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

Celltrion Healthcare

Status and phase: Enrolling; Phase 3

Conditions: Relapsing-remitting Multiple Sclerosis

Treatments: Biological: US-Ocrevus; Biological: EU-Ocrevus; Biological: CT-P53

Study type: Interventional

Funder types: Industry

Identifiers

NCT05906992

CT-P53 3.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 512 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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512 participants in 3 patient groups

CT-P53

Experimental group

Description:

CT-P53(Ocrelizumab)

Treatment:

Biological: CT-P53

US-Ocrevus

Active Comparator group

Description:

US-licensed Ocrevus(Ocrelizumab)

Treatment:

Biological: US-Ocrevus

EU-Ocrevus

Active Comparator group

Description:

EU-approved Ocrevus(Ocrelizumab)

Treatment:

Biological: EU-Ocrevus