Efficacy and Safety of Remibrutinib after Switching from Ocrelizumab in Participants Living with Relapsing Multiple Sclerosis, Followed by Open-Label Treatment with Remibrutinib

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 (RMS), followed by open-label treatment with remibrutinib.

Purpose: To provide efficacy, safety, and tolerability data for remibrutinib after switching from ocrelizumab and in comparison to continuous ocrelizumab in a population with RMS.

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.

In order to participate you must meet the following criteria:

• Are male or female, 40 to 70 years of age (inclusive) at Screening.
• Have a diagnosis of RMS according to criteria.
• Have an EDSS score of 0 to 6.5 (inclusive) at Screening and randomization.
• Have need treated with ocrelizumab according to routine clinical practice and at standard dose for at least 18 months. The last administration of ocrelizumab must have occurred within 5 to 9 months prior to randomization.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.