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 (147) 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
Alabama Neurology Associates
Recruiting
Homewood
Arizona
Center for Neurology and Spine - Phoenix - Hunt - PPDS
Recruiting
Phoenix
California
North County Neurology Associates
Recruiting
Carlsbad
University of California Irvine
Recruiting
Irvine
SC3 Research Group, Inc
Recruiting
Pasadena
Colorado
University of Colorado Denver
Recruiting
Aurora
Mountain Neurological Research Center; Roaring Fork Neurologt, P.C.
Withdrawn
Basalt
Mountain View Clinical Research
Recruiting
Denver
Advanced Neurology of Colorado, LLC
Recruiting
Fort Collins
Florida
Neurology Associates, PA; Research Department
Recruiting
Maitland
Elite Clinical Research
Recruiting
Miami
Axiom Clinical Research of Florida
Withdrawn
Tampa
Illinois
NorthShore University HealthSystem
Recruiting
Highland Park
Indiana
Fort Wayne Neurological Center
Recruiting
Fort Wayne
Louisiana
The NeuroMedical Center
Recruiting
Baton Rouge
Massachusetts
University of Massachusetts Medical School
Recruiting
Worcester
Maryland
Johns Hopkins University School Of Medicine; Outpatient Center
Recruiting
Baltimore
Michigan
Henry Ford Health System
Recruiting
Detroit
Missouri
Washington University School of Medicine
Recruiting
Saint Louis
New Jersey
Rutgers New Jersey Medical School
Recruiting
Newark
Holy Name Hospital; Institute For Clinical Research
Recruiting
Teaneck
New York
St. Lawrence Health System
Withdrawn
Canton
Ohio
Miami Valley Hospital South; Dayton Physician's Office
Recruiting
Centerville
The Boster Center for MS
Recruiting
Columbus
MDH Research LLC
Recruiting
Westerville
Oklahoma
Oklahoma Medical Research Foundation; MS Center of Excellence
Recruiting
Oklahoma City
Pennsylvania
St. Luke's University Health network
Recruiting
Bethlehem
South Carolina
Premier Neurology
Recruiting
Greer
Tennessee
Neurology Clinic PC
Recruiting
Cordova
New Orleans Center for Clinical Research
Recruiting
Knoxville
Texas
Texas Institute for Neurological Disorders
Recruiting
Sherman
Virginia
Blacksburg Neurology, PC
Withdrawn
Christiansburg
Multiple Sclerosis Center of Greater Washington
Recruiting
Vienna
Washington
Evergreen MS Center
Recruiting
Kirkland
MultiCare Health System Institute for Research and Innovation
Withdrawn
Tacoma
Wisconsin
Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders
Recruiting
Milwaukee
Other Locations
Argentina
IME - Instituto Médico Especializado; Ensayos Clínicos
Active, not recruiting
Buenos Aires
Instituto de Investigaciones Metabolicas (Idim)
Active, not recruiting
Ciudad Autonoma De Buenos Aires
Instituto DIABAID
Recruiting
Ciudad Autónoma De Buenos Aires
Diagnostico Medico Oroño
Recruiting
Rosario
Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY
Active, not recruiting
San Miguel
China
Beijing Tiantan Hospital,Capital Medical University
Recruiting
Beijing City
Peking University First Hospital
Recruiting
Beijing City
the First Hospital of Jilin University
Recruiting
Changchun
Xiangya Hospital Central South University
Recruiting
Changsha City
West China Hospital, Sichuan University
Recruiting
Chengdu
The First Affiliated Hospital, Chongqing Medical University
Recruiting
Chongqing
The First Affiliated Hospital of Sun Yat-sen University
Recruiting
Guangzhou City
The affiliated Hospital of Guiyang Medical College
Recruiting
Guiyang
The First People's Hospital of Yunnan Province
Recruiting
Kunming City
