Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-25 @ 7:23 PM
Study NCT ID:
NCT05544032
Status:
AVAILABLE
Last Update Posted:
2025-10-08
First Post:
2022-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expanded Access of Axatilimab to Treat a Single Patient With Chronic Graft Versus Host Disease (GVHD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711669', 'term': 'axatilimab'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}, 'nPtrsToThisExpAccNctId': 3}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'lastUpdateSubmitDate': '2025-10-03', 'studyFirstSubmitDate': '2022-09-14', 'studyFirstSubmitQcDate': '2022-09-14', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Chronic Graft Vs. Host Disease', 'cGVHD'], 'conditions': ['Chronic Graft Vs. Host Disease']}, 'descriptionModule': {'briefSummary': 'This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee and Single Patient IND approval.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05544032', 'briefTitle': 'Expanded Access of Axatilimab to Treat a Single Patient With Chronic Graft Versus Host Disease (GVHD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'Expanded Access of Axatilimab to Treat a Single Patient With Chronic Graft Versus Host Disease (GVHD)', 'orgStudyIdInfo': {'id': 'I-34176-25-07'}}, 'armsInterventionsModule': {'interventions': [{'name': 'axatilimab', 'type': 'DRUG', 'otherNames': ['INCA34176'], 'description': 'Treatment with axatilimab includes receiving intravenous (IV) doses of axatilimab every 2 weeks'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Incyte Corporation Medical Information Call Center (US)', 'role': 'CONTACT', 'email': 'medinfo@incyte.com', 'phone': '1.855.463.3463'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}