CT-P53 3.1
What it found
No result yet.
What was tested
Treatment tested
- Ocrelizumab
B-lymphocyte antigen CD20 binding agent
Compared with
- Ocrelizumab
B-lymphocyte antigen CD20 binding agent
What it measured
Main measures
Area under the concentration-time curve in PK group
Up to Week 24
How the body handles the medicineTotal number of new GdE lesions on T1-weighted brain MRI in Main study group
Up to Week 24
MRI lesionsFor PK Group: Area under the concentration-time curve from time zero to Week 2 (AUC0-wk2)
How the body handles the medicineFor PK Group: Area under the concentration-time curve from Week 2 to Week 24 (AUCwk2-wk24)
How the body handles the medicine
Other measures (12)
Absoulte CD19+ B-cell counts for PD assessments
Up to Week 96
Immune responseArea under the concentration-time curve in PK group
Up to Week 16
How the body handles the medicineTotal body clearance in PK group
Up to Week 2
How the body handles the medicineVolume of distribution at steady state in PK group
Up to Week 2
How the body handles the medicineSafety: Immunogenecity
Up to Week 96
Immune responseSafetyAnnualized Relapse Rate (ARR)
Up to Week 96
RelapsesChange in Expanded Disability Status Score (EDSS)
Up to Week 96
Disability progressionChange in Multiple Sclerosis Functional Composite Score (MSFCS)
Up to Week 96
Thinking and memoryTotal Number of Lesions on Brain Magnetic Resonance Imaging
Up to Week 96
MRI lesionsVolume of Hypointense Lesions on T1-weighted Brain Magnetic Resonance Imaging
Up to Week 96
MRI lesions
Who could take part
Relapsing MS · 18 to 55
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
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History
Started
Jan 2024
Main results due
Feb 2027
Finished
Jan 2029
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