A Randomized, Double-blind, Double-dummy, Parallel-group Study, Comparing the Efficacy and Safety of Remibrutinib Versus Teriflunomide in Participants With Relapsing Multiple Sclerosis, Followed by Extended Treatment With Open-label Remibrutinib
Who is this study for? Patients with relapsing multiple sclerosis
What treatments are being studied? Remibrutinib
Status: Recruiting
Location: See all (247) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:
• 18 to 55 years of age
• Diagnosis of RMS according to the 2017 McDonald diagnostic criteria
• At least: 1 documented relapse within the previous year. OR 2 documented relapses within the previous 2 years, OR 1 active Gadolinium (Gd)-enhancing lesion in the 12 months.
• EDSS score of 0 to 5.5 (inclusive)
• Neurologically stable within 1 month
Locations
United States
Arizona
Ctr for Neurology and Spine
ACTIVE_NOT_RECRUITING
Phoenix
California
Vladimir Royter MD APMC
RECRUITING
Hanford
VA Greater LA Healthcare System
RECRUITING
Los Angeles
Regina Berkovich MD PhD Inc
RECRUITING
West Hollywood
Colorado
CU Anschutz Med Campus
RECRUITING
Aurora
Colorado Springs Neurological Associates
WITHDRAWN
Colorado Springs
Colorado Neurological Research PC
RECRUITING
Denver
Connecticut
New England Institute for Clinical Research
ACTIVE_NOT_RECRUITING
Stamford
Washington, D.c.
Georgetown University Hospital
ACTIVE_NOT_RECRUITING
Washington D.c.
Georgetown University Hospital Research
RECRUITING
Washington D.c.
Florida
SFM Clinical Research LLC
WITHDRAWN
Boca Raton
Nova Clinical Research LLC
RECRUITING
Bradenton
University of Florida
ACTIVE_NOT_RECRUITING
Gainesville
Memorial Healthcare System
RECRUITING
Hollywood
Mayo Clinic Jacksonville
RECRUITING
Jacksonville
Neurology Associates PA
ACTIVE_NOT_RECRUITING
Maitland
Gables Neurology
RECRUITING
Miami
UM Department Of Neurology
RECRUITING
Miami
Aqualane Clinical Research
RECRUITING
Naples
Advent Health Orlando
ACTIVE_NOT_RECRUITING
Orlando
Humanity Clinical Research
RECRUITING
Pembroke Pines
Emerald Coast Neurology
ACTIVE_NOT_RECRUITING
Pensacola
Brain and Spine Institute
ACTIVE_NOT_RECRUITING
Port Orange
Vero Beach Neurology
ACTIVE_NOT_RECRUITING
Vero Beach
Conquest Research
ACTIVE_NOT_RECRUITING
Winter Park
Georgia
Georgia Neurology and Sleep Medicine Assoc
WITHDRAWN
Suwanee
Indiana
Methodist Neuroscience Institute
RECRUITING
Merrillville
Kansas
University of Kansas Hospital
ACTIVE_NOT_RECRUITING
Kansas City
Kentucky
Baptist Physicians Lexington
ACTIVE_NOT_RECRUITING
Nicholasville
Louisiana
Ochsner Clinic Foundation
RECRUITING
New Orleans
Massachusetts
Tufts Medical Center
RECRUITING
Boston
Maryland
Clinre Comprehensive Neurology
ACTIVE_NOT_RECRUITING
Frederick
Michigan
Memorial Healthcare
ACTIVE_NOT_RECRUITING
Owosso
Missouri
Kansas City VA Medical Center
RECRUITING
Kansas City
North Carolina
University Of NC At Chapel Hill
RECRUITING
Chapel Hill
Piedmont HealthCare
ACTIVE_NOT_RECRUITING
Charlotte
New York
South Shore Neurologic Associates
ACTIVE_NOT_RECRUITING
Patchogue
True North Neurology
ACTIVE_NOT_RECRUITING
Port Jefferson
Ohio
The Boster Ctr for MS
ACTIVE_NOT_RECRUITING
Columbus
Neurology Diagnostics Inc
ACTIVE_NOT_RECRUITING
Dayton
Pennsylvania
Penn State Hershey Medical Center
ACTIVE_NOT_RECRUITING
Hershey
South Carolina
Medical Uni of South Carolina
RECRUITING
Charleston
Premier Neurology
ACTIVE_NOT_RECRUITING
Greenville
Metrolina Neurological Associates PA
RECRUITING
Old Point Station
Tennessee
Sibyl Wray MD Neurology PC
RECRUITING
Knoxville
Texas
Neurology Consultants Of Dallas PA
ACTIVE_NOT_RECRUITING
Dallas
Med Research Inc
RECRUITING
El Paso
Lone Star Neurology
ACTIVE_NOT_RECRUITING
Frisco
Neurocare Plus
WITHDRAWN
Houston
Lonestar Neurology of San Antonio
RECRUITING
San Antonio
UT Health MARC Medical Arts and Research Center
RECRUITING
San Antonio
Texas Institute for Neurological Disorders
ACTIVE_NOT_RECRUITING
Sherman
Baylor Scott and White
RECRUITING
Temple
Washington
University of Washington MS Clinic
RECRUITING
Seattle
Virginia Mason Medical Centre
ACTIVE_NOT_RECRUITING
Seattle
Wisconsin
Aurora BayCare Medical Center
WITHDRAWN
Green Bay
Ascension St Francis Center
RECRUITING
Milwaukee
Medical College of Wisconsin
ACTIVE_NOT_RECRUITING
Milwaukee
West Virginia
Elligo Health Research
RECRUITING
Crab Orchard
Other Locations
Argentina
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bombal
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Buenos Aires
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Caba
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Córdoba
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Rosario
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Rosario
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
San Miguel De
Brazil
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Brasília
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Curitiba
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Joinville
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Porto Alegre
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Porto Alegre
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Porto Alegre
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
São Paulo
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Vitória
Bulgaria
Novartis Investigative Site
RECRUITING
Plovdiv
Novartis Investigative Site
RECRUITING
