๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-12

A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) (NCT04586010)

A Phase III Multicenter Randomized, Double-blind, Double-dummy, Parallel-group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Adult Patients With Relapsing Multiple Sclerosis

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Hoffmann-La Roche

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of Alabama Birmingham โ€” Birmingham, Alabama

Age range: 18 Years to 55 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (160 Sites)

Showing the first 25 of 160 sites.

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

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—