New drug trial aims to soothe painful pouchitis
NCT ID NCT06864403
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether mirikizumab (Omvoh) can reduce symptoms of chronic pouchitis, a condition where the internal pouch created after colon surgery becomes inflamed. Twenty-five adults will receive the drug every four weeks for a year. Researchers will track symptom changes using a standard scoring system.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mirikizumab (Omvoh)
- What this could lead to
- If it works, this could offer a new treatment option for people with chronic pouchitis, reducing symptoms and improving quality of life.
- What could go wrong
- This is a small, early-phase study with only 25 participants, so results may not apply to everyone. The drug may not work as hoped, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Allegheny Health Network
NOT_YET_RECRUITINGPittsburgh, Pennsylvania, 15212, United States
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States
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NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
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UCLA Vatche & Tamar Manoukian Division of Digestive Diseases
RECRUITINGLos Angeles, California, 90024, United States
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University of North Carolina
RECRUITINGChapel Hill, North Carolina, 27599-7080, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a simple topical treatment stop a common Post-Surgery complication in ulcerative colitis?
- Can a stool transplant soothe an inflamed pouch?
- Sound waves vs. scope: a gentler way to spot pouch inflammation?
- Can a stool transplant calm an inflamed pouch?
- Can a diabetes drug curb chronic Pouch-Related bathroom trips?
- Can a common antibiotic stop pouchitis from coming back?