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 (244) 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
Arkansas
The Belinga Clinic
COMPLETED
Fort Smith
Arizona
AZ Integrated Neuro and Spine
ACTIVE_NOT_RECRUITING
Phoenix
Honor Health Research Institute
RECRUITING
Scottsdale
Center for Neurosciences
RECRUITING
Tucson
California
The Research and Education Inst. of Alta Bates Summit Med. Grp
RECRUITING
Berkeley
The Neuron Clinic
RECRUITING
Chula Vista
Neur Ctr of N Orange County
WITHDRAWN
Fullerton
Glendale Adventist Medical Center
RECRUITING
Glendale
Hoag Health System
RECRUITING
Newport Beach
SC3 Research Pasadena
RECRUITING
Pasadena
Neuro Center
RECRUITING
Pomona
Colorado
Mountain Neuro Research Center PC
WITHDRAWN
Basalt
Alpine Clinical Research Center
RECRUITING
Boulder
Washington, D.c.
Washington Hospital Center
RECRUITING
Washington D.c.
Delaware
Christiana Care Health Services
RECRUITING
Newark
Florida
Neurology of Central FL Res Ctr
RECRUITING
Altamonte Springs
Arrow Clinical Trials
RECRUITING
Daytona Beach
Homestead Assoc In Research Inc
RECRUITING
Homestead
Reliant Medical Research
RECRUITING
Miami
US Associates in Research
WITHDRAWN
Miami
Comprehensive Neurology Clinic
RECRUITING
Orlando
Neurological Services of Orlando PA
RECRUITING
Orlando
Orlando Health Clinical Trials
RECRUITING
Orlando
Neurology Associates of Ormond Beach
RECRUITING
Ormond Beach
Neurostudies Inc
RECRUITING
Port Charlotte
Accel Research Sites St Pete-Largo
ACTIVE_NOT_RECRUITING
Seminole
Axiom Clinical Research of Florida
WITHDRAWN
Tampa
University Of South Florida
RECRUITING
Tampa
Conquest Research
RECRUITING
Winter Park
Georgia
Velocity Clinical Research
RECRUITING
Savannah
Hawaii
Hawaii Pacific Neuroscience LLC
WITHDRAWN
Honolulu
Illinois
Insight Hospital and Medical Center
WITHDRAWN
Chicago
Rush University Medical Center
RECRUITING
Chicago
Advocate Medical Group
WITHDRAWN
Park Ridge
Springfield Clinic
WITHDRAWN
Springfield
Indiana
IU Health Inc
RECRUITING
Fort Wayne
Kansas
College Park Family Care Center
ACTIVE_NOT_RECRUITING
Overland Park
Kentucky
Norton Neurology MS Services
RECRUITING
Louisville
Massachusetts
Beth Israel Deaconess Medical Cente
RECRUITING
Boston
Lahey Clinic
WITHDRAWN
Burlington
Neurology Center of New England PC
COMPLETED
Foxborough
Maryland
Mid Atlantic Epilepsy and Sleep Ctr
RECRUITING
Bethesda
International Neurorehab Institute
RECRUITING
Lutherville
Michigan
Wayne State University Multiple Sclerosis Clinic
RECRUITING
Detroit
Missouri
The MS Center for Innovation in Care
RECRUITING
St Louis
Montana
SCL Health
RECRUITING
Billings
North Carolina
The Neurological Institute PA
RECRUITING
Charlotte
Velocity Clinical Research
RECRUITING
Raleigh
New Jersey
Jersey Shore University Medical Ctr
RECRUITING
Neptune City
New York
NYU Langone Health
WITHDRAWN
Brooklyn
Neurological Associates of Long Island PC
RECRUITING
Lake Success
NYU Langone Med Center CV Research
RECRUITING
New York
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
Columbus Neuroscience
COMPLETED
Westerville
Oklahoma
Multiple Sclerosis Center of Excellence of OMRF
ACTIVE_NOT_RECRUITING
Oklahoma City
Oregon
Providence St Vincent Med Center
RECRUITING
Portland
Pennsylvania
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
University Of Pittsburgh Medical Ctr Magee-Womens Hospital
RECRUITING
Pittsburgh
Reading Hospital
ACTIVE_NOT_RECRUITING
Reading
South Carolina
Palmetto Clinical Research
RECRUITING
Summerville
Texas
Texas Neurology
COMPLETED
Dallas
Univ of Texas Southwest Med Center
WITHDRAWN
Dallas
Advc Neurology Epilepsy and Sleep
WITHDRAWN
El Paso
John Peter Smith Hospital
RECRUITING
Fort Worth
Neuro Eye Clinical Trials Inc
RECRUITING
Houston
DHR Health Institute
RECRUITING
Mcallen
North TX Inst of Neuro and Headache
RECRUITING
Plano
Utah
The University of Utah
WITHDRAWN
Salt Lake City
Virginia
MS Center of Greater Washington, P.C.
