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
Norfolk, Virginia 23502
2434
mi
from 98109
Norfolk, VA
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Bellaire, Texas 77401
1889
mi
from 98109
Bellaire, TX
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Berlin, New Jersey 08009
2389
mi
from 98109
Berlin, NJ
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Birmingham, Alabama
2079
mi
from 98109
Birmingham, AL
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Charleston, South Carolina
2423
mi
from 98109
Charleston, SC
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Coral Gables, Florida 33134
2729
mi
from 98109
Coral Gables, FL
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Corning, New York 14830
2216
mi
from 98109
Corning, NY
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Denver, Colorado 80206
1022
mi
from 98109
Denver, CO
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Forest Hills, New York 11375
2409
mi
from 98109
Forest Hills, NY
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Fort Smith, Arkansas 72916
1668
mi
from 98109
Fort Smith, AR
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1662
mi
from 98109
Fort Worth, TX
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Greer, South Carolina
2229
mi
from 98109
Greer, SC
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High Point, North Carolina
2291
mi
from 98109
High Point, NC
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Indianapolis, Indiana 46256
1870
mi
from 98109
Indianapolis, IN
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Long Beach, California
981
mi
from 98109
Long Beach, CA
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Los Angeles, California
962
mi
from 98109
Los Angeles, CA
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Murrieta, California 92562
?
mi
from 98109
Murrieta, CA
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New York, New York
2402
mi
from 98109
New York, NY
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Normal, Illinois 61761
1712
mi
from 98109
Normal, IL
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Oceanside, California
1030
mi
from 98109
Oceanside, CA
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Orange, California 92868
984
mi
from 98109
Orange, CA
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Plymouth, Minnesota 55441
1383
mi
from 98109
Plymouth, MN
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146
mi
from 98109
Portland, OR
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Raleigh, North Carolina
2362
mi
from 98109
Raleigh, NC
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Rockville, Maryland 20850
2310
mi
from 98109
Rockville, MD
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Rolling Hills Estates, California 90274
979
mi
from 98109
Rolling Hills Estates, CA
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Saint Joseph, Missouri 64506
?
mi
from 98109
Saint Joseph, MO
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San Antonio, Texas
1787
mi
from 98109
San Antonio, TX
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Santa Monica, California 90404
?
mi
from 98109
Santa Monica, CA
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Skokie, Illinois 60077
1722
mi
from 98109
Skokie, IL
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Tacoma, Washington 98405
27
mi
from 98109
Tacoma, WA
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Tampa, Florida
2527
mi
from 98109
Tampa, FL
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Tulsa, Oklahoma
1558
mi
from 98109
Tulsa, OK
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Webster, Texas 77598
?
mi
from 98109
Webster, TX
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Windsor, New Jersey 08520
?
mi
from 98109
Windsor, NJ
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