Multiple Sclerosis Clinical Trial

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

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). 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

For sites in Germany and Italy only, enrollment is restricted to participants aged 46-65 years
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 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.
Neurologically stable for at least 30 days prior to randomization and baseline assessments.
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.

Exclusion Criteria:

For participants enrolled in Germany and in Italy only: Presence of gadolinium-enhancing lesions on T1-weighted MRI (T1Gd +) lesion on the screening MRI
Any known or suspected active infection (excluding onychomycosis) 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).
Participants with a previous history of a serious Infusion-Related Reaction (IRR) (Common Terminology Criteria for Adverse Events [CTCAE] Grade >= 4) and/or any hypersensitivity reaction to ocrelizumab.
History of cancer including hematologic malignancy and solid tumors within 10 years of screening. Exceptions: Basal/squamous cell carcinoma of skin cured by excision. In situ carcinoma of the cervix successfully treated by curative therapy >1 year prior to screening.
Known presence of other neurological disorders, that could interfere with the diagnosis of MS or assessments of efficacy or safety during the study, clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease.
Presence of cirrhosis (Child-Pugh Class A, B, or C)
Any concomitant disease that may require chronic treatment with systemic corticosteroids, immunosuppressants or specific medication that could impact the primary evaluation of the study.
History of alcohol or other drug abuse within 12 months prior to screening.
Female participants who are pregnant or breastfeeding or intending to become pregnant during the study or 6 or 12 months (as applicable from the local label for ocrelizumab) after final dose of study drug.
Male participants intending to father a child during the study or for 28 days after final dose of study drug.
Lack of peripheral venous access.
Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period.
Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization.
Immunocompromised state, history of primary or secondary (non-drug related) immunodeficiency, or history of transplantation or antirejection therapy
Known bleeding diathesis, anemia, or history of hospitalization or transfusion for gastrointestinal (GI) bleed
Any previous treatment with cladribine, mitoxantrone, daclizumab, alemtuzumab, or cyclophosphamide

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.
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:

985

Study ID:

NCT04544449

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 188 Locations for this study

