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A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
Sponsor: Hoffmann-La Roche
Summary
A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized 1:1 to either fenebrutinib or teriflunomide. At the end of the DBT phase (after disclosure of the DBT results), the Sponsor will determine whether or not to initiate the open-label extension phase of the study.
Official title: A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Adult Patients With Relapsing Multiple Sclerosis
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
746
Start Date
2021-03-17
Completion Date
2027-11-30
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
Fenebrutinib
Participants will receive fenebrutinib.
Teriflunomide
Participants will receive teriflunomide.
Placebo
Participants will receive teriflunomide-matching placebo or fenebrutinib-matching placebo.
Locations (160)
University of Alabama Birmingham
Birmingham, Alabama, United States
Alabama Neurology Associates
Homewood, Alabama, United States
Center for Neurology and Spine - Phoenix - Hunt - PPDS
Phoenix, Arizona, United States
Profound Research, LLC
Carlsbad, California, United States
University of California Irvine
Irvine, California, United States
SC3 Research Group, Inc
Pasadena, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Mountain View Clinical Research
Denver, Colorado, United States
Advanced Neurology of Colorado, LLC
Fort Collins, Colorado, United States
Neurology Associates, PA; Research Department
Maitland, Florida, United States
NorthShore University HealthSystem
Highland Park, Illinois, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
The NeuroMedical Center
Baton Rouge, Louisiana, United States
Ochsner LSU Health
Shreveport, Louisiana, United States
Johns Hopkins University School Of Medicine; Outpatient Center
Baltimore, Maryland, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Holy Name Hospital; Institute For Clinical Research
Teaneck, New Jersey, United States
University of New Mexico; MS Specialty Clinic
Albuquerque, New Mexico, United States
Miami Valley Hospital South; Dayton Physician's Office
Centerville, Ohio, United States
OhioHealth
Columbus, Ohio, United States
The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company
Columbus, Ohio, United States
Oklahoma Medical Research Foundation; MS Center of Excellence
Oklahoma City, Oklahoma, United States
St. Luke's University Health network
Bethlehem, Pennsylvania, United States
Premier Neurology
Greenville, South Carolina, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States
North Texas Institute of Neurology and Headache NextStage Clinical Research Clinic
Plano, Texas, United States
Texas Institute for Neurological Disorders
Sherman, Texas, United States
Multiple Sclerosis Center of Greater Washington
Vienna, Virginia, United States
Evergreen MS Center
Kirkland, Washington, United States
Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders
Milwaukee, Wisconsin, United States
Instituto de Investigaciones Metabolicas (Idim)
Buenos Aires, Argentina
IME - Instituto Médico Especializado
Buenos Aires, Argentina
Centro de Especialidades Neurológicas y Rehabilitación - CENyR
Buenos Aires, Argentina
CIER
C. A. B. A., Argentina
Diagnostico Medico Oroño
Rosario, Argentina
Cer San Juan
San Juan, Argentina
Centro de Investigaciones Médicas Tucuman
San Miguel de Tucumán, Argentina
Peking University First Hospital
Beijing, China
Beijing Tiantan Hospital,Capital Medical University
Beijing, China
the First Hospital of Jilin University
Changchun, China
Xiangya Hospital Central South University
Changsha, China
West China Hospital, Sichuan University
Chengdu, China
The First Affiliated Hospital, Chongqing Medical University
Chongqing, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
The second Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
The affiliated Hospital of Guiyang Medical College
Guiyang, China
The First People?s Hospital of Yunnan Province
Kunming, China
The Second Hospital of Hebei Medical University
Shijiazhuang, China
The First Affiliated Hospital of Soochow University
Suzhou, China
1st Affiliated Hospital of Shanxi Medical University
Taiyuan, China
Tianjin Medical University General Hospital
Tianjin, China
Xinjiang People Hospital
Ürümqi, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
Tangdu Hospital, The Fourth Military Medical University
Xi'an, China
NeuroINC
Santiago de los Caballeros, Dominican Republic
Hospital Padre Billini
Santo Domingo, Dominican Republic
Helsinki University Central Hospital
Helsinki, Finland
New Hospitals
Tbilisi, Georgia
Pineo Medical Ecosystem
Tbilisi, Georgia
St. Michael hospital
Tbilisi, Georgia
MediClab Georgia
Tbilisi, Georgia
Khechinashvili University Hospital
Tbilisi, Georgia
Jüdisches Krankenhaus Berlin
Berlin, Germany
Studienzentrum Dr. Bischof GmbH
Böblingen, Germany
Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
Dresden, Germany
Universitätsklinikum Gießen und Marburg GmbH
Giessen, Germany
Uniklinik Schleswig-Holstein
Kiel, Germany
Praxis Dr. med. Andreas Kowalik, Arzt für Neurologie und Psychiatrie
Stuttgart, Germany
Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen, Germany
Universitätsklinikum Ulm
Ulm, Germany
Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
Westerstede, Germany
Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Clinexpert Kft.
Budapest, Hungary
S-Medicon Egeszsegugyi Szolgaltato Kft.
