Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT06897150
Status:
COMPLETED
Last Update Posted:
2025-04-02
First Post:
2025-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carotegrast Methyl in Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000588820', 'term': 'AJM300'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2025-03-19', 'studyFirstSubmitQcDate': '2025-03-19', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Clinical improvement', 'timeFrame': 'Week 24', 'description': 'Decreae of clinical score in the mayo score at least 1'}], 'primaryOutcomes': [{'measure': 'Clinical remission', 'timeFrame': 'Week 8', 'description': 'A total clinical subscores in the Mayo score of 0'}], 'secondaryOutcomes': [{'measure': 'Endoscopic remission', 'timeFrame': 'Week 8', 'description': 'Endoscopic subscore in the Mayo score of 0'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'Carotegrast methyl, an oral α4-integrin inhibitor, was recently approved in Japan for the treatment of active ulcerative colitis (UC). However, real-world data regarding its efficacy and safety remain scarce. This study aimed to assess the clinical effectiveness and safety profile of carotegrast methyl in patients with active UC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients diagnosed with UC based on endoscopic and histological findings\n* Patients with clinically and endoscopically moderate UC who were eligible for outpatient treatment (however, patients in clinical remission or with mild clinical activity but endoscopically moderate UC were also considered eligible as an exception)\n* Patients who exhibited an inadequate response to or intolerance of 5-ASA formulations (including topical agents) or budesonide formulations (including topical agents)\n* Patients who provided informed consent for endoscopic examinations at the start of treatment and during the treatment period\n* Patients who agreed to blood sampling and fecal biomarker tests\n\nExclusion Criteria:\n\n* Patients with severe disease on endoscopy (presumed ineffective due to the drug's characteristics)\n* Patients currently using biologics, JAK inhibitors, thiopurines, or calcineurin inhibitors (tacrolimus or cyclosporine)\n* Patients with a history of malignancy\n* Patients with severe hepatic dysfunction\n* Pregnant women or those planning pregnancy\n* Patients with acute severe conditions, such as toxic megacolon, sepsis, peritonitis, or infectious colitis"}, 'identificationModule': {'nctId': 'NCT06897150', 'acronym': 'CAR in UC', 'briefTitle': 'Carotegrast Methyl in Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Yokkaichi Hazu Medical Center'}, 'officialTitle': 'Efficacy and Safety of Carotegrast Methyl in Active Ulcerative Colitis: A Real-World Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'Yokkaichi Hazu 2024-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carotegrast methyl', 'description': 'Carotegrast methyl at a dosage of 960 mg three times daily', 'interventionNames': ['Drug: Carotegrast methyl']}], 'interventions': [{'name': 'Carotegrast methyl', 'type': 'DRUG', 'description': 'a dosage of 960 mg three times daily', 'armGroupLabels': ['Carotegrast methyl']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510-0016', 'city': 'Yokkaichi', 'state': 'Mie-ken', 'country': 'Japan', 'facility': 'Yokkaichi Hazu Medical Center', 'geoPoint': {'lat': 34.96667, 'lon': 136.61667}}], 'overallOfficials': [{'name': 'Takayuki Yamamoto, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Yokkaichi Hazu Medical Center'}, {'name': 'Takayuki Yamamoto, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yokkaichi Hazu Medical Center'}, {'name': 'Takayuki Yamamoto, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yokkaichi Hazu Medical Center'}]}, 'ipdSharingStatementModule': {'url': 'https://yokkaichi.jcho.go.jp/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Within 6 months of the publication of study results Data will be available for access for 1 year', 'ipdSharing': 'YES', 'accessCriteria': 'The data will be available for use in further scientific research, such as additional analyses, validating clinical outcomes, or investigating new treatment options.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takayuki Yamamoto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'The Director of the Hospital', 'investigatorFullName': 'Takayuki Yamamoto', 'investigatorAffiliation': 'Yokkaichi Hazu Medical Center'}}}}