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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Mirikizumab - Intravenous (IV)
Drug300 mg mirikizumab at Weeks 0, 4, and 8
Mirikizumab - Subcutaneous (SC)
DrugPre-filled syringes administered at Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: All patientsOther 2 interventions
Trial outcomes
Primary outcomes
1
Remission as measured by Modified Pouchitis Disease Activity Index (mPDAI)
The Pouchitis Disease Activity Index (PDAI) was developed for diagnosing active pouchitis and quantifying the severity of pouchitis. The PDAI includes the clinical criteria of 1) stool frequency 2) rectal bleeding 3) Fecal Urgency/Abdominal Cramps and 4) presence or absence of fever, endoscopic criteria, and histologic criteria through biopsies. The PDAI was modified to omit the biopsy and histology costs. The mPDAI includes the clinical portion and the endoscopic subscore of the PDAI. Score range is 0-12. The higher the score, the worse the disease activity. mPDAI remission is defined as an mPDAI score of 4 or lower and a reduction from baseline of 2 or more points in the mPDAI total score.
Time frame
Weeks 0, 24, and 52Secondary outcomes
1
Median change in the Endoscopic Pouch Score (EPS)
The endoscopic pouch score (EPS) is a standardized assessment of inflammation in the pouch of patients with an ileal pouch anal anastomosis (IPAA), including those with inflammation outside the pouch body. The EPS is a novel method of endoscopic scoring that has been developed to offer more granular longitudinal assessments of response to advanced therapies in patients with inflammatory conditions of the pouch. Score range is 0-45. The higher the score, the worse the disease activity.
Time frame
Weeks 0, 24, and 522
Median change in the endoscopic subscore of the mPDAI
The endoscopic subscore of the PDAI is a component of the PDAI that assesses endoscopic findings of pouchitis. Score range is 0-6. The higher the score, the worse the disease activity.
Time frame
Weeks 0, 24, and 523
Change in Cleveland Clinic Global Quality of Life (QoL) scale
The Cleveland Clinic Global Quality of Life scale asks the patient to rate their current QoL, current quality of health, and current energy level using a 1-10 rating (where 10 is best). The score on each of these 3 components is added and the final Cleveland Clinic Global Quality of Life utility score can be obtained by dividing this result by 30. A higher score means improved quality of life.
Time frame
Weeks 0, 4, 8, 12, 24, 38, and 524
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) incontinence measures
The PROMIS measure for incontinence includes 4 items that assess the frequency of bowel incontinence, soiling, stool leakage, and stool leakage while passing gas over the past 7 days. Score range is 0-20, where a higher score means increased incontinence.
Time frame
Weeks 0, 4, 8, 12, 24, 38, and 52Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
Eli Lilly and Company
Collaborator
Source ClinicalTrials.gov