Pouches, Ileoanal, Pouch, Ileal, Pouchitis
Conditions
Keywords
mirikizumab, Omvoh, chronic pouchitis, IPAA, Crohn's-like disease of the pouch, Ileal Pouch Anal Anastomosis
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
Interventions
300 mg mirikizumab at Weeks 0, 4, and 8
Pre-filled syringes administered at Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52.
Sponsors
University of North Carolina, Chapel Hill
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Interventional Study, open-label real-world observational study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remission as measured by Modified Pouchitis Disease Activity Index (mPDAI) | Weeks 0, 24, and 52 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median change in the Endoscopic Pouch Score (EPS) | Weeks 0, 24, and 52 | 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. |
| Median change in the endoscopic subscore of the mPDAI | Weeks 0, 24, and 52 | 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. |
| Change in Cleveland Clinic Global Quality of Life (QoL) scale | Weeks 0, 4, 8, 12, 24, 38, and 52 | 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. |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) incontinence measures | Weeks 0, 4, 8, 12, 24, 38, and 52 | 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. |
| Change in Urgency Numeric Rating Scale (NRS) | Weeks 0, 4, 8, 12, 24, 38, and 52 | Urgency will be measured by the 11-point Likert scale urgency question as validated in the mirikizumab clinical trials. Score range is 0-10. The higher the score, the worse the urgency. |
Countries
United States
Contacts
CONTACTMikki Sandridge
PRINCIPAL_INVESTIGATOREdward Barnes, MD, MPH
University of North Carolina
Outcome results
None listed