Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing BCD-281 for Relapsing-remitting Multiple Sclerosis (RRMS)

The aim of this study is to compare the how well it works, safety profile, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-281 and the reference drug in subjects with relapsing multiple sclerosis.

Official registry: https://clinicaltrials.gov/study/NCT07321093 · Biocad · enrollment listed as 292

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are BCD-281, or Ocrelizumab. The registry lists allocation as randomized. The aim of this study is to compare the how well it works, safety profile, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-281 and the reference drug in subjects with relapsing multiple sclerosis.

They plan to enroll about 292 people at Nizhny Novgorod. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

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

Interventions: BCD-281, Ocrelizumab

Primary outcome (registry wording): Total number of T1 gadolinium-enhancing (Gd+) lesions up to Week 24.

Who it is for (from inclusion criteria)

  • Ages 18 Years to 55 Years
  • 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:
  • at least one relapse within the last12 months, and/or

Public study contact (from the registry)

Marina Krasnova

+7 (812) 380 49 33

krasnovam@biocad.ru

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07321093 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07321093?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07321093?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary