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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

985

Participants

Timeline

Start Date

October 26, 2020

Primary Completion Date

September 17, 2025

Study Completion Date

July 21, 2027

Conditions
Multiple Sclerosis, Primary Progressive
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

Trial Locations (189)

0

Clinica Alemana, Vitacura

968

San Juan MS Center, Guaynabo

1000

University Clinic of Neurology, Skopje

1033

Clinexpert Kft., Budapest

1090

Medizinische Universität Wien, Vienna

1113

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

1138

S-Medicon Egeszsegugyi Szolgaltato Kft., Budapest

1204

Budapesti Jahn Ferenc Dél-pesti Kórház és Rendel?intézet, Budapest

2000

Fundacion Rosarina de Neurorehabilitacion, Rosario

2050

Brain and Mind Research Institute, Camperdown

2143

Pest Megyei Flor Ferenc Korhaz, Kistarcsa

2170

Liverpool Hospital, Liverpool

2305

John Hunter Hospital, New Lambton

2600

Rigshospitalet, Glostrup Municipality

3010

Inselspital Bern Medizin Neurologie, Bern

3050

Royal Melbourne Hospital, Parkville

3084

Austin Hospital, Heidelberg

3128

Box Hill Hospital, Box Hill

3300

Markhot Ferenc Oktatokorhaz és Rendelointezet, Eger

4020

Kepler Universitätsklinikum GmbH - Neuromed Campus, Linz

4031

Universitätsspital Basel, Basel

4102

Princess Alexandra Hospital, Woolloongabba

5800

UMHAT Dr. Georgi Stranski, Pleven

8200

Aarhus Universitetshospital, Aarhus N

10008

Medical Centre of PE First Private Clinic, Zhytomyr

10032

Columbia University Medical Center, New York

10117

Charite - Universitatsmedizin Berlin, Berlin

11009

Hospital Puerta del Mar, Cadiz

11525

401 Military Hospital of Athens, Athens

11794

Stony Brook University Medical Center, Stony Brook

13210

SUNY Upstate Medical University, Syracuse

14226

Dent Neurological Institute, Amherst

14642

University of Rochester, Rochester

15001

Clinica Internacional, Lima

15006

Complejo Hospitalario Universitario A Coruña (CHUAC), A Coruña

16132

Irccs A.O.U.San Martino Ist, Genoa

20007

Georgetown University Medical Center, Washington D.C.

