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

NCT ID: NCT06976853

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-13
• Study Completion Date: 2028-08-31

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 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.

Conditions

Crohn Disease (CD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tirzepatide group

Group Type: EXPERIMENTAL

Tirzepatide

Intervention Type: DRUG

Addition of tirzepatide to current biological therapy

Standard of Care Arm

Group Type: ACTIVE_COMPARATOR

Standard of care treatment

Intervention Type: DRUG

Intervention will be to change patient's current therapy to a 3rd or later advanced biologic patient have never been exposed to

Interventions

Tirzepatide

Addition of tirzepatide to current biological therapy

Intervention Type: DRUG

Standard of care treatment

Intervention will be to change patient's current therapy to a 3rd or later advanced biologic patient have never been exposed to

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subjects 18 to 80 years of age, inclusive, at the time of consent

2. Confirmed diagnosis of Crohn's disease based on documented findings on endoscopy and histopathology

3. Active ileal or ileocolonic inflammation on colonoscopy defined as

1. Ileal SES-CD > 4 with ulcer subscore > 1 (ulcers > 5mm)

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.

1. Anti-TNF: Infliximab, Adalimumab, Certolizumab, Golimumab

2. Anti-integrin agent: vedolizumab

3. Anti-IL12/23 agent: Ustekinumab

4. Anti-IL23: Risankizumab, Guselkumab, Mirikizumab

5. JAK inhibitor: Upadacitinib

5. In post surgical patients, must be at least 6 months post-op with endoscopic evidence of ileal disease

6. In females: compliance to recommended birth control requirements

Exclusion Criteria

1. Age < 18 or > 80 years

2. Pregnant or Breastfeeding female

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. BMI < 25

5. Current or previous diagnosis of anorexia nervosa

6. Type 1 or Type 2 diabetes

7. Use of concomitant hypoglycemic agents

8. Personal or family history of medullary thyroid carcinoma

9. History of multiple endocrine neoplasia

10. Known serious hypersensitivity to tirzepatide or any of its excipients

11. Have functional or post-operative short-bowel syndrome

12. Had intestinal resection ≤ 24 weeks prior to inclusion or other intra-abdominal surgeries ≤ 12 weeks prior to study inclusion

13. Active treatment with steroids*

14. Positive stool test for parasites, C. Diff or stool culture for pathologic bacteria within 30 days prior to enrollment

15. Current stricture not passable with an endoscope

16. Impending need for surgery per investigator

17. Have an ileostomy or a colostomy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Parakkal Deepak, MBBS, MS

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine GI Division

Louis Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Andres Yarur, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Beverly Hills, California, United States

Site Status: NOT_YET_RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status: RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Monique Lavalas Bright

Role: CONTACT

lavalas@wustl.edu

314-362-9044

Darren Nix

Role: CONTACT

nixd@wustl.edu

314-362-3201

Facility Contacts

Martha Bucaram

Role: primary

Martha.Bucaram@cshs.org

310-423-0035

Monique Lavalas Bright

Role: primary

lavalas@wustl.edu

314-362-9044

Katha Makwana

Role: primary

Katha.makwana@mssm.edu

212-327-8270

Other Identifiers

202504106

Identifier Type: -

Identifier Source: org_study_id