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NCT06864403 · ClinicalTrials.gov registry record · Phase 4
Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch
A Phase 4 study of Pouchitis and Pouches, Ileoanal, sponsored by University of North Carolina, Chapel Hill.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
- 5
- Study locations
NCT06864403: Recruiting Phase 4 study of Pouchitis and Pouches, Ileoanal, sponsored by University of North Carolina, Chapel Hill.
NCT06864403 is a Phase 4 study of Pouchitis and Pouches, Ileoanal that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 25 participants, roughly in line with the 23-participant average among 5 other Pouchitis trials with a reported enrollment target. The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06864403, a Phase 4 study of Pouchitis and Pouches, Ileoanal, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
- 5
- Study locations
Study Summary
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
Primary Outcome
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 ran
Conditions Studied
Interventions
- DRUG Mirikizumab - Intravenous (IV)
- DRUG Mirikizumab - Subcutaneous (SC)
Study Locations (5)
California
- UCLA Vatche & Tamar Manoukian Division of Digestive Diseases - Los Angeles
Minnesota
- Mayo Clinic - Rochester
New York
- NYU Langone Health - New York
North Carolina
- University of North Carolina - Chapel Hill
Pennsylvania
- Allegheny Health Network - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2025-08-12 |
| Est. Completion | 2027-04 |
| Phase | Phase 4 |
What NCT06864403 shows while recruiting
NCT06864403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, roughly in line with the 23-participant average among 5 other Pouchitis trials with a reported enrollment target.
The record links to 3 conditions, with Pouchitis appearing as the primary indexed condition, and to 2 interventions - of which Mirikizumab - Intravenous (IV) is the first listed.
NCT06864403 lists 5 locations in 5 states (California, Minnesota, New York).
Frequently Asked Questions
What is clinical trial NCT06864403 about?
NCT06864403 is a clinical study titled "Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch". 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 t...
What is the current status of trial NCT06864403?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2025-08-12. Estimated completion is 2027-04.
What conditions does trial NCT06864403 study?
This clinical trial studies the following conditions: Pouchitis, Pouches, Ileoanal, Pouch, Ileal.
What interventions are being tested in trial NCT06864403?
The interventions under investigation include: Mirikizumab - Intravenous (IV) (DRUG), Mirikizumab - Subcutaneous (SC) (DRUG).
Who is sponsoring clinical trial NCT06864403?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06864403 being conducted?
This trial has 5 study locations across California, Minnesota, New York, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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