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MS Trial Alert: Researchers Recruiting People with Relapsing MS for Phase 3 Studies Comparing Ublituximab to Teriflunomide

September 25, 2017

SUMMARY: Investigators nationwide are recruiting 880 people with relapsing MS for two identical studies comparing ublituximab (TG Therapeutics, Inc.), an experimental monoclonal antibody administered via intravenous (into the vein) infusion, with oral teriflunomide.  The study is funded by TG Therapeutics.
 
DETAILS
Rationale: Ublituximab is a monoclonal antibody that binds to a molecule (CD20) on the surface of immune cells called B cells, and depletes them from circulation. B cells have several functions including making antibodies, and evidence suggests they play a role in immune-system mediated damage to brain and spinal cord tissues in MS. Ublituximab binds to CD20 in a unique way, and thus may have greater B cell-depletion capabilities than similar agents, such as rituximab and Ocrevus® (ocrelizumab, Genentech, Inc.). In an ongoing small, phase 2 study in 24 people with MS, treatment was well tolerated and B cells were significantly depleted.
 
Eligibility and Details: Participants should be aged 18 to 55, and have a diagnosis of relapsing MS. Participants who have had previous treatment with other B cell-directed therapies (such as rituximab or ocrelizumab) will be excluded. Further enrollment criteria are available from the contact below.
 
Participants will be randomly assigned to receive either ublituximab infusions and oral placebo, or oral teriflunomide and placebo infusions for 96 weeks. The primary outcome being measured is the rate of relapses per year per participant. Safety and the incidence of adverse events will also be monitored.
 
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact the TG Therapeutics Clinical Support Team at rmsclinicalsupport@tgtxinc.com, or 212-554-4484.
 
Sites are enrolling in the following cities, and many more sites will be activated nationwide:
Albuquerque, NM
Amherst, NY
Aurora, CO
Carlsbad, CA
Chesterfield, MO
Columbus, OH
Dallas, TX
Detroit, MI
Franklin, TN
Kansas City, KS
Knoxville, TN
Las Vegas, NV
Lexington, KY
Long Beach, CA
Miami, FL
Northbrook, IL
Palo Alto, CA
Pasadena, CA
Patchogue, NY
Phoenix, AZ
Pittsburgh, PA
Round Rock, TX
San Antonio, TX
Seattle, WA
Tampa, FL
Teaneck, NJ
Westerville, OH
 
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.
 
Ocrevus is a registered trademark of Genentech

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.

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