Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-30 @ 10:09 AM
Study NCT ID:
NCT06864403
Status:
RECRUITING
Last Update Posted:
2025-09-15
First Post:
2025-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019449', 'term': 'Pouchitis'}], 'ancestors': [{'id': 'D007079', 'term': 'Ileitis'}, {'id': 'D004751', 'term': 'Enteritis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D007077', 'term': 'Ileal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Interventional Study, open-label real-world observational study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2025-03-03', 'studyFirstSubmitQcDate': '2025-03-03', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remission as measured by Modified Pouchitis Disease Activity Index (mPDAI)', 'timeFrame': 'Weeks 0, 24, and 52', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Median change in the Endoscopic Pouch Score (EPS)', 'timeFrame': 'Weeks 0, 24, and 52', 'description': '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.'}, {'measure': 'Median change in the endoscopic subscore of the mPDAI', 'timeFrame': 'Weeks 0, 24, and 52', 'description': '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.'}, {'measure': 'Change in Cleveland Clinic Global Quality of Life (QoL) scale', 'timeFrame': 'Weeks 0, 4, 8, 12, 24, 38, and 52', 'description': '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.'}, {'measure': 'Change in Patient-Reported Outcomes Measurement Information System (PROMIS) incontinence measures', 'timeFrame': 'Weeks 0, 4, 8, 12, 24, 38, and 52', 'description': '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.'}, {'measure': 'Change in Urgency Numeric Rating Scale (NRS)', 'timeFrame': 'Weeks 0, 4, 8, 12, 24, 38, and 52', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mirikizumab', 'Omvoh', 'chronic pouchitis', 'IPAA', "Crohn's-like disease of the pouch", 'Ileal Pouch Anal Anastomosis'], 'conditions': ['Pouchitis', 'Pouches, Ileoanal', 'Pouch, Ileal']}, 'referencesModule': {'references': [{'pmid': '30295784', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '30810748', 'type': 'BACKGROUND', 'citation': 'Gregory 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.'}, {'pmid': '31187322', 'type': 'BACKGROUND', 'citation': 'Ollech 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.'}, {'pmid': '36745039', 'type': 'BACKGROUND', 'citation': 'Akiyama S, Cohen NA, Kayal M, Dubinsky MC, Colombel JF, Rubin DT. 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Epub 2017 Aug 29.'}, {'pmid': '8170189', 'type': 'BACKGROUND', 'citation': 'Sandborn WJ, Tremaine WJ, Batts KP, Pemberton JH, Phillips SF. Pouchitis after ileal pouch-anal anastomosis: a Pouchitis Disease Activity Index. Mayo Clin Proc. 1994 May;69(5):409-15. doi: 10.1016/s0025-6196(12)61634-6.'}, {'pmid': '17567869', 'type': 'BACKGROUND', 'citation': "Isaacs KL, Sandler RS, Abreu M, Picco MF, Hanauer SB, Bickston SJ, Present D, Farraye FA, Wolf D, Sandborn WJ; Crohn's and Colitis Foundation of America Clinical Alliance. Rifaximin for the treatment of active pouchitis: a randomized, double-blind, placebo-controlled pilot study. Inflamm Bowel Dis. 2007 Oct;13(10):1250-5. doi: 10.1002/ibd.20187."}, {'type': 'BACKGROUND', 'citation': 'Gionchetti P, Morselli C, Rizzello F, et al. Infliximab in the treatment of refractory pouchitis. Gastroenterology 2005;128:A578-A578'}, {'pmid': '12730861', 'type': 'BACKGROUND', 'citation': 'Gionchetti P, Rizzello F, Helwig U, Venturi A, Lammers KM, Brigidi P, Vitali B, Poggioli G, Miglioli M, Campieri M. Prophylaxis of pouchitis onset with probiotic therapy: a double-blind, placebo-controlled trial. Gastroenterology. 