The Second Hospital of Hebei Medical University
Recruiting
Shijiazhuang
The First Affiliated Hospital of Soochow University; Neurology department
Recruiting
Soochow
1st Affiliated Hospital of Shanxi Medical University
Recruiting
Taiyuan City
Tianjin Medical University General Hospital
Recruiting
Tianjin
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Recruiting
Wuhan City
Tangdu Hospital, The Fourth Military Medical University; Neurology Department
Recruiting
Xi'an City
Finland
Helsinki University Central Hospital; Department of Neurology
Recruiting
Helsinki
Terveystalo Oulu
Recruiting
Oulu
Germany
Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
Recruiting
Berlin
Studienzentrum für Neurologie und Psychiatrie
Recruiting
Böblingen
Universitätsklinikum Carl Gustav Carus, Zentrum für Klinische Neurowissenschaften
Recruiting
Dresden
Universitätsklinikum Gießen und Marburg GmbH; Neurologie
Recruiting
Gießen
Uniklinik Schleswig-Holstein; Neuroimmunologie, Institut für Klinische Chemie + Klinik f. Neurologie
Recruiting
Kiel
Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
Recruiting
Münster
Nordwest-Krankenhaus Sanderbusch gGMBH; Neurologische Klinik
Recruiting
Sande
Praxis Dr. med. Andreas Kowalik, Arzt für Neurologie und Psychiatrie
Recruiting
Stuttgart
Universitätsklinikum Tübingen, Zentrum für Neurologie
Recruiting
Tübingen
Universitätsklinikum Ulm; Klinik für Neurologie
Recruiting
Ulm
Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz
Recruiting
Westerstede
Hong Kong Special Administrative Region
Pamela Youde Nethersole Eastern Hospital; Department of Medicine
Active, not recruiting
Hong Kong
Queen Mary Hospital; Department of Medicine, Division of Neurology
Withdrawn
Hong Kong
Prince of Wales Hospital; Division of Neurology, Department of Medicine and Therapeutics
Recruiting
Shatin, New Territories
Hungary
Clinexpert Kft.
Active, not recruiting
Budapest
S-Medicon Egeszsegugyi Szolgaltato Kft.
Recruiting
Budapest
Pest Megyei Flor Ferenc Korhaz
Recruiting
Kistarcsa
Italy
ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla
Recruiting
Bergamo
AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla
Recruiting
Catania
AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2
Recruiting
Firenze
Ospedale S.Antonio Abate; Neurologia 2 - Sclerosi Multipla e Recupero Neurologico
Recruiting
Gallarate
Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla
Recruiting
L'aquila
IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
Recruiting
Milano
Ospedale Regina Montis Regalis; SC Neurologia, Centro Sclerosi Multipla
Recruiting
Mondovì (cn)
AOU Policlinico - Università L. Vanvitelli; D.A.I. di Medicina Interna e Specialistica
Recruiting
Napoli
AOU Seconda Università degli Studi; Dip. Assistenziale Integrato Medicina Int-II Clinica Neurologica
Recruiting
Napoli
Azienda Ospedaliera di Padova; Clinica Neurologica
Recruiting
Padova
A.O.U. di Parma; SC Neurologia, Amb. Sclerosi Multipla (malattie demielinizzanti)
Recruiting
Parma
Azienda Ospedaliera Sant'Andrea; UOC Neurologia
Recruiting
Roma
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
Recruiting
Roma
Policlinico Umberto I; Centro Sclerosi Multipla DAI Neuroscienze e Salute Mentale
Recruiting
Roma
AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale
Recruiting
Siena
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
Recruiting
Torrette - Ancona
Mexico
Health Pharma Professional Research
Recruiting
Cdmx
Neurociencias Estudios Clinicos S.C.
