RECRUITING

Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch

Conditions

Pouchitis Pouches, Ileoanal Pouch, Ileal mirikizumab Omvoh chronic pouchitis IPAA Crohn's-like disease of the pouch Ileal Pouch Anal Anastomosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch

Quick Facts

Study Start:2025-06-12

Study Completion:2027-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06864403

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Mikki Sandridge

CONTACT

919-843-3873

mikki_sandridge@med.unc.edu

Principal Investigator

Edward Barnes, MD, MPH

PRINCIPAL_INVESTIGATOR

University of North Carolina

Study Locations (Sites)

Mayo Clinic

Rochester, Minnesota, 55905

United States

University of North Carolina

Chapel Hill, North Carolina, 27599-7080

United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

Edward Barnes, MD, MPH, PRINCIPAL_INVESTIGATOR, University of North Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-12

Study Completion Date2027-04

Study Record Updates

Study Start Date2025-06-12

Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

mirikizumab
Omvoh
chronic pouchitis
IPAA
Crohn's-like disease of the pouch
Ileal Pouch Anal Anastomosis

Additional Relevant MeSH Terms

Pouchitis
Pouches, Ileoanal
Pouch, Ileal