RECRUITING
Vienna
Washington
Swedish Medical Center
WITHDRAWN
Seattle
Wisconsin
University of Wisconsin Madison
ACTIVE_NOT_RECRUITING
Madison
Neuroscience Group
RECRUITING
Neenah
Other Locations
Argentina
Novartis Investigative Site
RECRUITING
Buenos Aires
Novartis Investigative Site
RECRUITING
Caba
Novartis Investigative Site
RECRUITING
Capital Federal
Novartis Investigative Site
RECRUITING
Capital Federal
Novartis Investigative Site
RECRUITING
Ciudad Autonoma De Bs As
Novartis Investigative Site
RECRUITING
Rosario
Novartis Investigative Site
RECRUITING
Santiago Del Estero
Austria
Novartis Investigative Site
RECRUITING
Graz
Novartis Investigative Site
RECRUITING
Klagenfurt
Novartis Investigative Site
RECRUITING
Linz
Novartis Investigative Site
RECRUITING
Linz
Belgium
Novartis Investigative Site
RECRUITING
Antwerp
Novartis Investigative Site
WITHDRAWN
Ath
Novartis Investigative Site
RECRUITING
Brasschaat
Novartis Investigative Site
RECRUITING
Bruges
Novartis Investigative Site
WITHDRAWN
Brussels
Novartis Investigative Site
RECRUITING
Brussels
Novartis Investigative Site
RECRUITING
Edegem
Novartis Investigative Site
WITHDRAWN
Lier
Novartis Investigative Site
RECRUITING
Melsbroek
Novartis Investigative Site
RECRUITING
Overpelt
Brazil
Novartis Investigative Site
RECRUITING
Porto Alegre
Novartis Investigative Site
RECRUITING
São Paulo
Novartis Investigative Site
RECRUITING
São Paulo
Novartis Investigative Site
RECRUITING
São Paulo
Novartis Investigative Site
RECRUITING
São Paulo
Bulgaria
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Pleven
Novartis Investigative Site
RECRUITING
Pleven
Novartis Investigative Site
RECRUITING
Sofia
Novartis Investigative Site
RECRUITING
Sofia
Novartis Investigative Site
RECRUITING
Sofia
Chile
Novartis Investigative Site
RECRUITING
Santiago
Novartis Investigative Site
RECRUITING
Santiago
China
Novartis Investigative Site
RECRUITING
Baotou
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
WITHDRAWN
Beijing
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Changchun
Novartis Investigative Site
RECRUITING
Changsha
Novartis Investigative Site
RECRUITING
Chongqing
Novartis Investigative Site
WITHDRAWN
Guangzhou
Novartis Investigative Site
RECRUITING
Guangzhou
Novartis Investigative Site
RECRUITING
Hohhot
Novartis Investigative Site
RECRUITING
Nanchang
Novartis Investigative Site
RECRUITING
Tianjin
Novartis Investigative Site
RECRUITING
Zhengzhou
Colombia
Novartis Investigative Site
WITHDRAWN
Bogotá
Novartis Investigative Site
RECRUITING
Bogotá
Novartis Investigative Site
RECRUITING
Medellín
Novartis Investigative Site
RECRUITING
Medellín
Novartis Investigative Site
RECRUITING
Puerto Colombia
Novartis Investigative Site
RECRUITING
Santiago De Cali
Novartis Investigative Site
RECRUITING
Santiago De Cali
Croatia
Novartis Investigative Site
RECRUITING
Osijek
Novartis Investigative Site
RECRUITING
Rijeka
