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
Indianapolis, Indiana 46256
651
mi
from
Indianapolis, IN
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Bellaire, Texas 77401
572
mi
from
Bellaire, TX
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Berlin, New Jersey 08009
1237
mi
from
Berlin, NJ
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Birmingham, Alabama
683
mi
from
Birmingham, AL
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Charleston, South Carolina
1064
mi
from
Charleston, SC
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Coral Gables, Florida 33134
1318
mi
from
Coral Gables, FL
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Corning, New York 14830
1137
mi
from
Corning, NY
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Denver, Colorado 80206
407
mi
from
Denver, CO
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Forest Hills, New York 11375
1295
mi
from
Forest Hills, NY
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Fort Smith, Arkansas 72916
257
mi
from
Fort Smith, AR
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348
mi
from
Fort Worth, TX
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Greer, South Carolina
888
mi
from
Greer, SC
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High Point, North Carolina
991
mi
from
High Point, NC
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Long Beach, California
1172
mi
from
Long Beach, CA
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Los Angeles, California
1168
mi
from
Los Angeles, CA
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Murrieta, California 92562
?
mi
from
Murrieta, CA
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New York, New York
1286
mi
from
New York, NY
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Norfolk, Virginia 23502
1186
mi
from
Norfolk, VA
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Normal, Illinois 61761
510
mi
from
Normal, IL
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Oceanside, California
1142
mi
from
Oceanside, CA
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Orange, California 92868
1154
mi
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Orange, CA
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Plymouth, Minnesota 55441
549
mi
from
Plymouth, MN
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1383
mi
from
Portland, OR
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Raleigh, North Carolina
1068
mi
from
Raleigh, NC
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Rockville, Maryland 20850
1120
mi
from
Rockville, MD
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Rolling Hills Estates, California 90274
1180
mi
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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
576
mi
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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
609
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Skokie, IL
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Tacoma, Washington 98405
1408
mi
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Tacoma, WA
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Tampa, Florida
1117
mi
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Tampa, FL
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Tulsa, Oklahoma
149
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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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