Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2025-12-29 @ 8:25 AM
Study NCT ID:
NCT06103695
Status:
COMPLETED
Last Update Posted:
2023-10-27
First Post:
2023-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vtama in Psoriasis Patients Being Treated With Biologics.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-04-09', 'mcpReleaseN': 1, 'releaseDate': '2024-03-14'}, {'resetDate': '2025-01-27', 'mcpReleaseN': 2, 'releaseDate': '2025-01-08'}], 'estimatedResultsFirstSubmitDate': '2024-03-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571829', 'term': 'tapinarof'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'open label'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-19', 'studyFirstSubmitDate': '2023-10-19', 'studyFirstSubmitQcDate': '2023-10-19', 'lastUpdatePostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body surface area ≤1%', 'timeFrame': '12 weeks', 'description': 'Patients who achieve body surface area of ≤1%'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'Open label study to assess 12 weeks of add-on VTAMA® (tapinarof) Cream, 1% QD in patients with ≥3% BSA who have received biologic therapy for at least 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female adult ≥ 18 years of age;\n2. Diagnosis of chronic plaque-type\n3. Patient with ≥3% BSA\n4. Patient has been treated with biologic for a minimum of 24 weeks\n5. Able and willing to give written informed consent prior to performance of any study-related procedures.\n\nExclusion Criteria:\n\n1. ≤3% BSA\n2. Patient not receiving biologic agent, or receiving biologic agent \\<24weeks'}, 'identificationModule': {'nctId': 'NCT06103695', 'briefTitle': 'Vtama in Psoriasis Patients Being Treated With Biologics.', 'organization': {'class': 'OTHER', 'fullName': 'Psoriasis Treatment Center of Central New Jersey'}, 'officialTitle': 'Open Label, Observational Study, Evaluating VTAMA® (Tapinarof) Cream, 1% QD in Psoriasis Patients Being Treated With Biologic Agents.', 'orgStudyIdInfo': {'id': 'PTC10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Vtama', 'description': 'open label Vtama', 'interventionNames': ['Drug: Tapinarof']}], 'interventions': [{'name': 'Tapinarof', 'type': 'DRUG', 'description': 'Add on Vtama (tapinarof) to biololgic therapy', 'armGroupLabels': ['Vtama']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08520', 'city': 'East Windsor', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Schweiger Derm Group', 'geoPoint': {'lat': 40.268, 'lon': -74.54043}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Psoriasis Treatment Center of Central New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MS', 'investigatorFullName': 'Jerry Bagel', 'investigatorAffiliation': 'Psoriasis Treatment Center of Central New Jersey'}}}}