Study of Dupilumab Auto-injector Device When Used by Patients With Atopic Dermatitis
NCT ID: NCT03050151
Last Updated: 2018-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
176 participants
INTERVENTIONAL
2017-02-28
2018-02-12
Brief Summary
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Detailed Description
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Part A - Patients with moderate-to-severe AD will be randomized to receive dupilumab (dose 1) by auto-injector (AI) device or prefilled syringe.
Once 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1 - Dupilumab (Part A)
Dose (dose 1) as per protocol delivered by auto-injector device
Dupilumab
Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe
Auto-injector Device
Delivery of Dupilumab by auto-injector device
2 - Dupilumab (Part A)
Dose (dose 1) as per protocol delivered by prefilled syringe
Dupilumab
Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe
Prefilled syringe
Delivery of Dupilumab by prefilled syringe
3 - Dupilumab (Part B)
Dose (dose 2) as per protocol delivered by auto-injector device
Dupilumab
Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe
Auto-injector Device
Delivery of Dupilumab by auto-injector device
4 - Dupilumab (Part B)
Dose (dose 2) as per protocol delivered by prefilled syringe
Dupilumab
Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe
Prefilled syringe
Delivery of Dupilumab by prefilled syringe
Interventions
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Dupilumab
Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe
Auto-injector Device
Delivery of Dupilumab by auto-injector device
Prefilled syringe
Delivery of Dupilumab by prefilled syringe
Eligibility Criteria
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Inclusion Criteria
2. Willing and able to comply with all clinic visits and study-related procedures
3. Provide signed informed consent
Exclusion Criteria
2. Patient who has previously participated in a dupilumab clinical study
3. Patient who has been treated with the following:
* An investigational drug within 8 weeks or within 5 half-lives (if known),whichever is longer, before the baseline visit
* 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
* An experimental monoclonal antibody within 5 half-lives or within 6◦months prior to visit 1 if the half-life is unknown
* Biologic agents within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever is longer
* Anti-immunoglobulin E therapy (omalizumab) within 130 days prior to visit 1
* A live (attenuated) vaccine within 4 weeks before the baseline visit
4. 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)
5. Patient who has skin comorbidities that may interfere with study assessments
6. Patient with a planned or anticipated major surgical procedure during the patient's participation in this study
7. Women of childbearing potential unwilling to use adequate birth control measures during the study
8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
12 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Regeneron Investigational Site
Birmingham, Alabama, United States
Regeneron Investigational Site
Birmingham, Alabama, United States
Regeneron Investigational Site
Fort Smith, Arkansas, United States
Regeneron Investigational Site
Long Beach, California, United States
Regeneron Investigational Site
Los Angeles, California, United States
Regeneron Investigational Site
Murrieta, California, United States
Regeneron Investigational Site
Oceanside, California, United States
Regeneron Investigational Site
Orange, California, United States
Regeneron Investigational Site
Rolling Hills Estates, California, United States
Regeneron Investigational Site
Santa Monica, California, United States
Regeneron Investigational Site
Denver, Colorado, United States
Regeneron Investigational Site
Coral Gables, Florida, United States
Regeneron Investigational Site
Tampa, Florida, United States
Regeneron Investigational Site
Normal, Illinois, United States
Regeneron Investigational Site
Skokie, Illinois, United States
Regeneron Investigational Site
Indianapolis, Indiana, United States
Regeneron Investigational Site
Rockville, Maryland, United States
Regeneron Investigational Site
Plymouth, Minnesota, United States
Regeneron Investigational Site
Saint Joseph, Missouri, United States
Regeneron Investigational Site
Berlin, New Jersey, United States
Regeneron Investigational Site
Windsor, New Jersey, United States
Regeneron Investigational Site
Corning, New York, United States
Regeneron Investigational Site
Forest Hills, New York, United States
Regeneron Investigational Site
New York, New York, United States
Regeneron Investigational Site
High Point, North Carolina, United States
Regeneron Investigational Site
Raleigh, North Carolina, United States
Regeneron Investigational Site
Tulsa, Oklahoma, United States
Regeneron Investigational Site
Portland, Oregon, United States
Regeneron Investigational Site
Charleston, South Carolina, United States
Regeneron Investigational Site
Greer, South Carolina, United States
Regeneron Investigational Site
Bellaire, Texas, United States
Regeneron Investigational Site
Fort Worth, Texas, United States
Regeneron Investigational Site
San Antonio, Texas, United States
Regeneron Investigational Site
San Antonio, Texas, United States
Regeneron Investigational Site
Webster, Texas, United States
Regeneron Investigational Site
Norfolk, Virginia, United States
Regeneron Investigational Site
Tacoma, Washington, United States
Countries
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References
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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.
Other Identifiers
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R668-AD-1607
Identifier Type: -
Identifier Source: org_study_id
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