RECRUITING

Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease

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Conditions

Crohn Disease (CD)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease

Quick Facts

Study Start:2025-05-13
Study Completion:2028-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06976853

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subjects 18 to 80 years of age, inclusive, at the time of consent
  2. 2. Confirmed diagnosis of Crohn's disease based on documented findings on endoscopy and histopathology
  3. 3. Active ileal or ileocolonic inflammation on colonoscopy defined as
  4. 1. Ileal SES-CD \> 4 with ulcer subscore \> 1 (ulcers \> 5mm)
  5. 4. 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.
  6. 1. Anti-TNF: Infliximab, Adalimumab, Certolizumab, Golimumab
  7. 2. Anti-integrin agent: vedolizumab
  8. 3. Anti-IL12/23 agent: Ustekinumab
  9. 4. Anti-IL23: Risankizumab, Guselkumab, Mirikizumab
  10. 5. JAK inhibitor: Upadacitinib
  11. 5. In post surgical patients, must be at least 6 months post-op with endoscopic evidence of ileal disease
  12. 6. In females: compliance to recommended birth control requirements
  1. 1. Age \< 18 or \> 80 years
  2. 2. Pregnant or Breastfeeding female
  3. 3. 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
  4. 4. BMI \< 25
  5. 5. Current or previous diagnosis of anorexia nervosa
  6. 6. Type 1 or Type 2 diabetes
  7. 7. Use of concomitant hypoglycemic agents
  8. 8. Personal or family history of medullary thyroid carcinoma
  9. 9. History of multiple endocrine neoplasia
  10. 10. Known serious hypersensitivity to tirzepatide or any of its excipients
  11. 11. Have functional or post-operative short-bowel syndrome
  12. 12. Had intestinal resection ≤ 24 weeks prior to inclusion or other intra-abdominal surgeries ≤ 12 weeks prior to study inclusion
  13. 13. Active treatment with steroids\*
  14. 14. Positive stool test for parasites, C. Diff or stool culture for pathologic bacteria within 30 days prior to enrollment
  15. 15. Current stricture not passable with an endoscope
  16. 16. Impending need for surgery per investigator
  17. 17. Have an ileostomy or a colostomy
  18. 18. 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

Contacts and Locations

Study Contact

Monique Lavalas Bright
CONTACT
314-362-9044
lavalas@wustl.edu
Darren Nix
CONTACT
314-362-3201
nixd@wustl.edu

Principal Investigator

Parakkal Deepak, MBBS, MS
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine GI Division
Louis Cohen, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Andres Yarur, MD
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars-Sinai Medical Center
Beverly Hills, California, 90211
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Parakkal Deepak, MBBS, MS, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine GI Division
  • Louis Cohen, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai
  • Andres Yarur, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-13
Study Completion Date2028-08

Study Record Updates

Study Start Date2025-05-13
Study Completion Date2028-08

Terms related to this study

Additional Relevant MeSH Terms

  • Crohn Disease (CD)