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

Relapsing-remitting Multiple Sclerosis Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

CT-P53, containing the active ingredient ocrelizumab, is a humanized monoclonal antibody that is being developed as a proposed biosimilar medicinal product to Ocrevus. The purpose of this study is to demonstrate similar efficacy, PK, PD and safety of CT-P53 and Ocrevus in patients with Relpasing-remitting Multiple Screlosis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05906992
Study type Interventional
Source Celltrion
Contact SoYoung Yoo
Phone +82 32 850 5791
Email soyoung.yoo@celltrion.com
Status Recruiting
Phase Phase 3
Start date January 11, 2024
Completion date January 2029
View Details
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