Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-03-09 @ 4:15 AM
Study NCT ID:
NCT04119102
Status:
RECRUITING
Last Update Posted:
2020-04-30
First Post:
2019-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Duobrii in Combination With Biologics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-04-09', 'mcpReleaseN': 2, 'releaseDate': '2024-03-14'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'open label'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-29', 'studyFirstSubmitDate': '2019-10-03', 'studyFirstSubmitQcDate': '2019-10-04', 'lastUpdatePostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body surface area improvement', 'timeFrame': '8 weeks', 'description': 'body surface area determined by palm method where 1 palm is equivalent to 1%'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': '12 weeks DUOBRII to patients with 2%-10% BSA who are receiving biologic therapy for at least 24 weeks', 'detailedDescription': 'A single center, pilot study of 25 subjects to assess 12 weeks DUOBRII to patients with 2%-10% body surface area who are receiving 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. Psoriasis affecting 2%-10% BSA\n4. Patient is being treated with biologic therapy 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. Psoriasis affecting ˂2% or \\>10% BSA\n2. Patient not receiving a biologic agent, or receiving biologic agent \\<24weeks\n3. Received treatment with any topical antipsoriatic drug product within 14 days prior to the Baseline visit.\n4. Has previously used DUOBRII'}, 'identificationModule': {'nctId': 'NCT04119102', 'briefTitle': 'Duobrii in Combination With Biologics', 'organization': {'class': 'OTHER', 'fullName': 'Psoriasis Treatment Center of Central New Jersey'}, 'officialTitle': 'Open Label Study Evaluating DUOBRII in Psoriasis Patients Being Treated With Biologic Agents.', 'orgStudyIdInfo': {'id': 'PTC07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open Label Duobrii', 'description': 'Duobrii QD', 'interventionNames': ['Drug: Duobrii']}], 'interventions': [{'name': 'Duobrii', 'type': 'DRUG', 'description': 'duobrii applied daily for 4 weeks followed by every other day for 4 weeks.', 'armGroupLabels': ['Open Label Duobrii']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08520', 'city': 'East Windsor', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elise Nelson', 'role': 'CONTACT', 'email': 'enelson@windsordermatology.com', 'phone': '609-443-4500', 'phoneExt': '1402'}, {'name': 'Jerry Bagel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Brian Keegan, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'David Nieves, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alexa Hetzel, PA-C', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Psoriasis Treatment Center of Central New Jersey', 'geoPoint': {'lat': 40.268, 'lon': -74.54043}}], 'centralContacts': [{'name': 'Jerry Bagel, MD', 'role': 'CONTACT', 'email': 'dreamacres1@aol.com', 'phone': '6094434500'}, {'name': 'Elise Nelson', 'role': 'CONTACT', 'email': 'enelson@windsordermatology.com', 'phone': '6094434500'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Psoriasis Treatment Center of Central New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ortho Dermatologics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}