AzTrials
AzTrials

Secondary Progressive Multiple Sclerosis (SPMS)Phase 3REMASTERNCT07225504

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

A Phase 3 study testing Remibrutinib (blinded) and Remibrutinib (Open label) in people with Secondary Progressive Multiple Sclerosis (SPMS), run by Novartis Pharmaceuticals at 296 sites in 36 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 65 years
What is being tested?
Remibrutinib (blinded) and Remibrutinib (Open label)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,275 participants
Where
296 sitesin 36 countries
Study dates
11 Nov 2025to 2 Jan 2034
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

296 sites in 36 countries. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

1-888-669-6682

novartis.email@novartis.com

Novartis Pharmaceuticals contact

+41613241111

296 sites in 36 countries

United States43 sites, 43 recruiting

  • University of New Mexico Hospital

    Albuquerque, New Mexico, 87106

    Sophia Pearson, +1 505 272 4550, SMPearson@salud.unm.edu

    Clotilde Hainline

    Recruiting

  • Neurology of Central FL Res Ctr

    Altamonte Springs, Florida, 32714

    Adiana Perez, +1 407 790 4990, adiresearchcfl@gmail.com

    Alicia V Cabrera

    Recruiting

  • UC Health Neuroscience Ctr

    Aurora, Colorado, 80045

    Isabel Adkisson, isabel.adkisson@cuanschutz.edu

    Enrique Alvarez

    Recruiting

  • Mid Atlantic Epilepsy and Sleep Ctr

    Bethesda, Maryland, 20817-1807

    Salman Hashmi, hashmis@epilepsydc.com

    Jonathan Ross

    Recruiting

  • Alabama Neurology Associates PC

    Birmingham, Alabama, 35209

    Virginia Weinacker, +1 205 803 2210, gweinacker@alaneuro.com

    Emily Sherill Riser

    Recruiting

  • Atrium Health

    Charlotte, North Carolina, 28207

    Catherine Tsoulos, +1 704 468 0101, catherine.tsoulos@atriumhealth.org

    Donna Graves

    Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

    Caroline Gebczak, caroline.Gebczak@northwestern.edu

    Edith Graham

    Recruiting

  • Cleveland Clinic Ohio

    Cleveland, Ohio, 44195

    Dawn Maniawski, maniawd@ccf.org

    Robert Bermel

    Recruiting

  • Neurology Clinic PC

    Cordova, Tennessee, 38018

    Ye Liu, +1 901 866 9252, yliu@neuroclinic.org

    Lee Stein

    Recruiting

  • Carum Research

    Dallas, Texas, 75231

    Maya Manjane, +1 214 750 9977, maya.manjane@carumresearch.com

    Adnan Subei

    Recruiting

  • Michigan Institute of Neurological

    Farmington Hills, Michigan, 48334

    Emily Blazejewski, +1 248 553 0010, eblazejewski@mindonline.com

    Martin Belkin

    Recruiting

  • Neuro Institute of New England P C

    Foxborough, Massachusetts, 02035

    Jillian Pellegrini, +1 781 551 5812, jpellegrini@neurocenterne.com

    Salvatore Napoli

    Recruiting

  • Clinre Comprehensive Neurology

    Frederick, Maryland, 21702

    Saad Masroor Syed, +1 240 566 3130, ssyed@clinre.com

    Shahid Rafiq

    Recruiting

  • Fullerton Neuro and Headache Ctr

    Fullerton, California, 92835

    Alexandra Vasquez, +1 714 738 0800, avasquez@fullertonneuro.net

    Jack H Florin

    Recruiting

  • UF Health Cancer Center

    Gainesville, Florida, 32610

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

    Torge Rempe

    Recruiting

  • Premier Neurology

    Greenville, South Carolina, 29605

    Jada Crawford, jada.c@premier-neuro.com

    Mary Denise Hughes

    Recruiting

  • Homestead Assoc In Research Inc

    Homestead, Florida, 33033

    Daydene Ordaz, 13052460873, dordaz@associatesinresearch.com

    Angel Carrasco

    Recruiting

  • Hawaii Pacific Neuroscience LLC

    Honolulu, Hawaii, 96817

    Gina McNarney, +1 808 261 4476, gmcnarney@hawaiineuroscience.com

    Natalia Gonzalez-Caldito

    Recruiting

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

    Sarah Razor, +1 913 945 5059, sbellis2@kumc.edu

    Sharon Lynch

    Recruiting

  • Neurology Associates PA

    Maitland, Florida, 32751

    Mary Grace Remedio, +1 407 647 5996, grace.recruiter@naparesearch.com

    William David Honeycutt

    Recruiting

  • Miami NS Ins Baptist Health S FL

    Miami, Florida, 33176

    Sukie Hernandez, sukie.hernandez@baptisthealth.net

    Luis Compres Brugal

    Recruiting

  • Aqualane Clinical Research

    Naples, Florida, 34105

    Felicity Schlonsky, +1 239 434 0332, felicity@aqualaneresearch.com

    Matthew J Baker

    Recruiting

  • Vanderbilt Breast Center at One Hundred Oaks

    Nashville, Tennessee, 37204

    Jordon Winn, jordon.winn@vumc.org

    Francesca Bagnato

    Recruiting

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

    Rachel Romansik, +1 949 288 5701, Rachel.romansik@hoag.org

    Yasir Jassam

    Recruiting

  • Orlando Health Clinical Trials

    Orlando, Florida, 32806

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

    Amparo Gutierrez

    Recruiting

  • Comprehensive Neurology Clinic

    Orlando, Florida, 32825

    Elliuz Leal, +1 407 913 9120, elealcrc@gmail.com

    Refaat El-Said

    Recruiting

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida, 32174

    Heather Schutz, +1 386 676 6340, hschutz@naobresearch.com

    James Scott

    Recruiting

  • Xenoscience Inc

    Phoenix, Arizona, 85004

    Derek Soto, +1 602 265 6500, dsoto@xenoscience.com

    Stephen Flitman

    Recruiting

  • Ctr for Neurology and Spine

    Phoenix, Arizona, 85018

    Madison Turner, madison@centerforneurologyandspine.com

    Leslie Zuniga

    Recruiting

  • AZ Integrated Neuro and Spine

    Phoenix, Arizona, 85037

    Nicole Hank, nhank@prcresearcheducation.com

    Barry Hendin

    Recruiting

  • Saturn Research Solution

    Plano, Texas, 75024

    Maxine Fligg, mfligg@saturnclinical.com

    Annette Okai

    Recruiting

  • Velocity Clinical Research

    Raleigh, North Carolina, 27607

    Harsh Patel, +1 984 251 1336, HPatel@velocityclinical.com

    Casey Jeffreys

    Recruiting

  • University of Washington MS Clinic

    Seattle, Washington, 98133

    Elisa McGee, +1 206 598 3344, emcgee@uw.edu

    Gloria von Geldern

    Recruiting

  • Joi Life Wellness Group LLC

    Smyrna, Georgia, 30080

    Semene Clement, 4043830845, sclement@usf.edu

    Mitzi Joi Williams

    Recruiting

  • Citta Clinical Research

    Spokane, Washington, 99202

    Jill Ciccarello, jciccarello@cittaclinicalresearch.com

    Michael Coats

    Recruiting

  • Axiom Brain Health

    Tampa, Florida, 33609

    Analie Herbert, aherbert@axiombrainhealth.com

    Mark Cascione

    Recruiting

  • University Of South Florida

    Tampa, Florida, 33612

    Eduardo Sucre, +1 813 974 6378, eduardosucre@usf.edu

    John Ciotti

    Recruiting

  • Center for Neurosciences

    Tucson, Arizona, 85718

    Lisa Alvarez, +1 520 320 2147, lalvarez@neurotucson.com

    Francisco Valdivia

    Recruiting

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

    Sree Nagaraj, +1 202 444 8830, sn1031@georgetown.edu

    Faria Amjad

    Recruiting

  • Medstar Washington Hosp Ctr

    Washington D.C., District of Columbia, 20010

    Anu Bhooshan, +1 202 877 7000, anu.r.bhooshan@medstar.net

    Brian Barry

    Recruiting

  • Elliot Lewis MS Center

    Wellesley, Massachusetts, 02481

    Isabelle Messina, +1 781 591 8300, isabellemessina@elliotlewisms.org

    Andrew Bouley

    Recruiting

  • Regina Berkovich MD PhD Inc

    West Hollywood, California, 90048

    Divya Venkataramu, +1 310 493 4715, venkataramu.neuro@gmail.com

    Regina Berkovich

    Recruiting

  • U Mass Memorial Medical Center

    Worchester, Massachusetts, 01605

    Nimmy Francis, +1 508 856 5073, nimmy.rosefrancis@umassmed.edu

    Carolina Ionete

    Recruiting

Other trials in United States

Spain22 sites, 22 recruiting

  • Novartis Investigative Site

    Albacete, Castille-La Mancha, 02006

    Recruiting

  • Novartis Investigative Site

    Alicante, 03010

    Recruiting

  • Novartis Investigative Site

    Barakaldo, Vizcaya, 48903

    Recruiting

  • Novartis Investigative Site

    Barcelona, Barcelona, 08035

    Recruiting

  • Novartis Investigative Site

    Castilleja de la Cuesta, Sevilla, 41950

    Recruiting

  • Novartis Investigative Site

    El Palmar, Murcia, 30120

    Recruiting

  • Novartis Investigative Site

    Jerez de la Frontera, Cadiz, 11407

    Recruiting

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907

