Mirikizumab for chronic inflammatory conditions of the ileal pouch
Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch
This trial will test whether mirikizumab given every 4 weeks can reduce symptoms in adults with chronic pouch disorders.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Drugs / interventions | mirikizumab |
| Locations | 5 sites (Los Angeles, California and 4 other locations) |
| Trial ID | NCT06864403 on ClinicalTrials.gov |
What this trial studies
This Phase 4 interventional trial gives mirikizumab by IV or subcutaneous injection every four weeks for one year to adults with chronic antibiotic-dependent or -refractory pouchitis or Crohn's-like disease of the pouch. Participants will visit a study clinic monthly for the first two months and again at the end of the year while keeping a symptom diary throughout. The protocol focuses on symptom change and clinical course while monitoring safety under real-world use conditions. The trial is sponsored by a major academic center in collaboration with an industry partner and is conducted at several U.S. tertiary medical centers.
Who should consider this trial
Good fit: Adults aged 18–80 with a confirmed diagnosis of chronic antibiotic-dependent or antibiotic-refractory pouchitis, or Crohn's-like disease of the pouch, are the intended participants.
Not a fit: People without a confirmed chronic pouch diagnosis, those with contraindications to biologic therapy, or those unwilling to attend regular clinic visits may not benefit from participation.
Why it matters
Potential benefit: If successful, mirikizumab could decrease pouch symptoms and reduce dependence on long-term antibiotics, improving daily functioning and quality of life.
How similar studies have performed: IL-23–targeting therapies including mirikizumab have shown benefit in ulcerative colitis and related IBD, but evidence specifically for chronic pouchitis remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Los Angeles, California and 4 other locations
- UCLA Vatche & Tamar Manoukian Division of Digestive Diseases — Los Angeles, California, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
- University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
- Allegheny Health Network — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Edward Barnes, MD, MPH — University of North Carolina
- Study coordinator: Mikki Sandridge
- Email: mikki_sandridge@med.unc.edu
- Phone: 919-843-3873
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.