Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-01 @ 6:34 AM
Study NCT ID:
NCT04278235
Status:
AVAILABLE
Last Update Posted:
2025-07-10
First Post:
2020-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access to Elezanumab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723102', 'term': 'elezanumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True, 'intermediate': True}, 'nPtrsToThisExpAccNctId': 1}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2020-02-18', 'studyFirstSubmitQcDate': '2020-02-18', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Expanded Access', 'Pre-approval Access', 'Compassionate Use', 'Special Access Program', 'Named Patient Basis', 'Special Access Scheme'], 'conditions': ['Acute Spinal Cord Injury (SCI)']}, 'descriptionModule': {'briefSummary': "This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Elezanumab prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- The participant must not be eligible for an elezanumab clinical trial.'}, 'identificationModule': {'nctId': 'NCT04278235', 'briefTitle': 'Expanded Access to Elezanumab', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Expanded Access to Elezanumab', 'orgStudyIdInfo': {'id': 'C20-203'}, 'secondaryIdInfos': [{'id': 'C20-284', 'type': 'OTHER_GRANT', 'domain': 'Abbvie'}, {'id': 'C20-285', 'type': 'OTHER_GRANT', 'domain': 'Abbvie'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Elezanumab', 'type': 'DRUG', 'otherNames': ['ABT-555'], 'description': 'Solution for intravenous (IV) infusion'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ABBVIE CALL CENTER', 'role': 'CONTACT', 'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '844-663-3742'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}