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

May 18, 2026 updated by: Novartis Pharmaceuticals

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)

Study Overview

Status

Recruiting

Conditions

Secondary Progressive Multiple Sclerosis (SPMS)

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1275

Phase

Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Novartis Pharmaceuticals
Phone Number: 1-888-669-6682
Email: novartis.email@novartis.com

Study Contact Backup

Name: Novartis Pharmaceuticals
Phone Number: +41613241111

Study Locations

Argentina
- - Buenos Aires, Argentina, C1012AAR
    - Recruiting
    - Novartis Investigative Site
  - CABA, Argentina, C1181ACH
    - Recruiting
    - Novartis Investigative Site
  - Caba, Argentina, C1424BYD
    - Recruiting
    - Novartis Investigative Site
  - Caba, Argentina, C1055AAF
    - Recruiting
    - Novartis Investigative Site
  - Caba, Argentina, C1182
    - Recruiting
    - Novartis Investigative Site
  - Santiago del Estero, Argentina, 4200
    - Recruiting
    - Novartis Investigative Site
- Buenos Aires
  - Capital Federal, Buenos Aires, Argentina, 1424
    - Recruiting
    - Novartis Investigative Site
- Mendoza Province
  - Bombal, Mendoza Province, Argentina, M5500DXO
    - Recruiting
    - Novartis Investigative Site
Australia
- New South Wales
  - Kogarah, New South Wales, Australia, 2217
    - Recruiting
    - Novartis Investigative Site
  - New Lambton Heights, New South Wales, Australia, 2305
    - Recruiting
    - Novartis Investigative Site
  - Westmead, New South Wales, Australia, 2145
    - Recruiting
    - Novartis Investigative Site
- Victoria
  - Clayton, Victoria, Australia, 3168
    - Recruiting
    - Novartis Investigative Site
  - Heidelberg, Victoria, Australia, 3084
    - Recruiting
    - Novartis Investigative Site
Austria
- - Linz, Austria, 4020
    - Recruiting
    - Novartis Investigative Site
  - Vienna, Austria, 1180
    - Recruiting
    - Novartis Investigative Site
Bulgaria
- - Pleven, Bulgaria, 5800
    - Recruiting
    - Novartis Investigative Site
  - Sofia, Bulgaria, 1431
    - Recruiting
    - Novartis Investigative Site
  - Sofia, Bulgaria, 1407
    - Recruiting
    - Novartis Investigative Site
  - Sofia, Bulgaria, 1606
    - Recruiting
    - Novartis Investigative Site
  - Sofia, Bulgaria, 1113
    - Recruiting
    - Novartis Investigative Site
  - Sofia, Bulgaria, 1510
    - Recruiting
    - Novartis Investigative Site
Canada
- British Columbia
  - Vancouver, British Columbia, Canada, V6T 2A1
    - Recruiting
    - Novartis Investigative Site
- Ontario
  - Ottawa, Ontario, Canada, K1H 8L6
    - Recruiting
    - Novartis Investigative Site
- Quebec
  - Lévis, Quebec, Canada, G6W 0M5
    - Recruiting
    - Novartis Investigative Site
  - Montreal, Quebec, Canada, H2W 1T8
    - Recruiting
    - Novartis Investigative Site
  - Montreal, Quebec, Canada, H3A 2B4
    - Recruiting
    - Novartis Investigative Site
  - Montreal, Quebec, Canada, H4A 3T2
    - Recruiting
    - Novartis Investigative Site
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - Recruiting
    - Novartis Investigative Site
China
- - Beijing, China, 100034
    - Recruiting
    - Novartis Investigative Site
  - Beijing, China, 065001
    - Recruiting
    - Novartis Investigative Site
  - Chongqing, China, 400016
    - Recruiting
    - Novartis Investigative Site
  - Shanghai, China, 200040
    - Recruiting
    - Novartis Investigative Site
  - Tianjin, China, 300052
    - Recruiting
    - Novartis Investigative Site
- Guangdong
  - Guangzhou, Guangdong, China, 510030
    - Recruiting
    - Novartis Investigative Site
- Henan
  - Zhengzhou, Henan, China, 450003
    - Recruiting
