The purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS).
Male or female aged 40 to 70 years (inclusive)
Diagnosis of RMS according to the 2017 McDonald diagnostic criteria
Treated with ocrelizumab according to routine clinical practice and at standard dose
Neurologically stable within 30 days
Diagnosis of primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald criteria
History of clinically significant Central Nervous System disease or neurological disorders
History of confirmed Progressive Multifocal Leukoencephalopathy or neurological symptoms consistent
Active clinically significant systemic bacterial, viral, parasitic or fungal infections
Parallel
Remibrutinib oral treatment
DrugRemibrutinib tablet taken daily
Ocrelizumab
DrugOcrelizumab 600mg infusion or 920mg injection
Annualized rate of new or enlarging T2 lesions_Core Part
Number of new/enlarging T2 lesions per year on MRI at month 24 (relative to baseline)
Participants with no evidence of disease activity-3 (NEDA-3)_Core Part
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
Number of adverse events (AEs) and serious adverse events (SAEs)_Core Part
Adverse events will be collected throughout the trial. Any safety assessment findings such as laboratory, vital signs, electrocardiogram data that are considered clinically significant or meet the protocol definition of an adverse event will be reported as adverse event or serious adverse event, as appropriate
Annualized rate of new or enlarging T2 lesions_Extension Part
Number of new/enlarging T2 lesions per year on MRI
Participants with no evidence of disease activity-3 (NEDA-3)_Extension Part
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
Click on the lead sponsor to view all of their trials.
