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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

746

Participants

Timeline

Start Date

March 17, 2021

Primary Completion Date

January 27, 2026

Study Completion Date

November 30, 2027

Conditions
Relapsing Multiple Sclerosis
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.

Trial Locations (160)

1000

PHO General City Hospital 8th September Center for dialysis, Skopje

University Clinic for Neurology - Skopje, Skopje

1033

Clinexpert Kft., Budapest

1138

S-Medicon Egeszsegugyi Szolgaltato Kft., Budapest

2000

Diagnostico Medico Oroño, Rosario

Clinical Hospital Stip, Shtip

2010

Hopital Razi, Mannouba

2143

Pest Megyei Flor Ferenc Korhaz, Kistarcsa

3010

Inselspital Bern Medizin Neurologie, Bern

3029

Hospital Habib Bourguiba, Sfax

3300

Markhot Ferenc Oktatokorhaz és Rendelointezet, Eger

5000

Fattouma Bourguiba Hospital, Monastir

6725

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ, Szeged

6903

Ospedale Regionale di Lugano - Civico, Lugano

10210

Hospital Padre Billini, Santo Domingo

11000

University Clinical Center of Serbia, Belgrade

12084

Ospedale Regina Montis Regalis, Mondovì (CN)

13347

Jüdisches Krankenhaus Berlin, Berlin

15018

Hospital Nacional Dos de Mayo, Lima

18015

St. Luke's University Health network, Bethlehem

20132

IRCCS Ospedale San Raffaele, Milan

21009

Salutem Medical Center, Vinnytsia

Medical Clinical Research Center of Medical Center LLC Health Clinic, Vinnytsi

21287

Johns Hopkins University School Of Medicine; Outpatient Center, Baltimore

22182

Multiple Sclerosis Center of Greater Washington, Vienna

24105

Uniklinik Schleswig-Holstein, Kiel

24127

ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla, Bergamo

25050

Clinical Research Institute Saltillo, Saltillo

26655

Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz, Westerstede

28006

Hospital Universitario de la Princesa, Madrid

28007

Hospital General Universitario Gregorio Marañon, Madrid

28034

Hospital Ramon y Cajal, Madrid

28040

Fundacion Jimenez Diaz, Madrid

28223

Hospital Quiron de Madrid, Pozuelo de Alarcón

29010

Hospital Regional Universitario de Malaga ? Hospital General, Málaga

29605

Premier Neurology, Greenville

30120

Hospital Universitario Virgen de Arrixaca, EL Palmar (EL Palmar)

32751

Neurology Associates, PA; Research Department, Maitland

35128

Azienda Ospedaliera di Padova, Padua

35209

Alabama Neurology Associates, Homewood

35233

University of Alabama Birmingham, Birmingham

35385

Universitätsklinikum Gießen und Marburg GmbH, Giessen

36213

Hospital Alvaro Cunqueiro, Vigo

37920

New Orleans Center for Clinical Research, Knoxville

41009

Hospital Universitario Virgen Macarena, Seville

43126

A.O.U. di Parma, Parma

43214

OhioHealth, Columbus

43235

The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company, Columbus

45459

Miami Valley Hospital South; Dayton Physician's Office, Centerville

46805

Fort Wayne Neurological Center, Fort Wayne

48202

Henry Ford Health System, Detroit

49027

SI USSRI of Medical and Social Problems of Disabilities of MOHU, Dnipro

51000

NeuroINC, Santiago de los Caballeros

53215

Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders, Milwaukee

60035

NorthShore University HealthSystem, Highland Park

61068

Ams of Ukraine, Kharkiv

63110

Washington University School of Medicine, St Louis

65117

Odesa Regional Clinical Hospital, Odesa

69600

"LCC Medical center Unimed", Zaporizhia

Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council, Zaporizhzhia

70174

Praxis Dr. med. Andreas Kowalik, Arzt für Neurologie und Psychiatrie, Stuttgart

70810

The NeuroMedical Center, Baton Rouge

71034

Studienzentrum Dr. Bischof GmbH, Böblingen

71100

AO.U. Policlinico Riuniti Foggia, Foggia

71103

Ochsner LSU Health, Shreveport

72076

Universitätsklinikum Tübingen, Zentrum für Neurologie, Tübingen

73104

Oklahoma Medical Research Foundation; MS Center of Excellence, Oklahoma City

75024

North Texas Institute of Neurology and Headache NextStage Clinical Research Clinic, Plano

