Regeneron Pharmaceuticals has completed enrollment for a pivotal trial in its Phase III program for the treatment of CIAS1-associated periodic syndrome (CAPS), a spectrum of rare genetic disorders. This orphan-drug program is assessing the efficacy and safety of the Interleukin-1 (IL-1) Trap in adult patients with these auto-inflammatory diseases. The efficacy phase of this trial is expected to be completed by the end of 2006.
The trial is designed to evaluate the efficacy and safety of the IL-1 Trap, a long-acting IL-1 inhibitor, in adult patients with CAPS, a spectrum of rare diseases characterized by spontaneous systemic inflammation. The trial will include a six-month, placebo-controlled efficacy phase and be followed by a six-month, open label extension phase, which will help to characterize the safety of the IL-1 Trap.