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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-70
SponsorNovartis Pharmaceuticals

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Remibrutinib oral treatment
  • Ocrelizumab

Treatment groups

360 Participants
are divided into 4 treatment groups

Sponsors and collaborators