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ACTIVE NOT RECRUITING
NCT04586010
PHASE3

A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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

Interventions

DRUG

Fenebrutinib

Participants will receive fenebrutinib.

DRUG

Teriflunomide

Participants will receive teriflunomide.

DRUG

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