MS Trial Alert: Investigators Recruiting for Two Phase 3 Trials of Experimental Tolebrutinib in Progressive MS
December 14, 2020
PLEASE NOTE: ENROLLMENT IN THIS STUDY HAS BEEN PLACED ON HOLD IN THE UNITED STATES BY THE FDA DUE TO SOME CASES OF LIVER INJURY. PLEASE SEE HERE FOR MORE INFORMATION.
SUMMARY: Investigators in the U.S. and abroad are recruiting a total of 2280 people with progressive forms of MS for two separate studies comparing investigational oral tolebrutinib with placebo. The studies – also called HERCULES and PERSEUS – are sponsored by Sanofi .
: Tolebrutinib 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. Tolebrutinib also penetrates the brain and spinal cord and inhibits immune cells in the brain called microglia, which have been linked to MS progression. Tolebrutinib is one of several “BTK” inhibitors being tested in the MS pipeline.
Eligibility and Details
: Participants should be 18 to 60 years old, and diagnosed with non-relapsing secondary progressive
MS (HERCULES trial) or primary progressive
MS (PERSEUS trial).
In both studies, participants will be randomly assigned to once daily treatment with either tolebrutinib or a placebo for a treatment duration of 24-48 months. The primary outcome of both studies will compare how treatment affects the time it takes for disability to progress using the EDSS scale. Secondary outcomes include safety, walking speed, cognitive function, disease activity on MRI scans, quality of life, and laboratory biomarkers of immune and nervous system activity. The study involves up to 16 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.
: To learn more about the enrollment criteria for these studies, and to find out if you are eligible to participate, please call 1-800-633-1610 extension option 6, or email Contact-US@sanofi.com
- To see if you might qualify for this clinical trial and to be referred to the local trial center in your area, visit: https://mymstrials.com/
In the U.S., sites are enrolling in the following cities:
Boca Raton, Florida
Fort Collins, Colorado
Greer, South Carolina
Long Beach, California
Raleigh, North Carolina
San Antonio, Texas
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