Type of MS: PPMS|PRMS
Treatment mode of action: To affect immune function
Number of Subjects: 2280
Medication: Experimental Tolebrutinib, placebo
Location: California|Colorado|Florida|Georgia|Hawaii|Illinois|North Carolina|Ohio|South Carolina|Tennessee|Texas|Washington
Institutions: Multicenter, worldwide
Sanofi, extension option 6
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