Recruiting
Culiacán
Grupo Medico de Investigacion Clinica Multidisciplinaria
Recruiting
Mexico City
Clinical Research Institute Saltillo
Recruiting
Saltillo
Netherlands
Zuyderland Medisch Centrum - Sittard Geleen
Recruiting
Sittard-geleen
Peru
Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
Recruiting
Bellavista
HOSPITAL NACIONAL GUILLERMO ALMENARA IRIGOYEN; Unidad de Investigacion en Neurologia
Recruiting
La Victoria, Lima
Clinica Internacional Sede Lima
Recruiting
Lima
Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
Recruiting
Lima
ASOCIACION CIVIL PORLASALUD; Unidad de Investigación
Recruiting
Miraflores
Clinica Centenario Peruano Japonesa; Neurology
Recruiting
Pueblo Libre
Poland
Centrum Neurologii Krzysztof Selmaj
Recruiting
Lodz
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
Recruiting
Warszawa
Portugal
Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)
Recruiting
Braga
HUC; Servico de Neurologia
Recruiting
Coimbra
Hospital da Luz; Neurologia
Recruiting
Lisboa
Hospital de Santa Maria; Servico de Neurologia
Withdrawn
Lisboa
Hospital Santo Antonio dos Capuchos; Servico de Neurologia
Recruiting
Lisboa
Hospital Beatriz Angelo; Servico de Neurologia
Withdrawn
Loures
Hospital Geral de Santo Antonio; Servico de Neurologia
Recruiting
Porto
Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião; Servilo de Neurologia
Recruiting
Santa Maria Da Feira
Russian Federation
Regional State Budgetary Institution of Healthcare Regional Clinical Hospital
Recruiting
Barnaul
SHI Sverdlovsk Regional Clinical Hospital #1;Neurology
Recruiting
Ekaterinburg
Center of Cardiology and Neurology
Recruiting
Kirov
Siberian Regional Medical Centre; Centre of Multiple Sclerosis
Active, not recruiting
Novosibirsk
N.P. Bechtereva Institute of the Human Brain
Recruiting
Sankt-petersburg
Leningrad Regional Clinical Hospital
Recruiting
St Petersburg
Pavlov State Medical Uni ; Neurology
Recruiting
St Petersburg
Republican clinical hospital named after G.G. Kuvatov
Recruiting
Ufa
Ulyanovsk Regional Clinical Hospital
Recruiting
Ulyanovsk
Spain
Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
Recruiting
Barcelona
Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
Recruiting
El Palmar (el Palmar)
Hospital Universitari de Bellvitge; Servicio de Neurologia
Recruiting
L'hospitalet De Llobregat
Hospital General Universitario Gregorio Marañon; Servicio de Neurologia
Recruiting
Madrid
Hospital Ramon y Cajal; Servicio de Neurologia
Recruiting
Madrid
Hospital Universitario de la Princesa; Servicio de Neurologia
Recruiting
Madrid
Hospital Quiron de Madrid; Servicio de Neurologia
Recruiting
Pozuelo De Alarcon
Hospital Universitario Virgen Macarena; Servicio de Neurologia
Recruiting
Sevilla
Hospital Alvaro Cunqueiro; Servicio de Neurologia
Recruiting
Vigo
Switzerland
Inselspital Bern Medizin Neurologie; Neurologische Poliklinik
Recruiting
Bern
Ospedale Regionale di Lugano - Civico; Neurologia
Recruiting
Lugano
Taiwan
China Medical University Hospital; Neurology
Withdrawn
North Dist.
National Taiwan University Hospital; Neurology
Withdrawn
Taipei
Chang Gung Memorial Foundation - Linkou - Neurology
Withdrawn
Taoyuan
Ukraine
Municipal Institution Dnipropetrovsk Regional Clinical Hospital n a I I Mechnykov; Neurology dept #1
Active, not recruiting
Dnipro
Miska Klinichna Likarnia №16
Recruiting
Dnipropetrovsk
Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology
Recruiting
Kharkov
Medical Center Dopomoga Plus
Active, not recruiting
Kyiv
Medical Center of Private Execution First Private Clinic
Active, not recruiting
Kyiv
Lviv Regional Clinical Hospital; Department of Neurology
Active, not recruiting
Lviv
MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care
Active, not recruiting
Lviv
Odesa Regional Clinical Hospital; Neurosurgery Department
Active, not recruiting
Odesa
Medical Clinical Research Center of Medical Center LLC Health Clinic
Active, not recruiting
Vinnytsia
Salutem Medical Center
Active, not recruiting
Vinnytsia
Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council
Active, not recruiting
Zaporizhzhia
Zaporizhia City Multispecialty Clinical Hospital #9
Active, not recruiting
Zaporizhzhye
Contact Information
Primary
Reference Study ID Number: GN41851 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date: March 17, 2021
Estimated Completion Date: February 26, 2026
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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