Summary:Investigators are recruiting 125 people with relapsing MS in the United States and Canada to determine the safety and effectiveness of ELND002, a variation of an alpha-4-integrin inhibitor delivered via injection under the skin. Elan Pharmaceuticals is sponsoring the study.
Rationale: ELND002 is thought to work by preventing certain white blood cells (called mononuclear leukocytes) from entering the central nervous system. Blocking these cells may prevent the inflammation associated with disease activity in MS. The exact mechanism of action is not known. ELND002 is a “pegylated” molecule that is delivered via subcutaneous injection, rather than in-vein infusion. Pegylated molecules are attached to a molecule of polyethylene glycol, which enables them to maintain effects in the body for longer periods of time. ELND002 is hypothesized to be a selective inhibitor of alpha-4 integrin. Further studies are needed to support this hypothesis.
Eligibility and Details:Participants will have relapsing forms of MS with documented medical history of relapse in the past year or MRI-documented evidence of MS activity in the past year. Excluding criteria include a positive test for the JC virus DNA in plasma (which causes PML). Further information on the detailed inclusion and exclusion criteria are available from the contact below.
One hundred participants are being randomly assigned to receive escalating doses of the study drug, and 25 are being assigned to receive inactive placebo, for a period of 12 weeks. All participants will also be followed for one year thereafter. The primary objective is to determine the safety and tolerability of ELND002 and to determine the maximum tolerated dose. Secondary objectives include the compound’s effectiveness at reducing disease activity on MRI and relapse rates.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact Lacey Powers, D. Anderson & Company, (469) 916-8641, orms@dandersoncompany.com, or visit www.RMStrials.com.
Sites are recruiting in the following cities:
Cordova, TN
Newport Beach, CA
Montreal, QC
San Antonio, TX
Fresno, CA
Raleigh, NC
Tampa, FL
Berkeley, CA
Albuquerque, NM
Knoxville, TN
Greenfield Park, Quebec
Cincinnati, OH
Teaneck, NJ
Farmington Hills, MI
Vero Beach, FL
Uniontown, OH
Minneapolis, MN
Aurora, CO
Salt Lake City, UT
Northbrook, IL
Calgary, Alberta
Vancouver, BC
Newport Beach, CA
Montreal, QC
San Antonio, TX
Fresno, CA
Raleigh, NC
Tampa, FL
Berkeley, CA
Albuquerque, NM
Knoxville, TN
Greenfield Park, Quebec
Cincinnati, OH
Teaneck, NJ
Farmington Hills, MI
Vero Beach, FL
Uniontown, OH
Minneapolis, MN
Aurora, CO
Salt Lake City, UT
Northbrook, IL
Calgary, Alberta
Vancouver, BC
