Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease
The purpose of this research study is to evaluate what type of treatment will be beneficial for people with Crohn's disease and difficult to treat inflammation in the small bowel. Current therapies are used to control the inflammation due to Crohn's disease in your digestive tract. In some patients, those therapies are not sufficient to fully treat the disease. This objective of this study is to evaluate the efficacy of a different type of therapy, tirzepatide, that may promote healing of the affected intestinal segment. To evaluate the efficacy of this medication, a member of the research team will ask patients questions about how they feel and observe whether this medication heals the their bowel at colonoscopy. A member of the research team will also use blood samples, stool samples and samples of the small intestine taken during a colonoscopy to understand how tirzepatide helps heal the intestine.
• Subjects 18 to 80 years of age, inclusive, at the time of consent
• Confirmed diagnosis of Crohn's disease based on documented findings on endoscopy and histopathology
• Active ileal or ileocolonic inflammation on colonoscopy defined as
• 1\. Ileal SES-CD \> 4 with ulcer subscore \> 1 (ulcers \> 5mm)
• Failure to respond to (primary or secondary non-response) at least 2 advanced class drugs, without evidence of immunogenicity (anti-TNFa only). Must have been at least 6 months optimized on most recent therapy without corticosteroids.
‣ Anti-TNF: Infliximab, Adalimumab, Certolizumab, Golimumab
⁃ Anti-integrin agent: vedolizumab
⁃ Anti-IL12/23 agent: Ustekinumab
⁃ Anti-IL23: Risankizumab, Guselkumab, Mirikizumab
⁃ JAK inhibitor: Upadacitinib
• In post surgical patients, must be at least 6 months post-op with endoscopic evidence of ileal disease
• In females: compliance to recommended birth control requirements