Multiple Sclerosis Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Disease duration of > 10 years from the onset of symptoms and an EDSS score at screening < 2.0.
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 test 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.
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.

OLE Inclusion Criteria:

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.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

746

Study ID:

NCT04586010

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 156 Locations for this study

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University of Alabama Birmingham
Birmingham Alabama, 35233, United States
Alabama Neurology Associates
Homewood Alabama, 35209, United States
Center for Neurology and Spine - Phoenix - Hunt - PPDS
Phoenix Arizona, 85032, United States
Profound Research, LLC
Carlsbad California, 92011, United States
University of California Irvine
Irvine California, 92697, United States
SC3 Research Group, Inc
Pasadena California, 91105, United States
University of Colorado Denver
Aurora Colorado, 80045, United States
Mountain View Clinical Research
Denver Colorado, 80209, United States
Advanced Neurology of Colorado, LLC
Fort Collins Colorado, 80528, United States
Neurology Associates, PA; Research Department
Maitland Florida, 32751, United States
NorthShore University HealthSystem
Highland Park Illinois, 60035, United States
Fort Wayne Neurological Center
Fort Wayne Indiana, 46805, United States
The NeuroMedical Center
Baton Rouge Louisiana, 70810, United States
Ochsner LSU Health
Shreveport Louisiana, 71103, United States
Johns Hopkins University School Of Medicine; Outpatient Center
Baltimore Maryland, 21287, United States
University of Massachusetts Medical School
Worcester Massachusetts, 01655, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Holy Name Hospital; Institute For Clinical Research
Teaneck New Jersey, 07666, United States
University of New Mexico; MS Specialty Clinic
Albuquerque New Mexico, 87131, United States
Miami Valley Hospital South; Dayton Physician's Office
Centerville Ohio, 45459, United States
OhioHealth
Columbus Ohio, 43214, United States
The Boster Center for MS
Columbus Ohio, 43235, United States
Oklahoma Medical Research Foundation; MS Center of Excellence
Oklahoma City Oklahoma, 73104, United States
St. Luke's University Health network
Bethlehem Pennsylvania, 18015, United States
Premier Neurology
Greenville South Carolina, 29605, United States
New Orleans Center for Clinical Research
Knoxville Tennessee, 37920, United States
North Texas Institute of Neurology and Headache NextStage Clinical Research Clinic
Plano Texas, 75024, United States
Texas Institute for Neurological Disorders
Sherman Texas, 75092, United States
Multiple Sclerosis Center of Greater Washington
Vienna Virginia, 22182, United States
Evergreen MS Center
Kirkland Washington, 98034, United States
Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders
Milwaukee Wisconsin, 53215, United States
Centro de Especialidades Neurológicas y Rehabilitación - CENyR
Buenos Aires , C1424, Argentina
CIER
C. A. B. A. , C1055, Argentina
NeuroSite
Ciudad Autonoma Buenos Aires , C1405, Argentina
Instituto de Investigaciones Metabolicas (Idim)
Ciudad Autonoma de Buenos Aires , C1012, Argentina
Diagnostico Medico Oroño
Rosario , S2000, Argentina
Cer San Juan
San Juan , J5400, Argentina
Centro de Investigaciones Médicas Tucuman
San Miguel de Tucuman , T4000, Argentina
Peking University First Hospital
Beijing City , 10003, China
Beijing Tiantan Hospital,Capital Medical University
Beijing City , 10005, China
the First Hospital of Jilin University
Changchun , 13002, China
Xiangya Hospital Central South University
Changsha City , 41000, China
West China Hospital, Sichuan University
Chengdu , 61004, China
The First Affiliated Hospital, Chongqing Medical University
Chongqing , 40001, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou City , 51008, China
The second Affiliated Hospital of Guangzhou Medical University
Guangzhou City , 51026, China
The affiliated Hospital of Guiyang Medical College
Guiyang , , China
The First People?s Hospital of Yunnan Province
Kunming City , 65002, China
Lanzhou University Second Hospital
Lanzhou , 73003, China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing City , 21000, China
The Second Hospital of Hebei Medical University
Shijiazhuang , 05000, China
The First Affiliated Hospital of Soochow University; Neurology department
Suzhou City , 21503, China
1st Affiliated Hospital of Shanxi Medical University
Taiyuan City , 03000, China
