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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-55
SponsorCelltrion

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • CT-P53
  • US-Ocrevus
  • EU-Ocrevus

Treatment groups

512 Participants
are divided into 3 treatment groups

Sponsors and collaborators