    - Novartis Investigative Site
- Hubei
  - Wuhan, Hubei, China, 430030
    - Recruiting
    - Novartis Investigative Site
  - Wuhan, Hubei, China, 430060
    - Recruiting
    - Novartis Investigative Site
- Inner Mongolia
  - Hohhot, Inner Mongolia, China, 010017
    - Recruiting
    - Novartis Investigative Site
- Jiangsu
  - Suzhou, Jiangsu, China, 215004
    - Recruiting
    - Novartis Investigative Site
- Jilin
  - Changchun, Jilin, China, 130021
    - Recruiting
    - Novartis Investigative Site
- Ningxia
  - Yinchuan, Ningxia, China, 750004
    - Recruiting
    - Novartis Investigative Site
- Shaanxi
  - Xianyang, Shaanxi, China, 712000
    - Recruiting
    - Novartis Investigative Site
- Shanxi
  - Taiyuan, Shanxi, China, 030001
    - Recruiting
    - Novartis Investigative Site
- Zhejiang
  - Hangzhou, Zhejiang, China, 310016
    - Recruiting
    - Novartis Investigative Site
  - Hangzhou, Zhejiang, China, 310002
    - Recruiting
    - Novartis Investigative Site
  - Wenzhou, Zhejiang, China, 325000
    - Recruiting
    - Novartis Investigative Site
Colombia
- - Bogotá, Colombia, 111321
    - Recruiting
    - Novartis Investigative Site
  - Medellín, Colombia, 050034
    - Recruiting
    - Novartis Investigative Site
  - Medellín, Colombia, 050001
    - Recruiting
    - Novartis Investigative Site
- Atlántico
  - Barranquilla, Atlántico, Colombia, 080020
    - Recruiting
    - Novartis Investigative Site
Czechia
- - Hradec Králové, Czechia, 500 05
    - Recruiting
    - Novartis Investigative Site
  - Jihlava, Czechia, 586 01
    - Recruiting
    - Novartis Investigative Site
  - Prague, Czechia, 150 06
    - Recruiting
    - Novartis Investigative Site
  - Prague, Czechia, 140 59
    - Recruiting
    - Novartis Investigative Site
  - Teplice, Czechia, 415 29
    - Recruiting
    - Novartis Investigative Site
Denmark
- - Esbjerg, Denmark, 6700
    - Recruiting
    - Novartis Investigative Site
Estonia
- - Tallinn, Estonia, 11315
    - Recruiting
    - Novartis Investigative Site
France
- - Ajaccio, France, 20090
    - Recruiting
    - Novartis Investigative Site
  - Amiens, France, 80054
    - Recruiting
    - Novartis Investigative Site
  - Clermont-Ferrand, France, 63003
    - Recruiting
    - Novartis Investigative Site
  - Gonesse, France, 95500
    - Recruiting
    - Novartis Investigative Site
  - Grenoble, France, 38043
    - Recruiting
    - Novartis Investigative Site
  - Lille, France, 59000
    - Recruiting
    - Novartis Investigative Site
  - Lille, France, 59037
    - Recruiting
    - Novartis Investigative Site
  - Montpellier, France, 34090
    - Recruiting
    - Novartis Investigative Site
  - Nancy, France, 54035
    - Recruiting
    - Novartis Investigative Site
  - Nice, France, 06001
    - Recruiting
    - Novartis Investigative Site
  - Nîmes, France, 30029
    - Recruiting
    - Novartis Investigative Site
  - Orsay, France, 91400
    - Recruiting
    - Novartis Investigative Site
  - Paris, France, 75013
    - Recruiting
    - Novartis Investigative Site
  - Paris, France, 75940
    - Recruiting
    - Novartis Investigative Site
  - Poitiers, France, 86021
    - Recruiting
    - Novartis Investigative Site
  - Rennes, France, 35033
    - Recruiting
    - Novartis Investigative Site
  - Rouen, France, 76031
    - Recruiting
    - Novartis Investigative Site
  - Strasbourg, France, 67000
    - Recruiting
    - Novartis Investigative Site
  - Toulouse, France, 31059
    - Recruiting
    - Novartis Investigative Site
  - Tours, France, 37044
    - Recruiting
    - Novartis Investigative Site
- Haute Vienne
  - Limoges, Haute Vienne, France, 87000
    - Recruiting
    - Novartis Investigative Site
Germany
- - Erfurt, Germany, 99089
    - Recruiting
