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

Who is this study for? Patients with Multiple Sclerosis
Status: Recruiting
Location: See all (137) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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. Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: No
View:

• Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening.

• 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.

Locations
United States
Alabama
North Central Neurology Associates
Recruiting
Cullman
Arizona
Xenoscience
Recruiting
Phoenix
California
Stanford University Medical Center; Stanford Neuroscience Health Center
Recruiting
Stanford
Los Angeles Biomedical Research Institute at Harbor-UCLA
Recruiting
Torrance
Connecticut
KI Health Partners, LLC; New England Institute for Clinical Research
Recruiting
Stamford
Washington, D.c.
Georgetown University Medical Center
Recruiting
Washington
Florida
SFM Clinical Research, LLC
Recruiting
Boca Raton
University of South Florida
Recruiting
Tampa
Georgia
Atlanta Neuroscience Institute
Recruiting
Atlanta
Indiana
American Health Network Institute, LLC
Recruiting
Avon
Kansas
University of Kansas Medical Center
Recruiting
Kansas City
Massachusetts
Neuro Institute of New England P.C.; Research
Recruiting
Foxboro
Michigan
Wayne State University; Department of Neurology
Recruiting
Detroit
Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis
Recruiting
Owosso
Ohio
NeuroScience Research Center
Recruiting
Canton
University of Cincinnati; Department of Neurology
Recruiting
Cincinnati
Oregon
Providence Neurological Specialties
Recruiting
Portland
Pennsylvania
Geisinger Medical Center
Withdrawn
Danville
Allegheny Neurological Associates
Recruiting
Pittsburgh
Tennessee
Hope Neurology
Recruiting
Knoxville
Texas
Baylor College of Medicine
Recruiting
Houston
Central Texas Neurology Consultants
Recruiting
Round Rock
Virginia
Integrated Neurology Services PLLC
Recruiting
Falls Church
Wisconsin
Medical College of Wisconsin, Inc.
Recruiting
Milwaukee
Other Locations
Austria
Kepler Universitätskliniken GmbH - Med Campus III; Neurologie & Psychiatrie
Recruiting
Linz
Medizinische Universität Wien; Univ.Klinik fuer Neurologie
Recruiting
Wien
Brazil
Santa Casa de Misericordia; de Belo Horizonte
Active, not recruiting
Belo Horizonte
L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar
Recruiting
Brasilia
Hospital das Clinicas - UNICAMP
Active, not recruiting
Campinas
Instituto de Neurologia de Curitiba
Recruiting
Curitiba
Clinica Neurologica; Neurocirurgica de Joinville
Recruiting
Joinville
Hospital Sao Lucas - PUCRS
Recruiting
Porto Alegre
IMV Pesquisa Neurológica
Recruiting
Porto Alegre
Núcleo de Pesquisa do Rio Grande do Sul
Recruiting
Porto Alegre
Hospital Universitario Clementino Fraga Filho - UFRJ
Withdrawn
Rio De Janeiro
Praxis Pesquisa Médica
Recruiting
Santo Andre
CEMEC - Centro Multidisciplinar de Estudos Clínicos
Active, not recruiting
Sao Bernardo Do Campo
Centro de Pesquisas Clinicas; CPCLIN
Recruiting
Sao Paulo
Hospital Santa Marcelina; AME - Ambulatório de Especialidades Médicas
Recruiting
Sao Paulo
Jordy Sinapse Medicina LTDA ME
Recruiting
Sao Paulo
Bulgaria
UMHAT Dr. Georgi Stranski; 2nd Neurology Clinic, Occupational Diseases
Recruiting
Pleven
MHATNP Sveti Naum EAD
Recruiting
Sofia
Canada
CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital
Recruiting
Chicoutimi
University of Alberta Hospital
Recruiting
Edmonton
Recherche Sepmus Inc.
Recruiting
Greenfield Park
MUCH - Montreal Neurological Institute & Hospital
Recruiting
Montreal
The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis
Recruiting
Ottawa
CHU de Québec
Recruiting
Quebec City
Denmark
Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken
Recruiting
Aabenraa
Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.
Withdrawn
Aalborg
Sydvestjysk Sygehus Esbjerg; Neurologisk Afd., Skleroseklinikken
Recruiting
Esbjerg
Rigshospitalet; Neurologisk Klinik Glostrup
Withdrawn
Glostrup
France
Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie
Recruiting
Bordeaux
Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
Recruiting
Clermont-ferrand
Hopital européen de Marseille; Neurologie
Recruiting
Marseille
Hopital Gui de Chauliac; Neurologie
Recruiting
Montpellier
Hôpital Pasteur; Service de Neurologie
Active, not recruiting
Nice
Hôpital Charles Nicolle; Service de Neurologie
Recruiting
Rouen
CHU toulouse - Hôpital Purpan; Departement de Neurologie
Recruiting
Toulouse
Greece
University General Hospital of Larisa; Neurology Clinic
Recruiting
Larisa
AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.
Recruiting
Thessaloniki
Hospital Eginition; First Department of Neurology
Recruiting
Αθηνα
University General Hospital of Ioannina; Neurology Clinic
Recruiting
Ιωαννινα
Guatemala
Nucare
Recruiting
Ciudad Guatemala
India
Postgraduate Institute of Medical Education & Research
Recruiting
Chandigarh
Fortis Escorts Hospital
Recruiting
Jaipur
Christian Medical College and Hospital
Recruiting
Ludhiana
Seth G.S Medical College K.E.M Hospital
Recruiting
Mumbai
Sir Gangaram Hospital
Recruiting
New Delhi Delhi
Deenanath Mangeshkar Hospital & Research Centre
Recruiting
Pune
Italy
Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari; Neuroscienze e Organi di Senso
Recruiting
Bari
Ospedale Binaghi; Centro Sclerosi Multipla
Recruiting
Cagliari
Universita' G. D'Annunzio; Dipartimento di Neuroscienze, Imaging e Scienze Cliniche
Recruiting
Chieti
Irccs A.O.U.San Martino Ist; Dinogmi
Recruiting
Genova
Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
Active, not recruiting
Milano
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; UOSD Malattie Neurodegenerative
Recruiting
Milano
Ospedale Civile di Montichiari; Centro Sclerosi Multipla
Recruiting
Montichiari
A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche
Recruiting
Napoli
AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla
Recruiting
Palermo
IRCCS Istituto Neurologico C. Mondino-Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
Recruiting
Pavia
IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
Recruiting
Pozzilli
NCL Institute Neuroscience
Active, not recruiting
Roma
Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico
Recruiting
Roma
Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla
Recruiting
Roma
Mexico
Unidad de Investigación en Salud; Psiquiatria
Active, not recruiting
Chihuahua
Grupo Médico Camino S.C.
Recruiting
Ciudad De México
Mexico Centre for Clinical Research
Recruiting
Ciudad De México
Unidad de investigacion en salud (UIS); Neurociencias
Recruiting
Ciudad De México
Clinstile S.A de C.V.
Recruiting
Mexico City
Poland
Neurocentrum Bydgoszcz sp. z o.o
Recruiting
Bydgoszcz
NZOZ Vitamed
Recruiting
Bydgoszcz
COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddział Neurologiczny
Recruiting
Gdansk
Gornoslaskie Centrum Medyczne
Recruiting
Katowice
RESMEDICA Spolka z o.o.
Recruiting
Kielce
Centrum Neurologii Klinicznej
Recruiting
Krakow
Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.
Recruiting
Krakow
MT Medic Krosno
Recruiting
Krosno
Centrum Neurologii Krzysztof Selmaj
Recruiting
Lodz
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
Recruiting
Lublin
Wojewodzki Szpital Specjalistyczny
Active, not recruiting
Olsztyn
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
Recruiting
Oswiecim
Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Badań Klinicznych
Active, not recruiting
Plewiska
MedPolonia
Recruiting
Poznan
NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek
Active, not recruiting
Poznań
Wojewódzki Szpital Specjalistyczny Nr 3
Recruiting
Rybnik
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
Active, not recruiting
Warszawa
Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie
Recruiting
Warszawa
EMC Instytut Medyczny S.A.
Recruiting
Wrocław
Wro Medica
Recruiting
Wrocław
IBISMED Wielospecjalistyczne Centrum Medyczne
Active, not recruiting
Zabrze
Puerto Rico
San Juan MS Center
Recruiting
Guaynabo
Republic of Korea
Keimyung University Dongsan Medical Center
Recruiting
Daegu
National Cancer Center
Active, not recruiting
Goyang-si
Samsung Medical Center
Recruiting
Seoul
Seoul National University Hospital
Recruiting
Seoul
Russian Federation
Regional clinical hospital named after prof. S.V. Ochapovsky
Recruiting
Krasnodar
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
Recruiting
Krasnoyarsk
Krasnoyarsk State Medical Academy
Recruiting
Krasnoyarsk
Federal center of brain research and neurotechnologies
Recruiting
Moskva
Regional Clinical Hospital N.A. Semashko; Neurology
Recruiting
Nizhny Novgorod
State Novosibirsk Regional Clinical Hospital
Recruiting
Novosibirsk
National Center of Social Significant Disease
Active, not recruiting
Sankt-peterburg
Nebbiolo Center for Clinical Trials
Recruiting
Tomsk
Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology
Recruiting
Tyumen
Turkey
Gazi University Medical Faculty; Departmant of Neurology.
Recruiting
Ankara
Hacettepe University Medical Faculty; Neurology
Recruiting
Ankara
Bakirkoy State Mental Hospital
Recruiting
Istanbul
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
Recruiting
Istanbul
Sancaktepe Training and Research Hospital; Neurology
Active, not recruiting
Istanbul
Kocaeli University Hospital; Department of Neurology
Active, not recruiting
Kocaeli
Selcuk University Medical Faculty; Norology department
Active, not recruiting
Konya
Ege Üniversitesi Tip Fakültesi
Active, not recruiting
Lzmir
Mersin University Medical Faculty; Neurology
Active, not recruiting
Mersin
Ondokuz Mayis University School of Medicine; Neurology
Active, not recruiting
Samsun
Karadeniz Tecnical Uni. Med. Fac.; Neurology
Active, not recruiting
Trabzon
Van Yuzuncu Yil University Hospital; Neurology
Recruiting
Van
United Kingdom
Salford Royal NHS Foundation Trust
Active, not recruiting
Salford
Contact Information
Primary
Reference Study ID Number: GN42272 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date: March 24, 2021
Estimated Completion Date: November 27, 2025
Participants
Target number of participants: 736
Treatments
Experimental: fenebrutinib
Participants will receive oral fenebrutinib with teriflunomide-matching placebo.
Active Comparator: teriflunomide
Participants will receive oral teriflunomide with fenebrutinib-matching placebo in a blinded fashion.
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov

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