Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-22 @ 11:55 AM
Study NCT ID:
NCT06590051
Status:
AVAILABLE
Last Update Posted:
2024-09-19
First Post:
2024-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AMG 335 Expanded Access Program for IgG4-Related Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}, 'nPtrsToThisExpAccNctId': 5}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'lastUpdateSubmitDate': '2024-09-06', 'studyFirstSubmitDate': '2024-09-06', 'studyFirstSubmitQcDate': '2024-09-06', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}}, 'descriptionModule': {'briefSummary': 'Expanded access requests for AMG 335 may be considered for adult patients with a confirmed diagnosis of IgG4-related disease. To request access, use Responsible Party contact information provided in this record.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06590051', 'briefTitle': 'AMG 335 Expanded Access Program for IgG4-Related Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'orgStudyIdInfo': {'id': 'AMG335 Expanded Access Program'}}, 'armsInterventionsModule': {'interventions': [{'name': 'UPLIZNA', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Amgen Call Center', 'role': 'CONTACT', 'email': 'medinfo@amgen.com', 'phone': '866-572-6436'}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}