Comparison of treatment effect between phase 2 and phase 3 trials in patients with inflammatory bowel disease.
Pauline WilsVipul JairathBruce E SandsFernando MagroWalter ReinischDavid T RubinSilvio DaneseCédric BaumannLaurent Peyrin BirouletPublished in: United European gastroenterology journal (2023)
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.