A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Patients With Primary Progressive Multiple Sclerosis.

Who is this study for? Patients with Multiple Sclerosis
Status: Recruiting
Location: See all (211) 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 in adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible participants will be randomized 1:1 to either daily oral fenebrutinib (or placebo) or intravenous (IV) ocrelizumab (or placebo) in a blinded fashion through an interactive voice or web-based response system (IxRS). Approximately 946 participants will be enrolled and will be recruited globally. Participants who discontinue study medication early or discontinue from the study will not be replaced. The 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: 65
Healthy Volunteers: No
View:

• A diagnosis of PPMS in accordance to the revised 2017 McDonald Criteria (Thompson et al. 2018).

• Disability progression in the 12 months prior to screening.

• Expanded Disability Status Scale (EDSS) score from 3.0 to 6.5 inclusive at screening.

• Pyramidal functional subscore >=2 at screening.

• For participants currently receiving proton pump inhibitors (PPIs), H2-receptor antagonists (H2RAs), symptomatic treatment for Multiple Sclerosis (MS) (e.g. fampridine, cannabis) and/or physiotherapy: treatment at a stable dose during the screening period prior to the initiation of study treatment and plans to remain at a stable dose for the duration of study treatment.

• Ability to complete the 9-Hole Peg Test (9-HPT) for each hand in <240 seconds.

