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ACTIVE NOT RECRUITING
NCT04544449
PHASE3

A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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 (and placebo) or intravenous (IV) ocrelizumab (and placebo) in a blinded fashion through an interactive voice or web-based response system (IxRS). 985 participants were enrolled and 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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

985

Start Date

2020-10-26

Completion Date

2027-07-21

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

DRUG

Fenebrutinib

Participants will receive fenebrutinib.

DRUG

Ocrelizumab

Participants will receive ocrelizumab.

DRUG

Placebo matched to ocrelizumab

Participants will receive ocrelizumab-matching placebo.

DRUG

Placebo matched to fenebrutinib

Participants will receive fenebrutinib-matching placebo

Locations (189)

Alabama Neurology Associates

Homewood, Alabama, United States

Sutter East Bay Medical Foundation

Berkeley, California, United States

Fullerton Neurology and Headache Center

Fullerton, California, United States

Palo Alto Medical Foundation Research Center

Sunnyvale, California, United States

University of Colorado Denver

Aurora, Colorado, United States

Yale University School Of Medicine

Fairfield, Connecticut, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Neurology Associates PA

Maitland, Florida, United States

Neurological Services of Orlando

Orlando, Florida, United States

University of South Florida

Tampa, Florida, United States

Josephson Wallack Munshower Neurology PC

Indianapolis, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Johns Hopkins University School Of Medicine

Baltimore, Maryland, United States

Dragonfly Research, LLC

Wellesley, Massachusetts, United States

Wayne State University

Detroit, Michigan, United States

Minneapolis Clinic of Neurology

Golden Valley, Minnesota, United States

Washington University

St Louis, Missouri, United States

Cleveland Clinic Lou Ruvo

Las Vegas, Nevada, United States

Hackensack U Med Ctr

Hackensack, New Jersey, United States

Barnabas Health Ambulatory Care Center

Livingston, New Jersey, United States

Jersey Shore University Medical Centre

Neptune City, New Jersey, United States

Rutgers New Jersey Medical School

Newark, New Jersey, United States

Holy Name Hospital

Teaneck, New Jersey, United States

Dent Neurological Institute

Amherst, New York, United States

Columbia University Medical Center

New York, New York, United States

University of Rochester

Rochester, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Atrium Health Neurosciences Institute ? Charlotte

Charlotte, North Carolina, United States

Raleigh Neurology Associates

Raleigh, North Carolina, United States

Miami Valley Hospital South

Centerville, Ohio, United States

UC Health, LLC.

Cincinnati, Ohio, United States

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, United States

Providence Brain and Spine Institute

Portland, Oregon, United States

Neurology Clinic PC

Cordova, Tennessee, United States

Hope Neurology

Knoxville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Uni of Texas Health Science Center At Houston

Houston, Texas, United States

Texas Institute for Neurological Disorders

Sherman, Texas, United States

Evergreen MS Center

Kirkland, Washington, United States

Swedish Medical Center

Seattle, Washington, United States

West Virginia University

Morgantown, West Virginia, United States

Medical College of Wisconsin, Inc.

