BCD-281 versus ocrelizumab for relapsing-remitting multiple sclerosis

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

This study tests whether BCD-281 works as well and is as safe as ocrelizumab for adults 18–55 with relapsing‑remitting multiple sclerosis.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 292 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Biocad (industry)
• Drugs / interventions: ocrelizumab
• Locations: 1 site (Nizhny Novgorod)
• Trial ID: NCT07321093 on ClinicalTrials.gov

What this trial studies

This phase 3, randomized, double-blind trial enrolls adults 18–55 with relapsing‑remitting MS (EDSS 0–5.5) and compares BCD‑281 to the reference drug ocrelizumab. Participants are randomized 1:1 and followed through a 72‑week double‑blind period, a 24‑week open‑label extension (weeks 72–96), and a 4‑week follow-up (weeks 96–100). The study measures clinical efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity, with required discontinuation of prior disease‑modifying therapies before dosing. The trial is sponsored by Biocad and conducted at LLC "Medis" in Nizhny Novgorod, Russia.

Who should consider this trial

Good fit: Adults 18–55 with relapsing‑remitting MS, EDSS 0–5.5, recent relapses or MRI activity, positive VZV IgG, neurological stability, and willingness to stop other DMTs are the intended participants.

Not a fit: Patients with progressive MS, EDSS >5.5, those outside the 18–55 age range, VZV seronegative individuals, or people unable or unwilling to discontinue prior DMTs or attend the Nizhny Novgorod site are unlikely to benefit from or qualify for this trial.

Why it matters

Potential benefit: If successful, BCD‑281 could provide an additional anti‑CD20 treatment option with comparable effectiveness and safety to ocrelizumab, potentially improving choice or access for patients.

How similar studies have performed: Other anti‑CD20 monoclonal antibodies such as ocrelizumab and rituximab have demonstrated strong efficacy in RRMS, while BCD‑281 is a newer agent being directly compared to an established therapy.

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.

Where this trial is running

Nizhny Novgorod

• LLC "Medis" — Nizhny Novgorod, Russia (RECRUITING)

Study contacts

• Study coordinator: Marina Krasnova

Conditions: Relapsing-remitting Multiple Sclerosis, Multiple Sclerosis, anti CD20, monoclonal antibody