Recruiting
Phase 3

Remibrutinib vs. Ocrelizumab

Sponsor:

Novartis Pharmaceuticals

Code:

NCT06846281

Conditions

Relapsing Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Not accepted

Interventions

Remibrutinib oral treatment

Ocrelizumab

Study Details

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).

Conditions

Relapsing Multiple Sclerosis

Study ID

NCT06846281

Start date

Jun 23, 2025

Status verified date

Aug, 2026

Completion date

Jun 25, 2031

Anticipated

Primary completion date

Jul 25, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Remibrutinib Core

Remibrutinib tablet taken orally

active comparator: Ocrelizumab Core

Ocrelizumab at standard dose and route of administration (i.v. or s.c) per label

experimental: Remibrutinib Extension

Remibrutinib tablet taken orally

experimental: Remibrutinib Extension (Ocrelizumab in Core)

Remibrutinib tablet taken orally

Interventions

Remibrutinib oral treatment

Remibrutinib tablet taken daily

Ocrelizumab

Ocrelizumab 600mg infusion or 920mg injection

Primary outcome measure

  • Annualized rate of new or enlarging T2 lesions_Core Part [ Time Frame: Baseline up to month 24 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

Perseverance Research Center

Recruiting

Scottsdale, Arizona, United States, 85253

Contacts

Adriana Romero

aromero@prcresearcheducation.com

Principal Investigator:

Barry Hendin

University of California Irvine

Recruiting

Irvine, California, United States, 92697

Contacts

Veronica Martin

vero@hs.uci.edu

Principal Investigator:

Michael Sy

Medstar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010-2975

Contacts

Anu Bhooshan

+1 202 877 8946anu.r.bhooshan@medstar.net

Principal Investigator:

Brian Barry

Neurology of Central FL Res Ctr

Recruiting

Altamonte Springs, Florida, United States, 32714

Contacts

Adiana Perez

+1 407 790 4990adiresearchcfl@gmail.com

Principal Investigator:

Alicia V Cabrera

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Whitney Miller

wjm1433@ufl.edu

Principal Investigator:

Torge Rempe

Memorial Healthcare System

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Hina Khan

+1 954 265 6934hikhan@mhs.net

Principal Investigator:

Buse Sengul

Neurology Associates PA

Recruiting

Maitland, Florida, United States, 32751

Contacts

Kelly Holley

+1 407 647 5996admin@naparesearch.com

Principal Investigator:

William David Honeycutt

Elite Clinical Research

Recruiting

Miami, Florida, United States, 33144

Contacts

Rebeca Fernandez

+1 305 262 3396rfernandez@eliteclinicalresearch.com

Principal Investigator:

Gelasio A Baras

Aqualane Clinical Research

Recruiting

Naples, Florida, United States, 34105

Contacts

Taylor Kerskie

+1 239 434 0332taylor@aqualaneresearch.com

Principal Investigator:

Matthew J Baker

Advent Health Orlando

Recruiting

Orlando, Florida, United States, 32803

Contacts

McKinzie McTyeire

+1 407 303 5600mckinzie.mctyeire@adventhealth.com

Principal Investigator:

Anita Fletcher

Orlando Health Clinical Trials

Recruiting

Orlando, Florida, United States, 32806

Contacts

Charlene Carlo

+1 407 352 5434Charlene.carlo@orlandohealth.com

Principal Investigator:

Amparo Gutierrez

Tallahassee Neurological Clinic

Recruiting

Tallahassee, Florida, United States, 32308

Contacts

Sharon Devore

+1 850 878 8121sharondevore@hotmail.com

Principal Investigator:

Winston Ortiz

University Of South Florida

Recruiting

Tampa, Florida, United States, 33612

Contacts

Amber McPherson

+1 813 974 9423amjackson@usf.edu

Principal Investigator:

John Ciotti

Vero Beach Neurology

Recruiting

Vero Beach, Florida, United States, 32960

Contacts

Clellia Bergamino

+1 772 492 7051#232cbergamino@geodysseyrsch.com

Principal Investigator:

Stuart Shafer

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60607

Contacts

Bartosz Jacher

Bartosz.Jacher@Northwestern.edu

Principal Investigator:

Allison Osen

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Cheryl Bibbs

+1 773 702 5382cbibbs@bsd.uchicago.edu

Principal Investigator:

Veronica Cipriani

University of Kansas Hospital

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Vonda Whitley

+1 913 588 9600vwhitley@kumc.edu

Principal Investigator:

Sharon Lynch

MedStar Montgomery Medical Center

Recruiting

Olney, Maryland, United States, 20832

Contacts

Yemisrach Tadesse

yemisrach.g.tadesse@medstar.net

Principal Investigator:

Faria Amjad

Lahey Hospital and Medical Center

Recruiting

Burlington, Massachusetts, United States, 01805

Contacts

Anish Panda

+1 781 744 3874Anish.Panda@lahey.org

Principal Investigator:

