The Immune Tolerance Network (ITN) has completed enrolling the full cohort of 83 patients in its Autoimmunity-blocking Antibody for Tolerance in type 1 diabetes, or ‘AbATE’ trial.
The clinical trial is aimed at determining whether the antibody teplizumab -- also known as hOKT3g1(Ala-Ala) – can halt progression of newly diagnosed type 1 diabetes.
Type 1 diabetes is an autoimmune disease in which the body’s immune system attacks and destroys the insulin-producing beta cells in the pancreas. Typically, upon first diagnosis, not all beta cells have been destroyed and patients retain at least some natural ability to produce insulin. If these remaining beta cells can be saved, the future need for insulin shots could be avoided, and the number and severity of secondary complications of type 1 diabetes, which include kidney disease and nerve damage, may be reduced.
Teplizumab is a humanized anti-CD3 monoclonal antibody that targets white blood cells known as “T cells” that are involved in the autoimmune attack on the beta cells. A pilot study of teplizumab in 21 subjects, whose results were published in 2005, showed that a single course of the antibody could delay progression of the disease over a two year period. The AbATE trial is a larger follow-up study, in which two courses of the antibody are administered, one year apart, in an effort to extend its effects on beta cell preservation.
The study is being led by Dr. Kevan Herold of Yale University, with clinical sites in Denver, Seattle and San Francisco. Subjects will be studied over a period of two years following initial treatment.
Although enrollment for the AbATE trial is now closed, other related clinical trials in newly diagnosed type 1 diabetes are currently seeking participants, including the ITN-sponsored “START” trial of thymoglobulin (www.type1diabetestrial.org ) and the Protégé study conducted by Macrogenics, Inc. (www.protegediabetes.org ), another study of teplizumab.
