full eligibility criteria
- Provided written ICF to participate in the study.
- Male and female people 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:
- 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 people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nizhny Novgorod, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nizhny Novgorod, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.