What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Remibrutinib oral treatment, or Ocrelizumab. The registry lists allocation as randomized. The purpose of this Phase 3b study is to assess the how well it works, whether it is safe and how hard side effects are to live with of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS).
They plan to enroll about 400 people at 122 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Randomized, Open-label, Parallel-group, Non-inferiority Study Comparing Efficacy, Safety, and Tolerability of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis, Followed by Open-label Treatment With Remibrutinib
Interventions: Remibrutinib oral treatment, Ocrelizumab
Primary outcome (registry wording): Annualized rate of new or enlarging T2 lesions_Core Part