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A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Participants With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis

A Multicenter, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Chinese Patients With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis
Running, not recruitingPhase 4Relapsing and progressiveNCT07483450

What it found

Still running

No result yet.

What was tested

Treatment tested

What it measured

Main measures

  • RMS Cohort: Annualized Protocol-defined Relapse Rate

    Up to approximately 1.6 years

    Relapses

  • PPMS Cohort: B-cell Levels in Blood

    Up to Week 48

    Immune response

  • PPMS Cohort: Percentage of Participants Achieving Cluster of Differentiation 19 (CD19+) B-cell Levels of <10 Cells/Microliter (μL) at Week 48

    At Week 48

    Immune response

Other measures (18)

  • RMS Cohort: Percentage of Participants Who Have No Evidence of Disease Activity (NEDA3) During a 48-week Period

    Up to Week 48

  • RMS Cohort: Percentage of Relapse-free Participants by Week 48

    Up to Week 48

    Relapses

  • RMS Cohort: Percentage of Participants Who Have NEDA3 During a 24-week Period

    Up to Week 24

  • RMS Cohort: Total Number of T1 Gadolinium (Gd)-enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI)

    Up to Week 48

    MRI lesions

  • RMS Cohort: Total Number of New or Enlarging T2 Hyperintense Lesions as Detected by Brain MRI

    Up to Week 48

    MRI lesions

  • RMS and PPMS Cohorts: Change From Baseline to Week 48 in the Concentration of Serum Neurofilament Light Chain (Nfl)

    Baseline up to Week 48

    Blood or spinal fluid markers

  • RMS and PPMS Cohorts: Change From Baseline to Week 48 in Expanded Disability Status Scale (EDSS)

    Baseline up to Week 48

    Disability progressionFatigueBladder, bowel and sexual function

  • RMS and PPMS Cohorts: Change From Baseline to Week 48 in Timed 25-Foot Walk Test (T25FWT)

    Baseline up to Week 48

    Disability progressionWalking and mobility

  • RMS and PPMS Cohorts: Change From Baseline to Week 48 in 9-Hole Peg Test (9-HPT)

    Baseline up to Week 48

    Disability progressionArm and hand function

  • RMS and PPMS Cohorts: Change From Baseline in EuroQoL 5-Dimension Questionnaire (5-Level Version; EQ-5D-5L) Index Score at Week 48

    Baseline, Week 48

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)

Who could take part

Relapsing and progressive · 18 to 55

Inclusion Criteria: * Diagnosis of RMS/PPMS in accordance with the revised 2017 McDonald Criteria * EDSS score from 0-5.5 (RMS) or 3.0-6.5 (PPMS), inclusive, at screening and baseline * Documented MRI of brain with abnormalities consistent with MS before screening Exclusion Criteria: * Diagnosis of PPMS or non-active secondary progressive multiple sclerosis (SPMS) (only for RMS cohort) * History of relapsing remitting multiple sclerosis (RRMS) or SPMS at screening (only for PPMS cohort) * Disease duration of more than 10 years in participants with an EDSS ≤ 2.0 at screening (only for RMS cohort) * History of confirmed or suspected progressive multifocal leukoencephalopathy (PML) * Inability to complete an MRI scan or contraindication to Gd administration * Contraindications to mandatory pre-medications (i.e., corticosteroids and antihistamines) * Known presence of other neurologic disorders if they could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study * Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study * Known history of human immunodeficiency virus (HIV) infection * Lack of peripheral venous access * Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab), unless the last infusion was at least 6 months prior to screening * Positive screening tests for hepatitis B virus (HBV) and/or hepatitis C virus (HCV)

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The main purpose of this study is to evaluate the efficacy of ocrelizumab in participants with relapsing multiple sclerosis (RMS) and to characterize the ocrelizumab pharmacodynamic (PD) profile in Chinese participants with primary progressive multiple sclerosis (PPMS).

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Related trials

History

    1. Started

      Jul 2025

    2. Main results due

      Dec 2027

    3. Finished

      Dec 2028

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