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

CT-P53 3.1

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.

2023-12-01

2027-02-01

2029-01-01

Not yet recruiting

Early phase I

512

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 512, 'type': 'ESTIMATED'}}

2023-06-18