• Ability to perform 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
California
Sutter East Bay Medical Foundation
Active, not recruiting
Berkeley
North County Neurology Associates
Recruiting
Carlsbad
Fullerton Neurology and Headache Center
Active, not recruiting
Fullerton
Palo Alto Medical Foundation Research Center
Recruiting
Sunnyvale
Colorado
University of Colorado Denver
Recruiting
Aurora
Connecticut
Yale University School Of Medicine
Recruiting
New Haven
Washington, D.c.
Georgetown University Medical Center
Active, not recruiting
Washington
Florida
Neurology Associates PA
Recruiting
Maitland
Uni of Miami School of Medicine
Recruiting
Miami
Neurological Services of Orlando
Recruiting
Orlando
University of South Florida
Recruiting
Tampa
Vero Beach Neurology and Research Institute
Withdrawn
Vero Beach
Indiana
Josephson Wallack Munshower Neurology PC
Recruiting
Indianapolis
Kansas
University of Kansas Medical Center
Active, not recruiting
Kansas City
Massachusetts
Dragonfly Research, LLC
Recruiting
Wellesley
Maryland
Johns Hopkins University School Of Medicine; Outpatient Center
Recruiting
Baltimore
University of Maryland Medical Center; Department of Neurology
Recruiting
Baltimore
Michigan
Wayne State University
Recruiting
Detroit
Minnesota
Minneapolis Clinic of Neurology
Recruiting
Golden Valley
Missouri
Washington University
Recruiting
Saint Louis
North Carolina
Atrium Health Neurosciences Institute - Charlotte
Recruiting
Charlotte
Raleigh Neurology Associates
Active, not recruiting
Raleigh
New Jersey
Hackensack U Med Ctr
Recruiting
Hackensack
Barnabas Health Ambulatory Care Center
Recruiting
Livingston
Jersey Shore University Medical Centre
Recruiting
Neptune
Rutgers New Jersey Medical School
Recruiting
Newark
Holy Name Hospital; Institute For Clinical Research
Recruiting
Teaneck
Nevada
Cleveland Clinic Lou Ruvo; Center for Brain Research
Active, not recruiting
Las Vegas
New York
Dent Neurological Institute
Recruiting
Amherst
NYU Winthrop-Huntington, NY
Withdrawn
Huntington Station
Columbia University Medical Center
Recruiting
New York
University of Rochester
Recruiting
Rochester
Stony Brook University Medical Center
Recruiting
Stony Brook
SUNY Upstate Medical University
Recruiting
Syracuse
Ohio
Miami Valley Hospital South; Dayton Physician's Office
Recruiting
Centerville
UC Health, LLC.
Recruiting
Cincinnati
OhioHealth Riverside Methodist Hospital; Pharmacy Services
Active, not recruiting
Columbus
Oregon
Providence Brain and Spine Institute
Recruiting
Portland
Tennessee
Neurology Clinic PC
Recruiting
Cordova
Hope Neurology
Recruiting
Knoxville
Vanderbilt University Medical Center
Recruiting
Nashville
Texas
Uni of Texas Health Science Center At Houston
Active, not recruiting
Houston
Texas Institute for Neurological Disorders
Recruiting
Sherman
Washington
Evergreen MS Center
Recruiting
Kirkland
Swedish Medical Center
Recruiting
Seattle
Wisconsin
Medical College of Wisconsin, Inc.
Active, not recruiting
Milwaukee
West Virginia
West Virginia University
Recruiting
Charleston
Other Locations
Argentina
Instituto De Neurología Cognitiva - INECO
Recruiting
Caba
Instituto de Investigaciones Metabolicas (Idim)
Recruiting
Ciudad Autonoma De Buenos Aires
Instituto DIABAID
Active, not recruiting
Ciudad Autónoma De Buenos Aires
Instituto Reumatológico Strusberg
Recruiting
Cordoba
Fundacion Rosarina de Neurorehabilitacion
Active, not recruiting
Rosario
Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY
Active, not recruiting
San Miguel
Australia
Box Hill Hospital; Department of Neurology
Recruiting
Box Hill
Brain and Mind Research Institute
Recruiting
Camperdown
St Vincent's Hospital Sydney
Withdrawn
Darlinghurst
Austin Hospital; Department of Neurology
Active, not recruiting
Heidelberg
Liverpool Hospital
Recruiting
Liverpool
St Vincents Hospital
Withdrawn
Melbourne
John Hunter Hospital
Recruiting
New Lambton
Royal Melbourne Hospital; Department of Neurology
Active, not recruiting
Parkville
Princess Alexandra Hospital
Recruiting
Woolloongabba
Austria
Kepler Universitätsklinikum GmbH - Neuromed Campus; Neurologie
Recruiting
Linz
Medizinische Universität Wien; Univ.Klinik fuer Neurologie
Recruiting
Wien
Brazil
Santa Casa de Misericordia; de Belo Horizonte
Recruiting
Belo Horizonte
Instituto de Neurologia de Curitiba
Recruiting
Curitiba
Clinica Neurologica; Neurocirurgica de Joinville
Recruiting
Joinville
IMV Pesquisa Neurológica
Recruiting
Porto Alegre
Núcleo de Pesquisa do Rio Grande do Sul
Recruiting
Porto Alegre
Hospital Universitario Gaffree e Guinle
Recruiting
Rio De Janeiro
Centro de Pesquisas Clinicas; CPCLIN
Recruiting
Sao Paulo
Bulgaria
UMHAT Dr. Georgi Stranski; 2nd Neurology Clinic, Occupational Diseases
Recruiting
Pleven
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD
Recruiting
Sofia
Canada