Novartis Investigative Site
WITHDRAWN
Zadar
Novartis Investigative Site
WITHDRAWN
Zagreb
Novartis Investigative Site
RECRUITING
Zagreb
Denmark
Novartis Investigative Site
RECRUITING
Slagelse
Georgia
Novartis Investigative Site
RECRUITING
Tbilisi
Novartis Investigative Site
RECRUITING
Tbilisi
Novartis Investigative Site
RECRUITING
Tbilisi
Novartis Investigative Site
RECRUITING
Tbilisi
Novartis Investigative Site
RECRUITING
Tbilisi
Novartis Investigative Site
RECRUITING
Tbilisi
Guatemala
Novartis Investigative Site
RECRUITING
Guatemala City
Hong Kong Special Administrative Region
Novartis Investigative Site
RECRUITING
Shatin
India
Novartis Investigative Site
RECRUITING
Chandigarh
Novartis Investigative Site
RECRUITING
Dehradun
Novartis Investigative Site
WITHDRAWN
Hyderabad
Novartis Investigative Site
RECRUITING
Lucknow
Novartis Investigative Site
RECRUITING
Ludhiana
Novartis Investigative Site
RECRUITING
Mangalore
Novartis Investigative Site
RECRUITING
Mangalore
Novartis Investigative Site
RECRUITING
Mumbai
Novartis Investigative Site
RECRUITING
Nashik
Novartis Investigative Site
RECRUITING
Nashik
Novartis Investigative Site
RECRUITING
New Delhi
Ireland
Novartis Investigative Site
RECRUITING
Dublin
Novartis Investigative Site
RECRUITING
Dublin
Israel
Novartis Investigative Site
RECRUITING
Ashkelon
Novartis Investigative Site
RECRUITING
Hadera
Novartis Investigative Site
RECRUITING
Haifa
Novartis Investigative Site
RECRUITING
Haifa
Novartis Investigative Site
RECRUITING
Jerusalem
Novartis Investigative Site
RECRUITING
Sefad
Novartis Investigative Site
RECRUITING
Tel Aviv
Italy
Novartis Investigative Site
RECRUITING
Milan
Novartis Investigative Site
WITHDRAWN
Montichiari
Novartis Investigative Site
RECRUITING
Napoli
Novartis Investigative Site
RECRUITING
Novara
Novartis Investigative Site
RECRUITING
Roma
Novartis Investigative Site
RECRUITING
Roma
Novartis Investigative Site
RECRUITING
Roma
Novartis Investigative Site
RECRUITING
Verona
Jordan
Novartis Investigative Site
RECRUITING
Amman
Latvia
Novartis Investigative Site
RECRUITING
Riga
Novartis Investigative Site
RECRUITING
Riga
Lebanon
Novartis Investigative Site
RECRUITING
Beirut
Novartis Investigative Site
RECRUITING
Beirut
Novartis Investigative Site
RECRUITING
El Achrafiyé
Novartis Investigative Site
RECRUITING
El Chouf
Novartis Investigative Site
RECRUITING
Tripoli
Lithuania
Novartis Investigative Site
RECRUITING
Klaipėda
Novartis Investigative Site
RECRUITING
Šiauliai
Malaysia
Novartis Investigative Site
RECRUITING
Kuala Lumpur
Novartis Investigative Site
RECRUITING
Kuala Terengganu
Novartis Investigative Site
RECRUITING
Kuching
Novartis Investigative Site
RECRUITING
Seberang Jaya
Mexico
Novartis Investigative Site
RECRUITING
San Pedro Garza García
Novartis Investigative Site
RECRUITING
Veracruz
Novartis Investigative Site
RECRUITING
Zapopan
Netherlands
Novartis Investigative Site
