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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 .
 
DETAILS
Rationale: 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.
 
Contact: 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

Online - 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
Columbus, Ohio
Cordova, Tennessee
Dayton, Ohio
Fort Collins, Colorado
Franklin, Tennessee
Greer, South Carolina
Honolulu, Hawaii
Long Beach, California
Maitland, Florida
Naples, Florida
Northbrook, Illinois
Durham, NC
Raleigh, North Carolina
San Antonio, Texas
Savannah, Georgia
Spokane, Washington
Springfield, Illinois
Tampa, Florida
Torrance, California
Westerville, Ohio
 
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.
 

About Multiple Sclerosis

Multiple sclerosis is an unpredictable disease of the central nervous system. Currently there is no cure. Symptoms vary from person to person and may include disabling fatigue, mobility challenges, cognitive changes, and vision issues. An estimated 1 million people live with MS in the United States. Early diagnosis and treatment are critical to minimize disability. Significant progress is being made to achieve a world free of MS.

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