Fraser Health Authority - Fraser Health Multiple Sclerosis
Recruiting
Burnaby
University of Alberta Hospital
Recruiting
Edmonton
Clinique NeuroOutaouais
Recruiting
Gatineau
Recherche Sepmus Inc.
Recruiting
Greenfield Park
London Health Sciences Centre Uni Campus
Recruiting
London
Regional health authority A vitalite health network
Recruiting
Moncton
Montreal Neurological Institute and Hospital
Recruiting
Montreal
The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis
Recruiting
Ottawa
St. Michael's Hospital; MS Clinic
Recruiting
Toronto
Sunnybrook Health Sciences Centre
Recruiting
Toronto
University of British Columbia
Recruiting
Vancouver
Chile
CeCim Biocinetic
Recruiting
Santiago
Clinica Alemana
Recruiting
Vitacura
Colombia
Organizacion Sanitas Internacional
Recruiting
Bogota, D.c.
Fundacion Clinica Valle del Lili; Unidad de Investigaciones Clinicas
Recruiting
Cali
Instituto Neurologico de Colombia INDEC
Recruiting
Medellin
Denmark
Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken
Withdrawn
Aabenraa
Aarhus Universitetshospital, Neurologisk Afd. F, Skleroseklinikken
Recruiting
Aarhus N
Rigshospitalet; Neurologisk Klinik Glostrup
Recruiting
Glostrup
France
Groupe Hospitalier Pellegrin; Service de neurochirurgie B
Active, not recruiting
Bordeaux
Hopital Pierre Wertheimer; Neurologie D
Recruiting
Bron
CHRU de Montpellier, Hopital Gui de Chauliac; Service de Neuropediatrie
Active, not recruiting
Montpellier
Hopital Guillaume Et Rene Laennec
Recruiting
Nantes
Hôpital Pasteur; Service de Neurologie
Active, not recruiting
Nice
Hopital Civil de Strasbourg; Service de Neurologie
Recruiting
Strasbourg
Germany
Charite - Universitatsmedizin Berlin; Klinik fur Neurologie
Active, not recruiting
Berlin
Studienzentrum für Neurologie und Psychiatrie
Recruiting
Böblingen
Universitätsklinikum Carl Gustav Carus, Zentrum für Klinische Neurowissenschaften
Recruiting
Dresden
Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie
Recruiting
Freiburg
Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum
Recruiting
München
Universitaetsklinikum Tuebingen; Abteilung Neurologie
Recruiting
Tuebingen
Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz
Withdrawn
Westerstede
Deutsche Klinik für Diagnostik; DKD Helios Klinik Wiesbaden, Abt. Neurologie
Recruiting
Wiesbaden
Greece
401 Military Hospital of Athens; Neurology Department
Recruiting
Athens
AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.
Active, not recruiting
Thessaloniki
Hospital Eginition; First Department of Neurology
Recruiting
Αθηνα
Hungary
Clinexpert Kft.
Recruiting
Budapest
Jahn Ferenc Dél-Pesti Kórház
Recruiting
Budapest
S-Medicon Egeszsegugyi Szolgaltato Kft.
Active, not recruiting
Budapest
Pest Megyei Flor Ferenc Korhaz
Recruiting
Kistarcsa
Israel
Rambam Medical Center; Neurology Unit
Recruiting
Haifa
Hadassah University Hospital - Ein Kerem
Withdrawn
Jerusalem
The Chaim Sheba Medical Center; Multiple Sclerosis Center
Active, not recruiting
Ramat-gan
Tel Aviv Sourasky Medical Center; Department of Neurology
Recruiting
Tel Aviv
Italy
Irccs A.O.U.San Martino Ist; Dinogmi
Recruiting
Genova
Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
Recruiting
Milano
IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
Recruiting
Milano
Ospedale Civile di Montichiari; Centro Sclerosi Multipla
Recruiting
Montichiari
AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica
Recruiting
Napoli
A.R.N.A.S. Civico Di Cristina Benfratelli; U.O.C. Neurologia con Stroke Unit
Recruiting
Palermo
A.O.U. di Parma; SC Neurologia, Amb. Sclerosi Multipla (malattie demielinizzanti)
Recruiting
Parma
IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
Recruiting
Pozzilli
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
Recruiting
Roma
Mexico
Grupo Médico Camino S.C.
Recruiting
Ciudad De México
Hospital Juarez de Mexico
Recruiting
Ciudad De México
Mexico Centre for Clinical Research
Active, not recruiting
Ciudad De México
Clinstile S.A de C.V.
Recruiting
Mexico City
Clinical Research Institute
Recruiting
Tlalnepantla De Baz
Peru
Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
Recruiting
Bellavista
Clinica Internacional; Unidad De Investigacion
Recruiting
Lima
Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo; Peru
Recruiting
Lima
Poland
Neurocentrum Bydgoszcz sp. z o.o
Recruiting
Bydgoszcz
Care Clinic
Active, not recruiting
Katowice
Specjalistyczny Szpital Sw. Lukasza
Withdrawn
Konskie
Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.
Withdrawn
Krakow
Centrum Neurologii Krzysztof Selmaj
Recruiting
Lodz
Rejdak Konrad Indywidualna Praktyka Lekarska dr hab. Konrad Rejdak
Recruiting
Lublin
Med Polonia
Recruiting
Poznań
Centrum Medyczne MEDYK
Recruiting
Rzeszow
Nzoz Palomed
Recruiting
Rzeszów
NEURO-CARE Sp. z o.o. Sp. Komandytowa
Recruiting
Siemianowice Śląskie