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Alabama Neurology Associates
Homewood Alabama, 35209, United States
Sutter East Bay Medical Foundation
Berkeley California, 94705, United States
Fullerton Neurology and Headache Center
Fullerton California, 92835, United States
Palo Alto Medical Foundation Research Center
Sunnyvale California, 94086, United States
University of Colorado Denver
Aurora Colorado, 80045, United States
Yale University School Of Medicine
New Haven Connecticut, 06519, United States
Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Uni of Miami School of Medicine
Miami Florida, 33136, United States
Neurological Services of Orlando
Orlando Florida, 32806, United States
University of South Florida
Tampa Florida, 33612, United States
Josephson Wallack Munshower Neurology PC
Indianapolis Indiana, 46256, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States
Johns Hopkins University School Of Medicine; Outpatient Center
Baltimore Maryland, 21287, United States
Dragonfly Research, LLC
Wellesley Massachusetts, 02481, United States
Wayne State University
Detroit Michigan, 48201, United States
Minneapolis Clinic of Neurology
Golden Valley Minnesota, 55422, United States
Washington University
Saint Louis Missouri, 63128, United States
Cleveland Clinic Lou Ruvo; Center for Brain Research
Las Vegas Nevada, 89106, United States
Hackensack U Med Ctr
Hackensack New Jersey, 07601, United States
Barnabas Health Ambulatory Care Center
Livingston New Jersey, 07039, United States
Jersey Shore University Medical Centre
Neptune New Jersey, 07753, United States
Rutgers New Jersey Medical School
Newark New Jersey, 07103, United States
Holy Name Hospital; Institute For Clinical Research
Teaneck New Jersey, 07666, United States
Dent Neurological Institute
Amherst New York, 14226, United States
Columbia University Medical Center
New York New York, 10032, United States
University of Rochester
Rochester New York, 14642, United States
Stony Brook University Medical Center
Stony Brook New York, 11794, United States
SUNY Upstate Medical University
Syracuse New York, 13210, United States
Atrium Health Neurosciences Institute ? Charlotte
Charlotte North Carolina, 28204, United States
Neurology Associates PA
Hickory North Carolina, 28602, United States
Raleigh Neurology Associates
Raleigh North Carolina, 27607, United States
Miami Valley Hospital South; Dayton Physician's Office
Centerville Ohio, 45459, United States
UC Health, LLC.
Cincinnati Ohio, 45219, United States
OhioHealth Riverside Methodist Hospital; Pharmacy Services
Columbus Ohio, 43214, United States
Providence Brain and Spine Institute
Portland Oregon, 97225, United States
Neurology Clinic PC
Cordova Tennessee, 38018, United States
Hope Neurology
Knoxville Tennessee, 37922, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37212, United States
Uni of Texas Health Science Center At Houston
Houston Texas, 77030, United States
Texas Institute for Neurological Disorders
Sherman Texas, 75092, United States
Evergreen MS Center
Kirkland Washington, 98034, United States
Swedish Medical Center
Seattle Washington, 98104, United States
West Virginia University
Charleston West Virginia, 25304, United States
Medical College of Wisconsin, Inc.
Milwaukee Wisconsin, 53226, United States
Centro de Especialidades Neurológicas y Rehabilitación - CENyR
Buenos Aires , C1424, Argentina
Instituto De Neurología Cognitiva - INECO
Caba , C1126, Argentina
Instituto de Investigaciones Metabolicas (Idim)
Ciudad Autonoma de Buenos Aires , C1012, Argentina
Instituto Reumatológico Strusberg
Cordoba , X5000, Argentina
Fundacion Rosarina de Neurorehabilitacion
Rosario , S2000, Argentina
Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY
San Miguel , T4000, Argentina
Brain and Mind Research Institute
Camperdown New South Wales, 2050, Australia
Liverpool Hospital
Liverpool New South Wales, 2170, Australia
John Hunter Hospital
New Lambton New South Wales, 2305, Australia
Princess Alexandra Hospital
Woolloongabba Queensland, 4102, Australia
Box Hill Hospital; Department of Neurology
Box Hill Victoria, 3128, Australia
Austin Hospital; Department of Neurology
Heidelberg Victoria, 3084, Australia
Royal Melbourne Hospital; Department of Neurology
Parkville Victoria, 3050, Australia
Kepler Universitätsklinikum GmbH - Neuromed Campus; Neurologie
Linz , 4020, Austria
Medizinische Universität Wien; Univ.Klinik fuer Neurologie
Wien , 1090, Austria
Santa Casa de Misericordia; de Belo Horizonte
Belo Horizonte MG, 30150, Brazil
Instituto de Neurologia de Curitiba
Curitiba PR, 81210, Brazil
Hospital Universitario Gaffree e Guinle
Rio de Janeiro RJ, 20270, Brazil
IMV Pesquisa Neurológica
Porto Alegre RS, 90110, Brazil
Núcleo de Pesquisa do Rio Grande do Sul
Porto Alegre RS, 90430, Brazil
Clinica Neurologica; Neurocirurgica de Joinville
Joinville SC, 89202, Brazil
Centro de Pesquisas Clinicas; CPCLIN