WITHDRAWN
's-hertogenbosch
Novartis Investigative Site
WITHDRAWN
Dordrecht
Novartis Investigative Site
RECRUITING
Rotterdam
Poland
Novartis Investigative Site
RECRUITING
Bydgoszcz
Novartis Investigative Site
RECRUITING
Kielce
Novartis Investigative Site
RECRUITING
Lodz
Novartis Investigative Site
RECRUITING
Lodz
Novartis Investigative Site
RECRUITING
Lublin
Novartis Investigative Site
RECRUITING
Piotrkow Trybunalski
Novartis Investigative Site
RECRUITING
Poznan
Novartis Investigative Site
RECRUITING
Rzeszów
Novartis Investigative Site
RECRUITING
Szczecin
Novartis Investigative Site
RECRUITING
Wroclaw
Saudi Arabia
Novartis Investigative Site
RECRUITING
Jeddah
Novartis Investigative Site
RECRUITING
Jeddah
Novartis Investigative Site
RECRUITING
Khorais Street
Slovakia
Novartis Investigative Site
RECRUITING
Bratislava
Novartis Investigative Site
RECRUITING
Košice
Novartis Investigative Site
RECRUITING
Nitra
Novartis Investigative Site
RECRUITING
Trnava
Spain
Novartis Investigative Site
RECRUITING
A Coruña
Novartis Investigative Site
RECRUITING
Alcorcón
Novartis Investigative Site
WITHDRAWN
Barakaldo
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Cadiz
Novartis Investigative Site
RECRUITING
Castilleja De La Cuesta
Novartis Investigative Site
RECRUITING
Córdoba
Novartis Investigative Site
RECRUITING
El Palmar
Novartis Investigative Site
RECRUITING
Getafe
Novartis Investigative Site
RECRUITING
Las Palmas De Gran Canaria
Novartis Investigative Site
RECRUITING
León
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Málaga
Novartis Investigative Site
RECRUITING
Salt
Novartis Investigative Site
RECRUITING
Sant Joan Despí
Novartis Investigative Site
RECRUITING
Seville
Novartis Investigative Site
RECRUITING
Valencia
Novartis Investigative Site
RECRUITING
Valladolid
Novartis Investigative Site
RECRUITING
Vigo
Switzerland
Novartis Investigative Site
RECRUITING
Basel
Novartis Investigative Site
RECRUITING
Bern
Taiwan
Novartis Investigative Site
RECRUITING
Kaohsiung City
Novartis Investigative Site
RECRUITING
Tainan City
Novartis Investigative Site
RECRUITING
Taipei
Novartis Investigative Site
RECRUITING
Taoyuan District
Turkey
Novartis Investigative Site
RECRUITING
Ankara
Novartis Investigative Site
RECRUITING
Ankara
Novartis Investigative Site
RECRUITING
Haseki Istanbul
Novartis Investigative Site
RECRUITING
Istanbul
Novartis Investigative Site
RECRUITING
Izmir
Novartis Investigative Site
RECRUITING
Izmir
Novartis Investigative Site
RECRUITING
Mersin
United Arab Emirates
Novartis Investigative Site
RECRUITING
Abu Dhabi
Novartis Investigative Site
RECRUITING
Dubai
United Kingdom
Novartis Investigative Site
RECRUITING
Glasgow
Novartis Investigative Site
RECRUITING
Westbruy On Trym
Novartis Investigative Site
RECRUITING
Winchester
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2021-12-16
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