Type of MS: RRMS|SPMS
Treatment mode of action: To affect immune function
Number of Subjects: 1800
Medication: Experimental Tolebrutinib, Aubagio
Location: Alabama|California|Colorado|Florida|Georgia|Illinois|Louisiana|New York|North Carolina|Ohio|Oklahoma|South Carolina|Tennessee|Texas
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 are recruiting a total of 1800 people with relapsing forms of MS worldwide for two studies comparing investigational oral tolebrutinib with Aubagio®
(teriflunomide, Sanofi Genzyme). The studies – also called GEMINI 1 and GEMINI 2 – 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 55 years old, and diagnosed with relapsing forms of MS, which include relapsing-remitting
disease and active secondary progressive
disease (with relapses).
In both studies, all participants will receive active treatment. Half will be randomly assigned to once daily treatment with either tolebrutinib and an inactive placebo matching Aubagio, and the other half will receive Aubagio and an inactive placebo matching tolebrutinib, for 36 months. 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, quality of life, safety, 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