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)
Annualized Relapse Rate (ARR) — Minimum of 96 weeks
Trial sites (160)
Facility
City
Region
Status
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.
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.
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