Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch

University of North Carolina (UNC)

Status and phase

Enrolling

Phase 4

Conditions

Pouchitis

Pouch, Ileal

Pouches, Ileoanal

Treatments

Drug: Mirikizumab - Intravenous (IV)

Drug: Mirikizumab - Subcutaneous (SC)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06864403

24-2214

Details and patient eligibility

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

Enrollment

25 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.