Sofia
Novartis Investigative Site
RECRUITING
Sofia
Novartis Investigative Site
RECRUITING
Sofia
Canada
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Burnaby
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Edmonton
Novartis Investigative Site
WITHDRAWN
Greenfield Park
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Halifax
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Lévis
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Montreal
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Ottawa
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Québec
Novartis Investigative Site
RECRUITING
Saint-jérôme
China
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Beijing
Novartis Investigative Site
WITHDRAWN
Fuzhou
Novartis Investigative Site
RECRUITING
Hangzhou
Novartis Investigative Site
RECRUITING
Hangzhou
Novartis Investigative Site
RECRUITING
Nanjing
Novartis Investigative Site
RECRUITING
Shanghai
Novartis Investigative Site
RECRUITING
Shanghai
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Taiyuan
Novartis Investigative Site
RECRUITING
Wenzhou
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Wuhan
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Wuhan
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Yinchuan
Croatia
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Split
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Varaždin
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Vukovar
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Zagreb
Estonia
Novartis Investigative Site
RECRUITING
Tallinn
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Tartu
France
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Caen
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Clermont-ferrand
Novartis Investigative Site
WITHDRAWN
Contamine-sur-arve
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Dijon
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Gonesse
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Grenoble
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Lille
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Lille
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Limoges
Novartis Investigative Site
RECRUITING
Marseille
Novartis Investigative Site
RECRUITING
Nantes
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Nice
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Nîmes
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Poissy
Novartis Investigative Site
WITHDRAWN
Suresnes
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Toulon
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Toulouse
Germany
Novartis Investigative Site
RECRUITING
Essen
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Freiburg Im Breisgau
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Hamburg
Novartis Investigative Site
RECRUITING
Siegen
Novartis Investigative Site
RECRUITING
Ulm
Greece
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Athens
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Athens
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Chaïdári
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Ioannina
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Larissa
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Thessaloniki
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Thessaloniki
India
Novartis Investigative Site
RECRUITING
Amritsar
Novartis Investigative Site
RECRUITING
Hyderabad
Novartis Investigative Site
RECRUITING
Kochi
Novartis Investigative Site
RECRUITING
Kolkata
Novartis Investigative Site
RECRUITING
Lucknow
Novartis Investigative Site
RECRUITING
New Delhi
Novartis Investigative Site
WITHDRAWN
Pune
Novartis Investigative Site
RECRUITING
Pune
Italy
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Brindisi
Novartis Investigative Site
WITHDRAWN
Florence
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Foggia
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Messina
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Modena
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Napoli
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Orbassano
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Pavia
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Pozzilli
Japan
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Chiba
Novartis Investigative Site
RECRUITING
Fukuoka
Novartis Investigative Site
RECRUITING
Fukuoka
Novartis Investigative Site
RECRUITING
Higashi-matsuyama
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Ichihara
Novartis Investigative Site
RECRUITING
Isehara
Novartis Investigative Site
RECRUITING
Itabashi-ku
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Kashihara
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Kobe
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Kodaira
Novartis Investigative Site
WITHDRAWN
Kōriyama
Novartis Investigative Site
RECRUITING
Kyoto
Novartis Investigative Site
RECRUITING
Moriguchi
Novartis Investigative Site
RECRUITING
Nagoya
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Niigata
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Nishinomiya
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Sagamihara
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Sapporo
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Sendai
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Shinjuku Ku