    Recruiting

  • Novartis Investigative Site

    Las Palmas GC, 35010

    Recruiting

  • Novartis Investigative Site

    Lleida, 25198

    Recruiting

  • Novartis Investigative Site

    Logroño, La Rioja, 26006

    Recruiting

  • Novartis Investigative Site

    Madrid, 28006

    Recruiting

  • Novartis Investigative Site

    Madrid, 28009

    Recruiting

  • Novartis Investigative Site

    Madrid, 28034

    Recruiting

  • Novartis Investigative Site

    Madrid, 28040

    Recruiting

  • Novartis Investigative Site

    Málaga, 29010

    Recruiting

  • Novartis Investigative Site

    Pozuelo de Alarcón, Madrid, 28223

    Recruiting

  • Novartis Investigative Site

    Salamanca, 37007

    Recruiting

  • Novartis Investigative Site

    Seville, 41009

    Recruiting

  • Novartis Investigative Site

    Torrejón de Ardoz, Madrid, 28850

    Recruiting

  • Novartis Investigative Site

    Valencia, Valencia, 46017

    Recruiting

  • Novartis Investigative Site

    Valencia, 46026

    Recruiting

Other trials in Spain

France21 sites, 21 recruiting

  • Novartis Investigative Site

    Ajaccio, 20090

    Recruiting

  • Novartis Investigative Site

    Amiens, 80054

    Recruiting

  • Novartis Investigative Site

    Clermont-Ferrand, 63003

    Recruiting

  • Novartis Investigative Site

    Grenoble, 38043

    Recruiting

  • Novartis Investigative Site

    Lille, 59000

    Recruiting

  • Novartis Investigative Site

    Lille, 59037

    Recruiting

  • Novartis Investigative Site

    Limoges, Haute Vienne, 87000

    Recruiting

  • Novartis Investigative Site

    Montpellier, 34090

    Recruiting

  • Novartis Investigative Site

    Nancy, 54035

    Recruiting

  • Novartis Investigative Site

    Nantes, 44093

    Recruiting

  • Novartis Investigative Site

    Nice, 06000

    Recruiting

  • Novartis Investigative Site

    Nîmes, 30029

    Recruiting

  • Novartis Investigative Site

    Orsay, 91400

    Recruiting

  • Novartis Investigative Site

    Paris, 75013

    Recruiting

  • Novartis Investigative Site

    Paris, 75940

    Recruiting

  • Novartis Investigative Site

    Poitiers, 86021

    Recruiting

  • Novartis Investigative Site

    Rennes, 35033

    Recruiting

  • Novartis Investigative Site

    Rouen, 76031

    Recruiting

  • Novartis Investigative Site

    Strasbourg, 67000

    Recruiting

  • Novartis Investigative Site

    Toulouse, 31059

    Recruiting

  • Novartis Investigative Site

    Tours, 37044

    Recruiting

Other trials in France

China20 sites, 20 recruiting

  • Novartis Investigative Site

    Beijing, 100034

    Recruiting

  • Novartis Investigative Site

    Beijing, 100070

    Recruiting

  • Novartis Investigative Site

    Changchun, Jilin, 130021

    Recruiting

  • Novartis Investigative Site

    Chongqing, 400016

    Recruiting

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510080

    Recruiting

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310002

    Recruiting

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310016

    Recruiting

  • Novartis Investigative Site

    Hohhot, Inner Mongolia, 010017

    Recruiting

  • Novartis Investigative Site

    Shanghai, 200040

    Recruiting

  • Novartis Investigative Site

    Shenyang, Liaoning, 110011

    Recruiting

  • Novartis Investigative Site

    Suzhou, Jiangsu, 215004

    Recruiting

  • Novartis Investigative Site

    Taiyuan, Shanxi, 030001

    Recruiting

  • Novartis Investigative Site

    Tianjin, 300052

    Recruiting

  • Novartis Investigative Site

    Wenzhou, Zhejiang, 325000

    Recruiting

  • Novartis Investigative Site

    Wuhan, Hubei, 430030

    Recruiting

  • Novartis Investigative Site

    Wuhan, Hubei, 430060

    Recruiting

  • Novartis Investigative Site

    Xianyang, Shaanxi, 712000

    Recruiting

  • Novartis Investigative Site

    Yinchuan, Ningxia, 750004

    Recruiting

  • Novartis Investigative Site

    Zhengzhou, Henan, 450003

    Recruiting

  • Novartis Investigative Site

    Zunyi, Guizhou, 563000

    Recruiting

Other trials in China

Germany18 sites, 18 recruiting

  • Novartis Investigative Site

    Cottbus, Brandenburg, 03048

