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Clinical Trials in the USA / NCT04586010
Active, not recruiting Phase 3

A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)

NCT04586010 · tracked via the Priya Life Science USA tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2021-03-17
Last updated
2026-08-13

Condition(s) studied

Relapsing Multiple Sclerosis

Investigational drug(s) / intervention(s)

FenebrutinibTeriflunomidePlacebo

Fenebrutinib: Participants will receive fenebrutinib.

Teriflunomide: Participants will receive teriflunomide.

Placebo: Participants will receive teriflunomide-matching placebo or fenebrutinib-matching placebo.

Study summary

A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized in a 1:1 ratio to receive either fenebrutinib or teriflunomide. At the end of the double-blind treatment (DBT) phase (after disclosure of the DBT results), the Sponsor will determine whether or not to initiate the open-label extension (OLE) phase of the study.

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria: * Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening * A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria * Ability to complete the 9-Hole Peg Test (9-HPT) for each hand in \< 240 seconds * Ability to perform the 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 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 * Participants randomized to the teriflunomide treatment arm during the DBT phase must undergo the accelerated teriflunomide elimination procedure (ATEP) prior to the first administration of open-label 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: * Disease duration of \> 10 years from the onset of symptoms and an EDSS score at screening \< 2.0 * Female participants who are pregnant or breastfeeding, or intending to become pregnant * Male participants who intend to father a child during the study * A diagnosis of primary progressive multiple sclerosis (PPMS) or non-active secondary progressive multiple sclerosis (SPMS) * Any known or suspected active infection at screening, including but not limited to a positive screening test for hepatitis B (HBV) and hepatitis C (HCV), an active or latent or inadequately treated infection with tuberculosis (TB), a confirmed or suspected progressive multifocal leukoencephalopathy (PML) * History of cancer including hematologic malignancy and solid tumors within 10 years of screening * Known presence of other neurological disorders, that could interfere with the diagnosis of MS or assessments of efficacy or safety during the study and clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal (GI) disease * Rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption * Hypoproteinemia * Acute liver disease * Chronic liver disease unless considered stable for \> 6 months * Presence of cirrhosis (Child-Pugh Class A, B, or C) or Gilbert's Syndrome * Participants with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia * Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study * History of alcohol or other drug abuse within 12 months prior to screening * History of or currently active primary or secondary (non-drug-related) immunodeficiency, including known history of human immunodeficiency virus (HIV) infection * Inability to complete an MRI scan * Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to screening (inhaled and topical corticosteroids are allowed) * Receipt of a live-attenuated vaccine within 6 weeks prior to randomization * Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period OLE Exclusion Criteria: * Acute liver disease * Chronic liver disease unless considered stable for \> 6 months

Primary outcome measure(s)

Trial sites (160)

FacilityCityRegionStatus
University of Alabama Birmingham Birmingham Alabama
Alabama Neurology Associates Homewood Alabama
Center for Neurology and Spine - Phoenix - Hunt - PPDS Phoenix Arizona
Profound Research, LLC Carlsbad California
University of California Irvine Irvine California
Quantum Clinical Research, Inc Pasadena California
University of Colorado Denver Aurora Colorado
Mountain View Clinical Research Denver Colorado
Advanced Neurology of Colorado, LLC Fort Collins Colorado
Neurology Associates, PA; Research Department Maitland Florida
NorthShore University HealthSystem Highland Park Illinois
Fort Wayne Neurological Center Fort Wayne Indiana
The NeuroMedical Center Baton Rouge Louisiana
Ochsner LSU Health Shreveport Louisiana
Johns Hopkins University School Of Medicine; Outpatient Center Baltimore Maryland
University of Massachusetts Medical School Worcester Massachusetts
Henry Ford Health System Detroit Michigan
Washington University School of Medicine St Louis Missouri
Holy Name Hospital; Institute For Clinical Research Teaneck New Jersey
University of New Mexico; MS Specialty Clinic Albuquerque New Mexico
Miami Valley Hospital South; Dayton Physician's Office Centerville Ohio
OhioHealth Columbus Ohio
The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company Columbus Ohio
Oklahoma Medical Research Foundation; MS Center of Excellence Oklahoma City Oklahoma
St. Luke's University Health network Bethlehem Pennsylvania
Premier Neurology Greenville South Carolina
New Orleans Center for Clinical Research Knoxville Tennessee
North Texas Institute of Neurology and Headache NextStage Clinical Research Clinic Plano Texas
Texas Institute for Neurological Disorders Sherman Texas
Multiple Sclerosis Center of Greater Washington Vienna Virginia
Evergreen MS Center Kirkland Washington
Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders Milwaukee Wisconsin
Neurologia Infantil Buenos Aires (NIBA) Buenos Aires Argentina
IME - Instituto Médico Especializado Buenos Aires Argentina
Centro de Especialidades Neurológicas y Rehabilitación - CENyR Buenos Aires Argentina
CIER C. A. B. A. Argentina
Diagnostico Medico Oroño Rosario Argentina
Cer San Juan San Juan Argentina
Centro de Investigaciones Médicas Tucuman San Miguel de Tucumán Argentina
Peking University First Hospital Beijing China

+ 120 more sites — see the full list on the official registry below.

More Hoffmann-La Roche trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04586010 on ClinicalTrials.gov ↗ ← All trials in the USA