75092

Texas Institute for Neurological Disorders, Sherman

79007

MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care, Lviv

79010

Lviv Regional Clinical Hospital, Lviv

80020

Neurociencias Estudios Clinicos S.C., Culiacán

80045

University of Colorado Denver, Aurora

80131

AOU Seconda Università degli Studi, Napoli

80138

AOU Policlinico - Università L. Vanvitelli, Napoli

80209

Mountain View Clinical Research, Denver

80528

Advanced Neurology of Colorado, LLC, Fort Collins

85032

Center for Neurology and Spine - Phoenix - Hunt - PPDS, Phoenix

87131

University of New Mexico; MS Specialty Clinic, Albuquerque

89081

Universitätsklinikum Ulm, Ulm

91105

SC3 Research Group, Inc, Pasadena

92011

Profound Research, LLC, Carlsbad

92697

University of California Irvine, Irvine

95123

AOU Policlinico V. Emanuele - P.O G. Rodolico, Catania

98034

Evergreen MS Center, Kirkland

100034

Peking University First Hospital, Beijing

130021

the First Hospital of Jilin University, Changchun

194291

Leningrad Regional Clinical Hospital, Saint Petersburg

197022

Pavlov State Medical Uni, Saint Petersburg

215031

The First Affiliated Hospital of Soochow University, Suzhou

300052

Tianjin Medical University General Hospital, Tianjin

400016

The First Affiliated Hospital, Chongqing Medical University, Chongqing

410008

Xiangya Hospital Central South University, Changsha

430030

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan

432063

Ulyanovsk Regional Clinical Hospital, Ulyanovsk

450005

Republican clinical hospital named after G.G. Kuvatov, Ufa

510080

The First Affiliated Hospital of Sun Yat-sen University, Guangzhou

510260

The second Affiliated Hospital of Guangzhou Medical University, Guangzhou

610007

Center of Cardiology and Neurology, Kirov

610041

West China Hospital, Sichuan University, Chengdu

630007

FSBIH Siberian Regional Medical Centre of FMBA of Russia, Novosibirsk

650021

The First People?s Hospital of Yunnan Province, Kunming

830000

Xinjiang People Hospital, Ürümqi

01655

University of Massachusetts Medical School, Worcester

07666

Holy Name Hospital; Institute For Clinical Research, Teaneck

C1012AAR

Instituto de Investigaciones Metabolicas (Idim), Buenos Aires

C1405BCH

IME - Instituto Médico Especializado, Buenos Aires

C1424

Centro de Especialidades Neurológicas y Rehabilitación - CENyR, Buenos Aires

C1055AAF

CIER, C. A. B. A.

J5400CEP

Cer San Juan, San Juan

T4000AXL

Centro de Investigaciones Médicas Tucuman, San Miguel de Tucumán

Unknown

Beijing Tiantan Hospital,Capital Medical University, Beijing

The affiliated Hospital of Guiyang Medical College, Guiyang

1st Affiliated Hospital of Shanxi Medical University, Taiyuan

Tangdu Hospital, The Fourth Military Medical University, Xi'an

Pamela Youde Nethersole Eastern Hospital, Hong Kong

Prince of Wales Hospital, Shatin, New Territories

Separated structural unit ?University hospital? of Dnipro State Medical University, Dnipro

05000

The Second Hospital of Hebei Medical University, Shijiazhuang

00290

Helsinki University Central Hospital, Helsinki

0114

New Hospitals, Tbilisi

Pineo Medical Ecosystem, Tbilisi

0159

St. Michael hospital, Tbilisi

0160

MediClab Georgia, Tbilisi

0179

Khechinashvili University Hospital, Tbilisi

01307

"Universitätsklinikum Carl Gustav Carus, Zentrum für Klinische Neurowissenschaften", Dresden

00133

Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla, Rome

00185

Policlinico Umberto I, Rome

00189

Azienda Ospedaliera Sant'Andrea, Rome

00100

Aga Khan University Hospital, Nairobi

03100

Grupo Medico de Investigacion Clinica Multidisciplinaria, Mexico City

Health Pharma Professional Research, Mexico City

06726

Hospital General de Mexico, Mexico

6162 BG

Zuyderland Medisch Centrum - Sittard Geleen, Sittard-Geleen

Callao 2

Hospital IV Alberto Sabogal Sologuren, Bellavista

Lima 13

Hospital Nacional Guillermo Almenara Irigoyen, La Victoria, Lima

Lima 01

Clinica Internacional Sede Lima, Lima

Lima 29

Hospital Maria Auxiliadora, Lima

Lima 21

Clinica Centenario Peruano Japonesa, Pueblo Libre

44-240

ProNeuro Centrum Medyczne, ?ory

85-796

Neurocentrum Bydgoszcz sp. z o.o, Bydgoszcz

40-568

Care Clinic, Katowice

38-400

MT Medic Krosno, Krosno

90-324

Centrum Neurologii Krzysztof Selmaj, Lodz

20-492

Rodzinne Centrum Medyczne Lubimed.pl, Lublin

62-064

Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych, Plewiska

60-693

MedPolonia, Poznan

02-957

Instytut Psychiatrii i Neurologii II Klinika Neurologiczna, Warsaw

41-800

IBISMED Wielospecjalistyczne Centrum Medyczne, Zabrze

4710-243

Hospital de Braga, Braga

3000-075

HUC, Coimbra

1169-050

Hospital Santo Antonio dos Capuchos, Lisbon

1500-650

Hospital da Luz, Lisbon

4099-001

Hospital Geral de Santo Antonio, Porto

4200-319

Hospital de Sao Joao, Porto

4520-211

Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião, Santa Maria da Feira

08907

Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat

08035

Hospital Universitari Vall d'Hebron, Barcelona

02123

Medical Center Dopomoga Plus, Kyiv

03037

Medical Center of Private Execution First Private Clinic, Kyiv

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT04586010 - A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) | Biotech Hunter | Biotech Hunter