Recruiting

Phase 3

RemibrutinibA Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07225504

Conditions

Secondary Progressive Multiple Sclerosis (SPMS)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Remibrutinib (blinded)

Placebo

Remibrutinib (Open label)

Study Details

Brief summary:

The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)

Conditions

Secondary Progressive Multiple Sclerosis (SPMS)

Study ID

NCT07225504

Start date

Nov 11, 2025

Status verified date

Jul, 2026

Completion date

Jan 2, 2034

Anticipated

Primary completion date

Dec 3, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

Signed informed consent must be obtained prior to any assessment performed.
Male or female participants aged 18-65 (inclusive) at Screening.
Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018), with current SPMS in accordance with the revised clinical course (Lublin et al 2014) at Screening
Absence of documented clinical relapses in the 24 months before Screening and randomization.
EDSS score of 3.0 to 6.0 (inclusive) at Screening.
Documented evidence of disability progression in the 12 months before Screening.

Exclusion Criteria:

Unwilling or unable to undergo MRI scans as per protocol (for example, claustrophobia, or presents absolute contraindications to MRI (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator)).
History of clinically significant central nervous system (CNS) disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic multiple sclerosis (MS).
Ongoing substance abuse (drug or alcohol) or any other factor (e.g. serious psychiatric condition) that may interfere with the participant's ability to cooperate and comply with the study procedures.
Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML.
Women of childbearing potential (WOCBP), unless they are using highly effective methods of contraception (failure rate < 1% per year) while taking study treatment and for at least 1 week after stopping study treatment.
Significant bleeding risk or coagulation disorders, at Screening.
Use of exclusionary medication prior to Screening/randomization as listed in the protocol.

Other protocol-defined inclusion/exclusion critria may apply

Study Design

Enrollment

1275 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Remibrutinib (LOU064)

Core Part: Remibrutinib film-coated tablet taken orally

\[Extension Part: Open-label remibrutinib film-coated tablet taken orally\]

placebo comparator: Placebo

Core Part: Matching placebo film-coated tablet taken orally

\[Extension Part: Open-label remibrutinib film-coated tablet taken orally\]

Interventions

Remibrutinib (blinded)

Remibrutinib (Blinded) active treatment, oral tablet

Placebo

Matching placebo (binded), oral tablet

Remibrutinib (Open label)

Remibrutinib (Open Label), oral tablet

Primary outcome measure

Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS) [ Time Frame: From baseline up to approximately 5 years ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

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

Novartis Pharmaceuticals

+41613241111

Locations

Alabama Neurology Associates PC

Recruiting

Birmingham, Alabama, United States, 35209

Contacts

Virginia Weinacker

+1 205 803 2210 gweinacker@alaneuro.com

Principal Investigator:

Emily Sherill Riser

Ctr for Neurology and Spine

Recruiting

Phoenix, Arizona, United States, 85018

Contacts

Madison Turner

madison@centerforneurologyandspine.com

Principal Investigator:

Leslie Zuniga

AZ Integrated Neuro and Spine

Recruiting

Phoenix, Arizona, United States, 85037

Contacts

Nicole Hank

nhank@prcresearcheducation.com

Principal Investigator:

Barry Hendin

Center for Neurosciences

Recruiting

Tucson, Arizona, United States, 85718

Contacts

Lisa Alvarez

+1 520 320 2147 lalvarez@neurotucson.com

Principal Investigator:

Francisco Valdivia

Fullerton Neuro and Headache Ctr

Recruiting

Fullerton, California, United States, 92835

Contacts

Alexandra Vasquez

+1 714 738 0800 avasquez@fullertonneuro.net

Principal Investigator:

Jack H Florin

Regina Berkovich MD PhD Inc

Recruiting

West Hollywood, California, United States, 90048

Contacts

Divya Venkataramu

+1 310 493 4715 venkataramu.neuro@gmail.com

Principal Investigator:

Regina Berkovich

UC Health Neuroscience Ctr

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Isabel Adkisson

isabel.adkisson@cuanschutz.edu

Principal Investigator:

Enrique Alvarez

Georgetown University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Grace Inserra

+1 202 444 8830 gi90@georgetown.edu

Principal Investigator:

Faria Amjad

Medstar Washington Hosp Ctr

Recruiting

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

Contacts

Anu Bhooshan

+1 202 877 7000 anu.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 4990 adiresearchcfl@gmail.com

Principal Investigator:

Alicia V Cabrera

UF Health Cancer Center

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Kyle Rizer

+1 352 733 2412 kyle.rizer@neurology.ufl.edu

Principal Investigator:

Torge Rempe

Homestead Assoc In Research Inc

Recruiting

Homestead, Florida, United States, 33033

Contacts

Daydene Ordaz

13052460873 dordaz@associatesinresearch.com

Principal Investigator:

Angel Carrasco

Neurology Associates PA

Recruiting

Maitland, Florida, United States, 32751

Contacts

Kelly Holley

+1 407 647 5996 admin@naparesearch.com

Principal Investigator:

William David Honeycutt

Miami NS Ins Baptist Health S FL

Recruiting

Miami, Florida, United States, 33176

Contacts

Sukie Hernandez

sukie.hernandez@baptisthealth.net

Principal Investigator:

