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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

2026-09-17

Healthy Volunteers

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

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. 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. 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) * Chronic liver disease unless considered stable for \>6 months * Acute liver disease * 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 Exclusion Criteria: * Chronic liver disease unless considered stable for \> 6 months * Acute liver disease * Cirrhosis (Child-pugh Class A, B or C) * Gilbert's syndrome

Locations (190)

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 De Neurología Cognitiva - INECO

Capital Federal, 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

Freire Pesquisa Clinica

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

And 90 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (190)