    Recruiting

  • Novartis Investigative Site

    Erbach im Odenwald, 64711

    Recruiting

  • Novartis Investigative Site

    Erfurt, 99089

    Recruiting

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

    Recruiting

  • Novartis Investigative Site

    Giessen, 35392

    Recruiting

  • Novartis Investigative Site

    Greifswald, 17475

    Recruiting

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06120

    Recruiting

  • Novartis Investigative Site

    Heidelberg, 69120

    Recruiting

  • Novartis Investigative Site

    Ibbenbueren, 49477

    Recruiting

  • Novartis Investigative Site

    Itzehoe, 25524

    Recruiting

  • Novartis Investigative Site

    Jena, Thuringia, 07740

    Recruiting

  • Novartis Investigative Site

    Leipzig, Saxony, 04103

    Recruiting

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg, 68167

    Recruiting

  • Novartis Investigative Site

    Munich, Bavaria, 81377

    Recruiting

  • Novartis Investigative Site

    Tübingen, 72076

    Recruiting

  • Novartis Investigative Site

    Ulm, 89073

    Recruiting

  • Novartis Investigative Site

    Unterhaching, Bavaria, 82008

    Recruiting

  • Novartis Investigative Site

    Wiesbaden, 65191

    Recruiting

Other trials in Germany

Argentina15 sites, 15 recruiting

  • Novartis Investigative Site

    Bombal, Mendoza Province, M5500DXO

    Recruiting

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires F.D., 1221

    Recruiting

  • Novartis Investigative Site

    Buenos Aires, C1012AAR

    Recruiting

  • Novartis Investigative Site

    Caba, C1055AAF

    Recruiting

  • Novartis Investigative Site

    Caba, C1182

    Recruiting

  • Novartis Investigative Site

    Caba, C1424BYD

    Recruiting

  • Novartis Investigative Site

    CABA, Buenos Aires, C1428AQK

    Recruiting

  • Novartis Investigative Site

    CABA, C1181ACH

    Recruiting

  • Novartis Investigative Site

    Capital Federal, Buenos Aires, 1424

    Recruiting

  • Novartis Investigative Site

    Rosario, Santa Fe Province, 2000

    Recruiting

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000BZL

    Recruiting

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DSW

    Recruiting

  • Novartis Investigative Site

    San Juan, San Juan Province, J5402DIL

    Recruiting

  • Novartis Investigative Site

    San Miguel de, Tucumán Province, T4000

    Recruiting

  • Novartis Investigative Site

    Santiago del Estero, Santiago del Estero Province, G4200AIR

    Recruiting

Other trials in Argentina

Poland15 sites, 15 recruiting

  • Novartis Investigative Site

    Bydgoszcz, Woj Kujawsko Pomorskie, 85-796

    Recruiting

  • Novartis Investigative Site

    Chojnice, 89-600

    Recruiting

  • Novartis Investigative Site

    Katowice, 40-081

    Recruiting

  • Novartis Investigative Site

    Katowice, 40-686

    Recruiting

  • Novartis Investigative Site

    Krakow, Lesser Poland Voivodeship, 30-727

    Recruiting

  • Novartis Investigative Site

    Krakow, Poland, 31-531

    Recruiting

  • Novartis Investigative Site

    Krakow, 30-565

    Recruiting

  • Novartis Investigative Site

    Lodz, 93-113

    Recruiting

  • Novartis Investigative Site

    Lublin, 20-410

    Recruiting

  • Novartis Investigative Site

    Rzeszów, 35-323

    Recruiting

  • Novartis Investigative Site

    Skorzewo, 60-185

    Recruiting

  • Novartis Investigative Site

    Szczecin, 71-252

    Recruiting

  • Novartis Investigative Site

    Warsaw, 01-684

    Recruiting

  • Novartis Investigative Site

    Zabrze, 41-800

    Recruiting

  • Novartis Investigative Site

    Żory, 44-240

    Recruiting

Other trials in Poland

Canada12 sites, 12 recruiting

  • Novartis Investigative Site

    Burnaby, British Columbia, V5G 2X6

    Recruiting

  • Novartis Investigative Site

    Calgary, Alberta, T2N 2T9

    Recruiting

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 2B7

    Recruiting

  • Novartis Investigative Site

    Halifax, Nova Scotia, B3H 4K4

    Recruiting

  • Novartis Investigative Site

    Lévis, Quebec, G6W 0M5

    Recruiting

  • Novartis Investigative Site