Luis Compres Brugal

Aqualane Clinical Research

Recruiting

Naples, Florida, United States, 34105

Contacts

Taylor Kerskie

+1 239 434 0332 taylor@aqualaneresearch.com

Principal Investigator:

Matthew J Baker

Orlando Health Clinical Trials

Recruiting

Orlando, Florida, United States, 32806

Contacts

Charlene Carlo

+1 321 841 3686 Charlene.carlo@orlandohealth.com

Principal Investigator:

Amparo Gutierrez

Comprehensive Neurology Clinic

Recruiting

Orlando, Florida, United States, 32825

Contacts

Elliuz Leal

+1 407 913 9120 elealcrc@gmail.com

Principal Investigator:

Refaat El-Said

Neurology Associates of Ormond Beach

Recruiting

Ormond Beach, Florida, United States, 32174

Contacts

Heather Schutz

+1 386 676 6340 hschutz@naobresearch.com

Principal Investigator:

James Scott

Axiom Brain Health

Recruiting

Tampa, Florida, United States, 33609

Contacts

Jennifer Fornes

jfornes@axiombrainhealth.com

Principal Investigator:

Mark Cascione

University Of South Florida

Recruiting

Tampa, Florida, United States, 33612

Contacts

Eduardo Sucre

+1 813 974 6378 eduardosucre@usf.edu

Principal Investigator:

John Ciotti

Joi Life Wellness Group LLC

Recruiting

Smyrna, Georgia, United States, 30080

Contacts

Carmel Ibeawuchi

cibeawuchi@msm.edu

Principal Investigator:

Mitzi Joi Williams

Hawaii Pacific Neuroscience LLC

Recruiting

Honolulu, Hawaii, United States, 96817

Contacts

Gina McNarney

+1 808 261 4476 gmcnarney@hawaiineuroscience.com

Principal Investigator:

Natalia Gonzalez-Caldito

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Caroline Gebczak

caroline.Gebczak@northwestern.edu

Principal Investigator:

Edith Graham

University of Kansas Hospital

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Sarah Razor

+1 913 945 5059 sbellis2@kumc.edu

Principal Investigator:

Sharon Lynch

Mid Atlantic Epilepsy and Sleep Ctr

Recruiting

Bethesda, Maryland, United States, 20817-1807

Contacts

Salman Hashmi

hashmis@epilepsydc.com

Principal Investigator:

Jonathan Ross

Neuro Institute of New England P C

Recruiting

Foxborough, Massachusetts, United States, 02035

Contacts

Jillian Pellegrini

+1 781 551 5812 jpellegrini@neurocenterne.com

Principal Investigator:

Salvatore Napoli

Elliot Lewis MS Center

Recruiting

Wellesley, Massachusetts, United States, 02481

Contacts

Isabelle Messina

+1 781 591 8300 isabellemessina@elliotlewisms.org

Principal Investigator:

Andrew Bouley

U Mass Memorial Medical Center

Recruiting

Worchester, Massachusetts, United States, 01605

Contacts

Nimmy Francis

+1 508 856 5073 nimmy.rosefrancis@umassmed.edu

Principal Investigator:

Carolina Ionete

Michigan Institute of Neurological

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

Emily Blazejewski

+1 248 553 0010 eblazejewski@mindonline.com

Principal Investigator:

Martin Belkin

University of New Mexico Hospital

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Sophia Pearson

+1 505 272 4550 SMPearson@salud.unm.edu

Principal Investigator:

Clotilde Hainline

Premier Neurology

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Mallory Gedeon

mallory.g@premier-neuro.com

Principal Investigator:

Mary Denise Hughes

Neurology Clinic PC

Recruiting

Cordova, Tennessee, United States, 38018

Contacts

Ye Liu

+1 901 866 9252 yliu@neuroclinic.org

Principal Investigator:

Lee Stein

Carum Research

Recruiting

Dallas, Texas, United States, 75231

Contacts

Sarah Pelfrey

Spelfrey@neurologydallas.com

Principal Investigator:

Adnan Subei

Saturn Research Solution

Recruiting

Plano, Texas, United States, 75024

Contacts

Maxine Fligg

mfligg@saturnclinical.com

Principal Investigator:

Annette Okai

Citta Clinical Research

Recruiting

Spokane, Washington, United States, 99202

Contacts

Jill Ciccarello

jciccarello@cittaclinicalresearch.com

Principal Investigator:

Michael Coats

Novartis Investigative Site

Recruiting

Vancouver, British Columbia, Canada, V6T 2A1

Novartis Investigative Site

Recruiting

Halifax, Nova Scotia, Canada, B3H 4K4

Novartis Investigative Site

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Novartis Investigative Site

Recruiting

Lévis, Quebec, Canada, G6W 0M5

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H2X 1R9

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H3A 2B4

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H4A 3T2

Novartis Investigative Site

Recruiting

Québec, Quebec, Canada, G1J 1Z4

Novartis Investigative Site

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

MS
Multiple sclerosis
secondary progressive multiple sclerosis
SPMS
remibrutinib
LOU064
adult
Expanded Disability Status Scale
EDSS
McDonald diagnostic criteria

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-07-29.