    - Novartis Investigative Site
  - Giessen, Germany, 35392
    - Recruiting
    - Novartis Investigative Site
  - Greifswald, Germany, 17475
    - Recruiting
    - Novartis Investigative Site
  - Heidelberg, Germany, 69120
    - Recruiting
    - Novartis Investigative Site
  - Itzehoe, Germany, 25524
    - Recruiting
    - Novartis Investigative Site
  - Tübingen, Germany, 72076
    - Recruiting
    - Novartis Investigative Site
- Baden-Wurttemberg
  - Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
    - Recruiting
    - Novartis Investigative Site
  - Mannheim, Baden-Wurttemberg, Germany, 68167
    - Recruiting
    - Novartis Investigative Site
- Bavaria
  - Munich, Bavaria, Germany, 81377
    - Recruiting
    - Novartis Investigative Site
  - Unterhaching, Bavaria, Germany, 82008
    - Recruiting
    - Novartis Investigative Site
- Saxony-Anhalt
  - Halle, Saxony-Anhalt, Germany, 06120
    - Recruiting
    - Novartis Investigative Site
Greece
- - Chaïdári, Greece, 124 62
    - Recruiting
    - Novartis Investigative Site
Hungary
- - Budapest, Hungary, 1044
    - Recruiting
    - Novartis Investigative Site
  - Kistarcsa, Hungary, 2143
    - Recruiting
    - Novartis Investigative Site
India
- Haryana
  - Gurugram, Haryana, India, 122011
    - Recruiting
    - Novartis Investigative Site
- Karnataka
  - Mangalore, Karnataka, India, 575003
    - Recruiting
    - Novartis Investigative Site
- Kerala
  - Kochi, Kerala, India, 682025
    - Recruiting
    - Novartis Investigative Site
- National Capital Territory of Delhi
  - New Delhi, National Capital Territory of Delhi, India, 110060
    - Recruiting
    - Novartis Investigative Site
  - New Delhi, National Capital Territory of Delhi, India, 110029
    - Recruiting
    - Novartis Investigative Site
- Punjab
  - Chandigarh, Punjab, India, 160012
    - Recruiting
    - Novartis Investigative Site
- Tamil Nadu
  - Vellore, Tamil Nadu, India, 632 004
    - Recruiting
    - Novartis Investigative Site
- Telangana
  - Hyderabad, Telangana, India, 500082
    - Recruiting
    - Novartis Investigative Site
Israel
- - Haifa, Israel, 3436212
    - Recruiting
    - Novartis Investigative Site
  - Jerusalem, Israel, 9112001
    - Recruiting
    - Novartis Investigative Site
  - Ramat Gan, Israel, 5265601
    - Recruiting
    - Novartis Investigative Site
  - Rehovot, Israel, 7661041
    - Recruiting
    - Novartis Investigative Site
  - Tel Aviv, Israel, 6423906
    - Recruiting
    - Novartis Investigative Site
  - Ẕerifin, Israel, 7030000
    - Recruiting
    - Novartis Investigative Site
Italy
- BG
  - Bergamo, BG, Italy, 24127
    - Recruiting
    - Novartis Investigative Site
- FG
  - Foggia, FG, Italy, 71122
    - Recruiting
    - Novartis Investigative Site
- IS
  - Pozzilli, IS, Italy, 86077
    - Recruiting
    - Novartis Investigative Site
- PV
  - Pavia, PV, Italy, 27100
    - Recruiting
    - Novartis Investigative Site
- RM
  - Roma, RM, Italy, 00133
    - Recruiting
    - Novartis Investigative Site
Netherlands
- - Leiden, Netherlands, 2334 CN
    - Recruiting
    - Novartis Investigative Site
- Gelderland
  - Arnhem, Gelderland, Netherlands, 6815 AD
    - Recruiting
    - Novartis Investigative Site
- North Brabant
  - 's-Hertogenbosch, North Brabant, Netherlands, 5223 GZ
    - Recruiting
    - Novartis Investigative Site
Poland
- - Chojnice, Poland, 89-600
    - Recruiting
    - Novartis Investigative Site
  - Katowice, Poland, 40-081
    - Recruiting
    - Novartis Investigative Site
  - Katowice, Poland, 40-686
    - Recruiting
    - Novartis Investigative Site
  - Krakow, Poland, 31 531
    - Recruiting
    - Novartis Investigative Site
  - Rzeszów, Poland, 35-323
    - Recruiting
    - Novartis Investigative Site
