NCT06864403 Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch
| NCT ID | NCT06864403 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Pouchitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-08-12 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 25 participants in total. It began in 2025-08-12 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 stage of Ileal Pouch Anal Anastomosis (IPAA) surgery, stricture of the pouch body or pre-pouch ileum, or the presence of pre-pouch ileitis. Pouch body inflammation (pouchitis) may often coexist in the setting of Crohn's-like disease of the pouch. * Participants with a proven history of ulcerative colitis and history of 1,2, modified -2 or 3 stage IPAA and ileostomy takedown * Ability to access internet for electronic database entry * Only those individuals for whom a provider is considering initiating mirikizumab for the treatment of chronic pouchitis or Crohn's-like disease of the pouch will be eligible for participation. Exclusion Criteria: * Prior exposure to mirikizumab * Known hypersensitivity to mirikizumab or its metabolites * Current infection with Clostridioides difficile * Known HIV or active Hepatitis B/C * Clinically significant liver disease (Primary Sclerosing Cholangitis with LFT's \<1.5 upper limit of normal can be included) * Severe hepatic impairment, defined as Child-Pugh Class C * Known decreased kidney function with a glomerular filtration rate \<45 ml/min/1.732 * History of malignancy, except for basal cell carcinoma, non-metastatic squamous cell carcinoma of the skin, or prior malignancy with curative therapy completed at least 5 years prior to screening and no recurrence. * Clinically significant laboratory results at screening or baseline, as judged by the Investigator from local testing. * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. * Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening. * Any disorder, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
Contact & Investigator
Edward Barnes, MD, MPH
PRINCIPAL INVESTIGATOR
University of North Carolina
Frequently Asked Questions
Who can join the NCT06864403 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Pouchitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06864403 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06864403 currently recruiting?
Yes, NCT06864403 is actively recruiting participants. Contact the research team at mikki_sandridge@med.unc.edu for enrollment information.
Where is the NCT06864403 trial being conducted?
This trial is being conducted at Los Angeles, United States, Rochester, United States, New York, United States, Chapel Hill, United States and 1 additional location.
Who is sponsoring the NCT06864403 clinical trial?
NCT06864403 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Edward Barnes, MD, MPH at University of North Carolina. The trial plans to enroll 25 participants.