Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-04-17 @ 1:21 PM
Study NCT ID:
NCT05522556
Status:
AVAILABLE
Last Update Posted:
2025-11-18
First Post:
2022-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-approval Single-patient Expanded Access for Ritlecitinib (PF-06651600)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000506', 'term': 'Alopecia Areata'}, {'id': 'D000505', 'term': 'Alopecia'}, {'id': 'C537055', 'term': 'Alopecia universalis'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}, 'nPtrsToThisExpAccNctId': 2}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2022-08-26', 'studyFirstSubmitQcDate': '2022-08-26', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Alopecia Areata (AA)', 'Alopecia', 'Patchy AA', 'Alopecia Universalis (AU)', 'Alopecia Totalis (AT)', 'Ophiasis', 'Eyelash Loss', 'Eyebrow Loss', 'Hair Loss'], 'conditions': ['Alopecia Areata']}, 'descriptionModule': {'briefSummary': 'Provide pre-approval single patient Expanded Access (compassionate use) of Ritlecitinib for patients.', 'detailedDescription': 'In Expanded Access, treating physicians are the Sponsors. Expanded Access requests from treating physicians may be submitted to www.pfizercares.com. Availability will depend on location and country.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'eligibilityCriteria': 'Must have ≥ 50% hair loss on scalp due to Alopecia Areata (AA) and be intolerant or have inadequate response to all commonly used AA therapies accessible in the country. Additional eligibility criteria may be required.'}, 'identificationModule': {'nctId': 'NCT05522556', 'briefTitle': 'Pre-approval Single-patient Expanded Access for Ritlecitinib (PF-06651600)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'orgStudyIdInfo': {'id': 'B798'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ritlecitinib', 'type': 'DRUG', 'description': 'capsules'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Pfizer Cares', 'role': 'CONTACT', 'email': 'PfizerCares@Pfizer.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}