Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
Purpose
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).
Condition
- Relapsing Multiple Sclerosis
Eligibility
- Eligible Ages
- Between 40 Years and 70 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
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 Other inclusion and exclusion criteria may apply
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Remibrutinib Core |
Remibrutinib tablet taken orally |
|
|
Active Comparator Ocrelizumab Core |
Ocrelizumab at standard dose and route of administration (i.v. or s.c) per label |
|
|
Experimental Remibrutinib Extension |
Remibrutinib tablet taken orally |
|
|
Experimental Remibrutinib Extension (Ocrelizumab in Core) |
Remibrutinib tablet taken orally |
|
Recruiting Locations
Kansas City 4273837, Kansas 4273857 66160
More Details
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
Detailed 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, 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.