Sao Paulo SP, 01228, Brazil
UMHAT Dr. Georgi Stranski; 2nd Neurology Clinic, Occupational Diseases
Pleven , 5800, Bulgaria
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD
Sofia , 1113, Bulgaria
University of Alberta Hospital
Edmonton Alberta, T6G 1, Canada
Fraser Health Authority - Fraser Health Multiple Sclerosis
Burnaby British Columbia, V5G 2, Canada
University of British Columbia
Vancouver British Columbia, V6T 1, Canada
Regional health authority A vitalite health network
Moncton New Brunswick, E1C 8, Canada
London Health Sciences Centre Uni Campus
London Ontario, N6A 5, Canada
The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis
Ottawa Ontario, K1H 8, Canada
Sunnybrook Health Sciences Centre
Toronto Ontario, M4N 3, Canada
St. Michael's Hospital; MS Clinic
Toronto Ontario, M5B-1, Canada
Clinique NeuroOutaouais
Gatineau Quebec, J8Y 1, Canada
Recherche Sepmus Inc.
Greenfield Park Quebec, J4V 2, Canada
Montreal Neurological Institute and Hospital
Montreal Quebec, H3A 2, Canada
CeCim Biocinetic
Santiago , 83311, Chile
Clinica Alemana
Vitacura , 76505, Chile
Organizacion Sanitas Internacional
Bogota, D.C. , 11132, Colombia
Fundacion Clinica Valle del Lili; Unidad de Investigaciones Clinicas
Cali , , Colombia
Instituto Neurologico de Colombia INDEC
Medellin , , Colombia
Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken
Aarhus N , 8200, Denmark
Rigshospitalet; Neurologisk Klinik Glostrup
Glostrup , 2600, Denmark
Groupe Hospitalier Pellegrin; Service de neurochirurgie B
Bordeaux , 33076, France
Hopital Pierre Wertheimer; Neurologie D
Bron , 69677, France
CHRU de Montpellier, Hopital Gui de Chauliac; Service de Neuropediatrie
Montpellier , 34295, France
Hopital Guillaume Et Rene Laennec
Nantes , 44805, France
Hôpital Pasteur; Service de Neurologie
Nice , 06002, France
Hopital Civil de Strasbourg; Service de Neurologie
Strasbourg , 67091, France
Charite - Universitatsmedizin Berlin; Klinik fur Neurologie
Berlin , 10117, Germany
Studienzentrum für Neurologie und Psychiatrie
Böblingen , 71034, Germany
Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
Dresden , 01307, Germany
Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie
Freiburg , 79106, Germany
Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum
München , 81675, Germany
Universitaetsklinikum Tuebingen; Abteilung Neurologie
Tuebingen , 72076, Germany
Deutsche Klinik für Diagnostik; DKD Helios Klinik Wiesbaden, Abt. Neurologie
Wiesbaden , 65191, Germany
401 Military Hospital of Athens; Neurology Department
Athens , 115 2, Greece
Hospital Eginition; First Department of Neurology
Athens , 115 2, Greece
AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.
Thessaloniki , 546 3, Greece
Clinexpert Kft.
Budapest , 1033, Hungary
S-Medicon Egeszsegugyi Szolgaltato Kft.
Budapest , 1138, Hungary
Budapesti Jahn Ferenc Dél-pesti Kórház és Rendel?intézet
Budapest , 1204, Hungary
Markhot Ferenc Oktatokorhaz és Rendelointezet; Neurologiai és Stroke Osztaly
Eger , 3300, Hungary
Pest Megyei Flor Ferenc Korhaz
Kistarcsa , 2143, Hungary
Rambam Medical Center; Neurology Unit
Haifa , 31096, Israel
The Chaim Sheba Medical Center; Multiple Sclerosis Center
Ramat-Gan , 52621, Israel
Tel Aviv Sourasky Medical Center; Department of Neurology
Tel Aviv , 64239, Israel
AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica
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
Irccs A.O.U.San Martino Ist; Dinogmi
Genova Liguria, 16132, Italy
IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
Milano Lombardia, 20132, Italy
Ospedale Civile di Montichiari; Centro Sclerosi Multipla
Montichiari Lombardia, 25018, Italy
IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
Pozzilli Molise, 86077, Italy
A.R.N.A.S. Civico Di Cristina Benfratelli; U.O.C. Neurologia con Stroke Unit
Palermo Sicilia, 90127, Italy
Mexico Centre for Clinical Research
Ciudad de México Mexico CITY (federal District), 03100, Mexico
Grupo Médico Camino S.C.
Ciudad de México Mexico CITY (federal District), 03600, Mexico
Hospital Juarez de Mexico
Ciudad de México Mexico CITY (federal District), 07760, Mexico
Clinstile S.A de C.V.
Mexico City Mexico CITY (federal District), 06700, Mexico
Clinical Research Institute
Tlalnepantla de Baz Mexico CITY (federal District), 54055, Mexico
University Clinic of Neurology; Movement Disorders
Skopje , 1000, North Macedonia
Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
Bellavista , Calla, Peru
Clinica Internacional; Unidad De Investigacion
Lima , 15001, Peru
Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo; Peru
Lima , Lima , Peru
Neurocentrum Bydgoszcz sp. z o.o
Bydgoszcz , 85-79, Poland
Care Clinic
Katowice , 40-56, Poland
NEURO-CARE Sp. z o.o. Sp. Komandytowa
Katowice , 40-74, Poland
Centrum Neurologii Krzysztof Selmaj
Lodz , 90-32, Poland
Med Polonia
Pozna? , 60-69, Poland
Centrum Medyczne "MEDYK"
Rzeszow , 35-05, Poland