    Montreal, Quebec, H2X 1R9

    Recruiting

  • Novartis Investigative Site

    Montreal, Quebec, H3A 2B4

    Recruiting

  • Novartis Investigative Site

    Montreal, Quebec, H4A 3T2

    Recruiting

  • Novartis Investigative Site

    Ottawa, Ontario, K1H 8L6

    Recruiting

  • Novartis Investigative Site

    Québec, Quebec, G1J 1Z4

    Recruiting

  • Novartis Investigative Site

    Sherbrooke, Quebec, J1H 5N4

    Recruiting

  • Novartis Investigative Site

    Vancouver, British Columbia, V6T 2A1

    Recruiting

Other trials in Canada

Italy11 sites, 11 recruiting

  • Novartis Investigative Site

    Ancona, AN, 60020

    Recruiting

  • Novartis Investigative Site

    Bergamo, BG, 24127

    Recruiting

  • Novartis Investigative Site

    Chieti, CH, 66100

    Recruiting

  • Novartis Investigative Site

    Foggia, FG, 71122

    Recruiting

  • Novartis Investigative Site

    Gallarate, VA, 21013

    Recruiting

  • Novartis Investigative Site

    Naples, 80138

    Recruiting

  • Novartis Investigative Site

    Pavia, PV, 27100

    Recruiting

  • Novartis Investigative Site

    Pozzilli, IS, 86077

    Recruiting

  • Novartis Investigative Site

    Roma, RM, 00133

    Recruiting

  • Novartis Investigative Site

    Roma, RM, 00168

    Recruiting

  • Novartis Investigative Site

    Roma, RM, 00189

    Recruiting

Other trials in Italy

Brazil9 sites, 9 recruiting

  • Novartis Investigative Site

    Fortaleza, Ceará, 60120-002

    Recruiting

  • Novartis Investigative Site

    Joinville, Santa Catarina, 89202-165

    Recruiting

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90430-001

    Recruiting

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90560-032

    Recruiting

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90620-130

    Recruiting

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 22775-001

    Recruiting

  • Novartis Investigative Site

    Santo André, São Paulo, 09040-010

    Recruiting

  • Novartis Investigative Site

    São Paulo, São Paulo, 01244-030

    Recruiting

  • Novartis Investigative Site

    São Paulo, São Paulo, 04076-004

    Recruiting

Other trials in Brazil

United Kingdom9 sites, 9 recruiting

  • Novartis Investigative Site

    Brighton, East Sussex, BN2 5BE

    Recruiting

  • Novartis Investigative Site

    Bristol, BS10 5NB

    Recruiting

  • Novartis Investigative Site

    Coventry, CV2 2DX

    Recruiting

  • Novartis Investigative Site

    Glasgow, EH9 1LF

    Recruiting

  • Novartis Investigative Site

    Leeds, LS1 3EX

    Recruiting

  • Novartis Investigative Site

    London, E1 2AT

    Recruiting

  • Novartis Investigative Site

    Nottingham, NG7 2UH

    Recruiting

  • Novartis Investigative Site

    Romford, Essex, RM7 0AG

    Recruiting

  • Novartis Investigative Site

    Stoke-on-Trent, ST4 6QG

    Recruiting

Other trials in United Kingdom

Bulgaria8 sites, 8 recruiting

  • Novartis Investigative Site

    Pleven, 5800

    Recruiting

  • Novartis Investigative Site

    Sofia, 1113

    Recruiting

  • Novartis Investigative Site

    Sofia, 1309

    Recruiting

  • Novartis Investigative Site

    Sofia, 1407

    Recruiting

  • Novartis Investigative Site

    Sofia, 1408

    Recruiting

  • Novartis Investigative Site

    Sofia, 1431

    Recruiting

  • Novartis Investigative Site

    Sofia, 1510

    Recruiting

  • Novartis Investigative Site

    Sofia, 1606

    Recruiting

Other trials in Bulgaria

India8 sites, 8 recruiting

  • Novartis Investigative Site

    Chandigarh, Punjab, 160012

    Recruiting

  • Novartis Investigative Site

    Gurugram, Haryana, 122011

    Recruiting

  • Novartis Investigative Site

    Hyderabad, Telangana, 500082

    Recruiting

  • Novartis Investigative Site

    Kochi, Kerala, 682025

    Recruiting

  • Novartis Investigative Site

    Mangalore, Karnataka, 575003

    Recruiting

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110029

    Recruiting

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110060

    Recruiting

  • Novartis Investigative Site

    Vellore, Tamil Nadu, 632004

    Recruiting

Other trials in India

Israel8 sites, 8 recruiting

