Mirikizumab for Pouchitis

Recruiting in Palo Alto (17 mi)

Overseen byEdward Barnes, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of North Carolina, Chapel Hill

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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

Adults with chronic inflammatory conditions of the pouch, such as Pouchitis or Ileal Pouchitis, are eligible for this trial. Participants must be willing to take mirikizumab injections and visit the clinic regularly for one year while keeping a symptom diary.

Inclusion Criteria

I have been diagnosed with Chronic Pouchitis or Crohn's-like disease of the pouch.

I am between 18 and 80 years old.

Informed consent will be obtained before any study-related procedures

+3 more

Exclusion Criteria

Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening

I am currently infected with C. difficile.

Known hypersensitivity to mirikizumab or its metabolites

+9 more

Participant Groups

The study is testing whether mirikizumab can reduce symptoms in patients with pouch disorders. It involves receiving either subcutaneous (SC) or intravenous (IV) doses of mirikizumab every four weeks and attending monthly clinic visits.

1Treatment groups

Experimental Treatment

Group I: All patientsExperimental Treatment2 Interventions

Open Label Mirikizumab