NCT06864403 · University of North Carolina, Chapel Hill
Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch
What this study 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
View original scientific description
The goal of this clinical trial is to learn if mirikizumab works to treat pouch disorders in adults.
Interventions
DRUG
Mirikizumab - Intravenous (IV)
300 mg mirikizumab at Weeks 0, 4, and 8
DRUG
Mirikizumab - Subcutaneous (SC)
Pre-filled syringes administered at Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52.
Primary outcome measures
Remission as measured by Modified Pouchitis Disease Activity Index (mPDAI)
Time frame: Weeks 0, 24, and 52
The Pouchitis Disease Activity Index (PDAI) was developed for diagnosing active pouchitis and quantifying the severity of pouchitis. The PDAI includes the clinical criteria of 1) stool frequency 2) rectal bleeding 3) Fecal Urgency/Abdominal Cramps and 4) presence or absence of fever, endoscopic criteria, and histologic criteria through biopsies. The PDAI was modified to omit the biopsy and histology costs. The mPDAI includes the clinical portion and the endoscopic subscore of the PDAI. Score range is 0-12. The higher the score, the worse the disease activity. mPDAI remission is defined as an mPDAI score of 4 or lower and a reduction from baseline of 2 or more points in the mPDAI total score.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Informed consent will be obtained before any study-related procedures
- Age \>/= 18 and \</= 80 years
- Diagnosis of Chronic Pouchitis or Crohn's-like disease of the pouch based on the following criteria:
- Chronic Antibiotic-Dependent Pouchitis: Recurrent symptoms of pouchitis (frequency, urgency, bleeding, abdominal pain or cramping, or pelvic discomfort) that respond to antibiotic therapy but relapse shortly after stopping antibiotics, thus necessitating continuous antibiotic therapy to achieve symptom control.
- Chronic Antibiotic Refractory Pouchitis: Lack of response to standard antibiotic therapy, requirement of a longer duration of antibiotic therapy than expected with minimal improvement in symptoms, in association with typical symptoms of pouchitis (frequency, urgency, bleeding, abdominal pain or cramping, or pelvic discomfort).
- Crohn's-like disease of the pouch: Presence of a perianal or other fistula that developed at least 12 months after th
Where
- Los Angeles, California
- Rochester, Minnesota
- New York, New York
- Chapel Hill, North Carolina
- Pittsburgh, Pennsylvania
Collaborators
Eli Lilly and Company
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 30, 2026 · Source of record for eligibility and locations