Budapest, Hungary
Markhot Ferenc Oktatokorhaz és Rendelointezet
Eger, Hungary
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Hungary
AO.U. Policlinico Riuniti Foggia
Foggia, Apulia, Italy
AOU Seconda Università degli Studi
Naples, Campania, Italy
AOU Policlinico - Università L. Vanvitelli
Naples, Campania, Italy
A.O.U. di Parma
Parma, Emilia-Romagna, Italy
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
Rome, Lazio, Italy
Policlinico Umberto I
Rome, Lazio, Italy
Azienda Ospedaliera Sant'Andrea
Rome, Lazio, Italy
ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla
Bergamo, Lombardy, Italy
IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy
Ospedale Regina Montis Regalis
Mondovì (CN), Piedmont, Italy
AOU Policlinico V. Emanuele - P.O G. Rodolico
Catania, Sicily, Italy
Azienda Ospedaliera di Padova
Padova, Veneto, Italy
The Aga Khan University-Kenya.
Nairobi, Kenya
Clinical Research Institute Saltillo
Saltillo, Coahuila, Mexico
Grupo Medico de Investigacion Clinica Multidisciplinaria
Mexico City, Mexico CITY (federal District), Mexico
Health Pharma Professional Research
Mexico City, Mexico CITY (federal District), Mexico
Neurociencias Estudios Clinicos S.C.
Culiacán, Sinaloa, Mexico
Hospital General de Mexico
Mexico, Tlaxcala, Mexico
Zuyderland Medisch Centrum - Sittard Geleen
Sittard-Geleen, Netherlands
Clinical Hospital Stip
Shtip, North Macedonia
PHO General City Hospital 8th September Center for dialysis
Skopje, North Macedonia
University Clinic for Neurology - Skopje
Skopje, North Macedonia
Hospital IV Alberto Sabogal Sologuren
Bellavista, Peru
Hospital Nacional Guillermo Almenara Irigoyen
La Victoria, Lima, Peru
Hospital Nacional Dos de Mayo
Lima, Peru
Clinica Internacional Sede Lima
Lima, Peru
Hospital Maria Auxiliadora
Lima, Peru
Clinica Centenario Peruano Japonesa
Pueblo Libre, Peru
ProNeuro Centrum Medyczne
?ory, Poland
Neurocentrum Bydgoszcz sp. z o.o
Bydgoszcz, Poland
Care Clinic
Katowice, Poland
MT Medic Krosno
Krosno, Poland
Centrum Neurologii Krzysztof Selmaj
Lodz, Poland
Rodzinne Centrum Medyczne Lubimed.pl
Lublin, Poland
Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych
Plewiska, Poland
MedPolonia
Poznan, Poland
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
Warsaw, Poland
IBISMED Wielospecjalistyczne Centrum Medyczne
Zabrze, Poland
Hospital de Braga
Braga, Portugal
HUC
Coimbra, Portugal
Hospital Santo Antonio dos Capuchos
Lisbon, Portugal
Hospital da Luz
Lisbon, Portugal
Hospital Geral de Santo Antonio
Porto, Portugal
Hospital de Sao Joao
Porto, Portugal
Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião
Santa Maria da Feira, Portugal
Republican clinical hospital named after G.G. Kuvatov
Ufa, Bashkortostan Republic, Russia
Leningrad Regional Clinical Hospital
Saint Petersburg, Sankt-Peterburg, Russia
Pavlov State Medical Uni
Saint Petersburg, Sankt-Peterburg, Russia
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, Ulyanovsk Oblast, Russia
Center of Cardiology and Neurology
Kirov, Russia
FSBIH Siberian Regional Medical Centre of FMBA of Russia
Novosibirsk, Russia
University Clinical Center of Serbia
Belgrade, Serbia
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Quiron de Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Virgen de Arrixaca
EL Palmar (EL Palmar), Murcia, Spain
Hospital Alvaro Cunqueiro
Vigo, Pontevedra, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario de la Princesa
Madrid, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Hospital Ramon y Cajal
Madrid, Spain
Fundacion Jimenez Diaz
Madrid, Spain
Hospital Regional Universitario de Malaga ? Hospital General
Málaga, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Inselspital Bern Medizin Neurologie
Bern, Switzerland
Ospedale Regionale di Lugano - Civico
Lugano, Switzerland
Hopital Razi
Mannouba, Tunisia
Fattouma Bourguiba Hospital
Monastir, Tunisia
Hospital Habib Bourguiba
Sfax, Tunisia
Salutem Medical Center
Vinnytsia, KIEV Governorate, Ukraine
Separated structural unit ?University hospital? of Dnipro State Medical University
Dnipro, Tavria Okruha, Ukraine
SI USSRI of Medical and Social Problems of Disabilities of MOHU
Dnipro, Ukraine
Ams of Ukraine
Kharkiv, Ukraine
Medical Center Dopomoga Plus
Kyiv, Ukraine
Medical Center of Private Execution First Private Clinic
Kyiv, Ukraine
Lviv Regional Clinical Hospital
Lviv, Ukraine
"Neurofocus" LLC
Lviv, Ukraine
Odesa Regional Clinical Hospital
Odesa, Ukraine
Medical Clinical Research Center of Medical Center LLC Health Clinic
Vinnytsi, Ukraine
LCC "Medical center "Unimed"
Zaporizhzhia, Ukraine
Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council
Zaporizhzhia, Ukraine