Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:28 PM
Study NCT ID:
NCT04583358
Status:
UNKNOWN
Last Update Posted:
2022-11-07
First Post:
2020-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-03', 'studyFirstSubmitDate': '2020-09-16', 'studyFirstSubmitQcDate': '2020-10-05', 'lastUpdatePostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mayo Score', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Endoscopic Remission Rate', 'timeFrame': '12 weeks'}, {'measure': 'Mucosal Healing Rate', 'timeFrame': '12 weeks'}, {'measure': 'Histologic Remission Rate', 'timeFrame': '12 weeks'}, {'measure': 'Clinical Remission Rate', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inflammatory Bowel Diseases'], 'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis.', 'detailedDescription': 'This is a Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study to evaluate the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female subjects aged 18 to 75 years, inclusive.\n* Diagnosis of moderate to severe UC.\n* Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and at the randomization visit.\n* Able to participate fully in all aspects of this clinical trial.\n* Written informed consent must be obtained and documented.\n\nExclusion Criteria:\n\n* Known gastrologic, or systemic condition that may compromise severity or diagnosis of disease.\n* History or current evidence of colonic or abdominal abnormalities.\n* Prohibited therapies or procedures before the screening period as specified per protocol.\n* A concurrent clinically significant, serious, unstable, or uncontrolled underlying cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might confound the study results, pose additional risk to the subject, or interfere with the subject's ability to participate fully in the study.\n* Pregnant or lactating females.\n* Current or recent history of alcohol dependence, illicit drug use, mental or legal incapacitation, or a history of clinically significant psychiatric disorders that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures.\n* Unable to attend study visits or comply with procedures.\n* Previous exposure to AMT-101 or similar and known hypersensitivity to AMT-101 or its excipients."}, 'identificationModule': {'nctId': 'NCT04583358', 'briefTitle': 'Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Applied Molecular Transport'}, 'officialTitle': 'A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects With Moderate to Severe Ulcerative Colitis (LOMBARD)', 'orgStudyIdInfo': {'id': 'AMT-101-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'AMT-101', 'description': 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