Centrum Medyczne NeuroProtect
Recruiting
Warszawa
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
Recruiting
Warszawa
Wro Medica
Active, not recruiting
Wrocław
SPSK nr 1; Klinika Neurologii
Recruiting
Zabrze
Portugal
Hospital de Braga; Servico de Neurologia
Recruiting
Braga
Hospital de Santa Maria; Servico de Neurologia
Recruiting
Lisboa
Hospital Santo Antonio dos Capuchos; Servico de Neurologia
Recruiting
Lisboa
Hospital de Sao Joao; Servico de Neurologia
Recruiting
Porto
Hospital Geral de Santo Antonio; Servico de Neurologia
Recruiting
Porto
Puerto Rico
San Juan MS Center
Recruiting
Guaynabo
Russian Federation
Sverdlovsk Regional Clinical Hospital 1
Active, not recruiting
Ekaterinburg
Vertebronevrologiya LLC
Active, not recruiting
Kazan
Kemerovo Regional Clinical Hospital
Recruiting
Kemerovo
Center of Cardiology and Neurology
Active, not recruiting
Kirov
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
Active, not recruiting
Krasnoyarsk
Krasnoyarsk State Medical Academy
Active, not recruiting
Krasnoyarsk
City Clinical Hospital #24; Multipal Sclerosis department
Active, not recruiting
Moskva
Federal center of brain research and neurotechnologies
Active, not recruiting
Moskva
FSBIH Siberian Regional Medical Centre of FMBA of Russia
Recruiting
Novosibirsk
State Novosibirsk Regional Clinical Hospital
Active, not recruiting
Novosibirsk
National Center of Social Significant Disease
Active, not recruiting
Sankt-peterburg
Pavlov State Medical Uni ; Neurology
Recruiting
St Petersburg
City Hospital #40 of Resort Administrative District
Active, not recruiting
St. Petersburg
Nebbiolo Center for Clinical Trials
Recruiting
Tomsk
Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology
Active, not recruiting
Tyumen
Spain
Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
Recruiting
Barcelona
Hospital Puerta del Mar; Sevicio de Neurologia
Recruiting
Cadiz
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia
Recruiting
Coruña
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología
Recruiting
Lleida
Hospital Ramon y Cajal; Servicio de Neurologia
Active, not recruiting
Madrid
Hospital Regional Universitario de Malaga - Hospital General; Servicio de Neurologia
Recruiting
Malaga
Hospital Quiron de Madrid; Servicio de Neurologia
Active, not recruiting
Pozuelo De Alarcon
Hospital Universitario Virgen Macarena; Servicio de Neurologia
Recruiting
Sevilla
Hospital Alvaro Cunqueiro; Servicio de Neurologia
Recruiting
Vigo
Switzerland
Universitätsspital Basel; Neurologie
Active, not recruiting
Basel
Inselspital Bern Medizin Neurologie
Recruiting
Bern
UniversitätsSpital Zürich; Klinik für Neurologie
Withdrawn
Zürich
Turkey
Hacettepe University Medical Faculty; Neurology
Active, not recruiting
Ankara
Baskent Universitesi Ankara Hastanesi; Noroloji Bolumu
Recruiting
Çankaya
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
Mersin University Medical Faculty; Neurology
Active, not recruiting
Mersin
Ondokuz Mayis Univ. Med. Fac.; Neurology
Recruiting
Samsun
Karadeniz Tecnical Uni. Med. Fac.; Neurology
Active, not recruiting
Trabzon
Van Yuzuncu Yil University Hospital; Neurology
Recruiting
Van
Ukraine
CNPE City Clinical Hospital #3 of Chernivtsi City Council
Recruiting
Chernivtsi
Municipal Institution Dnipropetrovsk Regional Clinical Hospital n a I I Mechnykov; Neurology dept #1
Recruiting
Dnipro
Regional Clinical Hospital; Neurology Department
Recruiting
Ivano-frankivsk
Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital
Completed
Kharkiv
Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology
Active, not recruiting
Kharkov
MEDBUD
Active, not recruiting
Kyiv
Volyn Regional Clinical Hospital
Active, not recruiting
Lutsk
Lviv Regional Clinical Hospital
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
Recruiting
Vinnytsia
Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
Active, not recruiting
Zaporizhzhia
Medical Centre of PE First Private Clinic
Recruiting
Zhytomir
United Kingdom
Queen Elizabeth University Hospital
Recruiting
Glasgow
Charing Cross Hospital
Recruiting
London
Nottingham University Hospitals NHS Trust
Active, not recruiting
Nottingham
Derriford Hospital
Recruiting
Plymouth
Morriston Hospital
Recruiting
Swansea
Contact Information
Primary
Reference Study ID Number: GN41791 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date: October 26, 2020
Estimated Completion Date: December 18, 2026
Participants
Target number of participants: 946
Treatments
Experimental: fenebrutinib
Participants will receive oral fenebrutinib and intravenous (IV) ocrelizumab-matching placebo.
Active Comparator: ocrelizumab
Participants will receive intravenous (IV) ocrelizumab and oral fenebrutinib-matching placebo.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov

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