Milwaukee, Wisconsin, United States

Centro de Especialidades Neurológicas y Rehabilitación - CENyR

Buenos Aires, Argentina

Focus CECIC

Buenos Aires, Argentina

Instituto Reumatológico Strusberg

Córdoba, Argentina

Fundacion Rosarina de Neurorehabilitacion

Rosario, Argentina

Centro de Investigaciones Médicas Tucuman

San Miguel, Argentina

Brain and Mind Research Institute

Camperdown, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

John Hunter Hospital

New Lambton, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Austin Hospital

Heidelberg, Victoria, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

Kepler Universitätsklinikum GmbH - Neuromed Campus

Linz, Austria

Medizinische Universität Wien

Vienna, Austria

Santa Casa de Misericordia

Belo Horizonte, Minas Gerais, Brazil

Instituto de Neurologia de Curitiba

Curitiba, Paraná, Brazil

Núcleo de Pesquisa do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

IMV Pesquisa Neurológica

Porto Alegre, Rio Grande do Sul, Brazil

Clinica Neurologica

Joinville, Santa Catarina, Brazil

Centro de Pesquisas Clinicas

São Paulo, São Paulo, Brazil

Hospital Universitario Gaffree e Guinle

Rio de Janeiro, Brazil

UMHAT Dr. Georgi Stranski

Pleven, Bulgaria

Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD

Sofia, Bulgaria

University of Alberta Hospital

Edmonton, Alberta, Canada

Fraser Health Authority - Fraser Health Multiple Sclerosis

Burnaby, British Columbia, Canada

University of British Columbia

Vancouver, British Columbia, Canada

London Health Sciences Centre Uni Campus

London, Ontario, Canada

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Clinique NeuroOutaouais

Gatineau, Quebec, Canada

Recherche Sepmus Inc.

Greenfield Park, Quebec, Canada

Montreal Neurological Institute and Hospital

Montreal, Quebec, Canada

CeCim Biocinetic

Santiago, Chile

Clinica Alemana

Vitacura, Chile

Organizacion Sanitas Internacional

Bogotá, Colombia

Fundacion Clinica Valle del Lili

Cali, Colombia

Instituto Neurologico de Colombia INDEC

Medellín, Colombia

Aarhus Universitetshospital

Aarhus N, Denmark

Rigshospitalet

Glostrup Municipality, Denmark

Groupe Hospitalier Pellegrin

Bordeaux, France

Hopital Pierre Wertheimer

Bron, France

CHRU de Montpellier, Hopital Gui de Chauliac

Montpellier, France

Hopital Guillaume Et Rene Laennec

Nantes, France

Hôpital Pasteur

Nice, France

Hopitaux Universitaires de Strasbourg

Strasbourg, France

Charite - Universitatsmedizin Berlin

Berlin, Germany

Studienzentrum Dr. Bischof GmbH

Böblingen, Germany

Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

Dresden, Germany

Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie

Freiburg im Breisgau, Germany

Klinikum rechts der Isar der TU Muenchen

München, Germany

Universitaetsklinikum Tuebingen

Tübingen, Germany

Deutsche Klinik für Diagnostik

Wiesbaden, Germany

Hospital Eginition

Athens, Greece

401 Military Hospital of Athens

Athens, Greece

AHEPA Univ. General Hospital of Thessaloniki

Thessaloniki, Greece

Clinexpert Kft.

Budapest, Hungary

S-Medicon Egeszsegugyi Szolgaltato Kft.

Budapest, Hungary

Budapesti Jahn Ferenc Dél-pesti Kórház és Rendel?intézet

Budapest, Hungary

Markhot Ferenc Oktatokorhaz és Rendelointezet

Eger, Hungary

Pest Megyei Flor Ferenc Korhaz

Kistarcsa, Hungary

Rambam Medical Center

Haifa, Israel

The Chaim Sheba Medical Center

Ramat Gan, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

AOU Seconda Università degli Studi

Naples, Campania, Italy

A.O.U. di Parma

Parma, Emilia-Romagna, Italy

Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

Rome, Lazio, Italy

Irccs A.O.U.San Martino Ist

Genoa, Liguria, Italy

IRCCS Ospedale San Raffaele

Milan, Lombardy, Italy

Ospedale Civile di Montichiari

Montichiari, Lombardy, Italy

IRCCS Istituto Neurologico Neuromed

Pozzilli, Molise, Italy

A.R.N.A.S. Civico Di Cristina Benfratelli

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

Hospital Juarez de Mexico

Mexico City, Mexico CITY (federal District), Mexico

Grupo Médico Camino S.C.

México, Mexico CITY (federal District), Mexico

Clinical Research Institute

Tialnepantla, Mexico, Mexico

University Clinic of Neurology

Skopje, North Macedonia

Hospital IV Alberto Sabogal Sologuren

Bellavista, Peru

Clinica Internacional

Lima, Peru

Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo

Lima, Peru

Neurocentrum Bydgoszcz sp. z o.o

Bydgoszcz, Poland

Care Clinic

Katowice, Poland

NEURO-CARE Sp. z o.o. Sp. Komandytowa

Katowice, Poland

Centrum Neurologii Krzysztof Selmaj

Lodz, Poland

Med Polonia

Późna, Poland

Centrum Medyczne "MEDYK"

Rzeszów, Poland

Nmedis sp. z o.o.

