SUMMARY: Investigators in the U.S. and abroad are recruiting a total of 125 people with relapsing forms of MS for a phase 2 study comparing investigational BIIB091 with Vumerity® (diroximel fumarate, Biogen). The study – also called FUSION– is sponsored by Biogen.
DETAILS
Rationale: The experimental treatment BIIB091 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. BIIB091 is one of several “BTK” inhibitors being tested in clinical trials involving people with different types of MS.
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 and/or new MRI activity). Other criteria may apply.
Participants will be randomly assigned to daily oral treatment with either BIIB091 or Vumerity for 48 weeks. At week 16, an analysis will determine if there would be a part 2 to this study, where these treatments may be combined. That study will recruit another 150 people with relapsing MS. Either way, part 1 would proceed.
The primary outcome of the first part of the study will be to compare treatment safety. In the second part of the study, researchers will be looking for benefits using brain imaging scans.
What Else is Involved? The study involves up to 20 in-person visits to the study site. Visits will involve brain MRI scans, blood draws, clinical exams, urine tests, electrocardiograms, 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.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please visit the study website at
http://www.fusionclinicaltrial.com/, call 866-633-4636 or email
clinicaltrials@biogen.com.
In the U.S., sites are enrolling in the following cities:
Scottsdale, Arizona
Berkeley, California
Aurora, Colorado
Vero Beach, Florida
Fort Wayne, Indiana
Kansas City, Kansas
Lutherville, Maryland
Saint Louis, Missouri
Albuquerque, New Mexico
Patchogue, New York
Winston-Salem, North Carolina
Columbus, Ohio
Cordova, Tennessee
Madison, Wisconsin
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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.
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