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).
The study is a randomized, open-label, non-inferiority multi-center, Phase 3b study to provide efficacy, safety, and tolerability data for remibrutinib after switching from ocrelizumab and in comparison to continuous ocrelizumab in plwRMS. This study consists of an initial Core Part (CP) (maximum duration per participant of up to 24 months), followed by an Extension Part (EP) (of up to 24 months duration) for eligible participants. All participants completing the 24-month treatment of the Core Part of the study may be eligible to continue in the Extension Part, an open-label, single-arm, fixed-dose design in which participants are treated with remibrutinib for up to 24 months. The study will be conducted in the USA among other countries globally.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Remibrutinib tablet taken daily
Ocrelizumab 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)
Time frame: Baseline up to month 24
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
Time frame: Baseline up to month 24
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
Time frame: Baseline up to month 24
Annualized rate of new or enlarging T2 lesions_Extension Part
Number of new/enlarging T2 lesions per year on MRI
Time frame: Month 24 up to month 48
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
Time frame: Month 24 up to month 48
Number of Adverse events and serious adverse events_Extension 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Perseverance Research Center
Scottsdale, Arizona, United States
RECRUITINGUniversity of California Irvine
Irvine, California, United States
RECRUITINGMedstar Washington Hospital Center
Washington D.C., District of Columbia, United States
RECRUITINGNeurology of Central FL Res Ctr
Altamonte Springs, Florida, United States
RECRUITINGUniversity of Florida
Gainesville, Florida, United States
RECRUITINGMemorial Healthcare System
Hollywood, Florida, United States
RECRUITINGNeurology Associates PA
Maitland, Florida, United States
RECRUITINGElite Clinical Research
Miami, Florida, United States
RECRUITINGAqualane Clinical Research
Naples, Florida, United States
RECRUITINGAdvent Health Orlando
Orlando, Florida, United States
RECRUITING...and 119 more locations
Time frame: Month 24 up to month 48