Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of North Carolina, Chapel Hill
About 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
Qualifiers
Informed consent will be obtained before any study-related procedures
Age >/= 18 and </= 80 years
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).
Disqualifiers
Prior exposure to mirikizumab
Known hypersensitivity to mirikizumab or its metabolites
Current infection with Clostridioides difficile
Known HIV or active Hepatitis B/C
Trial design
Treatments tested in this trial
- Mirikizumab - Intravenous (IV)
- Mirikizumab - Subcutaneous (SC)
Treatment groups
25 Participants
are divided into 1 treatment groupLocations
5UCLA Vatche & Tamar Manoukian Division of Digestive Diseases90024, Los AngelesCalifornia, United States
Mayo Clinic55905, RochesterMinnesota, United States
NYU Langone Health10016, New YorkNew York, United States
University of North Carolina27599-7080, Chapel HillNorth Carolina, United States
Sponsors and collaborators
University of North Carolina, Chapel Hill
Lead sponsor
Eli Lilly and Company
Collaborator
Source ClinicalTrials.gov