Rzeszów, Poland

Centrum Medyczne NeuroProtect

Warsaw, Poland

Wro Medica

Wroc?aw, Poland

SPSK nr 1

Zabrze, Poland

Hospital de Braga

Braga, Portugal

Hospital Santo Antonio dos Capuchos

Lisbon, Portugal

Hospital de Santa Maria

Lisbon, Portugal

Hospital Geral de Santo Antonio

Porto, Portugal

Hospital de Sao Joao

Porto, Portugal

San Juan MS Center

Guaynabo, Puerto Rico

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

City Clinical Hospital #24

Moskva, Moscow Oblast, Russia

National Center of Social Significant Disease

Saint Petersburg, Sankt-Peterburg, Russia

City Hospital #40 of Resort Administrative District

Saint Petersburg, Sankt-Peterburg, Russia

Sverdlovsk Regional Clinical Hospital 1

Yekaterinburg, Sverdlovsk Oblast, Russia

Vertebronevrologiya LLC

Kazan', Tatarstan Republic, Russia

Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik

Tyumen, Tyumen Oblast, Russia

Center of Cardiology and Neurology

Kirov, Russia

State Novosibirsk Regional Clinical Hospital

Novosibirsk, Russia

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, LA Coruna, Spain

Hospital Universitari Arnau de Vilanova de Lleida

Lleida, Lerida, Spain

Hospital Quiron de Madrid

Pozuelo de Alarcón, Madrid, Spain

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Puerta del Mar

Cadiz, Spain

Hospital Ramon y Cajal

Madrid, Spain

Hospital Regional Universitario de Malaga ? Hospital General

Málaga, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Universitätsspital Basel

Basel, Switzerland

Inselspital Bern Medizin Neurologie

Bern, Switzerland

Hacettepe University Medical Faculty

Ankara, Turkey (Türkiye)

Baskent Universitesi Ankara Hastanesi

Çankaya, Turkey (Türkiye)

Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi

Istanbul, Turkey (Türkiye)

Sancaktepe Training and Research Hospital

Istanbul, Turkey (Türkiye)

Selcuk University Medical Faculty

Istanbul, Turkey (Türkiye)

Kocaeli University Hospital

Kocaeli, Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, Turkey (Türkiye)

Ondokuz Mayis Univ. Med. Fac.

Samsun, Turkey (Türkiye)

Karadeniz Tecnical Uni. Med. Fac.

Trabzon, Turkey (Türkiye)

Van Yuzuncu Yil University Hospital

Van, Turkey (Türkiye)

CNPE City Clinical Hospital #3 of Chernivtsi City Council

Chernivtsi, Chernihiv Governorate, Ukraine

Medical Centre of PE First Private Clinic

Zhytomyr, Crimean Regional Governmenta, Ukraine

Ams of Ukraine

Kharkiv, Kharkiv Governorate, Ukraine

Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council

Zaporizhzhia, Kharkiv Governorate, Ukraine

MEDBUD

Kyiv, KIEV Governorate, Ukraine

Lviv Regional Clinical Hospital

Lviv, KIEV Governorate, Ukraine

Salutem Medical Center

Vinnytsia, KIEV Governorate, Ukraine

Separated structural unit ?University hospital? of Dnipro State Medical University

Dnipro, Tavria Okruha, Ukraine

Regional Clinical Hospital

Ivano-Frankivsk, Ukraine

Volyn Regional Clinical Hospital

Lutsk, Ukraine

"Neurofocus" LLC

Lviv, Ukraine

Odesa Regional Clinical Hospital

Odesa, Ukraine

Medical Clinical Research Center of Medical Center LLC Health Clinic

Vinnytsia, Ukraine

Queen Elizabeth University Hospital

Glasgow, United Kingdom

Charing Cross Hospital

London, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Morriston Hospital

Swansea, United Kingdom