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

NCT06846281

RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Relapsing Multiple Sclerosis

Interventions: Remibrutinib oral treatment, Ocrelizumab

Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark

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 overview

Sex: ALL

Age: 40 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 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

Locations (120)

Scottsdale, Arizona, United States
Irvine, California, United States
Washington D.C., District of Columbia, United States
Altamonte Springs, Florida, United States
Gainesville, Florida, United States
Maitland, Florida, United States
Naples, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Olney, Maryland, United States
Boston, Massachusetts, United States
Burlington, Massachusetts, United States
Foxborough, Massachusetts, United States
Farmington Hills, Michigan, United States
Owosso, Michigan, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Teaneck, New Jersey, United States
Albuquerque, New Mexico, United States
Buffalo, New York, United States
Raleigh, North Carolina, United States
Fargo, North Dakota, United States
Centerville, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
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