PLEASE NOTE: New enrollment for this study is paused, due to two recent cases of liver enzyme elevation suggestive of treatment-induced liver injury. If you are participating in this study and have questions, please contact the study coordinator or your healthcare provider.
SUMMARY: Investigators in the U.S. and abroad are recruiting a total of 1468 people with relapsing forms of MS for two separate studies comparing investigational oral fenebrutinib with Aubagio®
(teriflunomide, Sanofi Genzyme). The studies – also called FENhance – are sponsored by F. Hoffmann-La Roche.
: 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 55 years old, and diagnosed with relapsing forms of MS, which include relapsing-remitting
disease and active secondary progressive
disease (with relapses). Other criteria may apply.
In both studies, participants will be randomly assigned to daily treatment with fenebrutinib and a placebo matching Aubagio, or daily treatment with Aubagio and a placebo matching fenebrutinib, for a treatment duration of 96 weeks. The primary outcome of both studies will compare how treatment affects the annual rate of relapses. Secondary outcomes include disability worsening, disease activity on MRI scans, physical function, cognition, and safety.
What Else is Involved?
The study involves up to 20 in-person visits each to the study site. Visits will involve MRI scans, blood draws, clinical exams, and responding to questionnaires. Patients who complete this phase may be eligible to enter an open-label extension phase for 96 weeks, during which all participants will receive fenebrutinib.
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.
: 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 firstname.lastname@example.org
In the U.S., sites are enrolling in the following cities:
Palo Alto, CA
Fort Collins, CO
Glenwood Springs, CO
Boca Raton, FL
Fort Wayne, IN
Kansas City, KS
Baton Rouge, LA
Oklahoma City, OK
Greer, South Carolina
Round Rock, TX
Falls Church, VA
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.