PouchitisPhase 4NCT06864403
Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch
A Phase 4 study testing Mirikizumab - Intravenous (IV) and Mirikizumab - Subcutaneous (SC) in people with Pouchitis and Pouches, Ileoanal, run by University of North Carolina, Chapel Hill at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pouchitis, Pouches, Ileoanal, Pouch, Ileal
- What is being tested?
- Mirikizumab - Intravenous (IV) and Mirikizumab - Subcutaneous (SC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 5 sitesUnited States
- Study dates
- 12 Aug 2025to Apr 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599-7080
Emily English, 919-843-8105, emily_english@med.unc.edu
Edward Barnes, MD, MPH
- Recruiting
UCLA Vatche & Tamar Manoukian Division of Digestive Diseases
Los Angeles, California, 90024
Xiaoxiao Yin, 310-206-3778, Xiaoxiaoyin@mednet.ucla.edu
Gaurav Syal, MD
- Recruiting
NYU Langone Health
New York, New York, 10016
Nathasha Melukkaran, 646-754-3417, Nathasha.melukkaran@nyulangone.org
Shannon Chang, MD, MBA
- Not yet recruiting
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Brianna Smith, 412-228-8310, Brianna.smith@ahn.org
Gursimran Kochhar
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Chad Rypstra, 507-538-4289, Rypstra.Chad@mayo.edu
Laura Raffals
About this study
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
- Conditions
- Pouchitis, Pouches, Ileoanal, Pouch, Ileal
- Being tested
- Mirikizumab - Intravenous (IV), Mirikizumab - Subcutaneous (SC)
- Keywords
- mirikizumab, Omvoh, chronic pouchitis, IPAA, Crohn's-like disease of the pouch, Ileal Pouch Anal Anastomosis
- Medical subject headings
- Pouchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirikizumab - Intravenous (IV)Drug
Also called Omvoh
300 mg mirikizumab at Weeks 0, 4, and 8
Mirikizumab - Subcutaneous (SC)Drug
Also called Omvoh
Pre-filled syringes administered at Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Other | Open Label Mirikizumab Receives: Drug: Mirikizumab - Intravenous (IV); Drug: Mirikizumab - Subcutaneous (SC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 0, 24, and 52
Secondary outcomes (5)
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.
Measured: Weeks 0, 24, and 52
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.
Measured: Weeks 0, 24, and 52
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.
Measured: Weeks 0, 4, 8, 12, 24, 38, and 52
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.
Measured: Weeks 0, 4, 8, 12, 24, 38, and 52
Change in Urgency Numeric Rating Scale (NRS)
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.
Measured: Weeks 0, 4, 8, 12, 24, 38, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start12 Aug 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (63)Papers the sponsor has linked to this study.
- Other trials for PouchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional Study, open-label real-world observational study
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Edward Barnes, MD, MPH, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864403
- Sponsor's protocol ID
- 24-2214
- Status last verified
- Sep 2025
- First submitted
- 3 Mar 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 12 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
Weaver KN, Gregory M, Syal G, Hoversten P, Hicks SB, Patel D, Christophi G, Beniwal-Patel P, Isaacs KL, Raffals L, Deepak P, Herfarth HH, Barnes EL. Ustekinumab Is Effective for the Treatment of Crohn's Disease of the Pouch in a Multicenter Cohort. Inflamm Bowel Dis. 2019 Mar 14;25(4):767-774. doi: 10.1093/ibd/izy302.
PubMed 30295784Gregory M, Weaver KN, Hoversten P, Hicks SB, Patel D, Ciorba MA, Gutierrez AM, Beniwal-Patel P, Palam S, Syal G, Herfarth HH, Christophi G, Raffals L, Barnes EL, Deepak P. Efficacy of Vedolizumab for Refractory Pouchitis of the Ileo-anal Pouch: Results From a Multicenter US Cohort. Inflamm Bowel Dis. 2019 Aug 20;25(9):1569-1576. doi: 10.1093/ibd/izz030.
PubMed 30810748Ollech JE, Rubin DT, Glick L, Weisshof R, El Jurdi K, Israel A, Krugliak Cleveland N, Hyman N, Sakuraba A, Pekow J, Cohen RD, Dalal SR. Ustekinumab Is Effective for the Treatment of Chronic Antibiotic-Refractory Pouchitis. Dig Dis Sci. 2019 Dec;64(12):3596-3601. doi: 10.1007/s10620-019-05697-1. Epub 2019 Jun 11.
PubMed 31187322Akiyama S, Cohen NA, Kayal M, Dubinsky MC, Colombel JF, Rubin DT. Treatment of Chronic Inflammatory Pouch Conditions With Tofacitinib: A Case Series From 2 Tertiary IBD Centers in the United States. Inflamm Bowel Dis. 2023 Sep 1;29(9):1504-1507. doi: 10.1093/ibd/izad011. No abstract available.
