Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-02-23 @ 10:40 PM
Study NCT ID:
NCT03050151
Status:
COMPLETED
Last Update Posted:
2018-08-01
First Post:
2017-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Dupilumab Auto-injector Device When Used by Patients With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582203', 'term': 'dupilumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-30', 'studyFirstSubmitDate': '2017-02-08', 'studyFirstSubmitQcDate': '2017-02-08', 'lastUpdatePostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of validated AI device-associated product technical failures (PTFs) during the treatment period divided by total number of actual injections', 'timeFrame': 'To week 12'}, {'measure': 'Type of validated AI device-associated PTFs during the treatment period divided by total number of actual injections.', 'timeFrame': 'To week 12'}], 'secondaryOutcomes': [{'measure': 'Number of patients with an AI device-associated PTF', 'timeFrame': 'To week 12'}, {'measure': 'Percentage of patients with an AI device-associated PTF', 'timeFrame': 'To week 12'}, {'measure': 'Number of AI device-associated product technical complaints (PTCs) divided by total number of actual injections', 'timeFrame': 'To week 12'}, {'measure': 'Type of AI device-associated PTCs divided by total number of actual injections', 'timeFrame': 'To week 12'}, {'measure': 'Number of patients with an AI device-associated PTC', 'timeFrame': 'To week 12'}, {'measure': 'Percentage of patients with an AI device-associated PTC', 'timeFrame': 'To week 12'}, {'measure': 'Number of AI device-associated failed drug deliveries (defined as patient failure to administer the full dose at a given attempt, excluding PTF) divided by total number of actual injections', 'timeFrame': 'To week 12'}, {'measure': 'Type of AI device-associated failed drug deliveries (defined as patient failure to administer the full dose at a given attempt, excluding PTF) divided by total number of actual injections', 'timeFrame': 'To week 12'}, {'measure': 'Number of patients with an AI device-associated failure to deliver dose', 'timeFrame': 'To week 12'}, {'measure': 'Percentage of patients with an AI device-associated failure to deliver dose', 'timeFrame': 'To week 12'}, {'measure': 'Number of patients with response to patient satisfaction questions with the AI device', 'timeFrame': 'To week 12'}, {'measure': 'Percentage of patients with response to patient satisfaction questions with the AI device', 'timeFrame': 'To week 12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Atopic Disorders', 'Eczema, Atopic']}, 'referencesModule': {'references': [{'pmid': '35567671', 'type': 'DERIVED', 'citation': "Blauvelt A, Guttman-Yassky E, Paller AS, Simpson EL, Cork MJ, Weisman J, Browning J, Soong W, Sun X, Chen Z, Kosloski MP, Kamal MA, Delevry D, Chuang CC, O'Malley JT, Bansal A. Long-Term Efficacy and Safety of Dupilumab in Adolescents with Moderate-to-Severe Atopic Dermatitis: Results Through Week 52 from a Phase III Open-Label Extension Trial (LIBERTY AD PED-OLE). Am J Clin Dermatol. 2022 May;23(3):365-383. doi: 10.1007/s40257-022-00683-2. Epub 2022 May 14."}]}, 'descriptionModule': {'briefSummary': 'To collect data on actual-use to assess technical performance and user injections of dupilumab auto-injection device by patients with atopic dermatitis (AD).', 'detailedDescription': 'Study is conducted in 2 parts: part A and part B.\n\nPart A - Patients with moderate-to-severe AD will be randomized to receive dupilumab (dose 1) by auto-injector (AI) device or prefilled syringe.\n\nOnce part A is completely enrolled, part B will randomize patients with moderate-to-severe AD to receive dupilumab (dose 2) by auto-injector (AI) device or prefilled syringe.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Diagnosis of chronic atopic dermatitis for at least 3 years with inadequate response to topical medications within 6 months before screening\n2. Willing and able to comply with all clinic visits and study-related procedures\n3. Provide signed informed consent\n\nKey Exclusion Criteria:\n\n1. Patient \\< 30.0 kilograms (Kg) in weight\n2. Patient who has previously participated in a dupilumab clinical study\n3. Patient who has been treated with the following:\n\n * An investigational drug within 8 weeks or within 5 half-lives (if known),whichever is longer, before the baseline visit\n * Immunosuppressive/ immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mufti, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.) or Phototherapy for AD within 4 weeks before the baseline visit\n * An experimental monoclonal antibody within 5 half-lives or within 6◦months prior to visit 1 if the half-life is unknown\n * Biologic agents within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever is longer\n * Anti-immunoglobulin E therapy (omalizumab) within 130 days prior to visit 1\n * A live (attenuated) vaccine within 4 weeks before the baseline visit\n4. Patient who has initiated treatment with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (patients may continue using stable doses of such moisturizers if initiated before the screening visit)\n5. Patient who has skin comorbidities that may interfere with study assessments\n6. Patient with a planned or anticipated major surgical procedure during the patient's participation in this study\n7. Women of childbearing potential unwilling to use adequate birth control measures during the study\n8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT03050151', 'briefTitle': 'Study of Dupilumab Auto-injector Device When Used by Patients With Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'An Open-label, Randomized, Actual Use Study of Dupilumab Auto-injector Device in Patients With Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'R668-AD-1607'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 - Dupilumab (Part A)', 'description': 'Dose (dose 1) as per protocol delivered by auto-injector device', 'interventionNames': ['Drug: Dupilumab', 'Device: Auto-injector Device']}, {'type': 'EXPERIMENTAL', 'label': '2 - Dupilumab (Part A)', 'description': 'Dose (dose 1) as per protocol delivered by prefilled syringe', 'interventionNames': ['Drug: Dupilumab', 'Device: Prefilled syringe']}, {'type': 'EXPERIMENTAL', 'label': '3 - Dupilumab (Part B)', 'description': 'Dose (dose 2) as per protocol delivered by auto-injector device', 'interventionNames': ['Drug: Dupilumab', 'Device: Auto-injector Device']}, {'type': 'EXPERIMENTAL', 'label': '4 - Dupilumab (Part B)', 'description': 'Dose (dose 2) as per protocol delivered by prefilled syringe', 'interventionNames': ['Drug: Dupilumab', 'Device: Prefilled syringe']}], 'interventions': [{'name': 'Dupilumab', 'type': 'DRUG', 'description': 'Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe', 'armGroupLabels': ['1 - Dupilumab (Part A)', '2 - Dupilumab (Part A)', '3 - Dupilumab (Part B)', '4 - Dupilumab (Part B)']}, {'name': 'Auto-injector Device', 'type': 'DEVICE', 'description': 'Delivery of Dupilumab by auto-injector device', 'armGroupLabels': ['1 - Dupilumab (Part A)', '3 - Dupilumab (Part B)']}, {'name': 'Prefilled syringe', 'type': 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