RecruitingPhase 3NCT05906992

A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With 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


Sponsor

Celltrion

Enrollment

512 participants

Start Date

Jan 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a double-blind, randomized, active-controlled, parallel group, Phase 1/3 study to compare efficacy, PK, PD and overall safety of CT-P53 with Ocrevus in patients with Relapsing-remitting Multiple Sclerosis.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a biosimilar drug (CT-P53) to the brand-name medication Ocrevus (ocrelizumab) in people with relapsing-remitting multiple sclerosis (MS). A biosimilar is a near-identical version of an approved drug. The study aims to confirm that CT-P53 works the same way and is equally safe. **You may be eligible if...** - You have been diagnosed with relapsing-remitting MS - You have had recent MS activity (as defined by the study protocol) - Your neurological condition has been stable for at least 30 days - Your disability score (EDSS) is between 0 and 6.0 **You may NOT be eligible if...** - You have primary or secondary progressive MS - You have had MS for more than 15 years with a low disability score - You cannot have an MRI scan - You have an allergy to corticosteroids or the study drug - You are on or have taken medications that are prohibited per the study protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCT-P53

Intravenous(IV) infusion

BIOLOGICALUS-Ocrevus

Intravenous(IV) infusion

BIOLOGICALEU-Ocrevus

Intravenous(IV) infusion


Locations(1)

CT-P53 3.1 investigational site

Poznan, Poland

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NCT05906992


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