Comparison of treatment effect between phase 2 and phase 3 trials in patients with inflammatory bowel disease.

Pauline Wils,Vipul Jairath,Bruce E Sands,Fernando Magro,Walter Reinisch,David Rubin,Silvio Danese,Cédric Baumann,Laurent Peyrin-Biroulet

United European gastroenterology journal（2023）

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摘要

In UC, we observed a similar percentage of treatment effect for clinical and histologic outcomes between phase 2 and 3 trials but not for endoscopic outcomes. Whereas in CD, we showed a failure to reproduce similar results between phases. These results may help sponsors in the design of future drug development programs.

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关键词

biologics, Crohn's disease, inflammatory bowel disease, randomized controlled trial, ulcerative colitis

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