News

SUMMARY: Investigators in the U.S. and abroad are recruiting a total of 1860 people with relapsing forms of MS for two separate studies comparing investigational oral evobrutinib with Aubagio® (teriflunomide, Sanofi Genzyme). The studies – also called evolutionRMS1 and evolutionRMS2 – are sponsored by EMD Serono.

DETAILS
Rationale: Evobrutinib is a different approach from existing, approved MS disease-modifying therapies. It 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. Evobrutinib also penetrates the brain and spinal cord and may inhibit immune cells in the brain called microglia, which have been linked to MS progression. Evobrutinib is one of several so-called “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).  Other criteria may apply.

In both studies, participants will be randomly assigned to twice daily treatment with evobrutinib and a placebo matching Aubagio, or once daily treatment with Aubagio and a placebo matching evobrutinib, for a treatment duration of 96 weeks. All participants who complete the 96-week Treatment Period will be offered participation in an Open-Label Extension Period of the study, which is expected to last approximately 144 weeks, followed by a 4-week Safety Follow-up Period. All participants will receive evobrutinib during the Open-Label Extension Period. 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, fatigue, and safety.

What Else is Involved? The study involves up to in-person visits each to the study site. Visits will involve MRI scans, blood draws, clinical exams, and responding to 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 1-888-275-7376, or email eMediUSA@emdserono.com.  

In the U.S., sites are enrolling in the following cities:

Mobile, Alabama Phoenix, Arizona Scottsdale, Arizona Tucson, Arizona Hanford, California Long Beach, California Panorama City, California Pasadena, California San Diego, California West Hollywood, California Fort Collins, Colorado Stamford, Connecticut Altamonte Springs, Florida Delray Beach, Florida Jacksonville, Florida Naples, Florida Orlando, Florida Ormond Beach, Florida Port Charlotte, Florida Sarasota, Florida Tallahassee, Florida Tampa, Florida Vero Beach, Florida Weeki Wachee, Florida West Palm Beach, Florida Honolulu, Hawaii Elk Grove Village, Illinois Evanston, Illinois Lake Barrington, Illinois Northbrook, Illinois Fort Wayne, Indiana Indianapolis, Indiana Lafayette, Indiana Overland Park, Kansas

Baton Rouge, Louisiana Scarborough, Maine Baltimore, Maryland Boston, Massachusetts Worcester, Massachusetts Detroit, Michigan Saint Louis, Missouri Town and Country, Missouri Omaha, Nebraska Las Vegas, Nevada Audubon, New Jersey Amherst, New York New York, New York Riverhead, New York Asheville, North Carolina Raleigh, North Carolina Canton, Ohio Columbus, Ohio Dayton, Ohio Toledo, Ohio Springfield, Oregon Abington, Pennsylvania Franklin, Tennessee Knoxville, Tennessee Fort Wayne, Texas Houston, Texas Lubbock, Texas Round Rock, Texas San Antonio, Texas Alexandria, Virginia Norfolk, Virginia Virginia Beach, Virginia

 
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.