Tianjin Medical University General Hospital
Tianjin , 30005, China
Xinjiang People Hospital
Urumqi City , 83000, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan City , 43003, China
Tangdu Hospital, The Fourth Military Medical University; Neurology Department
Xi'an City , 71003, China
NeuroINC
Santiago de los Caballeros , 51000, Dominican Republic
Hospital Padre Billini
Santo Domingo , 10210, Dominican Republic
Helsinki University Central Hospital; Department of Neurology
Helsinki , 00290, Finland
New Hospitals; Neurology and Neurorehabilitation
Tbilisi , 0114, Georgia
Pineo Medical Ecosystem; Neurological Department
Tbilisi , 0114, Georgia
Archangel St. Michael Multiprofile Clinical Hospital
Tbilisi , 0159, Georgia
MediClab Georgia
Tbilisi , 0160, Georgia
Khechinashvili University Hospital; Neurological Department
Tbilisi , 0179, Georgia
Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
Berlin , 13347, Germany
Studienzentrum für Neurologie und Psychiatrie
Böblingen , 71034, Germany
Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
Dresden , 01307, Germany
Universitätsklinikum Gießen und Marburg GmbH; Neurologie
Gießen , 35392, Germany
Uniklinik Schleswig-Holstein; Neuroimmunologie, Institut für Klinische Chemie + Klinik f. Neurologie
Kiel , 24105, Germany
Praxis Dr. med. Andreas Kowalik, Arzt für Neurologie und Psychiatrie
Stuttgart , 70174, Germany
Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen , 72076, Germany
Universitätsklinikum Ulm; Klinik für Neurologie
Ulm , 89081, Germany
Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
Westerstede , 26655, Germany
Pamela Youde Nethersole Eastern Hospital; Department of Medicine
Hong Kong , , Hong Kong
Prince of Wales Hospital; Division of Neurology, Department of Medicine and Therapeutics
Shatin, New Territories , , Hong Kong
Clinexpert Kft.
Budapest , 1033, Hungary
S-Medicon Egeszsegugyi Szolgaltato Kft.
Budapest , 1138, Hungary
Markhot Ferenc Oktatokorhaz és Rendelointezet; Neurologiai és Stroke Osztaly
Eger , 3300, Hungary
Pest Megyei Flor Ferenc Korhaz
Kistarcsa , 2143, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika
Szeged , 6725, Hungary
Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla
L'Aquila Abruzzo, 67100, Italy
AOU Seconda Università degli Studi; Dip. Assistenziale Integrato Medicina Int-II Clinica Neurologica
Napoli Campania, 80131, Italy
AOU Policlinico - Università L. Vanvitelli; D.A.I. di Medicina Interna e Specialistica
Napoli Campania, 80138, Italy
A.O.U. di Parma; SC Neurologia, Amb. Sclerosi Multipla (malattie demielinizzanti)
Parma Emilia-Romagna, 43126, Italy
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
Roma Lazio, 00133, Italy
Policlinico Umberto I; Centro Sclerosi Multipla DAI Neuroscienze e Salute Mentale
Roma Lazio, 00185, Italy
Azienda Ospedaliera Sant'Andrea; UOC Neurologia
Roma Lazio, 00189, Italy
ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla
Bergamo Lombardia, 24127, Italy
IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
Milano Lombardia, 20132, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
Torrette - Ancona Marche, 60100, Italy
Ospedale Regina Montis Regalis; SC Neurologia, Centro Sclerosi Multipla
Mondovì (CN) Piemonte, 12084, Italy
AO.U. Policlinico Riuniti Foggia; Neurologia Univ.-Centro intradip. malattie demielinizzanti
Foggia Puglia, 71100, Italy
AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla
Catania Sicilia, 95123, Italy
AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2
Firenze Toscana, 50134, Italy
AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale
Siena Toscana, 53100, Italy
Azienda Ospedaliera di Padova; Clinica Neurologica
Padova Veneto, 35128, Italy
Aga Khan University Hospital
Nairobi , 00100, Kenya
Clinical Research Institute Saltillo
Saltillo Coahuila, 25050, Mexico
Health Pharma Professional Research
Cdmx Mexico CITY (federal District), 03100, Mexico
Grupo Medico de Investigacion Clinica Multidisciplinaria
Mexico City Mexico CITY (federal District), 03100, Mexico
Neurociencias Estudios Clinicos S.C.
Culiacán Sinaloa, 80020, Mexico
Hospital General de Mexico
Mexico Tlaxcala, 06726, Mexico
Zuyderland Medisch Centrum - Sittard Geleen
Sittard-Geleen , 6162 , Netherlands
PHO General City Hospital 8th September Center for dialysis
Skopje , 1000, North Macedonia
University Clinic for Neurology - Skopje
Skopje , 1000, North Macedonia
Clinical Hospital Stip
Stip , 2000, North Macedonia
Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
Bellavista , Calla, Peru
HOSPITAL NACIONAL GUILLERMO ALMENARA IRIGOYEN; Unidad de Investigacion en Neurologia
La Victoria, Lima , Lima , Peru
Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
Lima , 15003, Peru
Clinica Internacional Sede Lima
LIma , Lima , Peru
Hospital Maria Auxiliadora
Lima , Lima , Peru
Clinica Centenario Peruano Japonesa; Neurology
Pueblo Libre , Lima , Peru
ProNeuro Centrum Medyczne
?ory , 44-24, Poland
Neurocentrum Bydgoszcz sp. z o.o
Bydgoszcz , 85-79, Poland
Care Clinic
Katowice , 40-56, Poland
MT Medic Krosno
Krosno , 38-40, Poland
Centrum Neurologii Krzysztof Selmaj
Lodz , 90-32, Poland
Rodzinne Centrum Medyczne Lubimed.pl
Lublin , 20-49, Poland
Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych
Plewiska , 62-06, Poland
MedPolonia
Poznan , 60-69, Poland
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
Warszawa , 02-95, Poland
IBISMED Wielospecjalistyczne Centrum Medyczne
Zabrze , 41-80, Poland
Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)
Braga , 4710-, Portugal
HUC; Servico de Neurologia
Coimbra , 3000-, Portugal
Hospital Santo Antonio dos Capuchos; Servico de Neurologia
Lisboa , 1169-, Portugal
Hospital da Luz; Neurologia
Lisboa , 1500-, Portugal
Hospital Geral de Santo Antonio; Servico de Neurologia
Porto , 4099-, Portugal
Hospital de Sao Joao; Servico de Neurologia
Porto , 4200-, Portugal
Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião; Servilo de Neurologia
Santa Maria Da Feira , 4520-, Portugal
Republican clinical hospital named after G.G. Kuvatov
UFA Baskortostan, 45000, Russian Federation
N.P. Bechtereva Institute of the Human Brain
Sankt-petersburg Sankt Petersburg, 19737, Russian Federation
Leningrad Regional Clinical Hospital
St Petersburg Sankt Petersburg, 19429, Russian Federation
Pavlov State Medical Uni ; Neurology
St Petersburg Sankt Petersburg, 19702, Russian Federation
Ulyanovsk Regional Clinical Hospital
Ulyanovsk Uljanovsk, 43206, Russian Federation
Center of Cardiology and Neurology
Kirov , 61000, Russian Federation
FSBIH Siberian Regional Medical Centre of FMBA of Russia
Novosibirsk , 63000, Russian Federation
University Clinical Center of Serbia; Clinic of neurology
Belgrade , 11000, Serbia
Hospital Universitari de Bellvitge; Servicio de Neurologia
L'Hospitalet de Llobregat Barcelona, 08907, Spain
Hospital Quiron de Madrid; Servicio de Neurologia
Pozuelo de Alarcon Madrid, 28223, Spain
Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
EL Palmar (EL Palmar) Murcia, 30120, Spain
Hospital Alvaro Cunqueiro; Servicio de Neurologia
Vigo Pontevedra, , Spain
Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
Barcelona , 08035, Spain
Hospital Universitario de la Princesa; Servicio de Neurologia
Madrid , 28006, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Neurologia
Madrid , 28007, Spain
Hospital Ramon y Cajal; Servicio de Neurologia
Madrid , 28034, Spain
Fundacion Jimenez Diaz; Servicio de Neurología
Madrid , 28040, Spain
Hospital Regional Universitario de Malaga ? Hospital General; Servicio de Neurologia
Malaga , 29010, Spain
Hospital Universitario Virgen Macarena; Servicio de Neurologia
Sevilla , 41009, Spain
Inselspital Bern Medizin Neurologie; Neurologische Poliklinik
Bern , 3010, Switzerland
Ospedale Regionale di Lugano - Civico; Neurologia
Lugano , 6903, Switzerland
Hopital Razi; Neurology Department
Mannouba , 2010, Tunisia
Fattouma Bourguiba Hospital
Monastir , 5000, Tunisia
Hospital Habib Bourguiba
Sfax , 3029, Tunisia
Medical Center Dopomoga Plus
Kyiv Chernihiv Governorate, 02123, Ukraine
MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care
Lviv Chernihiv Governorate, 79007, Ukraine
Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council
Zaporizhzhia Katerynoslav Governorate, 69600, Ukraine
Zaporizhia City Multispecialty Clinical Hospital #9
Zaporizhzhye Katerynoslav Governorate, 69063, Ukraine
Separated structural unit ?University clinic? of Dnipro State Medical University
Dnipro Kharkiv Governorate, 49038, Ukraine
SI USSRI of Medical and Social Problems of Disabilities of MOHU
Dnipro KIEV Governorate, 49027, Ukraine
Medical Center of Private Execution First Private Clinic
Kyiv KIEV Governorate, 03037, Ukraine
Salutem Medical Center
Vinnytsia KIEV Governorate, 21009, Ukraine
Medical Clinical Research Center of Medical Center LLC Health Clinic
Vinnytsia Podolia Governorate, 21009, Ukraine
Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology
Kharkov , 61068, Ukraine
Lviv Regional Clinical Hospital; Department of Neurology
Lviv , 79010, Ukraine
Odesa Regional Clinical Hospital; Neurosurgery Department
Odesa , 65117, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

746

Study ID:

NCT04586010

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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