  - Skorzewo, Poland, 60-185
    - Recruiting
    - Novartis Investigative Site
  - Warsaw, Poland, 01-684
    - Recruiting
    - Novartis Investigative Site
  - Zabrze, Poland, 41-800
    - Recruiting
    - Novartis Investigative Site
  - Żory, Poland, 44-240
    - Recruiting
    - Novartis Investigative Site
- Woj Kujawsko Pomorskie
  - Bydgoszcz, Woj Kujawsko Pomorskie, Poland, 85-796
    - Recruiting
    - Novartis Investigative Site
Portugal
- - Braga, Portugal, 4710243
    - Recruiting
    - Novartis Investigative Site
  - Lisbon, Portugal, 1349-019
    - Recruiting
    - Novartis Investigative Site
  - Porto, Portugal, 4200 319
    - Recruiting
    - Novartis Investigative Site
Romania
- - Bucharest, Romania, 040215
    - Recruiting
    - Novartis Investigative Site
  - Campulung Muscel, Romania, 115100
    - Recruiting
    - Novartis Investigative Site
- ROM
  - Constanța, ROM, Romania, 900123
    - Recruiting
    - Novartis Investigative Site
Slovakia
- - Bratislava, Slovakia, 851 01
    - Recruiting
    - Novartis Investigative Site
  - Komárno, Slovakia, 945 05
    - Recruiting
    - Novartis Investigative Site
  - Nitra, Slovakia, 950 01
    - Recruiting
    - Novartis Investigative Site
  - Trnava, Slovakia, 917 02
    - Recruiting
    - Novartis Investigative Site
South Africa
- Western Cape
  - Cape Town, Western Cape, South Africa, 7405
    - Recruiting
    - Novartis Investigative Site
Spain
- - Alicante, Spain, 03010
    - Recruiting
    - Novartis Investigative Site
  - Barcelona, Spain, 08035
    - Recruiting
    - Novartis Investigative Site
  - Las Palmas GC, Spain, 35010
    - Recruiting
    - Novartis Investigative Site
  - Lleida, Spain, 25198
    - Recruiting
    - Novartis Investigative Site
  - Madrid, Spain, 28034
    - Recruiting
    - Novartis Investigative Site
  - Madrid, Spain, 28040
    - Recruiting
    - Novartis Investigative Site
  - Madrid, Spain, 28009
    - Recruiting
    - Novartis Investigative Site
  - Málaga, Spain, 29010
    - Recruiting
    - Novartis Investigative Site
  - Salamanca, Spain, 37007
    - Recruiting
    - Novartis Investigative Site
  - Valencia, Spain, 46026
    - Recruiting
    - Novartis Investigative Site
- Barcelona
  - L'Hospitalet de Llobregat, Barcelona, Spain, 08907
    - Recruiting
    - Novartis Investigative Site
- Madrid
  - Pozuelo de Alarcón, Madrid, Spain, 28223
    - Recruiting
    - Novartis Investigative Site
  - Torrejón de Ardoz, Madrid, Spain, 28850
    - Recruiting
    - Novartis Investigative Site
- Murcia
  - El Palmar, Murcia, Spain, 30120
    - Recruiting
    - Novartis Investigative Site
- Sevilla
  - Castilleja de la Cuesta, Sevilla, Spain, 41950
    - Recruiting
    - Novartis Investigative Site
- Valencia
  - Valencia, Valencia, Spain, 46017
    - Recruiting
    - Novartis Investigative Site
- Vizcaya
  - Barakaldo, Vizcaya, Spain, 48903
    - Recruiting
    - Novartis Investigative Site
Switzerland
- - Bern, Switzerland, 3010
    - Recruiting
    - Novartis Investigative Site
  - Lausanne, Switzerland, 1011
    - Recruiting
    - Novartis Investigative Site
United Kingdom
- - Coventry, United Kingdom, CV2 2DX
    - Recruiting
    - Novartis Investigative Site
  - Glasgow, United Kingdom, G51 4TF
    - Recruiting
    - Novartis Investigative Site
  - Leeds, United Kingdom, LS1 3EX
    - Recruiting
    - Novartis Investigative Site
  - Nottingham, United Kingdom, NG7 2UH
    - Recruiting
    - Novartis Investigative Site
- East Sussex
  - Brighton, East Sussex, United Kingdom, BN2 5BE
    - Recruiting
    - Novartis Investigative Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35209
    - Recruiting
    - Alabama Neurology Associates PC
    - Principal Investigator:
      
