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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Relapsing Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT04586010

Run by

Hoffmann-La Roche

People needed

746

Starts

2021-03-17

Expected to finish

2027-11-30

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alabama Neurology Associates — Homewood, Alabama, United States
• Center for Neurology and Spine - Phoenix - Hunt - PPDS — Phoenix, Arizona, United States
• Profound Research, LLC — Carlsbad, California, United States
• University of California Irvine — Irvine, California, United States
• Quantum Clinical Research, Inc — Pasadena, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• Mountain View Clinical Research — Denver, Colorado, United States
• Advanced Neurology of Colorado, LLC — Fort Collins, Colorado, United States
• Neurology Associates, PA; Research Department — Maitland, Florida, United States
• NorthShore University HealthSystem — Highland Park, Illinois, United States
• Fort Wayne Neurological Center — Fort Wayne, Indiana, United States
• The NeuroMedical Center — Baton Rouge, Louisiana, United States
• Ochsner LSU Health — Shreveport, Louisiana, United States
• Johns Hopkins University School Of Medicine; Outpatient Center — Baltimore, Maryland, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Holy Name Hospital; Institute For Clinical Research — Teaneck, New Jersey, United States
• University of New Mexico; MS Specialty Clinic — Albuquerque, New Mexico, United States
• Miami Valley Hospital South; Dayton Physician's Office — Centerville, Ohio, United States
• OhioHealth — Columbus, Ohio, United States
• The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company — Columbus, Ohio, United States
• Oklahoma Medical Research Foundation; MS Center of Excellence — Oklahoma City, Oklahoma, United States
• St. Luke's University Health network — Bethlehem, Pennsylvania, United States
• University of Alabama Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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