Actively Recruiting
Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch
Led by University of North Carolina, Chapel Hill · Updated on 2026-01-30
25
Participants Needed
5
Research Sites
85 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if mirikizumab works to treat pouch disorders in adults. The main questions it aims to answer are: Does mirikizumab reduce symptoms of pouch disorders Participants will: Take mirikizumab every 4 weeks for one year Visit the clinic once every month for two months and at the end of the study Keep a diary of their symptoms
CONDITIONS
Official Title
Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must provide informed consent before any study procedures
- Aged 18 to 80 years
- Diagnosed with Chronic Antibiotic-Dependent Pouchitis, Chronic Antibiotic Refractory Pouchitis, or Crohn's-like disease of the pouch based on specified clinical criteria
- History of ulcerative colitis and 1, 2, modified -2, or 3 stage Ileal Pouch Anal Anastomosis (IPAA) surgery with ileostomy takedown
- Ability to access the internet for electronic data entry
- Provider is considering starting mirikizumab for chronic pouchitis or Crohn's-like disease of the pouch
You will not qualify if you...
- Prior exposure to mirikizumab
- Known allergy or hypersensitivity to mirikizumab or its metabolites
- Current infection with Clostridioides difficile
- Known HIV infection or active Hepatitis B or C
- Significant liver disease (except Primary Sclerosing Cholangitis with liver function tests less than 1.5 times the upper limit of normal)
- Severe liver impairment (Child-Pugh Class C)
- Kidney function with glomerular filtration rate less than 45 ml/min/1.732
- History of cancer except for basal cell carcinoma, non-metastatic squamous cell carcinoma of the skin, or prior malignancy treated with curative therapy completed at least 5 years ago with no recurrence
- Significant abnormal lab results at screening or baseline as judged by the investigator
- Female who is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential not using effective contraception
- Participation in any investigational drug trial within 30 days before screening
- Any medical condition that might risk participant safety or study compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
UCLA Vatche & Tamar Manoukian Division of Digestive Diseases
Los Angeles, California, United States, 90024
Actively Recruiting
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
3
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
4
University of North Carolina
Chapel Hill, North Carolina, United States, 27599-7080
Actively Recruiting
5
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15212
Not Yet Recruiting
Research Team
M
Mikki Sandridge
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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