Back to Clinical Trials
Phase 3Recruiting

Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.

Sponsored by Novartis Pharmaceuticals

About this study

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.

Where this study is enrolling (43)

Show all 43 locations
Who can participate

Inclusion criteria

  • ✓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
  • ✓Suitable to be switched to remibrutinib based on physician judgement or patient preference

Exclusion criteria

  • ✕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
  • ✕Active, chronic disease of the immune system other than MS
  • ✕Severe cardiac disease or significant findings on the ECG
  • ✕Participant who is unable to undergo MRI scans
  • ✕History of life-threatening infusion or injection reaction related to ocrelizumab
  • ✕Participants not adequately controlled on ocrelizumab (CD19+ B-cell count ≥10 cells/µL at screening)
  • ✕Other inclusion and exclusion criteria may apply

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.