2003 May;124(5):1202-9. doi: 10.1016/s0016-5085(03)00171-9.'}, {'pmid': '17934776', 'type': 'BACKGROUND', 'citation': 'Gionchetti P, Rizzello F, Morselli C, Poggioli G, Tambasco R, Calabrese C, Brigidi P, Vitali B, Straforini G, Campieri M. High-dose probiotics for the treatment of active pouchitis. Dis Colon Rectum. 2007 Dec;50(12):2075-82; discussion 2082-4. doi: 10.1007/s10350-007-9068-4. Epub 2007 Oct 13.'}, {'pmid': '10930365', 'type': 'BACKGROUND', 'citation': 'Gionchetti P, Rizzello F, Venturi A, Brigidi P, Matteuzzi D, Bazzocchi G, Poggioli G, Miglioli M, Campieri M. Oral bacteriotherapy as maintenance treatment in patients with chronic pouchitis: a double-blind, placebo-controlled trial. Gastroenterology. 2000 Aug;119(2):305-9. doi: 10.1053/gast.2000.9370.'}, {'pmid': '10383499', 'type': 'BACKGROUND', 'citation': 'Gionchetti P, Rizzello F, Venturi A, Ugolini F, Rossi M, Brigidi P, Johansson R, Ferrieri A, Poggioli G, Campieri M. Antibiotic combination therapy in patients with chronic, treatment-resistant pouchitis. Aliment Pharmacol Ther. 1999 Jun;13(6):713-8. doi: 10.1046/j.1365-2036.1999.00553.x.'}, {'pmid': '16401690', 'type': 'BACKGROUND', 'citation': 'Kuhbacher T, Ott SJ, Helwig U, Mimura T, Rizzello F, Kleessen B, Gionchetti P, Blaut M, Campieri M, Folsch UR, Kamm MA, Schreiber S. Bacterial and fungal microbiota in relation to probiotic therapy (VSL#3) in pouchitis. Gut. 2006 Jun;55(6):833-41. doi: 10.1136/gut.2005.078303. Epub 2006 Jan 9.'}, {'pmid': '14684584', 'type': 'BACKGROUND', 'citation': 'Mimura T, Rizzello F, Helwig U, Poggioli G, Schreiber S, Talbot IC, Nicholls RJ, Gionchetti P, Campieri M, Kamm MA. Once daily high dose probiotic therapy (VSL#3) for maintaining remission in recurrent or refractory pouchitis. Gut. 2004 Jan;53(1):108-14. doi: 10.1136/gut.53.1.108.'}, {'pmid': '18573211', 'type': 'BACKGROUND', 'citation': 'Shen B, Remzi FH, Lopez AR, Queener E. Rifaximin for maintenance therapy in antibiotic-dependent pouchitis. BMC Gastroenterol. 2008 Jun 23;8:26. doi: 10.1186/1471-230X-8-26.'}, {'pmid': '38125203', 'type': 'BACKGROUND', 'citation': 'Barnes EL, Boynton MH, DeWalt DA, Herfarth HH, Kappelman MD. Patient Reported Outcome Assessments Used in the Evaluation of Patients after Ileal Pouch-Anal Anastomosis: A Systematic Review. Gastro Hep Adv. 2023;2(8):1044-1049. doi: 10.1016/j.gastha.2023.07.010. Epub 2023 Jul 29.'}, {'pmid': '3393032', 'type': 'BACKGROUND', 'citation': 'Stewart AL, Hays RD, Ware JE Jr. The MOS short-form general health survey. Reliability and validity in a patient population. Med Care. 1988 Jul;26(7):724-35. doi: 10.1097/00005650-198807000-00007. No abstract available.'}, {'pmid': '36777426', 'type': 'BACKGROUND', 'citation': 'Dubinsky MC, Panaccione R, Lewis JD, Sands BE, Hibi T, Lee SD, Naegeli AN, Shan M, Green LA, Morris N, Arora V, Bleakman AP, Belin R, Travis S. Impact of Bowel Urgency on Quality of Life and Clinical Outcomes in Patients With Ulcerative Colitis. Crohns Colitis 360. 2022 Jun 3;4(3):otac016. doi: 10.1093/crocol/otac016. eCollection 2022 Jul.'}, {'pmid': '37782274', 'type': 'BACKGROUND', 'citation': 'Barnes EL. A Practical Guide to the Use of Mirikizumab. Am J Gastroenterol. 2024 Mar 1;119(3):400-403. doi: 10.14309/ajg.0000000000002531. Epub 2023 Oct 2. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'European Medicines Agency: Vedolizumab.'