      Emily Sherill Riser
    - Contact:
      
      Virginia Weinacker
      
      Phone Number: +1 205 803 2210
      
      Email: gweinacker@alaneuro.com
- Arizona
  - Phoenix, Arizona, United States, 85037
    - Recruiting
    - AZ Integrated Neuro and Spine
    - Principal Investigator:
      
      Barry Hendin
    - Contact:
      
      Brandon McCravey
      
      Email: bmccravey@prcresearcheducation.com
  - Tucson, Arizona, United States, 85718
    - Recruiting
    - Center for Neurosciences
    - Principal Investigator:
      
      Francisco Valdivia
    - Contact:
      
      Lisa Alvarez
      
      Phone Number: 520-320-2147
      
      Email: lalvarez@neurotucson.com
- California
  - Fullerton, California, United States, 92835
    - Recruiting
    - Fullerton Neuro and Headache Ctr
    - Principal Investigator:
      
      Jack H Florin
    - Contact:
      
      Alexandra Vasquez
      
      Phone Number: 714-738-0800
      
      Email: avasquez@fullertonneuro.net
  - West Hollywood, California, United States, 90048
    - Recruiting
    - Regina Berkovich MD PhD Inc
    - Principal Investigator:
      
      Regina Berkovich
    - Contact:
      
      Divya Venkataramu
      
      Phone Number: 310-493-4715
      
      Email: venkataramu.neuro@gmail.com
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20007
    - Recruiting
    - Georgetown University Hospital
    - Principal Investigator:
      
      Faria Amjad
    - Contact:
      
      Grace Inserra
      
      Phone Number: 202-444-8830
      
      Email: gi90@georgetown.edu
  - Washington D.C., District of Columbia, United States, 20010
    - Recruiting
    - Medstar Washington Hosp Ctr
    - Principal Investigator:
      
      Brian Barry
    - Contact:
      
      Anu Bhooshan
      
      Phone Number: 202-877-7000
      
      Email: anu.r.bhooshan@medstar.net
- Florida
  - Altamonte Springs, Florida, United States, 32714
    - Recruiting
    - Neurology of Central FL Res Ctr
    - Principal Investigator:
      
      Alicia V Cabrera
    - Contact:
      
      Adiana Perez
      
      Phone Number: 407-790-4990
      
      Email: adiresearchcfl@gmail.com
  - Gainesville, Florida, United States, 32610
    - Recruiting
    - UF Health Cancer Center
    - Principal Investigator:
      
      Torge Rempe
    - Contact:
      
      Kyle Rizer
      
      Email: kyle.rizer@neurology.ufl.edu
  - Homestead, Florida, United States, 33033
    - Recruiting
    - Homestead Assoc In Research Inc
    - Principal Investigator:
      
      Angel Carrasco
    - Contact:
      
