Recruiting

Mirikizumab

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06864403

Conditions

Pouchitis

Pouches, Ileoanal

Pouch, Ileal

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Mirikizumab - Intravenous (IV)

Mirikizumab - Subcutaneous (SC)

Study Details

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

Conditions

Pouchitis

Pouches, Ileoanal

Pouch, Ileal

Study ID

NCT06864403

Start date

Aug 12, 2025

Status verified date

Sep, 2025

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: All patients

Open Label Mirikizumab

Interventions

Mirikizumab - Intravenous (IV)

300 mg mirikizumab at Weeks 0, 4, and 8

Mirikizumab - Subcutaneous (SC)

Pre-filled syringes administered at Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52.

Primary outcome measure

  • Remission as measured by Modified Pouchitis Disease Activity Index (mPDAI) [ Time Frame: Weeks 0, 24, and 52 ]

Central Contacts and Locations

Central contacts

Mikki Sandridge

919-843-3873mikki_sandridge@med.unc.edu

Locations

UCLA Vatche & Tamar Manoukian Division of Digestive Diseases

Recruiting

Los Angeles, California, United States, 90024

Contacts

Xiaoxiao Yin

310-206-3778Xiaoxiaoyin@mednet.ucla.edu

Principal Investigator:

Gaurav Syal, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Chad Rypstra

507-538-4289Rypstra.Chad@mayo.edu

Principal Investigator:

Laura Raffals

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Nathasha Melukkaran

646-754-3417Nathasha.melukkaran@nyulangone.org

Principal Investigator:

Shannon Chang, MD, MBA

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599-7080

Contacts

Emily English

919-843-8105emily_english@med.unc.edu

Principal Investigator:

Edward Barnes, MD, MPH

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Jan 30, 2026

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-01-30.