}]}, 'descriptionModule': {'briefSummary': '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:\n\nDoes mirikizumab reduce symptoms of pouch disorders\n\nParticipants will:\n\nTake 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent will be obtained before any study-related procedures\n* Age \\>/= 18 and \\</= 80 years\n* Diagnosis of Chronic Pouchitis or Crohn's-like disease of the pouch based on the following criteria:\n\n * 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.\n * 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).\n * 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.\n* Participants with a proven history of ulcerative colitis and history of 1,2, modified -2 or 3 stage IPAA and ileostomy takedown\n* Ability to access internet for electronic database entry\n* 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.\n\nExclusion Criteria:\n\n* Prior exposure to mirikizumab\n* Known hypersensitivity to mirikizumab or its metabolites\n* Current infection with Clostridioides difficile\n* Known HIV or active Hepatitis B/C\n* Clinically significant liver disease (Primary Sclerosing Cholangitis with LFT's \\<1.5 upper limit of normal can be included)\n* Severe hepatic impairment, defined as Child-Pugh Class C\n* Known decreased kidney function with a glomerular filtration rate \\<45 ml/min/1.732\n* 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.\n* Clinically significant laboratory results at screening or baseline, as judged by the Investigator from local testing.\n* 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.\n* Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening.\n* Any disorder, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol."}, 'identificationModule': {'nctId': 'NCT06864403', 'briefTitle': 'Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch', 'orgStudyIdInfo': {'id': '24-2214'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'All patients', 'description': 'Open Label Mirikizumab', 'interventionNames': ['Drug: Mirikizumab - Intravenous (IV)', 'Drug: Mirikizumab - Subcutaneous (SC)']}], 'interventions': [{'name': 'Mirikizumab - Intravenous (IV)', 'type': 'DRUG', 'otherNames': ['Omvoh'], 'description': '300 mg mirikizumab at Weeks 0, 4, and 8', 'armGroupLabels': ['All patients']}, {'name': 'Mirikizumab - Subcutaneous (SC)', 'type': 'DRUG', 'otherNames': ['Omvoh'], 'description': 'Pre-filled syringes administered at Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52.', 'armGroupLabels': ['All patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chad Rypstra', 'role': 'CONTACT', 'email': 'Rypstra.Chad@mayo.edu', 'phone': '507-538-4289'}, {'name': 'Laura Raffals', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nathasha Melukkaran', 'role': 'CONTACT', 'email': 'Nathasha.melukkaran@nyulangone.org', 'phone': '646-754-3417'}, {'name': 'Shannon Chang, MD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599-7080', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emily English', 'role': 'CONTACT', 'email': 'emily_english@med.unc.edu', 'phone': '919-843-8105'}, {'name': 'Edward Barnes, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brianna Smith', 'role': 'CONTACT', 'email': 'Brianna.smith@ahn.org', 'phone': '412-228-8310'}, {'name': 'Gursimran Kochhar', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Allegheny Health Network', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Mikki Sandridge', 'role': 'CONTACT', 'email': 'mikki_sandridge@med.unc.edu', 'phone': '919-843-3873'}], 'overallOfficials': [{'name': 'Edward Barnes, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'beginning 9 and continuing for 12 months following publication', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': 'Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}