Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease
ConditionCrohn Disease (CD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWashington University School of Medicine
About this trial
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.
Eligibility criteria
Qualifiers
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
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.
Disqualifiers
Age < 18 or > 80 years
Pregnant or Breastfeeding female
Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease-associated colitis, toxic megacolon, active infectious colitis or positive test for Clostridioides Difficile toxin at screening
BMI < 25
Trial design
Treatments tested in this trial
- Tirzepatide
- Standard of care treatment
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov