Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
Minnesota
Mayo Clinic
RECRUITING
Rochester
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
New York
NYU Langone Health
RECRUITING
New York
Pennsylvania
Allegheny Health Network
NOT_YET_RECRUITING
Pittsburgh
Contact Information
Primary
Mikki Sandridge
mikki_sandridge@med.unc.edu
919-843-3873
Time Frame
Start Date: 2025-08-12
Estimated Completion Date: 2027-04
Participants
Target number of participants: 25
Treatments
Other: All patients
Open Label Mirikizumab
Related Therapeutic Areas
Sponsors
Collaborators: Eli Lilly and Company
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov