A Double-blind, Randomized Clinical Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis

Official 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 Requirements

• Minimum Age: 18 Years
• Maximum Age: 55 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: TRIPLE
• Enrollment: 292 participants

Study Arms

• BCD-281 (EXPERIMENTAL)
  Subjects will receive 300 mg (for the first two infusions) and 600 mg via subsequent infusions.
• Ocrelizumab (ACTIVE_COMPARATOR)
  Subjects will receive 300 mg (for the first two infusions) and 600 mg via subsequent infusions.

Interventions

• BIOLOGICAL: BCD-281 — anti-CD20 monoclonal antibody
• BIOLOGICAL: Ocrelizumab — anti-CD20 monoclonal antibody

Primary Outcomes

• Total number of T1 gadolinium-enhancing (Gd+) lesions up to Week 24. (up to Week 24)

Secondary Outcomes

• Annualized relapse rate (ARR). (up to Week 100)
• Time to first relapse. (up to Week 100)
• Proportion of subjects without confirmed relapses. (up to Week 100)
• Total number of T1 Gd+ lesions at Weeks 48, 72, 100. (up to Week 100)
• Total number of new or enlarged T2 lesions. (up to Week 100)

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.

Trial Locations

• LLC "Medis", Nizhny Novgorod, Russia

Contact Information

• Marina Krasnova — CONTACT
  Phone: +7 (812) 380 49 33
  Email: krasnovam@biocad.ru

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