Novartis Investigative Site
RECRUITING
Shinjuku Ku
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Shinjuku-ku
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Suita
Mexico
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Chihuahua City
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Mexico City
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Mexico City
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Querétaro
Poland
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bialystok
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Glogow Wielkopolski
Novartis Investigative Site
RECRUITING
Katowice
Novartis Investigative Site
RECRUITING
Katowice
Novartis Investigative Site
RECRUITING
Katowice
Novartis Investigative Site
RECRUITING
Katowice
Novartis Investigative Site
WITHDRAWN
Krakow
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Lublin
Novartis Investigative Site
RECRUITING
Plewiska
Novartis Investigative Site
RECRUITING
Wroclaw
Novartis Investigative Site
RECRUITING
Zabrze
Portugal
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Braga
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Coimbra
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Leiria
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Lisbon
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Lisbon
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Matosinhos Municipality
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Santa Maria Da Feira
Puerto Rico
Caribbean Center for Clinical Research, Inc
RECRUITING
Guaynabo
Romania
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Brasov
Novartis Investigative Site
WITHDRAWN
Bucharest
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Campulung Muscel
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Constanța
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Constanța
Novartis Investigative Site
WITHDRAWN
Suceava
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Târgu Mureş
Slovakia
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Banská Bystrica
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Banská Bystrica
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bratislava
Slovenia
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Celje
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Ljubljana
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Maribor
South Africa
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bloemfontein
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Pretoria
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Rosebank
Spain
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Albacete
Novartis Investigative Site
WITHDRAWN
Badalona
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Barcelona
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Gijón
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
L'hospitalet De Llobregat
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Lleida
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Logroño
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Madrid
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Madrid
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Málaga
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Pozuelo De Alarcón
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Santiago Compostela
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Seville
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Torrejón De Ardoz
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Valencia
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Valencia
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Vitoria-gasteiz
Sweden
Novartis Investigative Site
WITHDRAWN
Stockholm
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Stockholm
Turkey
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bursa
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Istanbul
Novartis Investigative Site
RECRUITING
Istanbul
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Istanbul
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Istanbul
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Izmir
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Izmir
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Kayseri
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Kocaeli
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Konya
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Samsun
United Kingdom
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Canterbury
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Inverness
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
London
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2021-12-13
Estimated Completion Date: 2030-10-30
Participants
Target number of participants: 800
Treatments
Experimental: Remibrutinib - Core
Remibrutinib tablet and matching placebo of teriflunomide capsule
Active_comparator: Teriflunomide - Core
Teriflunomide capsule and matching placebo remibrutinib tablet
Experimental: Remibrutinib - Extension
Participants on remibrutinib in Core will continue on remibrutinib tablet
Experimental: Remibrutinib - Extension (on teriflunomide in Core)
Participants on teriflunomide in Core will switch to remibrutinib tablet
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals