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.
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.
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.
Parallel
CT-P53
Biological/VaccineIntravenous(IV) infusion
US-Ocrevus
Biological/VaccineIntravenous(IV) infusion
EU-Ocrevus
Biological/VaccineIntravenous(IV) infusion
Area under the concentration-time curve in PK group
To demonstrate PK comparability in terms of the area under the concentration time curve in patients with RRMS as follows: * Area under the concentration-time curve from time zero to Week 2 (AUC0-wk2) * Area under the concentration-time curve from Week 2 to Week 24 (AUCwk2-wk24)
Total number of new GdE lesions on T1-weighted brain MRI in Main study group
To demonstrate the equivalence of CT-P53 to reference drug (EU-Ocrevus and US-Ocrevus) in terms of efficacy in patients with RRMS as determined by the total number of new gadolinium-enhancing (GdE) lesions on T1-weighted brain magnetic resonance imaging (MRI)
Absoulte CD19+ B-cell counts for PD assessments
To assess PD of CT-P53 and reference drug (EU-Ocrevus and US-Ocrevus) as follows: • Absolute CD19+ B-cell counts
Area under the concentration-time curve in PK group
Area under the concentration-time curve from time zero to Week 16
Total body clearance in PK group
Total body clearance covering both administrations at Weeks 0 and 2 (CL)
Volume of distribution at steady state in PK group
Volume of distribution at steady state covering both administrations at Week 0 and 2 (Vss)
