Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04586023
PHASE3

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 in a 1:1 ratio to receive either fenebrutinib or teriflunomide. At the end of the double-blind treatment (DBT) phase (after disclosure of the DBT results), the Sponsor will determine whether or not to initiate the open-label extension (OLE) 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

751

Start Date

2021-03-24

Completion Date

2027-07-09

Last Updated

2026-03-16

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 (108)

North Central Neurology Associates

Cullman, Alabama, United States

Xenoscience

Phoenix, Arizona, United States

Los Angeles Biomedical Research Institute at Harbor-UCLA

Torrance, California, United States

KI Health Partners, LLC

Stamford, Connecticut, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

University of South Florida

Tampa, Florida, United States

American Health Network Institute, LLC

Avon, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Neuro Institute of New England P.C.

Foxborough, Massachusetts, United States

University of Cincinnati

Cincinnati, Ohio, United States

Hope Neurology

Knoxville, Tennessee, United States

Integrated Neurology Services PLLC

Falls Church, Virginia, United States

Medical College of Wisconsin, Inc.

Milwaukee, Wisconsin, United States

Kepler Universitätskliniken GmbH - Med Campus III

Linz, Austria

L2 Ip Instituto de Pesquisas Clinicas Ltda ME

Brasília, Federal District, Brazil

Santa Casa de Misericordia

Belo Horizonte, Minas Gerais, Brazil

Instituto de Neurologia de Curitiba

Curitiba, Paraná, Brazil

IMV Pesquisa Neurológica

Porto Alegre, Rio Grande do Sul, Brazil

Núcleo de Pesquisa do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Clinica Neurologica

Joinville, Santa Catarina, Brazil

Praxis Pesquisa Médica

Santo André, São Paulo, Brazil

CEMEC - Centro Multidisciplinar de Estudos Clínicos

São Bernardo do Campo, São Paulo, Brazil

Centro de Pesquisas Clinicas

São Paulo, São Paulo, Brazil

Hospital Santa Marcelina

São Paulo, São Paulo, Brazil

Jordy Sinapse Medicina LTDA ME

São Paulo, Brazil

UMHAT Dr. Georgi Stranski

Pleven, Bulgaria

MHATNP Sveti Naum EAD

Sofia, Bulgaria

University of Alberta Hospital

Edmonton, Alberta, Canada

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital

Chicoutimi, Quebec, Canada

MUCH - Montreal Neurological Institute & Hospital

Montreal, Quebec, Canada

CHU de Québec

Québec, Quebec, Canada

Sydvestjysk Sygehus Esbjerg

Esbjerg, Denmark

Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken

Sønderborg, Denmark

Hopital Gabriel Montpied CHU de Clermont-Ferrand

Clermont-Ferrand, France

Hôpital Pasteur

Nice, France

Hôpital Charles Nicolle

Rouen, France

CHU toulouse - Hôpital Purpan

Toulouse, France

Hospital Eginition

Athens, Greece

University General Hospital of Larisa

Larissa, Greece

AHEPA Univ. General Hospital of Thessaloniki

Thessaloniki, Greece

Nucare

Guatemala City, Guatemala

Zydus Hospital

Ahmedabad, Gujarat, India

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

Mumbai, Maharashtra, India

Deenanath Mangeshkar Hospital & Research Centre

Pune, Maharashtra, India

Sahyadri Superspeciality Hospital

Pune, Maharashtra, India

Max Super Speciality Hospital

New Delhi, National Capital Territory of Delhi, India

Sir Gangaram Hospital

New Delhi, National Capital Territory of Delhi, India

Christian Medical College and Hospital

Ludhiana, Punjab, India

SRM Institute of Medical Sciences

Vadapalani, Tamil Nadu, India

Postgraduate Institute of Medical Education and Research

Chandigarh, India

Universita? G. D'Annunzio

Chieti, Abruzzo, Italy

Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari

Bari, Apulia, Italy

A. O. U. Federico II

Naples, Campania, Italy

Ospedale S.Camillo Forlanini

Rome, Lazio, Italy

Policlinico Universitario A. Gemelli

Rome, Lazio, Italy

NCL Institute Neuroscience

Rome, Lazio, Italy

Irccs A.O.U.San Martino Ist

Genoa, Liguria, Italy

Fond. Istituto Neurologico C.Besta

Milan, Lombardy, Italy

Ospedale Civile di Montichiari

Montichiari, Lombardy, Italy

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

Pavia, Lombardy, Italy

IRCCS Istituto Neurologico Neuromed

Pozzilli, Molise, Italy

Ospedale Binaghi

Cagliari, Sardinia, Italy

AOU Policlinico Giaccone

Palermo, Sicily, Italy

Mexico Centre for Clinical Research

Mexico City, Mexico CITY (federal District), Mexico

Clinstile S.A de C.V.

Mexico City, Mexico CITY (federal District), Mexico

Grupo Médico Camino S.C.

México, Mexico CITY (federal District), Mexico

Unidad de Investigación en Salud

Chihuahua City, Mexico

Unidad de investigacion en salud (UIS)

Mexico City, Mexico

NZOZ Vitamed

Bydgoszcz, Poland

Neurocentrum Bydgoszcz sp. z o.o

Bydgoszcz, Poland

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

Gdansk, Poland

RESMEDICA Spolka z o.o.

Kielce, Poland

Centrum Neurologii Klinicznej

Krakow, Poland

Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.

Krakow, Poland

Centrum Neurologii Krzysztof Selmaj

Lodz, Poland

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

Oświęcim, Poland

Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych

Plewiska, Poland

MedPolonia

Poznan, Poland

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

Późna, Poland

Wojewódzki Szpital Specjalistyczny Nr 3

Rybnik, Poland

Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

Warsaw, Poland

Wro Medica

Wroc?aw, Poland

IBISMED Wielospecjalistyczne Centrum Medyczne

Zabrze, Poland

Krasnoyarsk State Medical Academy

Krasnoyarsk, Krasnoyarsk Krai, Russia

FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

Krasnoyarsk, Krasnoyarsk Krai, Russia

Federal center of brain research and neurotechnologies

Moskva, Moscow Oblast, Russia

Regional Clinical Hospital N.A. Semashko

Nizhny Novgorod, Niznij Novgorod, Russia

National Center of Social Significant Disease

Saint Petersburg, Sankt-Peterburg, Russia

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

Krasnodar, Russia

Nebbiolo Center for Clinical Trials

Tomsk, Russia

Keimyung University Dongsan Medical Center

Daegu, South Korea

National Cancer Center

Goyang-si, South Korea

Seoul National University Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Gazi University Medical Faculty

Ankara, Turkey (Türkiye)

Baskent Universitesi Ankara Hastanesi

Çankaya, Turkey (Türkiye)

Bakirkoy State Mental Hospital

Istanbul, Turkey (Türkiye)

Sancaktepe Training and Research Hospital

Istanbul, Turkey (Türkiye)

Selcuk University Medical Faculty

Istanbul, Turkey (Türkiye)

Kocaeli University Hospital

Kocaeli, Turkey (Türkiye)

Ege Üniversitesi Tip Fakültesi

Lzmir, Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, Turkey (Türkiye)

Ondokuz Mayis University School of Medicine

Samsun, Turkey (Türkiye)

Karadeniz Tecnical Uni. Med. Fac.

Trabzon, Turkey (Türkiye)

Van Yuzuncu Yil University Hospital

Van, Turkey (Türkiye)

Salford Royal NHS Foundation Trust

Salford, United Kingdom