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.
: 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.
: 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 firstname.lastname@example.org
, or 212-554-4484.
Sites are enrolling in the following cities, and many more sites will be activated nationwide:
Kansas City, KS
Las Vegas, NV
Long Beach, CA
Palo Alto, CA
Round Rock, TX
San Antonio, TX
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