Dan Michael Pineda

Neurology Center of New England PC

Recruiting

Foxborough, Massachusetts, United States, 02035

Contacts

Brianne Calitri

+1 781 551 5812bcalitri@neurocenterne.com

Principal Investigator:

Salvatore Napoli

Michigan Institute of Neurological

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

Emily Blazejewski

+1 248 553 0010eblazejewski@mindonline.com

Principal Investigator:

Martin Belkin

Memorial HC Ins for Neuroscience

Recruiting

Owosso, Michigan, United States, 48867

Contacts

Samantha Katt

skatt@memorialhealthcare.org

Principal Investigator:

Robert Joseph Pace

WA Uni School Of Med

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Kiontay Watson

+1 314 362 3293k.watson@wustl.edu

Principal Investigator:

Matthew R Brier

Cleveland Clinic Foundation

Recruiting

Las Vegas, Nevada, United States, 89106

Contacts

Laurinda Keelen

+1 702 483 6003keelenl@ccf.org

Principal Investigator:

Carrie M Hersh

Holy Name Medical Center

Recruiting

Teaneck, New Jersey, United States, 07666

Contacts

Diome Kramer

dkramer@holyname.org

Principal Investigator:

Mary Ann Picone

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87131-0001

Contacts

Emily Reese

+1 505 272 2836ejreese@salud.unm.edu

Principal Investigator:

Clotilde Hainline

SUNY Buffalo The Jacobs Neuro Inst

Recruiting

Buffalo, New York, United States, 14203

Contacts

Kara Patrick

kpatrick@buffalo.edu

Principal Investigator:

Bianca Weinstock-Guttman

Velocity Clinical Research

Recruiting

Raleigh, North Carolina, United States, 27607

Contacts

Harsh Patel

HPatel@velocityclinical.com

Principal Investigator:

Casey Jeffreys

Sanford Health

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Destini Spaeth

destini.spaeth@sanfordhealth.org

Principal Investigator:

Scott Belliston

Premier Health

Recruiting

Centerville, Ohio, United States, 45459

Contacts

Don McHone

djmchone@premierhealth.com

Principal Investigator:

Jon Williams

Univ of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Gideon Gyebi

+ 1 513 558 4489gyebign@ucmail.uc.edu

Principal Investigator:

Aram Zabeti

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Dawn Maniawski

+1 216 445 5788maniawd@ccf.org

Principal Investigator:

Devon Conway

Ohio Health Research Institute

Recruiting

Columbus, Ohio, United States, 43214

Contacts

Megan Heckathorn

1 614 566 1262Megan.Heckathorn@ohiohealth.com

Principal Investigator:

Jacqueline Nicholas

Providence Neurological Services West

Recruiting

Portland, Oregon, United States, 97225

Contacts

Hunter Weaver

+1 503 216 1150hunter.weaver@providence.org

Principal Investigator:

Jessica Rice

Premier Neurology

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Jada Crawford

+1 864 655 4005jada.c@premier-neuro.com

Principal Investigator:

Mary Denise Hughes

Sibyl Wray MD Neurology PC

Recruiting

Knoxville, Tennessee, United States, 37922

Contacts

Kim Puccio

+1 865 218 6222kpuccio@hopeneuro.com

Principal Investigator:

Sibyl Wray

Austin Regional Clinic

Recruiting

Austin, Texas, United States, 78731

Contacts

Katerina Rodriguez

+1 512 344 0362krodriguez@innovoresearch.com

Principal Investigator:

Diana Andino

Univ of Texas Southwest Med Center

Recruiting

Dallas, Texas, United States, 75390-9034

Contacts

Manuel Huichapa

manuel.huichapa@utsouthwestern.edu

Principal Investigator:

Peter Sguigna

John Peter Smith Hospital

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Valentina Jovic

Vjovic@jpshealth.org

Principal Investigator:

Horacio Chiong-Rivero

Saturn Research Solutions LLC

Recruiting

Plano, Texas, United States, 75024

Contacts

Maxine Fligg

+1 972 403 8184mfligg@saturnclinical.com

Principal Investigator:

Annette Okai

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298-0111

Contacts

Aarati Pokharel

aarati.pokharel@vcuhealth.org

Principal Investigator:

Ryan Canissario

Center for Neurological Disorders G

Recruiting

Greenfield, Wisconsin, United States, 53228-1321

Contacts

Emily Barraza

Emily.barraza@cndmilwaukee.com

Principal Investigator:

Bhupendra Khatri

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Anna Freiberg

+1 414 805 5249afreiberg@mcw.edu

Principal Investigator:

Ahmed Obeidat

Novartis Investigative Site

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Novartis Investigative Site

Recruiting

Vancouver, British Columbia, Canada, V6T 2A1

Novartis Investigative Site

Recruiting

Lévis, Quebec, Canada, G6W 0M5

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H4A 3T2

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • MS
  • RMS
  • Remibrutinib
  • LOU064
  • Ocrelizumab
  • Age
  • MRI
  • T2 lesions
  • NEDA-3

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-08-26.