Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
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
2 other identifiers
interventional
360
19 countries
106
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2025
Longer than P75 for phase_3
106 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2025
CompletedFirst Posted
Study publicly available on registry
February 26, 2025
CompletedStudy Start
First participant enrolled
July 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 24, 2031
June 1, 2026
May 1, 2026
4 years
February 24, 2025
May 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annualized rate of new or enlarging T2 lesions_Core Part
Number of new/enlarging T2 lesions per year on MRI at month 24 (relative to baseline)
Baseline up to month 24
Secondary Outcomes (5)
Participants with no evidence of disease activity-3 (NEDA-3)_Core Part
Baseline up to month 24
Number of adverse events (AEs) and serious adverse events (SAEs)_Core Part
Baseline up to month 24
Annualized rate of new or enlarging T2 lesions_Extension Part
Month 24 up to month 48
Participants with no evidence of disease activity-3 (NEDA-3)_Extension Part
Month 24 up to month 48
Number of Adverse events and serious adverse events_Extension Part
Month 24 up to month 48
Study Arms (4)
Remibrutinib Core
EXPERIMENTALRemibrutinib tablet taken orally
Ocrelizumab Core
ACTIVE COMPARATOROcrelizumab at standard dose and route of administration (i.v. or s.c) per label
Remibrutinib Extension
EXPERIMENTALRemibrutinib tablet taken orally
Remibrutinib Extension (Ocrelizumab in Core)
EXPERIMENTALRemibrutinib tablet taken orally
Interventions
Remibrutinib tablet taken daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (106)
Perseverance Research Center
Scottsdale, Arizona, 85253, United States
University of California Irvine
Irvine, California, 92697, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010-2975, United States
Neurology of Central FL Res Ctr
Altamonte Springs, Florida, 32714, United States
University of Florida
Gainesville, Florida, 32610, United States
Neurology Associates PA
Maitland, Florida, 32751, United States
Aqualane Clinical Research
Naples, Florida, 34105, United States
Advent Health Orlando
Orlando, Florida, 32803, United States
Orlando Health Clinical Trials
Orlando, Florida, 32806, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, 32308, United States
University Of South Florida
Tampa, Florida, 33612, United States
Vero Beach Neurology
Vero Beach, Florida, 32960, United States
Rush University Medical Center
Chicago, Illinois, 60607, United States
University of Kansas Hospital
Kansas City, Kansas, 66160, United States
MedStar Montgomery Medical Center
Olney, Maryland, 20832, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Neurology Center of New England PC
Foxborough, Massachusetts, 02035, United States
Michigan Institute of Neurological
Farmington Hills, Michigan, 48334, United States
Memorial HC Ins for Neuroscience
Owosso, Michigan, 48867, United States
WA Uni School Of Med
St Louis, Missouri, 63110, United States
Cleveland Clinic Foundation
Las Vegas, Nevada, 89106, United States
Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
University of New Mexico
Albuquerque, New Mexico, 87131-0001, United States
SUNY Buffalo The Jacobs Neuro Inst
Buffalo, New York, 14203, United States
Velocity Clinical Research
Raleigh, North Carolina, 27607, United States
Sanford Health
Fargo, North Dakota, 58122, United States
Premier Health
Centerville, Ohio, 45459, United States
Univ of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio Health Research Institute
Columbus, Ohio, 43214, United States
Premier Neurology
Greenville, South Carolina, 29605, United States
Sibyl Wray MD Neurology PC
Knoxville, Tennessee, 37922, United States
Austin Regional Clinic
Austin, Texas, 78731, United States
Univ of Texas Southwest Med Center
Dallas, Texas, 75390-9034, United States
John Peter Smith Hospital
Fort Worth, Texas, 76104, United States
Saturn Research Solutions LLC
Plano, Texas, 75024, United States
Center for Neurological Disorders G
Greenfield, Wisconsin, 53228-1321, United States
Novartis Investigative Site
Rosario, Santa Fe Province, 2000, Argentina
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Rosario, Santa Fe Province, S2000BZL, Argentina
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Buenos Aires, C1055AAF, Argentina
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Caba, C1182, Argentina
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Melbourne, Victoria, 3004, Australia
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Parkville, Victoria, 3050, Australia
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Liverpool, 2170, Australia
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St Leonards, 2065, Australia
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Bruges, 8000, Belgium
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Overpelt, 3900, Belgium
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São Paulo, São Paulo, 04076-004, Brazil
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Vancouver, British Columbia, V6T 2A1, Canada
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Lévis, Quebec, G6W 0M5, Canada
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Montreal, Quebec, H4A 3T2, Canada
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Brno, 602 00, Czechia
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Hradec Králové, 500 05, Czechia
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Aarhus N, 8200, Denmark
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Glostrup Municipality, 2600, Denmark
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Bordeaux, 33076, France
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Clermont-Ferrand, 63003, France
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Lille, 59000, France
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Marseille, 13885, France
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Nice, 06001, France
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Nîmes, 30029, France
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Paris, 75940, France
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Poitiers, 86021, France
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Strasbourg, 67000, France
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Toulouse, 31059, France
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Tours, 37044, France
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Bochum, 44791, Germany
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Ulm, 89081, Germany
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Chaïdári, 124 62, Greece
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Larissa, 411 10, Greece
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Thessaloniki, 53246, Greece
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Bergamo, BG, 24127, Italy
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Foggia, FG, 71122, Italy
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Genova, GE, 16132, Italy
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Milan, MI, 20132, Italy
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Pavia, PV, 27100, Italy
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Roma, RM, 00133, Italy
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Roma, RM, 00168, Italy
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Mexico City, Mexico City, 06700, Mexico
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Mexico City, 14050, Mexico
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Braga, 4710243, Portugal
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Coimbra, 3004-561, Portugal
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Lisbon, 1169-050, Portugal
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Bratislava, 826 06, Slovakia
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Trnava, 917 02, Slovakia
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Cape Town, Western Cape, 7405, South Africa
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Pretoria, 0041, South Africa
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Majadahonda, Madrid, 28222, Spain
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El Palmar, Murcia, 30120, Spain
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Valencia, Valencia, 46017, Spain
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Barcelona, 08035, Spain
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Córdoba, 14004, Spain
Novartis Investigative Site
Madrid, 28009, Spain
Novartis Investigative Site
Madrid, 28034, Spain
Novartis Investigative Site
Madrid, 28040, Spain
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Málaga, 29010, Spain
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Seville, 41009, Spain
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Valencia, 46026, Spain
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Bern, 3010, Switzerland
Novartis Investigative Site
Lausanne, 1011, Switzerland
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Zurich, 8091, Switzerland
Novartis Investigative Site
Sheffield, South Yorkshire, S10 2JF, United Kingdom
Novartis Investigative Site
Leeds, LS1 3EX, United Kingdom
Novartis Investigative Site
London, W6 8RF, United Kingdom
Novartis Investigative Site
Swansea, SA6 6NL, United Kingdom
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2025
First Posted
February 26, 2025
Study Start
July 23, 2025
Primary Completion (Estimated)
July 24, 2029
Study Completion (Estimated)
June 24, 2031
Last Updated
June 1, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.