RESHAPE · CLOU064C12306

Study analyzing the treatment switch from ocrelizumab to remibrutinib in participants with relapsing multiple sclerosis. The research aims to verify if the new drug maintains safety and disease control following the therapeutic transition.

A randomized, open-label, parallel-group non-inferiority study comparing the efficacy, safety, and tolerability of remibrutinib after switching from ocrelizumab in participants with relapsing multiple sclerosis, followed by open-label remibrutinib treatment. EU CT: 2023-509275-17.

Sponsor: NOVARTIS

Phase: III

Status: Follow-up

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Public study eligibility criteria

  • Key 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
  • Key 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