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.
- Conditions
- Multiple SclerosisMedDRA version: 20.1Level: PTClassification code: 10028245Term: Multiple sclerosis Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2022-501622-37-00
- Lead Sponsor
- Celltrion Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 547
Patient is male or female aged between 18 years and 55 years (both inclusive), Patient diagnosed as Multiple Sclerosis (MS) in accordance with the revised McDonald criteria (2017)., 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., 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method