Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
NCT ID: NCT06846281
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
360 participants
INTERVENTIONAL
2025-07-23
2031-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Remibrutinib Core
Remibrutinib tablet taken orally
Remibrutinib oral treatment
Remibrutinib tablet taken daily
Ocrelizumab Core
Ocrelizumab at standard dose and route of administration (i.v. or s.c) per label
Ocrelizumab
Ocrelizumab 600mg infusion or 920mg injection
Remibrutinib Extension
Remibrutinib tablet taken orally
Remibrutinib oral treatment
Remibrutinib tablet taken daily
Remibrutinib Extension (Ocrelizumab in Core)
Remibrutinib tablet taken orally
Remibrutinib oral treatment
Remibrutinib tablet taken daily
Interventions
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Remibrutinib oral treatment
Remibrutinib tablet taken daily
Ocrelizumab
Ocrelizumab 600mg infusion or 920mg injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
70 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Neurology of Central FL Res Ctr
Altamonte Springs, Florida, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Michigan Institute of Neurological
Farmington Hills, Michigan, United States
Premier Neurology
Greenville, South Carolina, United States
Sibyl Wray MD Neurology PC
Knoxville, Tennessee, United States
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Melbourne, Victoria, Australia
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Parkville, Victoria, Australia
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Liverpool, , Australia
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St Leonards, , Australia
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Bruges, , Belgium
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Lévis, Quebec, Canada
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Montreal, Quebec, Canada
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Aarhus N, , Denmark
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Glostrup Municipality, , Denmark
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Bordeaux, , France
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Clermont-Ferrand, , France
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Lille, , France
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Nice, , France
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Nîmes, , France
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Paris, , France
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Strasbourg, , France
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Toulouse, , France
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Tours, , France
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Chaïdári, , Greece
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Larissa, , Greece
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Thessaloniki, , Greece
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Bergamo, BG, Italy
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Foggia, FG, Italy
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Genova, GE, Italy
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Pavia, PV, Italy
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Roma, RM, Italy
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Roma, RM, Italy
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Mexico City, Mexico City, Mexico
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Mexico City, , Mexico
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Braga, , Portugal
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Lisbon, , Portugal
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Bratislava, , Slovakia
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Trnava, , Slovakia
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Cape Town, Western Cape, South Africa
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Pretoria, , South Africa
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Barcelona, Catalonia, Spain
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Majadahonda, Madrid, Spain
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El Palmar, Murcia, Spain
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Valencia, Valencia, Spain
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Córdoba, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Seville, , Spain
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Valencia, , Spain
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Bern, , Switzerland
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Lausanne, , Switzerland
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Zurich, , Switzerland
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Facility Contacts
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Other Identifiers
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CLOU064C12306
Identifier Type: -
Identifier Source: org_study_id
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