Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT06260267
Status:
WITHDRAWN
Last Update Posted:
2024-10-18
First Post:
2024-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate 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': 'D064307', 'term': 'Microbiota'}], 'ancestors': [{'id': 'D008827', 'term': 'Microbiological Phenomena'}, {'id': 'D058448', 'term': 'Biota'}, {'id': 'D044822', 'term': 'Biodiversity'}, {'id': 'D017753', 'term': 'Ecosystem'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Not due to safety concerns, but changes in strategy which this trial no longer fulfills.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-16', 'studyFirstSubmitDate': '2024-02-07', 'studyFirstSubmitQcDate': '2024-02-07', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment-emergent adverse events from baseline to week 52', 'timeFrame': 'From baseline to week 52'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'To explore the safety of FE 999322 (microbiota suspension) and FE 999324 (microbiota capsule) versus placebo in subjects with active mild to moderate ulcerative colitis (UC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject aged ≥18 at screening\n* Established diagnosis of ulcerative colitis by standard clinical, endoscopic and histological criteria, for more than 3 months at screening\n\nExclusion Criteria:\n\n* Active disease or history of Crohn's disease\n* Active disease or history of irritable bowel syndrome (IBS) or any other chronic intestinal disease apart from UC\n* Active gastrointestinal infection."}, 'identificationModule': {'nctId': 'NCT06260267', 'briefTitle': 'A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis', 'orgStudyIdInfo': {'id': '000417'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FE 999322', 'description': 'Microbiota suspension', 'interventionNames': ['Drug: Microbiota suspension']}, {'type': 'EXPERIMENTAL', 'label': 'FE 999324', 'description': 'Microbiota capsule', 'interventionNames': ['Drug: Microbiota capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo FE 999322', 'description': 'Placebo suspension', 'interventionNames': ['Drug: Placebo suspension']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo FE 999324', 'description': 'Placebo capsule', 'interventionNames': ['Drug: Placebo capsule']}], 'interventions': [{'name': 'Microbiota suspension', 'type': 'DRUG', 'description': 'Microbiota suspension', 'armGroupLabels': ['FE 999322']}, {'name': 'Microbiota capsule', 'type': 'DRUG', 'description': 'Microbiota capsule', 'armGroupLabels': ['FE 999324']}, {'name': 'Placebo suspension', 'type': 'DRUG', 'description': 'Placebo suspension', 'armGroupLabels': ['Placebo FE 999322']}, {'name': 'Placebo capsule', 'type': 'DRUG', 'description': 'Placebo capsule', 'armGroupLabels': ['Placebo FE 999324']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72117', 'city': 'North Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 34.76954, 'lon': -92.26709}}, {'zip': '06518', 'city': 'Hamden', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 41.39593, 'lon': -72.89677}}, {'zip': '34452', 'city': 'Inverness', 'state': 'Florida', 'country': 'United States', 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 28.83582, 'lon': -82.33037}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32763', 'city': 'Orange City', 'state': 'Florida', 'country': 'United States', 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '60026', 'city': 'Glenview', 'state': 'Illinois', 'country': 'United States', 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 42.06975, 'lon': -87.78784}}, {'zip': '60031', 'city': 'Gurnee', 'state': 'Illinois', 'country': 'United States', 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 42.3703, 'lon': -87.90202}}, {'zip': '71105', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '73102', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Global Clinical Compliance', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}