Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
NCT ID: NCT04586023
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
751 participants
INTERVENTIONAL
2021-03-24
2027-07-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Fenebrutinib
Participants will receive oral fenebrutinib with teriflunomide-matching placebo.
Fenebrutinib
Participants will receive fenebrutinib.
Placebo
Participants will receive teriflunomide-matching placebo or fenebrutinib-matching placebo.
Teriflunomide
Participants will receive oral teriflunomide with fenebrutinib-matching placebo in a blinded fashion.
Teriflunomide
Participants will receive teriflunomide.
Placebo
Participants will receive teriflunomide-matching placebo or fenebrutinib-matching placebo.
Interventions
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Fenebrutinib
Participants will receive fenebrutinib.
Teriflunomide
Participants will receive teriflunomide.
Placebo
Participants will receive teriflunomide-matching placebo or fenebrutinib-matching placebo.
Eligibility Criteria
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Inclusion Criteria
* A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria.
* Ability to complete the 9-Hole Peg Test (9-HPT) for each hand in \< 240 seconds.
* Ability to perform the Timed 25-Foot Walk Test (T25FWT) in \<150 seconds.
* For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs.
* For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm.
* Completed the Double-Blind Treatment (DBT) phase of the study (remaining on study treatment; no other Disease-Modifying Therapy (DMT) administered) and who, in the opinion of the investigator, may benefit from treatment with fenebrutinib.
* Participants randomized to the teriflunomide treatment arm during the DBT phase must undergo the accelerated teriflunomide elimination procedure (ATEP) prior to the first administration of open-label fenebrutinib.
* For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs.
* For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm.
Exclusion Criteria
* Female participants who are pregnant or breastfeeding, or intending to become pregnant.
* Male participants who intend to father a child during the study.
* A diagnosis of primary progressive MS (PPMS) or non-active secondary progressive MS (SPMS).
* Any known or suspected active infection at screening, including but not limited to a positive screening tests for Hepatitis B and C, an active or latent or inadequately treated infection with tuberculosis (TB), a confirmed or suspected progressive multifocal leukoencephalopathy (PML).
* History of cancer including hematologic malignancy and solid tumors within 10 years of screening.
* Known presence of other neurological disorders, that could interfere with the diagnosis of MS or assessments of efficacy or safety during the study and clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease.
* Rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
* Hypoproteinemia.
* Acute liver disease
* Chronic liver disease unless considered stable for \> 6 months.
* Presence of cirrhosis (Child-Pugh Class A, B, or C) or Gilbert's Syndrome.
* Participants with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia.
* Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
* History of alcohol or other drug abuse within 12 months prior to screening.
* History of or currently active primary or secondary (non-drug-related) immunodeficiency, including known history of human immunodeficiency virus (HIV) infection.
* Inability to complete an MRI scan.
* Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to screening (inhaled and topical corticosteroids are allowed).
* Receipt of a live-attenuated vaccine within 6 weeks prior to randomization.
* Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period.
* Chronic liver disease unless considered stable for \> 6 months
* Acute liver disease
18 Years
55 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Napoli, 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
Countries
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Other Identifiers
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2020-001168-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2022-502618-95-00
Identifier Type: CTIS
Identifier Source: secondary_id
GN42272
Identifier Type: -
Identifier Source: org_study_id