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MS Trial Alert: Investigators Recruiting for Two Phase 3 Trials of Experimental Evobrutinib in Relapsing MS

February 16, 2021

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.

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system. There is currently no cure for MS. Symptoms vary from person to person and range from numbness and tingling, to mobility challenges, blindness and paralysis. An estimated 1 million people live with MS in the United States. Most people are diagnosed between the ages of 20 and 50, and it affects women three times more than men.

About the National Multiple Sclerosis Society

The National MS Society, founded in 1946, funds cutting-edge research, drives change through advocacy, and provides programs and services to help people affected by MS live their best lives. Connect to learn more and get involved: nationalMSsociety.org, Facebook, Twitter, Instagram, YouTube or 1-800-344-4867.

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