Washout Periods in Inflammatory Bowel Disease Trials: A Systematic Literature Review and Proposed Solutions

Clin Gastroenterol Hepatol. 2024 Apr;22(4):896-898.e13. doi: 10.1016/j.cgh.2023.09.011.Epub 2023 Sep 22.


Pauline Wils 1Vipul Jairath 2Bruce E Sands 3Walter Reinisch 4Silvio Danese 5Laurent Peyrin-Biroulet 6


Author information

1Department of Gastroenterology, Claude Huriez Hospital, University of Lille 2, Lille, France; Inserm, CHU Lille, U1286-INFINITE-Institute for Translational Research in Inflammation, University of Lille, Lille, France.

2Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada.

3The Dr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.

4Medical University of Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology, Vienna, Austria.

5Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and, Vita-Salute San Raffaele University, Milan, Italy.

6University of Lorraine, CHRU-Nancy, Department of Gastroenterology, Nancy, France; University of Lorraine, Inserm, NGERE, Nancy, France; Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada. Electronic address: peyrinbiroulet@gmail.com.


Inflammatory bowel diseases (IBD), encompassing ulcerative colitis (UC) and Crohn's disease (CD), impose a substantial burden. Despite many effective molecules, significant numbers of patients do not achieve clinical remission at 1 year1 and undergo surgery during their lives, revealing an important unmet need and therapeutic gap. Multiple randomized controlled trials (RCTs) are ongoing or planned to develop more effective and tolerable therapies. In parallel, a dramatic decline in recruitment rates has been observed. A multitude of factors have contributed to poor recruitment rates, including a long washout period between the investigational drug and prior advanced therapies (ie, biologic or small molecule drug).2,3 This study aims to review the different washout periods with prior advanced therapies or immunosuppressants in phase 3 RCTs for UC and CD and to propose potential solutions to ultimately improve the design of clinical studies and patient enrollment in future trials.

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