Comparing CT-P53 and Ocrevus for treating relapsing-remitting multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 clinical trial is designed to compare the efficacy, pharmacokinetics, pharmacodynamics, and safety of CT-P53, a proposed biosimilar to Ocrevus, in patients with relapsing-remitting multiple sclerosis. The study employs a double-blind, randomized, active-controlled, parallel group design to ensure robust results. Participants will receive either CT-P53 or Ocrevus, and their responses will be closely monitored to assess treatment outcomes. The goal is to demonstrate that CT-P53 is as effective and safe as Ocrevus for this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient diagnosed as multiple sclerosis (MS) in accordance with the revised McDonald criteria.
* Patient has evidence of recent MS activity as defined in the study protocol
* Patient has neurological stability for ≥30 days.
* Patient with 0 to 6.0 (both inclusive) on the EDSS score.

Exclusion Criteria:

* Patient diagnosed with primary or secondary progressive MS.
* Patient diagnosed with MS for more than 15 years duration with an EDSS score ≤2.0 at Screening.
* Patient unable to complete or has a contraindication to an MRI
* Patient with contraindications and/or severe hypersensitivity to corticosteroids including methylprednisolone or any of the excipients of study drug or etcs defined in the study protocol.
* Patient who has currently or history of any of medical conditions described in the study protocol.
* Patients who have received or going to receive any of prohibited medications or treatments defined in the study protocol.

Where it's running

• CT-P53 3.1 investigational site
  Poznan, Poland Recruiting

Study contacts

• Study coordinator: SoYoung Yoo
• Email: soyoung.yoo@celltrion.com
• Phone: +82 32 850 5791

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.