      Daydene Ordaz
      
      Phone Number: 305-246-0873
      
      Email: dordaz@associatesinresearch.com
  - Maitland, Florida, United States, 32751
    - Recruiting
    - Neurology Associates PA
    - Principal Investigator:
      
      William David Honeycutt
    - Contact:
      
      Kelly Holley
      
      Phone Number: +1 407 647 5996
      
      Email: admin@naparesearch.com
  - Miami, Florida, United States, 33176
    - Recruiting
    - Miami NS Ins Baptist Health S FL
    - Contact:
      
      Sukie Hernandez
      
      Email: sukie.hernandez@baptisthealth.net
    - Principal Investigator:
      
      Luis Compres Brugal
  - Naples, Florida, United States, 34105
    - Recruiting
    - Aqualane Clinical Research
    - Principal Investigator:
      
      Matthew J Baker
    - Contact:
      
      Taylor Kerskie
      
      Phone Number: 239-434-0332
      
      Email: taylor@aqualaneresearch.com
  - Orlando, Florida, United States, 32825
    - Recruiting
    - Comprehensive Neurology Clinic
    - Contact:
      
      Elliuz Leal
      
      Phone Number: 407-913-9120
      
      Email: elealcrc@gmail.com
    - Principal Investigator:
      
      Refaat El-Said
  - Orlando, Florida, United States, 32806
    - Recruiting
    - Orlando Health Clinical Trials
    - Principal Investigator:
      
      Amparo Gutierrez
    - Contact:
      
      Charlene Carlo
      
      Phone Number: 321-841-3686
      
      Email: Charlene.carlo@orlandohealth.com
  - Ormond Beach, Florida, United States, 32174
    - Recruiting
    - Neurology Associates of Ormond Beach
    - Principal Investigator:
      
      James Scott
    - Contact:
      
      Heather Schutz
      
      Phone Number: 386-676-6340
      
      Email: hschutz@naobresearch.com
  - Tampa, Florida, United States, 33609
    - Recruiting
    - Axiom Brain Health
    - Principal Investigator:
      
      Mark Cascione
    - Contact:
      
      Jennifer Fornes
      
      Email: jfornes@axiombrainhealth.com
- Georgia
  - Smyrna, Georgia, United States, 30080
    - Recruiting
    - Joi Life Wellness Group LLC
    - Contact:
      
      Carmel Ibeawuchi
      
      Email: cibeawuchi@msm.edu
    - Principal Investigator:
      
      Mitzi Joi Williams
- Hawaii
  - Honolulu, Hawaii, United States, 96817
    - Recruiting
    - Hawaii Pacific Neuroscience LLC
    - Principal Investigator:
      
      Natalia Gonzalez-Caldito
    - Contact:
      
      Gina McNarney
      
      Phone Number: 808-261-4476
      
      Email: gmcnarney@hawaiineuroscience.com
- Kansas
  - Kansas City, Kansas, United States, 66160
    - Recruiting
    - University of Kansas Hospital
    - Principal Investigator:
      
      Sharon Lynch
    - Contact:
      
      Sarah Razor
      
      Phone Number: 913-945-5059
      
      Email: sbellis2@kumc.edu
- Maryland
  - Bethesda, Maryland, United States, 20817-1807
    - Recruiting
    - Mid Atlantic Epilepsy and Sleep Ctr
    - Principal Investigator:
      
      Jonathan Ross
    - Contact:
      
      Salman Hashmi
      
      Email: hashmis@epilepsydc.com
- Massachusetts
  - Foxborough, Massachusetts, United States, 02035
    - Recruiting
    - Neuro Institute of New England P C
    - Principal Investigator:
      
      Salvatore Napoli
    - Contact:
      
      Jillian Pellegrini
      
      Phone Number: 781-551-5812
      
      Email: jpellegrini@neurocenterne.com
- Michigan
  - Farmington Hills, Michigan, United States, 48334
    - Recruiting
    - Michigan Institute of Neurological
    - Principal Investigator:
      
      Martin Belkin
    - Contact:
      
      Emily Blazejewski
      
      Phone Number: 248-553-0010
      
      Email: eblazejewski@mindonline.com
- New Mexico
  - Albuquerque, New Mexico, United States, 87106
    - Recruiting
    - University of New Mexico Hospital
    - Principal Investigator:
      
