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 CT-P53 for Relapsing-remitting Multiple Sclerosis

This is a neither you nor the study doctors know who gets the real treatment, randomly assigned, active-controlled, parallel group, Phase 1/3 study to compare how well it works, PK, PD and overall safety of CT-P53 with Ocrevus in patients with Relapsing-remitting Multiple Sclerosis.

Official registry: https://clinicaltrials.gov/study/NCT05906992 · Celltrion · enrollment listed as 512

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 CT-P53, US-Ocrevus, or EU-Ocrevus. The registry lists allocation as randomized. This is a neither you nor the study doctors know who gets the real treatment, randomly assigned, active-controlled, parallel group, Phase 1/3 study to compare how well it works, PK, PD and overall safety of CT-P53 with Ocrevus in patients with Relapsing-remitting Multiple Sclerosis.

They plan to enroll about 512 people at Poznan. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

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

Interventions: CT-P53, US-Ocrevus, EU-Ocrevus

Primary outcome (registry wording): Area under the concentration-time curve in PK group

Who it is for (from inclusion criteria)

  • Ages 18 Years to 55 Years
  • 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

Public study contact (from the registry)

SoYoung Yoo

+82 32 850 5791

soyoung.yoo@celltrion.com

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 NCT05906992 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 NCT05906992?

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 NCT05906992?

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