  • Novartis Investigative Site

    Ashkelon, 7830604

    Recruiting

  • Novartis Investigative Site

    Hadera, 3820302

    Recruiting

  • Novartis Investigative Site

    Haifa, 3436212

    Recruiting

  • Novartis Investigative Site

    Jerusalem, 9112001

    Recruiting

  • Novartis Investigative Site

    Ramat Gan, 5265601

    Recruiting

  • Novartis Investigative Site

    Rehovot, 7661041

    Recruiting

  • Novartis Investigative Site

    Tel Aviv, 6423906

    Recruiting

  • Novartis Investigative Site

    Tsrifin, 7030000

    Recruiting

Other trials in Israel

Australia7 sites, 7 recruiting

  • Novartis Investigative Site

    Clayton, Victoria, 3168

    Recruiting

  • Novartis Investigative Site

    Heidelberg, Victoria, 3084

    Recruiting

  • Novartis Investigative Site

    Kogarah, New South Wales, 2217

    Recruiting

  • Novartis Investigative Site

    Murdoch, Western Australia, 6150

    Recruiting

  • Novartis Investigative Site

    New Lambton Heights, New South Wales, 2305

    Recruiting

  • Novartis Investigative Site

    Southport, 4215

    Recruiting

  • Novartis Investigative Site

    Westmead, New South Wales, 2145

    Recruiting

Other trials in Australia

Czechia6 sites, 6 recruiting

  • Novartis Investigative Site

    Brno, 602 00

    Recruiting

  • Novartis Investigative Site

    Hradec Králové, 500 05

    Recruiting

  • Novartis Investigative Site

    Jihlava, 586 01

    Recruiting

  • Novartis Investigative Site

    Prague, 140 59

    Recruiting

  • Novartis Investigative Site

    Prague, 150 06

    Recruiting

  • Novartis Investigative Site

    Teplice, 415 29

    Recruiting

Other trials in Czechia

Greece6 sites, 6 recruiting

  • Novartis Investigative Site

    Athens, Attica, 155 62

    Recruiting

  • Novartis Investigative Site

    Athens, 115 28

    Recruiting

  • Novartis Investigative Site

    Chaïdári, 124 62

    Recruiting

  • Novartis Investigative Site

    Ioannina, 455 00

    Recruiting

  • Novartis Investigative Site

    Larissa, 411 10

    Recruiting

  • Novartis Investigative Site

    Thessaloniki, 546 36

    Recruiting

Other trials in Greece

Hungary6 sites, 6 recruiting

  • Novartis Investigative Site

    Budapest, 1033

    Recruiting

  • Novartis Investigative Site

    Budapest, 1044

    Recruiting

  • Novartis Investigative Site

    Budapest, 1106

    Recruiting

  • Novartis Investigative Site

    Kistarcsa, 2143

    Recruiting

  • Novartis Investigative Site

    Pécs, Baranya, 7623

    Recruiting

  • Novartis Investigative Site

    Tatabánya, 2800

    Recruiting

Other trials in Hungary

Austria5 sites, 5 recruiting

  • Novartis Investigative Site

    Innsbruck, Tyrol, 6020

    Recruiting

  • Novartis Investigative Site

    Linz, Upper Austria, 4020

    Recruiting

  • Novartis Investigative Site

    Linz, 4020

    Recruiting

  • Novartis Investigative Site

    Vienna, 1180

    Recruiting

  • Novartis Investigative Site

    Vienna, 1210

    Recruiting

Other trials in Austria

Netherlands5 sites, 5 recruiting

  • Novartis Investigative Site

    's-Hertogenbosch, North Brabant, 5223 GZ

    Recruiting

  • Novartis Investigative Site

    Amsterdam, North Holland, 1081 HV

    Recruiting

  • Novartis Investigative Site

    Arnhem, Gelderland, 6815 AD

    Recruiting

  • Novartis Investigative Site

    Leiden, 2334 CN

    Recruiting

  • Novartis Investigative Site

    Sittard-Geleen, Limburg, 6162 BG

    Recruiting

Other trials in Netherlands

Portugal5 sites, 5 recruiting

  • Novartis Investigative Site

    Braga, 4710-243

    Recruiting

  • Novartis Investigative Site

    Lisbon, 1169-050

    Recruiting

  • Novartis Investigative Site

    Lisbon, 1349-019

    Recruiting

  • Novartis Investigative Site

    Lisbon, 1649-035

    Recruiting

  • Novartis Investigative Site

    Porto, 4200-319

    Recruiting

Other trials in Portugal

Slovakia5 sites, 5 recruiting

  • Novartis Investigative Site

    Bratislava, Slovakia, 826 06

    Recruiting

  • Novartis Investigative Site

    Bratislava, 851 01

    Recruiting

  • Novartis Investigative Site

    Komárno, 945 05

    Recruiting

