Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT05583604
Status:
AVAILABLE
Last Update Posted:
2025-12-18
First Post:
2022-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Managed Access Programs for AIN457, Secukinumab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}], 'ancestors': [{'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D016575', 'term': 'Hidradenitis'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C555450', 'term': 'secukinumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'intermediate': True}}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2022-10-04', 'studyFirstSubmitQcDate': '2022-10-12', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['MAP', 'Manage Access Program', 'Hidradenitis suppurativa (HS)', 'AIN457', 'secukinumab', 'Cosentyx'], 'conditions': ['Hidradenitis Suppurativa (HS)']}, 'descriptionModule': {'briefSummary': 'The purpose of this registration is to list Managed Access Programs (MAPs) related to AIN457, secukinumab', 'detailedDescription': 'CAIN457M2002M - Available - Managed Access Program (MAP) Cohort Treatment Plan CAIN457M2002M to provide access to Secukinumab for adult and adolescent patients with Hidradenitis Suppurativa (HS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* An independent request should be received from a licensed physician (in some instances from Health Authorities, Institutions or Governments).\n* The patient has a serious or life-threatening disease or condition and no comparable or satisfactory alternative therapy is available for diagnosis, monitoring or treatment; patient is not medically eligible for available treatment alternatives or has exhausted all available treatment options.\n* The patient is not eligible or able to enroll in a Novartis clinical trial or continue participation in a Novartis clinical trial.\n* There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.\n* The patient must meet any other medical criteria established by the medical experts responsible for the product or by the Health Authority in a country (as applicable).\n* Provision of the product will not interfere with the initiation, conduct or completion of a Novartis clinical trial or overall development program.'}, 'identificationModule': {'nctId': 'NCT05583604', 'briefTitle': 'Managed Access Programs for AIN457, Secukinumab', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Managed Access Programs for AIN457, Secukinumab', 'orgStudyIdInfo': {'id': 'CAIN457M2002M'}}, 'armsInterventionsModule': {'interventions': [{'name': 'secukinumab', 'type': 'DRUG', 'otherNames': ['Cosentyx, AIN457'], 'description': 'Patients receive secukinumab'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'MAP requests are initiated by a licensed physician.https:// www.novart is.com/healthcare-professionals/managed-access-programs', 'role': 'CONTACT', 'email': 'novartis.email@novartis.com', 'phone': '1-888-669-6682'}, {'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT', 'phone': '+41613241111'}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}