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

Relapsing Remitting Multiple Sclerosis

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

Inclusion Criteria4

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 Criteria6

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.