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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHoffmann-La Roche

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Ocrelizumab

    Drug

    Ocrelizumab will be administered as per the schedule specified in the respective arms.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: RMS CohortExperimental treatment 1 intervention
Group B: PPMS CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

RMS Cohort: Annualized Protocol-defined Relapse Rate

Time frame
Up to approximately 1.6 years
2

PPMS Cohort: B-cell Levels in Blood

Time frame
Up to Week 48
3

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

Time frame
At Week 48

Secondary outcomes

1

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

Time frame
Up to Week 48
2

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

Time frame
Up to Week 48
3

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

Time frame
Up to Week 24
4

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

Time frame
Up to Week 48

Other outcomes

Sponsors and contacts

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