  • Novartis Investigative Site

    Nitra, 950 01

    Recruiting

  • Novartis Investigative Site

    Trnava, Slovakia, 917 02

    Recruiting

Other trials in Slovakia

Belgium4 sites, 4 recruiting

  • Novartis Investigative Site

    Bonheiden, 2820

    Recruiting

  • Novartis Investigative Site

    Brussels, 1070

    Recruiting

  • Novartis Investigative Site

    Leuven, Vlaams Brabant, 3000

    Recruiting

  • Novartis Investigative Site

    Roeselare, West Vlaanderen, 8800

    Recruiting

Other trials in Belgium

Colombia4 sites, 4 recruiting

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080020

    Recruiting

  • Novartis Investigative Site

    Bogotá, 111321

    Recruiting

  • Novartis Investigative Site

    Medellín, 050001

    Recruiting

  • Novartis Investigative Site

    Medellín, 050034

    Recruiting

Other trials in Colombia

Denmark4 sites, 4 recruiting

  • Novartis Investigative Site

    Aarhus N, 8200

    Recruiting

  • Novartis Investigative Site

    Esbjerg, 6700

    Recruiting

  • Novartis Investigative Site

    Glostrup Municipality, 2600

    Recruiting

  • Novartis Investigative Site

    Odense C, 5000

    Recruiting

Other trials in Denmark

Mexico4 sites, 4 recruiting

  • Novartis Investigative Site

    Benito Juárez, Mexico City, 03100

    Recruiting

  • Novartis Investigative Site

    Chihuahua City, Chihuahua, 31203

    Recruiting

  • Novartis Investigative Site

    Mexico City, Mexico City, 06700

    Recruiting

  • Novartis Investigative Site

    San Luis Potosí City, 78216

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Other trials in Mexico

Romania3 sites, 3 recruiting

  • Novartis Investigative Site

    Bucharest, 040215

    Recruiting

  • Novartis Investigative Site

    Campulung Muscel, 115100

    Recruiting

  • Novartis Investigative Site

    Constanța, ROM, 900123

    Recruiting

Other trials in Romania

Croatia2 sites, 2 recruiting

  • Novartis Investigative Site

    Varaždin, Varaždin County, 42000

    Recruiting

  • Novartis Investigative Site

    Zagreb, 10000

    Recruiting

Other trials in Croatia

Estonia2 sites, 2 recruiting

  • Novartis Investigative Site

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    Recruiting

  • Novartis Investigative Site

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Other trials in Estonia

Sweden2 sites, 2 recruiting

  • Novartis Investigative Site

    Gothenburg, 413 46

    Recruiting

  • Novartis Investigative Site

    Stockholm, 141 86

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Other trials in Sweden

Switzerland2 sites, 2 recruiting

  • Novartis Investigative Site

    Bern, 3010

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  • Novartis Investigative Site

    Lausanne, 1011

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Other trials in Switzerland

Ireland1 site, 1 recruiting

  • Novartis Investigative Site

    Dublin, Ireland, D03 VX82

    Recruiting

Other trials in Ireland

Latvia1 site, 1 recruiting

  • Novartis Investigative Site

    Riga, LV-1002

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Other trials in Latvia

Lithuania1 site, 1 recruiting

  • Novartis Investigative Site

    Kaunas, LT-50161

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Other trials in Lithuania

Slovenia1 site, 1 recruiting

  • Novartis Investigative Site

    Ljubljana, 1000

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Other trials in Slovenia

South Africa1 site, 1 recruiting

  • Novartis Investigative Site

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Other trials in South Africa

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis

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

Read the detailed description

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, parallel-group, event-driven study to evaluate the efficacy, safety and tolerability of remibrutinib in SPMS patients. Approximately 1275 eligible participants will be randomized to receive either remibrutinib or matching placebo.

The study consists of an event-driven Core Part with double-blind treatment, followed by an Extension Part with open-label remibrutinib treatment.

