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.

中文翻译：

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Mongersen 和 SMAD-7 抑制，对 IBD 患者来说不是幸运的 7

II 期 mongersen (GED-0301) 试验在克罗恩病中产生了无与伦比的成功率，并为一种致残的疾病带来了很大的希望。不幸的是，随后的 III 期试验因缺乏疗效而提前终止。我们讨论了可能导致这些不同发现的试验设计差异，以及这些发现如何作为后续克罗恩病治疗试验的经验教训。