Overview
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.
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.
Eligibility
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.