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

RecruitingPhase 3

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

Who can join

Ages 40 to 70 · All sexes

Full 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
* Participants not adequately controlled on ocrelizumab (CD19+ B-cell count ≥10 cells/µL at screening)

Other inclusion and exclusion criteria may apply

About the study

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).

What is being tested

Sponsor: Novartis Pharmaceuticals · Participants: 400 · Started: Jun 23, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06846281

Locations in the U.S.

ArizonaPerseverance Research Center, Scottsdale
CaliforniaUniversity of California Irvine, Irvine
District of ColumbiaMedstar Washington Hospital Center, Washington D.C.
FloridaNeurology of Central FL Res Ctr, Altamonte Springs
University of Florida, Gainesville
Memorial Healthcare System, Hollywood
Neurology Associates PA, Maitland
Elite Clinical Research, Miami
Aqualane Clinical Research, Naples
Advent Health Orlando, Orlando
Orlando Health Clinical Trials, Orlando
Tallahassee Neurological Clinic, Tallahassee
University Of South Florida, Tampa
Vero Beach Neurology, Vero Beach
IllinoisRush University Medical Center, Chicago
University of Chicago, Chicago
KansasUniversity of Kansas Hospital, Kansas City
MarylandMedStar Montgomery Medical Center, Olney
MassachusettsLahey Hospital and Medical Center, Burlington
Neurology Center of New England PC, Foxborough
MichiganMichigan Institute of Neurological, Farmington Hills
Memorial HC Ins for Neuroscience, Owosso
MissouriWA Uni School Of Med, St Louis
NevadaCleveland Clinic Foundation, Las Vegas
New JerseyHoly Name Medical Center, Teaneck
New MexicoUniversity of New Mexico, Albuquerque
New YorkSUNY Buffalo The Jacobs Neuro Inst, Buffalo
North CarolinaVelocity Clinical Research, Raleigh
North DakotaSanford Health, Fargo
OhioPremier Health, Centerville
Univ of Cincinnati Medical Center, Cincinnati
Cleveland Clinic Foundation, Cleveland
Ohio Health Research Institute, Columbus
OregonProvidence Neurological Services West, Portland
South CarolinaPremier Neurology, Greenville
TennesseeSibyl Wray MD Neurology PC, Knoxville
TexasAustin Regional Clinic, Austin
Univ of Texas Southwest Med Center, Dallas
John Peter Smith Hospital, Fort Worth
Saturn Research Solutions LLC, Plano
VirginiaVirginia Commonwealth University, Richmond
WisconsinCenter for Neurological Disorders G, Greenfield
Medical College of Wisconsin, Milwaukee

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.