Mongersen and SMAD-7 Inhibition, Not a Lucky 7 for Patients With IBD: When Trial Design Is as Important as Disease Therapy

Abstract The phase II mongersen (GED-0301) trial produced unparalleled success rates in Crohn's disease and generated much hope for a crippling disease. Unfortunately, the subsequent phase III trial was terminated early because of a lack of efficacy. We discuss the differences in trial design that may have contributed to these disparate findings and how these findings may serve as a lesson in subsequent therapeutic trials in Crohn's disease.