Being tested
Remibrutinib (blinded), Placebo, Remibrutinib (Open label)
Keywords
MS, Multiple sclerosis, secondary progressive multiple sclerosis, SPMS, remibrutinib, LOU064, adult, Expanded Disability Status Scale, EDSS, McDonald diagnostic criteria
Medical subject headings
Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remibrutinib (blinded)Drug

    Also called LOU064

    Remibrutinib (Blinded) active treatment, oral tablet

  • PlaceboDrug

    Matching placebo (binded), oral tablet

  • Remibrutinib (Open label)Drug

    Also called LOU064

    Remibrutinib (Open Label), oral tablet

Study groups in NCT07225504
Study groupRoleWhat they receive
Remibrutinib (LOU064)ExperimentalCore Part: Remibrutinib film-coated tablet taken orally [Extension Part: Open-label remibrutinib film-coated tablet taken orally]
Receives: Drug: Remibrutinib (blinded); Drug: Remibrutinib (Open label)
PlaceboPlacebo comparatorCore Part: Matching placebo film-coated tablet taken orally [Extension Part: Open-label remibrutinib film-coated tablet taken orally]
Receives: Drug: Placebo; Drug: Remibrutinib (Open label)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS)

    The EDSS is an ordinal scale used for assessing neurologic impairment in MS based on a neurological examination. It consists of scores in each of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)).

    6mCDP is defined as an increase from baseline in EDSS sustained for at least 6 months.

    Measured: From baseline up to approximately 5 years

Secondary outcomes (8)

  1. Time to 3-month confirmed disability progression (3mCDP) on EDSS

    The EDSS is an ordinal scale used for assessing neurologic impairment in MS based on a neurological examination. It consists of scores in each of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)).

    3mCDP is defined as an increase from baseline in EDSS sustained for at least 3 months.

    Measured: From baseline up to approximately 5 years

  2. Time to 6-month confirmed disability improvement (6mCDI) on EDSS

    The EDSS is an ordinal scale used for assessing neurologic impairment in MS based on a neurological examination. It consists of scores in each of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)).

    A 6mCDI is defined as a decrease from baseline in EDSS sustained for at least 6 months.

    Measured: From baseline up to approximately 5 years

  3. Time to 3-month worsening by at least 20% in Timed 25-Foot Walk (T25FW)

    The T25FW is an ambulation measurement assessing speed of walking: a timed (in seconds) walk of 25 feet (7.62 meters). Longer time indicates poorer lower limb function.

    3-month worsening by at least 20% in T25FW is defined as an increase from baseline in T25FW of at least 20% sustained for at least 3 months.

    Measured: From baseline up to approximately 5 years

  4. Time to 3-month worsening by at least 20% in 9-Hole Peg Test (9-HPT)

    The 9-HPT is an objective quantitative test of neurological function. It is measured to assess both right and left arm scores, the metric is the time, in seconds, required to insert and remove 9 pegs. Longer time indicates poorer upper limb function.

    A 3-month worsening by at least 20% in 9-HPT is defined as an increase from baseline in 9-HPT of at least 20% sustained for at least 3 months

    Measured: From baseline up to approximately 5 years

  5. Annualized rate of new or enlarging T2 lesions

    Number of new or enlarging T2 lesions per year based on MRI

    Measured: From baseline up to approximately 5 years

  6. Annualized rate of brain atrophy

    Percentage change in brain volume relative to baseline per year based on MRI assessments

    Measured: From baseline up to approximately 5 years

  7. Time to 6-month worsening by at least 4 points in Symbol Digit Modalities Test (SDMT)

    The SDMT is a sensitive and specific test to assess information processing speed which is typically affected in cognitively impaired MS participants, The test scoring is calculated based on the number of correct answers in 90 seconds.

    A 6-month worsening by at least 4 points in SDMT is defined as an increase from baseline in SDMT of at least 4 points sustained for at least 6 months.

    Measured: From baseline up to approximately 5 years

  8. Number of participants with Adverse events and Serious adverse events (SAE)

    Incidence of adverse events including changes in laboratory data, vital signs, electrocardiogram (ECG) and Columbia Suicide Severity Rating Scale (C-SSRS) qualifying and reported as AEs.

    Measured: From baseline up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2025
  2. Study start11 Nov 2025
  3. Primary completion3 Dec 2030 (estimated)
  4. Study completion2 Jan 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,275 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07225504
Sponsor's protocol ID
CLOU064P12301
Other IDs
2025-521546-23, 2025
Acronym
REMASTER
Status last verified
Oct 2026
First submitted
4 Nov 2025
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Remibrutinib (blinded) and Remibrutinib (Open label) in people with Secondary Progressive Multiple Sclerosis (SPMS), run by Novartis Pharmaceuticals at 296 sites in 36 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 296 sites in United States, Spain, France, China, Germany and 31 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07225504.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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