PubMed 36745039Kayal M, Lambin T, Plietz M, Rizvi A, Radcliffe M, Khaitov S, Sylla P, Greenstein AJ, Colombel JF, Dubinsky MC, Ungaro RC. Recycling of Precolectomy Anti-Tumor Necrosis Factor Agents in Chronic Pouch Inflammation Is Associated With Treatment Failure. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1491-1493.e3. doi: 10.1016/j.cgh.2020.07.008. Epub 2020 Jul 12.
PubMed 32668342Shen B, Achkar JP, Connor JT, Ormsby AH, Remzi FH, Bevins CL, Brzezinski A, Bambrick ML, Fazio VW, Lashner BA. Modified pouchitis disease activity index: a simplified approach to the diagnosis of pouchitis. Dis Colon Rectum. 2003 Jun;46(6):748-53. doi: 10.1007/s10350-004-6652-8.
PubMed 12794576Barnes EL, Long MD, Raffals L, Isaacs K, Stidham RW, Herfarth HH; Contributors. Development of the Endoscopic Pouch Score for Assessment of Inflammatory Conditions of the Pouch. Clin Gastroenterol Hepatol. 2023 Jun;21(6):1663-1666.e3. doi: 10.1016/j.cgh.2022.04.026. Epub 2022 May 12.
PubMed 35568303Dubinsky MC, Irving PM, Panaccione R, Naegeli AN, Potts-Bleakman A, Arora V, Shan M, Travis S. Incorporating patient experience into drug development for ulcerative colitis: development of the Urgency Numeric Rating Scale, a patient-reported outcome measure to assess bowel urgency in adults. J Patient Rep Outcomes. 2022 Apr 1;6(1):31. doi: 10.1186/s41687-022-00439-w.
PubMed 35362902Yamamoto T, Shimoyama T, Bamba T, Matsumoto K. Consecutive Monitoring of Fecal Calprotectin and Lactoferrin for the Early Diagnosis and Prediction of Pouchitis after Restorative Proctocolectomy for Ulcerative Colitis. Am J Gastroenterol. 2015 Jun;110(6):881-7. doi: 10.1038/ajg.2015.129. Epub 2015 Apr 28.
PubMed 25916224Lin JF, Chen JM, Zuo JH, Yu A, Xiao ZJ, Deng FH, Nie B, Jiang B. Meta-analysis: fecal calprotectin for assessment of inflammatory bowel disease activity. Inflamm Bowel Dis. 2014 Aug;20(8):1407-15. doi: 10.1097/MIB.0000000000000057.
PubMed 24983982Ollech JE, Bannon L, Maharshak N, Bar N, Goren I, Tulchinsky H, Yanai H, Dotan I. Fecal Calprotectin Is Increased in Pouchitis and Progressively Increases With More Severe Endoscopic and Histologic Disease. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1839-1846.e2. doi: 10.1016/j.cgh.2021.11.012. Epub 2021 Nov 16.
PubMed 34798336Singh S, Ananthakrishnan AN, Nguyen NH, Cohen BL, Velayos FS, Weiss JM, Sultan S, Siddique SM, Adler J, Chachu KA; AGA Clinical Guidelines Committee. Electronic address: clinicalpractice@gastro.org. AGA Clinical Practice Guideline on the Role of Biomarkers for the Management of Ulcerative Colitis. Gastroenterology. 2023 Mar;164(3):344-372. doi: 10.1053/j.gastro.2022.12.007.
PubMed 36822736Fazio VW, O'Riordain MG, Lavery IC, Church JM, Lau P, Strong SA, Hull T. Long-term functional outcome and quality of life after stapled restorative proctocolectomy. Ann Surg. 1999 Oct;230(4):575-84; discussion 584-6. doi: 10.1097/00000658-199910000-00013.
PubMed 10522727D'Haens G, Dubinsky M, Kobayashi T, Irving PM, Howaldt S, Pokrotnieks J, Krueger K, Laskowski J, Li X, Lissoos T, Milata J, Morris N, Arora V, Milch C, Sandborn W, Sands BE; LUCENT Study Group. Mirikizumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2023 Jun 29;388(26):2444-2455. doi: 10.1056/NEJMoa2207940.
PubMed 37379135Sands BE, D'Haens G, Clemow DB, Irving PM, Johns JT, Hunter Gibble T, Abreu MT, Lee S, Hisamatsu T, Kobayashi T, Dubinsky MC, Vermeire S, Siegel CA, Peyrin-Biroulet L, Moses RE, Milata J, Arora V, Panaccione R, Dignass A. Two-Year Efficacy and Safety of Mirikizumab Following 104 Weeks of Continuous Treatment for Ulcerative Colitis: Results From the LUCENT-3 Open-Label Extension Study. Inflamm Bowel Dis. 2024 Dec 5;30(12):2245-2258. doi: 10.1093/ibd/izae024.
PubMed 38459910