Comparing CT-P53 and Ocrevus for treating relapsing-remitting multiple sclerosis
A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 1/3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis
This study is testing if a new treatment called CT-P53 works as well and is as safe as Ocrevus for people with relapsing-remitting multiple sclerosis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 512 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Celltrion Industry-sponsored |
| Drugs / interventions | ocrelizumab |
| Locations | 1 site (Poznan) |
| Trial ID | NCT05906992 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with relapsing-remitting multiple sclerosis who meet specific inclusion criteria and have neurological stability.
Not a fit: Patients with primary or secondary progressive multiple sclerosis or those with a long history of MS may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more affordable treatment option for relapsing-remitting multiple sclerosis.
How similar studies have performed: Other studies have shown success with biosimilars in similar contexts, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Poznan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.