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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

751

Participants

Timeline

Start Date

March 24, 2021

Primary Completion Date

September 5, 2025

Study Completion Date

July 9, 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 (108)

1113

MHATNP Sveti Naum EAD, Sofia

4021

Kepler Universitätskliniken GmbH - Med Campus III, Linz

5800

UMHAT Dr. Georgi Stranski, Pleven

6400

Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken, Sønderborg

6700

Sydvestjysk Sygehus Esbjerg, Esbjerg

10408

National Cancer Center, Goyang-si

14050

Unidad de investigacion en salud (UIS), Mexico City

16132

Irccs A.O.U.San Martino Ist, Genoa

20007

Georgetown University Medical Center, Washington D.C.

20133

Fond. Istituto Neurologico C.Besta, Milan

22043

Integrated Neurology Services PLLC, Falls Church

25018

Ospedale Civile di Montichiari, Montichiari

27100

IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla, Pavia

31059

CHU toulouse - Hôpital Purpan, Toulouse

31203

Unidad de Investigación en Salud, Chihuahua City

33079

Mersin University Medical Faculty, Mersin

33612

University of South Florida, Tampa

34000

Bakirkoy State Mental Hospital, Istanbul

34785

Sancaktepe Training and Research Hospital, Istanbul

35058

North Central Neurology Associates, Cullman

35100

Ege Üniversitesi Tip Fakültesi, Lzmir

37922

Hope Neurology, Knoxville

41380

Kocaeli University Hospital, Kocaeli

41931

Keimyung University Dongsan Medical Center, Daegu

42131

Selcuk University Medical Faculty, Istanbul

45219

University of Cincinnati, Cincinnati

46123

American Health Network Institute, LLC, Avon

54636

AHEPA Univ. General Hospital of Thessaloniki, Thessaloniki

55139

Ondokuz Mayis University School of Medicine, Samsun

61080

Karadeniz Tecnical Uni. Med. Fac., Trabzon

63003

Hopital Gabriel Montpied CHU de Clermont-Ferrand, Clermont-Ferrand

65080

Van Yuzuncu Yil University Hospital, Van

66100

Universita? G. D'Annunzio, Chieti

66160

University of Kansas Medical Center, Kansas City

70124

Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari, Bari

76031

Hôpital Charles Nicolle, Rouen

80131

A. O. U. Federico II, Napoli

85004

Xenoscience, Phoenix

86077

IRCCS Istituto Neurologico Neuromed, Pozzilli

90129

AOU Policlinico Giaccone, Palermo

90502

Los Angeles Biomedical Research Institute at Harbor-UCLA, Torrance

110017

Max Super Speciality Hospital, New Delhi

110060

Sir Gangaram Hospital, New Delhi

117997

Federal center of brain research and neurotechnologies, Moskva

141008

Christian Medical College and Hospital, Ludhiana

160012

Postgraduate Institute of Medical Education and Research, Chandigarh

197110

National Center of Social Significant Disease, Saint Petersburg

350086

Regional clinical hospital named after prof. S.V. Ochapovsky, Krasnodar

380054

Zydus Hospital, Ahmedabad

400012

Seth G.S Medical College K.E.M Hospital, Mumbai

411004

Deenanath Mangeshkar Hospital & Research Centre, Pune

411006

Sahyadri Superspeciality Hospital, Pune

600026

SRM Institute of Medical Sciences, Vadapalani

603126

Regional Clinical Hospital N.A. Semashko, Nizhny Novgorod

634009

Nebbiolo Center for Clinical Trials, Tomsk

660022

Krasnoyarsk State Medical Academy, Krasnoyarsk

660037

FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency, Krasnoyarsk

06905

KI Health Partners, LLC, Stamford

02035

Neuro Institute of New England P.C., Foxborough

53226-3596

Medical College of Wisconsin, Inc., Milwaukee

70200-730

L2 Ip Instituto de Pesquisas Clinicas Ltda ME, Brasília

30150-221

Santa Casa de Misericordia, Belo Horizonte

81210-310

Instituto de Neurologia de Curitiba, Curitiba

90110-000

IMV Pesquisa Neurológica, Porto Alegre

90430-001

Núcleo de Pesquisa do Rio Grande do Sul, Porto Alegre

90610-000

Hospital Sao Lucas - PUCRS, Porto Alegre

89201-165

Clinica Neurologica, Joinville

09090-790

Praxis Pesquisa Médica, Santo André

09715-090

CEMEC - Centro Multidisciplinar de Estudos Clínicos, São Bernardo do Campo

01228-200

Centro de Pesquisas Clinicas, São Paulo

08270-070

Hospital Santa Marcelina, São Paulo

Unknown

Jordy Sinapse Medicina LTDA ME, São Paulo

T6G 1Z1

University of Alberta Hospital, Edmonton

K1H 8L6

The Ottawa Hospital - General Campus, Ottawa

G7H 5H6

CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital, Chicoutimi

H3A 2B4

MUCH - Montreal Neurological Institute & Hospital, Montreal

G1J 1Z4

CHU de Québec, Québec

06002

Hôpital Pasteur, Nice

115 28

Hospital Eginition, Athens

411 10

University General Hospital of Larisa, Larissa

01015

Nucare, Guatemala City

00152

Ospedale S.Camillo Forlanini, Rome

00168

Policlinico Universitario A. Gemelli, Rome

00178

NCL Institute Neuroscience, Rome

09126

Ospedale Binaghi, Cagliari

03100

Mexico Centre for Clinical Research, Mexico City

06700

Clinstile S.A de C.V., Mexico City

03600

Grupo Médico Camino S.C., México

85-079

NZOZ Vitamed, Bydgoszcz

85-796

Neurocentrum Bydgoszcz sp. z o.o, Bydgoszcz

80-803

COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika, Gdansk

25-726

RESMEDICA Spolka z o.o., Kielce

31-505

Centrum Neurologii Klinicznej, Krakow

31-637

Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o., Krakow

90-324

Centrum Neurologii Krzysztof Selmaj, Lodz

32-600

Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k., Oświęcim

62-064

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

60-693

MedPolonia, Poznan

61-853

NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek, Późna

44-200

Wojewódzki Szpital Specjalistyczny Nr 3, Rybnik

02-097

Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie, Warsaw

51-685

Wro Medica, Wroc?aw

41-800

IBISMED Wielospecjalistyczne Centrum Medyczne, Zabrze

03080

Seoul National University Hospital, Seoul

06351

Samsung Medical Center, Seoul

06500

Gazi University Medical Faculty, Ankara

06490

Baskent Universitesi Ankara Hastanesi, Çankaya

M6 8HD

Salford Royal NHS Foundation Trust, Salford

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY