RecruitingPhase 3Relapsing MSNCT059069922022-501622-37-00

What it found

Still running

No result yet.

What was tested

Treatment tested

Compared with

What it measured

Main measures

  • Area under the concentration-time curve in PK group

    Up to Week 24

    How the body handles the medicine
  • Total number of new GdE lesions on T1-weighted brain MRI in Main study group

    Up to Week 24

    MRI lesions
  • For PK Group: Area under the concentration-time curve from time zero to Week 2 (AUC0-wk2)

    How the body handles the medicine
  • For 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 response
  • Area under the concentration-time curve in PK group

    Up to Week 16

    How the body handles the medicine
  • Total body clearance in PK group

    Up to Week 2

    How the body handles the medicine
  • Volume of distribution at steady state in PK group

    Up to Week 2

    How the body handles the medicine
  • Safety: Immunogenecity

    Up to Week 96

    Immune responseSafety
  • Annualized Relapse Rate (ARR)

    Up to Week 96

    Relapses
  • Change in Expanded Disability Status Score (EDSS)

    Up to Week 96

    Disability progression
  • Change in Multiple Sclerosis Functional Composite Score (MSFCS)

    Up to Week 96

    Thinking and memory
  • Total Number of Lesions on Brain Magnetic Resonance Imaging

    Up to Week 96

    MRI lesions
  • Volume 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 registry

About 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

    1. Started

      Jan 2024

    2. Main results due

      Feb 2027

    3. Finished

      Jan 2029

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