Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT04710056
Status:
AVAILABLE
Last Update Posted:
2025-11-14
First Post:
2021-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expanded Access to REGN4461 for Patients With Lipodystrophy or Monogenic Obesity With Complications of Leptin Deficiency or Deficient Leptin Signaling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008060', 'term': 'Lipodystrophy'}], 'ancestors': [{'id': 'D012875', 'term': 'Skin Diseases, Metabolic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2021-01-13', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Leptin (LEP)', 'Leptin Receptors (LEPR)'], 'conditions': ['Lipodystrophy']}, 'descriptionModule': {'briefSummary': 'Provide Expanded Access to REGN4461 for patients with lipodystrophy or monogenic obesity with complications of leptin deficiency or deficient leptin signaling', 'detailedDescription': 'Expanded Access requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications. Availability will depend on location.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT']}, 'identificationModule': {'nctId': 'NCT04710056', 'briefTitle': 'Expanded Access to REGN4461 for Patients With Lipodystrophy or Monogenic Obesity With Complications of Leptin Deficiency or Deficient Leptin Signaling', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'orgStudyIdInfo': {'id': 'R4461-LEPR'}}, 'armsInterventionsModule': {'interventions': [{'name': 'REGN4461', 'type': 'DRUG', 'otherNames': ['mibavademab']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Requests for compassionate use must be initiated by a treating physician. Physicians should contact', 'role': 'CONTACT', 'email': 'CompassionateUse_Requests@regeneron.com', 'phone': '844-734-6643'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}