SUMMARY: Investigators in the U.S. and abroad are recruiting 946 people with primary progressive MS for a study comparing investigational oral fenebrutinib with
Ocrevus® (ocrelizumab - Genentech, a member of the Roche Group). The study – also called FENtrepid – is sponsored by F. Hoffmann-La Roche.
DETAILS
Rationale: Fenebrutinib inhibits an enzyme called “Bruton’s tyrosine kinase,” reducing the activation of B cells, which are immune cells that play a role in the response that affects the brain and spinal cord in MS. Fenebrutinib also inhibits immune cells in the brain called microglia, which have been linked to MS progression. Fenebrutinib is one of several “BTK” inhibitors being tested in clinical trials involving people with different types of MS.
Eligibility and Details: Participants should be 18 to 65 years old, and diagnosed with
primary progressive MS.
All participants will receive active treatment. They will be randomly assigned to receive either oral fenebrutinib along with a placebo matching intravenous (infused into the vein) Ocrevus, or intravenous Ocrevus along with a placebo matching oral fenebrutinib. Treatment will last 120 weeks.
The primary outcome of the study will compare how these treatments affect disability progression using a composite measure that combines the EDSS scale of disability progression with measures of walking and hand function. Secondary outcomes include safety, changes in brain tissue volume, and cognition. The study involves up to 20 visits to the study site, and will involve MRI scans, blood draws, clinical exams, and questionnaires.
Please note: This study requires in-person visits to the study site. Precautions are being taken to reduce the on-site risks of exposure to COVID-19.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please visit the study website at
www.fenstudies.com, call 888-662-6728 or email
global-roche-genentech-trials@gene.com.
In the U.S., sites are enrolling in the following cities:
Homewood, AL
Berkeley, California
Fullerton, California
Palo Alto, California
Aurora, Colorado
Fairfield, CT
Maitland, Florida
Orlando, Florida
Tampa, Florida
Vero Beach, Florida
Miami, Florida
Indianapolis, Indiana
Kansas City, Kansas
Baltimore, Maryland
Wellesley, MA
Detroit, Michigan
Golden Valley, Minnesota
St. Louis, Missouri
Charlotte, North Carolina
Raleigh, North Carolina
Newark, NJ
New York, New Jersey
Hackensack, New Jersey
Livingston, NJ
Neptune, NJ
Teaneck, NJ
Las Vegas, Nevada
Rochester, NY
Stony Brook, New York
Amherst, New York
Syracuse, New York
New York, New York
Centerville, OH
Cincinnati, Ohio
Columbus, Ohio
Portland, Oregon
Guaynabo, Puerto Rico
Cordova, Tennessee
Nashville, Tennessee
Knoxville, Tennessee
Houston, Texas
Sherman, Texas
Seattle, Washington
Kirkland, Washington
Milwaukee, Wisconsin
Washington D.C.
Morgantown, West Virginia
Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).
Without participants in research studies, MS research would come to a standstill.
Read more here.