      Clotilde Hainline
    - Contact:
      
      Emily Reese
      
      Phone Number: 505-272-4550
      
      Email: ejreese@salud.unm.edu
- South Carolina
  - Greenville, South Carolina, United States, 29605
    - Recruiting
    - Premier Neurology
    - Principal Investigator:
      
      Mary Denise Hughes
    - Contact:
      
      Jada Crawford
      
      Email: jada.c@premier-neuro.com
- Tennessee
  - Cordova, Tennessee, United States, 38018
    - Recruiting
    - Neurology Clinic PC
    - Principal Investigator:
      
      Lee Stein
    - Contact:
      
      Ye Liu
      
      Phone Number: 901-866-9252
      
      Email: yliu@neuroclinic.org
- Texas
  - Plano, Texas, United States, 75024
    - Recruiting
    - Saturn Research Solution
    - Principal Investigator:
      
      Annette Okai
    - Contact:
      
      Geetha Rayala
      
      Email: grayala@saturnclinical.com
- Washington
  - Spokane, Washington, United States, 99202
    - Recruiting
    - Citta Clinical Research
    - Contact:
      
      Jill Ciccarello
      
      Email: jciccarello@cittaclinicalresearch.com
    - Principal Investigator:
      
      Michael Coats

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

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 SPMS according to the 2017 revised McDonald criteria (Thompson et al 2018) 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), defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remibrutinib (LOU064) Core Part: Remibrutinib film-coated tablet taken orally [Extension Part: Open-label remibrutinib film-coated tablet taken orally]	Drug: Remibrutinib (blinded) Remibrutinib (Blinded) active treatment, oral tablet Other Names: LOU064 Drug: Remibrutinib (Open label) Remibrutinib (Open Label), oral tablet Other Names: LOU064
Placebo Comparator: Placebo Core Part: Matching placebo film-coated tablet taken orally [Extension Part: Open-label remibrutinib film-coated tablet taken orally]	Drug: Remibrutinib (Open label) Remibrutinib (Open Label), oral tablet Other Names: LOU064 Drug: Placebo Matching placebo (binded), oral tablet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to 3-month confirmed disability progression (3mCDP) on EDSS Time Frame: From baseline up to approximately 5 years	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.	From baseline up to approximately 5 years
Time to 6-month confirmed disability improvement (6mCDI) on EDSS Time Frame: From baseline up to approximately 5 years	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.	From baseline up to approximately 5 years
Time to 3-month worsening by at least 20% in Timed 25-Foot Walk (T25FW) Time Frame: From baseline up to approximately 5 years	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.	From baseline up to approximately 5 years
Time to 3-month worsening by at least 20% in 9-Hole Peg Test (9-HPT) Time Frame: From baseline up to approximately 5 years	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	From baseline up to approximately 5 years
Annualized rate of new or enlarging T2 lesions Time Frame: From baseline up to approximately 5 years	Number of new or enlarging T2 lesions per year based on MRI	From baseline up to approximately 5 years
Annualized rate of brain atrophy Time Frame: From baseline up to approximately 5 years	Percentage change in brain volume relative to baseline per year based on MRI assessments	From baseline up to approximately 5 years
Time to 6-month worsening by at least 4 points in Symbol Digit Modalities Test (SDMT) Time Frame: From baseline up to approximately 5 years	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.	From baseline up to approximately 5 years
Number of participants with Adverse events and Serious adverse events (SAE) Time Frame: From baseline up to approximately 5 years	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.	From baseline up to approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2025

Primary Completion (Estimated)

December 3, 2030

Study Completion (Estimated)

January 2, 2034

Study Registration Dates

First Submitted

November 4, 2025

First Submitted That Met QC Criteria

November 4, 2025

First Posted (Actual)

November 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CLOU064P12301
2025-521546-23 (Other Identifier: EU Trial (CTIS) Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Expanded Access

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Secondary Progressive Multiple Sclerosis (SPMS)

Clinical Trials on Remibrutinib (blinded)

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