Nmedis sp. z o.o.
Rzeszów , 35-23, Poland
Centrum Medyczne NeuroProtect
Warszawa , 01-68, Poland
Wro Medica
Wroc?aw , 51-68, Poland
SPSK nr 1; Klinika Neurologii
Zabrze , 41-80, Poland
Hospital de Braga; Servico de Neurologia
Braga , 4710-, Portugal
Hospital Santo Antonio dos Capuchos; Servico de Neurologia
Lisboa , 1169-, Portugal
Hospital de Santa Maria; Servico de Neurologia
Lisboa , 1649-, Portugal
Hospital Geral de Santo Antonio; Servico de Neurologia
Porto , 4099-, Portugal
Hospital de Sao Joao; Servico de Neurologia
Porto , 4200-, Portugal
San Juan MS Center
Guaynabo , 00968, Puerto Rico
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
Krasnoyarsk Krasnojarsk, 66003, Russian Federation
Krasnoyarsk State Medical Academy
Krasnoyarsk Krasnojarsk, 66004, Russian Federation
National Center of Social Significant Disease
Sankt-peterburg Leningrad, 19711, Russian Federation
Federal center of brain research and neurotechnologies
Moskva Moskovskaja Oblast, 11799, Russian Federation
City Clinical Hospital #24; Multipal Sclerosis department
Moskva Moskovskaja Oblast, 12701, Russian Federation
City Hospital #40 of Resort Administrative District
St. Petersburg Sankt Petersburg, 19770, Russian Federation
Sverdlovsk Regional Clinical Hospital 1
Yekaterinburg Sverdlovsk, 62010, Russian Federation
Vertebronevrologiya LLC
Kazan Tatarstan, 42004, Russian Federation
Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology
Tyumen Tjumen, 62504, Russian Federation
Center of Cardiology and Neurology
Kirov , 61000, Russian Federation
State Novosibirsk Regional Clinical Hospital
Novosibirsk , 63008, Russian Federation
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia
Coruña LA Coruña, 15006, Spain
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología
Lleida Lerida, 25198, Spain
Hospital Quiron de Madrid; Servicio de Neurologia
Pozuelo de Alarcon Madrid, 28223, Spain
Hospital Alvaro Cunqueiro; Servicio de Neurologia
Vigo Pontevedra, , Spain
Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
Barcelona , 08035, Spain
Hospital Puerta del Mar; Sevicio de Neurologia
Cadiz , 11009, Spain
Hospital Ramon y Cajal; Servicio de Neurologia
Madrid , 28034, Spain
Hospital Regional Universitario de Malaga ? Hospital General; Servicio de Neurologia
Malaga , 29010, Spain
Hospital Universitario Virgen Macarena; Servicio de Neurologia
Sevilla , 41009, Spain
Universitätsspital Basel; Neurologie
Basel , 4031, Switzerland
Inselspital Bern Medizin Neurologie
Bern , 3010, Switzerland
Hacettepe University Medical Faculty; Neurology
Ankara , 06100, Turkey
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
Istanbul , 34098, Turkey
Sancaktepe Training and Research Hospital; Neurology
Istanbul , 34785, Turkey
Selcuk University Medical Faculty; Norology department
Istanbul , 42131, Turkey
Kocaeli University Hospital; Department of Neurology
Kocaeli , 41380, Turkey
Mersin University Medical Faculty; Neurology
Mersin , 33079, Turkey
Ondokuz Mayis Univ. Med. Fac.; Neurology
Samsun , 55139, Turkey
Karadeniz Tecnical Uni. Med. Fac.; Neurology
Trabzon , 61080, Turkey
Van Yuzuncu Yil University Hospital; Neurology
Van , 65080, Turkey
Baskent Universitesi Ankara Hastanesi; Noroloji Bolumu
Çankaya , 06490, Turkey
CNPE City Clinical Hospital #3 of Chernivtsi City Council
Chernivtsi Chernihiv Governorate, 58022, Ukraine
MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care
Lviv Chernihiv Governorate, 79007, Ukraine
Medical Centre of PE First Private Clinic
Zhytomir Crimean Regional Governmenta, 10008, Ukraine
Separated structural unit ?University clinic? of Dnipro State Medical University
Dnipro Kharkiv Governorate, 49038, Ukraine
Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital
Kharkiv Kharkiv Governorate, 61058, Ukraine
Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
Zaporizhzhia Kharkiv Governorate, 69600, Ukraine
MEDBUD
Kyiv KIEV Governorate, 03037, Ukraine
Lviv Regional Clinical Hospital
Lviv KIEV Governorate, 79010, Ukraine
Salutem Medical Center
Vinnytsia KIEV Governorate, 21009, Ukraine
Medical Clinical Research Center of Medical Center LLC Health Clinic
Vinnytsia Podolia Governorate, 21009, Ukraine
Regional Clinical Hospital; Neurology Department
Ivano-Frankivsk , 76008, Ukraine
Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology
Kharkov , 61068, Ukraine
Volyn Regional Clinical Hospital
Lutsk , 43024, Ukraine
Odesa Regional Clinical Hospital; Neurosurgery Department
Odesa , 65117, Ukraine
Queen Elizabeth University Hospital
Glasgow , G51 4, United Kingdom
Charing Cross Hospital
London , W6 8R, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham , NG7 2, United Kingdom
Morriston Hospital
Swansea , SA6 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

985

Study ID:

NCT04544449

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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