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
Novartis Pharmaceuticals
Summary
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).
Description
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, fix…
Eligibility
- Age range
- 40–70 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugRemibrutinib oral treatment
Remibrutinib tablet taken daily
- DrugOcrelizumab
Ocrelizumab 600mg infusion or 920mg injection
Locations (99)
- Perseverance Research CenterScottsdale, Arizona
- Medstar Washington Hospital CenterWashington D.C., District of Columbia
- Neurology of Central FL Res CtrAltamonte Springs, Florida
- University of FloridaGainesville, Florida
- Neurology Associates PAMaitland, Florida
- Aqualane Clinical ResearchNaples, Florida