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Research summary · AI summary · not yet reviewedHuman studyPhase 3Trial registry record – peer review not applicable
Human Study on Remibrutinib and Ocrelizumab for Relapsing Multiple Sclerosis
A Phase 3 study, involving 400 participants aged 40 to 70, was designed to compare the effects of Remibrutinib oral treatment with Ocrelizumab in patients with relapsing multiple sclerosis. The primary endpoint focused on the annualized rate of new T2 lesions. No results have been published, and enrollment is ongoing.
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This plain-English summary was written by AI from a trial registry record and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
- Human efficacy
- Not established from this source
- Mechanism
- Not reported
- Evidence strength
- No results yet
- Outcome
- Not reported
Why it matters
This research aims to evaluate a new treatment option for relapsing multiple sclerosis, which could impact clinical practices if successful.
What this does not prove
The lack of posted results means we cannot assess the study's outcomes or effectiveness.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 400 · planned enrolment
- Randomised
- Yes
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- RRMS
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Other
- Biological target
- Not reported
- Pathway
- Not reported
- Population
- Ages from 40 Years to 70 Years; sex All
- Size of effect
- Not reported
- Secondary endpoints
- Participants with no evidence of disease activity-3 (NEDA-3)_Core Part; Number of adverse events (AEs) and serious adverse events (SAEs)_Core Part; Annualized rate of new or enlarging T2 lesions_Extension Part; Participants with no evidence of disease activity-3 (NEDA-3)_Extension Part; Number of Adverse events and serious adverse events_Extension Part
- MRI endpoints
- Not reported
- Biomarkers
- Not reported
- Safety
- Not reported
Original sources
Supporting passages (20)
research categoriesOther
peer reviewedPublication date: unknown. No results are posted.
study phasePhase: Phase 3
study designStudy type: Interventional
subjectsParticipants: people; ages from 40 Years to 70 Years; sex All
speciesParticipants: people; ages from 40 Years to 70 Years; sex All
sample sizeEnrollment: 400 participants (estimated)
randomizedAllocation: Randomized
relevant ms typesConditions: Relapsing Multiple Sclerosis
interventionInterventions: Remibrutinib oral treatment; Ocrelizumab
comparatorInterventions: Remibrutinib oral treatment; Ocrelizumab
primary endpointPrimary endpoints: Annualized rate of new or enlarging T2 lesions_Core Part
follow upFollow-up: Baseline up to month 24; Month 24 up to month 48
limitationsNo results are posted. Planned enrolment and endpoints are not findings.
populationParticipants: people; ages from 40 Years to 70 Years; sex All
secondary endpoints"description": "Participants with no evidence of disease activity-3 (NEDA-3), as assessed by absence of confirmed MS relapses, 6-month confirmed disability progression (6mCDP) and new/enlarging T2 lesions on MRI",
findingsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
peer reviewedTrial registry record.
controlledArm types: Experimental; Active comparator; Experimental; Experimental
sample size basisEnrollment: 400 participants (estimated)
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