Study of Dupilumab Auto-injector Device When Used by Patients With Atopic Dermatitis
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ClinicalTrials.gov Identifier: NCT03050151 |
Recruitment Status :
Completed
First Posted : February 10, 2017
Last Update Posted : August 1, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atopic Disorders Eczema, Atopic | Drug: Dupilumab Device: Auto-injector Device Device: Prefilled syringe | Phase 1 |
Study is conducted in 2 parts: part A and part B.
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 176 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label, Randomized, Actual Use Study of Dupilumab Auto-injector Device in Patients With Atopic Dermatitis |
Actual Study Start Date : | February 28, 2017 |
Actual Primary Completion Date : | November 14, 2017 |
Actual Study Completion Date : | February 12, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 - Dupilumab (Part A)
Dose (dose 1) as per protocol delivered by auto-injector device
|
Drug: Dupilumab
Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe Device: Auto-injector Device Delivery of Dupilumab by auto-injector device |
Experimental: 2 - Dupilumab (Part A)
Dose (dose 1) as per protocol delivered by prefilled syringe
|
Drug: Dupilumab
Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe Device: Prefilled syringe Delivery of Dupilumab by prefilled syringe |
Experimental: 3 - Dupilumab (Part B)
Dose (dose 2) as per protocol delivered by auto-injector device
|
Drug: Dupilumab
Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe Device: Auto-injector Device Delivery of Dupilumab by auto-injector device |
Experimental: 4 - Dupilumab (Part B)
Dose (dose 2) as per protocol delivered by prefilled syringe
|
Drug: Dupilumab
Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe Device: Prefilled syringe Delivery of Dupilumab by prefilled syringe |
- Number of validated AI device-associated product technical failures (PTFs) during the treatment period divided by total number of actual injections [ Time Frame: To week 12 ]
- Type of validated AI device-associated PTFs during the treatment period divided by total number of actual injections. [ Time Frame: To week 12 ]
- Number of patients with an AI device-associated PTF [ Time Frame: To week 12 ]
- Percentage of patients with an AI device-associated PTF [ Time Frame: To week 12 ]
- Number of AI device-associated product technical complaints (PTCs) divided by total number of actual injections [ Time Frame: To week 12 ]
- Type of AI device-associated PTCs divided by total number of actual injections [ Time Frame: To week 12 ]
- Number of patients with an AI device-associated PTC [ Time Frame: To week 12 ]
- Percentage of patients with an AI device-associated PTC [ Time Frame: To week 12 ]
- 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 [ Time Frame: To week 12 ]
- 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 [ Time Frame: To week 12 ]
- Number of patients with an AI device-associated failure to deliver dose [ Time Frame: To week 12 ]
- Percentage of patients with an AI device-associated failure to deliver dose [ Time Frame: To week 12 ]
- Number of patients with response to patient satisfaction questions with the AI device [ Time Frame: To week 12 ]
- Percentage of patients with response to patient satisfaction questions with the AI device [ Time Frame: To week 12 ]

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Diagnosis of chronic atopic dermatitis for at least 3 years with inadequate response to topical medications within 6 months before screening
- Willing and able to comply with all clinic visits and study-related procedures
- Provide signed informed consent
Key Exclusion Criteria:
- Patient < 30.0 kilograms (Kg) in weight
- Patient who has previously participated in a dupilumab clinical study
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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
- 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)
- Patient who has skin comorbidities that may interfere with study assessments
- Patient with a planned or anticipated major surgical procedure during the patient's participation in this study
- Women of childbearing potential unwilling to use adequate birth control measures during the study
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
Note: Other protocol defined Inclusion/Exclusion criteria may apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050151
United States, Alabama | |
Regeneron Investigational Site | |
Birmingham, Alabama, United States, 35205 | |
Regeneron Investigational Site | |
Birmingham, Alabama, United States, 35209 | |
United States, Arkansas | |
Regeneron Investigational Site | |
Fort Smith, Arkansas, United States, 72916 | |
United States, California | |
Regeneron Investigational Site | |
Long Beach, California, United States, 90808 | |
Regeneron Investigational Site | |
Los Angeles, California, United States, 90025 | |
Regeneron Investigational Site | |
Murrieta, California, United States, 92562 | |
Regeneron Investigational Site | |
Oceanside, California, United States, 92056 | |
Regeneron Investigational Site | |
Orange, California, United States, 92868 | |
Regeneron Investigational Site | |
Rolling Hills Estates, California, United States, 90274 | |
Regeneron Investigational Site | |
Santa Monica, California, United States, 90404 | |
United States, Colorado | |
Regeneron Investigational Site | |
Denver, Colorado, United States, 80220 | |
United States, Florida | |
Regeneron Investigational Site | |
Coral Gables, Florida, United States, 33613 | |
Regeneron Investigational Site | |
Tampa, Florida, United States, 33612 | |
United States, Illinois | |
Regeneron Investigational Site | |
Normal, Illinois, United States, 61761 | |
Regeneron Investigational Site | |
Skokie, Illinois, United States, 60077 | |
United States, Indiana | |
Regeneron Investigational Site | |
Indianapolis, Indiana, United States, 46256 | |
United States, Maryland | |
Regeneron Investigational Site | |
Rockville, Maryland, United States, 20850 | |
United States, Minnesota | |
Regeneron Investigational Site | |
Plymouth, Minnesota, United States, 55441 | |
United States, Missouri | |
Regeneron Investigational Site | |
Saint Joseph, Missouri, United States, 64506 | |
United States, New Jersey | |
Regeneron Investigational Site | |
Berlin, New Jersey, United States, 08009 | |
Regeneron Investigational Site | |
Windsor, New Jersey, United States, 08520 | |
United States, New York | |
Regeneron Investigational Site | |
Corning, New York, United States, 14830 | |
Regeneron Investigational Site | |
Forest Hills, New York, United States, 11375 | |
Regeneron Investigational Site | |
New York, New York, United States, 10029 | |
United States, North Carolina | |
Regeneron Investigational Site | |
High Point, North Carolina, United States, 27262 | |
Regeneron Investigational Site | |
Raleigh, North Carolina, United States, 27612 | |
United States, Oklahoma | |
Regeneron Investigational Site | |
Tulsa, Oklahoma, United States, 74136 | |
United States, Oregon | |
Regeneron Investigational Site | |
Portland, Oregon, United States, 97223 | |
United States, South Carolina | |
Regeneron Investigational Site | |
Charleston, South Carolina, United States, 29420 | |
Regeneron Investigational Site | |
Greer, South Carolina, United States, 29650 | |
United States, Texas | |
Regeneron Investigational Site | |
Bellaire, Texas, United States, 77401 | |
Regeneron Investigational Site | |
Fort Worth, Texas, United States, 76244 | |
Regeneron Investigational Site | |
San Antonio, Texas, United States, 78213 | |
Regeneron Investigational Site | |
San Antonio, Texas, United States, 78218 | |
Regeneron Investigational Site | |
Webster, Texas, United States, 77598 | |
United States, Virginia | |
Regeneron Investigational Site | |
Norfolk, Virginia, United States, 23502 | |
United States, Washington | |
Regeneron Investigational Site | |
Tacoma, Washington, United States, 98405 |
Study Director: | Clinical Trial Management | Regeneron Pharmaceuticals |
Responsible Party: | Regeneron Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03050151 |
Other Study ID Numbers: |
R668-AD-1607 |
First Posted: | February 10, 2017 Key Record Dates |
Last Update Posted: | August 1, 2018 |
Last Verified: | May 2018 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | Yes |
Dermatitis, Atopic Dermatitis Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn |
Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |