Study Description
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). 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.
Interventions
Ocrelizumab
Remibrutinib oral treatment
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
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Buenos Aires,C1055aaf,Argentina
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Buenos Aires,C1012aar,Argentina
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Rosario,Santa Fe Province,2000,Argentina
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Rosario,Santa Fe Province,S2000bzl,Argentina
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Liverpool,2170,Australia
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Parkville,Victoria,3050,Australia
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Melbourne,Victoria,3004,Australia
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St Leonards,2065,Australia
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Bruges,8000,Belgium
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Montreal,Quebec,H4a 3t2,Canada
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Lévis,Quebec,G6w 0m5,Canada
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Vancouver,British Columbia,V6t 2a1,Canada
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Aarhus N,8200,Denmark
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Glostrup Municipality,2600,Denmark
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Lille,59000,France
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Toulouse,31059,France
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Clermont-Ferrand,63003,France
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Poitiers,86021,France
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Bordeaux,33076,France
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Tours,37044,France
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Strasbourg,67000,France
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Paris,75940,France
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Nîmes,30029,France
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Nice,06001,France
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Thessaloniki,53246,Greece
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Larissa,411 10,Greece
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Chaïdári,124 62,Greece
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Bergamo,BG,24127,Italy
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Pavia,PV,27100,Italy
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Foggia,FG,71122,Italy
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Roma,RM,00133,Italy
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Roma,RM,00168,Italy
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Milan,MI,20132,Italy
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Genova,GE,16132,Italy
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Mexico City,14050,Mexico
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Mexico City,Mexico City,06700,Mexico
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Coimbra,3004-561,Portugal
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Lisbon,1169-050,Portugal
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Braga,4710243,Portugal
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Trnava,917 02,Slovakia
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Bratislava,826 06,Slovakia
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Pretoria,0041,South Africa
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Cape Town,Western Cape,7405,South Africa
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Valencia,46026,Spain
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El Palmar,Murcia,30120,Spain
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Valencia,Valencia,46017,Spain
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Madrid,28040,Spain
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Málaga,29010,Spain
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Majadahonda,Madrid,28222,Spain
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Córdoba,14004,Spain
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Madrid,28009,Spain
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Madrid,28034,Spain
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Seville,41009,Spain
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Barcelona,08035,Spain
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Bern,3010,Switzerland
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Zurich,8091,Switzerland
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Lausanne,1011,Switzerland
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Swansea,Sa6 6nl,United Kingdom
Holy Name Medical Center
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Teaneck,New Jersey,07666,United States
Diome Kramer
Mary Ann Picone
Premier Neurology
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Greenville,South Carolina,29605,United States
Mary Denise Hughes
Sibyl Wray MD Neurology PC
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Knoxville,Tennessee,37922,United States
Sibyl Wray
Neurology of Central FL Res Ctr
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Altamonte Springs,Florida,32714,United States
Alicia V Cabrera
John Peter Smith Hospital
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Fort Worth,Texas,76104,United States
Valentina Jovic
Horacio Chiong-Rivero
Austin Regional Clinic
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Austin,Texas,78731,United States
Diana Andino
Sanford Health
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Fargo,North Dakota,58122,United States
Scott Belliston
Destini Spaeth
University of New Mexico
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Albuquerque,New Mexico,87131-0001,United States
Clotilde Hainline
Tallahassee Neurological Clinic
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Tallahassee,Florida,32308,United States
Winston Ortiz
Memorial HC Ins for Neuroscience
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Owosso,Michigan,48867,United States
Robert Joseph Pace
Mary Beth Blythe
Aqualane Clinical Research
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Naples,Florida,34105,United States
Matthew J Baker
Neurology Associates PA
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Maitland,Florida,32751,United States
William David Honeycutt
University of Florida
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Gainesville,Florida,32610,United States
Torge Rempe
Semene Clement
Perseverance Research Center
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Scottsdale,Arizona,85253,United States
Barry Hendin
Adriana Romero
Michigan Institute of Neurological
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Farmington Hills,Michigan,48334,United States
Taylor Hess
University of Kansas Hospital
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Kansas City,Kansas,66160,United States
Sharon Lynch
Worldwide Contacts
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