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
Murrieta, California 92562
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Murrieta, CA
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Bellaire, Texas 77401
1354
mi
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Bellaire, TX
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Berlin, New Jersey 08009
2388
mi
from 91732
Berlin, NJ
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Birmingham, Alabama
1785
mi
from 91732
Birmingham, AL
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Charleston, South Carolina
2185
mi
from 91732
Charleston, SC
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Coral Gables, Florida 33134
2318
mi
from 91732
Coral Gables, FL
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Corning, New York 14830
2272
mi
from 91732
Corning, NY
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Denver, Colorado 80206
819
mi
from 91732
Denver, CO
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Forest Hills, New York 11375
2441
mi
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Forest Hills, NY
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Fort Smith, Arkansas 72916
1344
mi
from 91732
Fort Smith, AR
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1195
mi
from 91732
Fort Worth, TX
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Greer, South Carolina
2027
mi
from 91732
Greer, SC
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High Point, North Carolina
2141
mi
from 91732
High Point, NC
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Indianapolis, Indiana 46256
1800
mi
from 91732
Indianapolis, IN
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Long Beach, California
23
mi
from 91732
Long Beach, CA
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Los Angeles, California
13
mi
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Los Angeles, CA
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New York, New York
2432
mi
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New York, NY
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Norfolk, Virginia 23502
2341
mi
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Norfolk, VA
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Normal, Illinois 61761
1647
mi
from 91732
Normal, IL
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Oceanside, California
70
mi
from 91732
Oceanside, CA
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Orange, California 92868
21
mi
from 91732
Orange, CA
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Plymouth, Minnesota 55441
1502
mi
from 91732
Plymouth, MN
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828
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Portland, OR
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Raleigh, North Carolina
2218
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Raleigh, NC
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Rockville, Maryland 20850
2274
mi
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Rockville, MD
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Rolling Hills Estates, California 90274
28
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Rolling Hills Estates, CA
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Saint Joseph, Missouri 64506
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Saint Joseph, MO
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San Antonio, Texas
1188
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San Antonio, TX
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Santa Monica, California 90404
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Santa Monica, CA
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Skokie, Illinois 60077
1724
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Skokie, IL
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Tacoma, Washington 98405
939
mi
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Tacoma, WA
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Tampa, Florida
2136
mi
from 91732
Tampa, FL
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Tulsa, Oklahoma
1250
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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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