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Clinical Trials in the USA / NCT06846281
Recruiting Phase 3

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

NCT06846281 · tracked via the Priya Life Science USA tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2025-06-23
Last updated
2026-08-26

Condition(s) studied

Relapsing Multiple Sclerosis

Investigational drug(s) / intervention(s)

Remibrutinib oral treatmentOcrelizumab

Remibrutinib oral treatment: Remibrutinib tablet taken daily

Ocrelizumab: Ocrelizumab 600mg infusion or 920mg injection

Study 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).

Eligibility

Sex
ALL
Min age
40 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (129)

FacilityCityRegionStatus
Perseverance Research Center Scottsdale Arizona Recruiting
University of California Irvine Irvine California Recruiting
Medstar Washington Hospital Center Washington D.C. District of Columbia Recruiting
Neurology of Central FL Res Ctr Altamonte Springs Florida Recruiting
University of Florida Gainesville Florida Recruiting
Memorial Healthcare System Hollywood Florida Recruiting
Neurology Associates PA Maitland Florida Recruiting
Elite Clinical Research Miami Florida Recruiting
Aqualane Clinical Research Naples Florida Recruiting
Advent Health Orlando Orlando Florida Recruiting
Orlando Health Clinical Trials Orlando Florida Recruiting
Tallahassee Neurological Clinic Tallahassee Florida Recruiting
University Of South Florida Tampa Florida Recruiting
Vero Beach Neurology Vero Beach Florida Recruiting
Rush University Medical Center Chicago Illinois Recruiting
University of Chicago Chicago Illinois Recruiting
University of Kansas Hospital Kansas City Kansas Recruiting
MedStar Montgomery Medical Center Olney Maryland Recruiting
Tufts Medical Center Boston Massachusetts Withdrawn
Lahey Hospital and Medical Center Burlington Massachusetts Recruiting
Neurology Center of New England PC Foxborough Massachusetts Recruiting
Michigan Institute of Neurological Farmington Hills Michigan Recruiting
Memorial HC Ins for Neuroscience Owosso Michigan Recruiting
WA Uni School Of Med St Louis Missouri Recruiting
Cleveland Clinic Foundation Las Vegas Nevada Recruiting
Holy Name Medical Center Teaneck New Jersey Recruiting
University of New Mexico Albuquerque New Mexico Recruiting
SUNY Buffalo The Jacobs Neuro Inst Buffalo New York Recruiting
Velocity Clinical Research Raleigh North Carolina Recruiting
Sanford Health Fargo North Dakota Recruiting
Premier Health Centerville Ohio Recruiting
Univ of Cincinnati Medical Center Cincinnati Ohio Recruiting
Cleveland Clinic Foundation Cleveland Ohio Recruiting
Ohio Health Research Institute Columbus Ohio Recruiting
Providence Neurological Services West Portland Oregon Recruiting
Premier Neurology Greenville South Carolina Recruiting
Sibyl Wray MD Neurology PC Knoxville Tennessee Recruiting
Austin Regional Clinic Austin Texas Recruiting
Univ of Texas Southwest Med Center Dallas Texas Recruiting
John Peter Smith Hospital Fort Worth Texas Recruiting

+ 89 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06846281 on ClinicalTrials.gov ↗ ← All trials in the USA