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Recruiting Phase 4 NCT06864403

Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch

Trial Parameters

Condition Pouchitis
Sponsor University of North Carolina, Chapel Hill
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 25
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2025-08-12
Completion 2027-04
Interventions
Mirikizumab - Intravenous (IV)Mirikizumab - Subcutaneous (SC)

Brief 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

Eligibility Criteria

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 the final

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