Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT05858632
Status:
RECRUITING
Last Update Posted:
2023-08-28
First Post:
2023-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immune Spatial Features of Guselkumab Cutaneous Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000588857', 'term': 'guselkumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-25', 'studyFirstSubmitDate': '2023-05-04', 'studyFirstSubmitQcDate': '2023-05-04', 'lastUpdatePostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in psoriasis scalp severity index score (PSSI)', 'timeFrame': 'baseline and 9 months', 'description': 'PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. PSSI scores will be taken pre- and mid-treatment. Scores range from 0 to 72, with higher scores indicating more severity.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriasis of Scalp']}, 'descriptionModule': {'briefSummary': 'This study examines the effect of IL-23 blockade with Guselkumab on the immune cells of scalp psoriasis lesions.', 'detailedDescription': 'This is a one-arm, open-label study to examine the effect of Guselkumab . Guselkumab is a FDA-approved medication for the treatment of psoriasis. This study will examine how Guselkumab affects immune cells within scalp psoriasis lesions. Ten subjects with moderate to severe scalp psoriasis will be enrolled. Biopsy samples will be collected and undergo molecular profiling to correlate profiles with Guselkumab treatment response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: possess a PSSI (psoriasis scalp severity index) of ≥12\n\nExclusion Criteria:\n\n1. taking systemic immunosuppressives in the last 4 weeks\n2. pregnancy\n3. severe immunodeficiency (either from genetic or infectious causes).\n4. tuberculosis or other active serious infection\n5. active systemic malignancy.\n6. breast-feeding\n7. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.\n8. Males who are trying to conceive\n\n \\-'}, 'identificationModule': {'nctId': 'NCT05858632', 'briefTitle': 'Immune Spatial Features of Guselkumab Cutaneous Response', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Immune Spatial Features of Guselkumab Cutaneous Response', 'orgStudyIdInfo': {'id': '21-35862'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Guselkumab treatment', 'description': 'Guselkumab treatment for \\~ 9 months', 'interventionNames': ['Drug: Guselkumab']}], 'interventions': [{'name': 'Guselkumab', 'type': 'DRUG', 'description': 'Guselkumab treatment for \\~ 9 months', 'armGroupLabels': ['Guselkumab treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey Cheng, MD, PhD', 'role': 'CONTACT', 'email': 'rashes@ucsf.edu', 'phone': '415-575-0524'}], 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Jeffrey Cheng, MD, PhD', 'role': 'CONTACT', 'email': 'rashes@ucsf.edu', 'phone': '415 575 0524'}, {'name': 'Raymond Cho, MD,PhD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Raymond Cho, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Janssen Scientific Affairs, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}