NCT05906992

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 512 (estimated)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Relapsing-remitting Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	CT-P53	Intravenous(IV) infusion
BIOLOGICAL	US-Ocrevus	Intravenous(IV) infusion
BIOLOGICAL	EU-Ocrevus	Intravenous(IV) infusion

Timeline

• Start date: 2024-01-11
• Primary completion: 2027-02-01
• Completion: 2029-01-01
• First posted: 2023-06-18
• Last updated: 2024-05-22

Locations

1 site across 1 country: Poland

Regulatory

• FDA-regulated drug study