Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2025-12-27 @ 10:02 PM
Study NCT ID:
NCT06749795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-24
First Post:
2024-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis (UC)
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-24', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-03-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2024-12-23', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with adverse events (AEs)', 'timeFrame': 'Baseline through Study Completion (Week 12).'}, {'measure': 'Number of subjects with clinical laboratory abnormalities', 'timeFrame': 'Baseline through Study Completion (Week 12).'}, {'measure': 'Number of subjects with changes in the 12-lead electrocardiogram (ECG)', 'timeFrame': 'Baseline through Study Completion (Week 12).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis (UC)']}, 'descriptionModule': {'briefSummary': 'A Phase 1b study to evaluate the safety and tolerability of LIV001 in Patients with Mild-to- Moderate Active Ulcerative Colitis', 'detailedDescription': 'A randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety and tolerability of LIV001 in patients with mild to moderate UC. Patients will receive LIV001 or placebo for 8 weeks. All patients will return to the site for a follow-up visit on week 12.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female aged 18 to 65 years (inclusive) at Screening.\n2. Established diagnosis of UC for at least 3 months prior to Screening, diagnosed by routine clinical, radiographic, endoscopic or pathologic criteria (Confirmed by colonoscopy and pathology records or, if unavailable, diagnosis confirmed by a letter from the subject's general practitioner.)\n\nExclusion Criteria:\n\n1. Possible or confirmed diagnosis of Crohn's Disease, other form of inflammatory bowel disorder and coeliac disease.\n2. History of a condition associated with significant immunosuppression, or chronic administration (\\> 14 consecutive days) of immunosuppressants or other immune-modifying drugs within 3 months prior to Visit 3 (subjects taking oral medications for UC, including corticosteroids or immunomodulators, are not excluded)."}, 'identificationModule': {'nctId': 'NCT06749795', 'briefTitle': 'LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis (UC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Liveome Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo Controlled, Multi -Center, Phase 1b Study to Evaluate the Safety and Tolerability of LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'LIV001-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LIV001', 'description': 'LIV001 will be given orally and daily from baseline until end of study', 'interventionNames': ['Drug: LIV001']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo will be given orally and daily from baseline until end of study', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LIV001', 'type': 'DRUG', 'description': 'Orally administered for 8 weeks', 'armGroupLabels': ['LIV001']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Orally administered for 8 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'centralContacts': [{'name': 'Sophie Hyun-Ja Ko, Doctor of Philosophy', 'role': 'CONTACT', 'email': 'sophieko@liveome.co.kr', 'phone': '+82-31-8065-8216'}], 'overallOfficials': [{'name': 'Piotr Napora, Doctor of Medicine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liveome Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}