20132

IRCCS Ospedale San Raffaele, Milan

21009

Salutem Medical Center, Vinnytsia

Medical Clinical Research Center of Medical Center LLC Health Clinic, Vinnytsia

21287

Johns Hopkins University School Of Medicine, Baltimore

25018

Ospedale Civile di Montichiari, Montichiari

25198

Hospital Universitari Arnau de Vilanova de Lleida, Lleida

26506

West Virginia University, Morgantown

28034

Hospital Ramon y Cajal, Madrid

28204

Atrium Health Neurosciences Institute ? Charlotte, Charlotte

28223

Hospital Quiron de Madrid, Pozuelo de Alarcón

29010

Hospital Regional Universitario de Malaga ? Hospital General, Málaga

32751

Neurology Associates PA, Maitland

32806

Neurological Services of Orlando, Orlando

33076

Groupe Hospitalier Pellegrin, Bordeaux

33079

Mersin University Medical Faculty, Mersin

33612

University of South Florida, Tampa

34098

Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi, Istanbul

34295

CHRU de Montpellier, Hopital Gui de Chauliac, Montpellier

34785

Sancaktepe Training and Research Hospital, Istanbul

35209

Alabama Neurology Associates, Homewood

36213

Hospital Alvaro Cunqueiro, Vigo

37232

Vanderbilt University Medical Center, Nashville

37922

Hope Neurology, Knoxville

38018

Neurology Clinic PC, Cordova

41009

Hospital Universitario Virgen Macarena, Seville

41380

Kocaeli University Hospital, Kocaeli

42131

Selcuk University Medical Faculty, Istanbul

43024

Volyn Regional Clinical Hospital, Lutsk

43126

A.O.U. di Parma, Parma

43214

OhioHealth Riverside Methodist Hospital, Columbus

44805

Hopital Guillaume Et Rene Laennec, Nantes

45267

UC Health, LLC., Cincinnati

45459

Miami Valley Hospital South, Centerville

46256

Josephson Wallack Munshower Neurology PC, Indianapolis

48201

Wayne State University, Detroit

54055

Clinical Research Institute, Tialnepantla

54636

AHEPA Univ. General Hospital of Thessaloniki, Thessaloniki

55139

Ondokuz Mayis Univ. Med. Fac., Samsun

55422

Minneapolis Clinic of Neurology, Golden Valley

58022

CNPE City Clinical Hospital #3 of Chernivtsi City Council, Chernivtsi

61068

Ams of Ukraine, Kharkiv

61080

Karadeniz Tecnical Uni. Med. Fac., Trabzon

63128

Washington University, St Louis

65080

Van Yuzuncu Yil University Hospital, Van

65117

Odesa Regional Clinical Hospital, Odesa

65191

Deutsche Klinik für Diagnostik, Wiesbaden

66160

University of Kansas Medical Center, Kansas City

67091

Hopitaux Universitaires de Strasbourg, Strasbourg

69600

Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council, Zaporizhzhia

69677

Hopital Pierre Wertheimer, Bron

71034

Studienzentrum Dr. Bischof GmbH, Böblingen

72076

Universitaetsklinikum Tuebingen, Tübingen

75092

Texas Institute for Neurological Disorders, Sherman

76008

Regional Clinical Hospital, Ivano-Frankivsk

77030

Uni of Texas Health Science Center At Houston, Houston

79007

MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care, Lviv

79010

Lviv Regional Clinical Hospital, Lviv

79106

Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie, Freiburg im Breisgau

80045

University of Colorado Denver, Aurora

80138

AOU Seconda Università degli Studi, Napoli

81675

Klinikum rechts der Isar der TU Muenchen, München

86077

IRCCS Istituto Neurologico Neuromed, Pozzilli

89106

Cleveland Clinic Lou Ruvo, Las Vegas

90127

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

92835

Fullerton Neurology and Headache Center, Fullerton

94086

Palo Alto Medical Foundation Research Center, Sunnyvale

94705

Sutter East Bay Medical Foundation, Berkeley

97225

Providence Brain and Spine Institute, Portland

98034

Evergreen MS Center, Kirkland

98122

Swedish Medical Center, Seattle

117997

Federal center of brain research and neurotechnologies, Moskva

127015

City Clinical Hospital #24, Moskva

197110

National Center of Social Significant Disease, Saint Petersburg

197706

City Hospital #40 of Resort Administrative District, Saint Petersburg

420047

Vertebronevrologiya LLC, Kazan'

610007

Center of Cardiology and Neurology, Kirov

620102

Sverdlovsk Regional Clinical Hospital 1, Yekaterinburg

625048

Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik, Tyumen

630087

State Novosibirsk Regional Clinical Hospital, Novosibirsk

660022

Krasnoyarsk State Medical Academy, Krasnoyarsk

660037

FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency, Krasnoyarsk

3109601

Rambam Medical Center, Haifa

5262100

The Chaim Sheba Medical Center, Ramat Gan

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

8331143

CeCim Biocinetic, Santiago

06824

Yale University School Of Medicine, Fairfield

02481

Dragonfly Research, LLC, Wellesley

07601

Hackensack U Med Ctr, Hackensack

07039

Barnabas Health Ambulatory Care Center, Livingston

07753

Jersey Shore University Medical Centre, Neptune City

07103

Rutgers New Jersey Medical School, Newark

07666

Holy Name Hospital, Teaneck

27607-6520

Raleigh Neurology Associates, Raleigh

53226-3596

Medical College of Wisconsin, Inc., Milwaukee

C1424

Centro de Especialidades Neurológicas y Rehabilitación - CENyR, Buenos Aires

Unknown

Focus CECIC, Buenos Aires

Organizacion Sanitas Internacional, Bogotá

Instituto Neurologico de Colombia INDEC, Medellín

Fundacion Clinica Valle del Lili, Santiago de Cali

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

X5000EDC

Instituto Reumatológico Strusberg, Córdoba

T4000AXL

Centro de Investigaciones Médicas Tucuman, San Miguel

30150-221

Santa Casa de Misericordia, Belo Horizonte

81210-310

Instituto de Neurologia de Curitiba, Curitiba

90430-001

Núcleo de Pesquisa do Rio Grande do Sul, Porto Alegre

90620-130

IMV Pesquisa Neurológica, Porto Alegre

89201-165

Clinica Neurologica, Joinville

01228-200

Centro de Pesquisas Clinicas, São Paulo

20270-004

Hospital Universitario Gaffree e Guinle, Rio de Janeiro

T6G 1Z1

University of Alberta Hospital, Edmonton

V5G 2X6

Fraser Health Authority - Fraser Health Multiple Sclerosis, Burnaby

V6T 1Z3

University of British Columbia, Vancouver

N6A 5A5

London Health Sciences Centre Uni Campus, London

K1H 8L6

The Ottawa Hospital - General Campus, Ottawa

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M5B-1W8

St. Michael's Hospital, Toronto

J8Y 1W2

Clinique NeuroOutaouais, Gatineau

J4V 2J2

Recherche Sepmus Inc., Greenfield Park

H3A 2B4

Montreal Neurological Institute and Hospital, Montreal

06002

Hôpital Pasteur, Nice

01307

"Universitätsklinikum Carl Gustav Carus, Zentrum für Klinische Neurowissenschaften", Dresden

115 28

Hospital Eginition, Athens

00133

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

03100

Mexico Centre for Clinical Research, Mexico City

06700

Clinstile S.A de C.V., Mexico City

07760

Hospital Juarez de Mexico, Mexico City

03600

Grupo Médico Camino S.C., México

Callao 2

Hospital IV Alberto Sabogal Sologuren, Bellavista

Lima 01

Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo, Lima

85-796

Neurocentrum Bydgoszcz sp. z o.o, Bydgoszcz

40-568

Care Clinic, Katowice

40-749

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

90-324

Centrum Neurologii Krzysztof Selmaj, Lodz

60-693

Med Polonia, Późna

35-055

"Centrum Medyczne MEDYK", Rzeszów

35-323

Nmedis sp. z o.o., Rzeszów

01-684

Centrum Medyczne NeuroProtect, Warsaw

51-685

Wro Medica, Wroc?aw

41-800

SPSK nr 1, Zabrze

4710-243

Hospital de Braga, Braga

1169-050

Hospital Santo Antonio dos Capuchos, Lisbon

1649-035

Hospital de Santa Maria, Lisbon

4099-001

Hospital Geral de Santo Antonio, Porto

4200-319

Hospital de Sao Joao, Porto

08035

Hospital Universitari Vall d'Hebron, Barcelona

06100

Hacettepe University Medical Faculty, Ankara

06490

Baskent Universitesi Ankara Hastanesi, Çankaya

03037

MEDBUD, Kyiv

G51 4TF

Queen Elizabeth University Hospital, Glasgow

W6 8RF

Charing Cross Hospital, London

NG7 2UH

Nottingham University Hospitals NHS Trust, Nottingham

SA6 6NL

Morriston Hospital, Swansea

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY