Status:
RECRUITING
Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease
Lead Sponsor:
Washington University School of Medicine
Conditions:
Crohn Disease (CD)
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 ar...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Current or previous diagnosis of anorexia nervosa
- Type 1 or Type 2 diabetes
- Use of concomitant hypoglycemic agents
- Personal or family history of medullary thyroid carcinoma
- History of multiple endocrine neoplasia
- Known serious hypersensitivity to tirzepatide or any of its excipients
- Have functional or post-operative short-bowel syndrome
- Had intestinal resection ≤ 24 weeks prior to inclusion or other intra-abdominal surgeries ≤ 12 weeks prior to study inclusion
- Active treatment with steroids\*
- Positive stool test for parasites, C. Diff or stool culture for pathologic bacteria within 30 days prior to enrollment
- Current stricture not passable with an endoscope
- Impending need for surgery per investigator
- Have an ileostomy or a colostomy
- In females: refusal to comply to recommended birth control requirements \*Corticosteroids have metabolic and hormonal effects which we are concerned may interfere with study outcomes and metabolic changes in the population. This exclusion criteria will allow the study population to be standardized across all patients
Key Trial Info
Start Date :
May 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06976853
Start Date
May 13 2025
End Date
August 1 2028
Last Update
June 11 2025
Active Locations (3)
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1
Cedars-Sinai Medical Center
Beverly Hills, California, United States, 90211
2
Washington University School of Medicine
St Louis, Missouri, United States, 63110
3
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029