Study of Dupilumab Auto-injector Device When Used by Patients With Atopic Dermatitis



Status:Completed
Conditions:Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:12 - Any
Updated:8/3/2018
Start Date:February 28, 2017
End Date:February 12, 2018

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An Open-label, Randomized, Actual Use Study of Dupilumab Auto-injector Device in Patients With Atopic Dermatitis

To collect data on actual-use to assess technical performance and user injections of
dupilumab auto-injection device by patients with atopic dermatitis (AD).

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.

Key Inclusion Criteria:

1. Diagnosis of chronic atopic dermatitis for at least 3 years with inadequate response
to topical medications within 6 months before screening

2. Willing and able to comply with all clinic visits and study-related procedures

3. Provide signed informed consent

Key Exclusion Criteria:

1. Patient < 30.0 kilograms (Kg) in weight

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply
We found this trial at
35
sites
Coral Gables, Florida 33134
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Bellaire, Texas 77401
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Berlin, New Jersey 08009
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Berlin, NJ
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Birmingham, Alabama
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Birmingham, AL
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Charleston, South Carolina
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Charleston, SC
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Corning, New York 14830
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Corning, NY
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Denver, Colorado 80206
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Denver, CO
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Forest Hills, New York 11375
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Forest Hills, NY
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Fort Smith, Arkansas 72916
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Fort Smith, AR
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Fort Worth, TX
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Greer, South Carolina
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Greer, SC
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High Point, North Carolina
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High Point, NC
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Indianapolis, Indiana 46256
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Indianapolis, IN
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Long Beach, California
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Long Beach, CA
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Los Angeles, California
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Los Angeles, CA
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Murrieta, California 92562
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Murrieta, CA
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New York, New York
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New York, NY
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Norfolk, Virginia 23502
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Norfolk, VA
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Normal, Illinois 61761
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Normal, IL
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Oceanside, California
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Oceanside, CA
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Orange, California 92868
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Orange, CA
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Plymouth, Minnesota 55441
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Plymouth, MN
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Portland, OR
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Raleigh, North Carolina
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Raleigh, NC
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Rockville, Maryland 20850
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Rolling Hills Estates, California 90274
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Saint Joseph, Missouri 64506
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Saint Joseph, MO
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San Antonio, Texas
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Santa Monica, California 90404
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Santa Monica, CA
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Skokie, Illinois 60077
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Tacoma, Washington 98405
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Tacoma, WA
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Tampa, Florida
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Tampa, FL
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Tulsa, Oklahoma
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Tulsa, OK
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Webster, Texas 77598
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Webster, TX
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Windsor, New Jersey 08520
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Windsor, NJ
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