Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)



Status:Active, not recruiting
Conditions:Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:6 - 11
Updated:3/27/2019
Start Date:November 17, 2017
End Date:September 12, 2019

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A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Dupilumab Administered Concomitantly With Topical Corticosteroids in Patients, ≥6 Years to <12 Years of Age, With Severe Atopic Dermatitis

The main objective of the trial is to demonstrate the efficacy of dupilumab administered
concomitantly with topical corticosteroids (TCS) in participants ≥6 years to <12 years of age
with severe atopic dermatitis (AD).

The secondary objective is to assess the safety of dupilumab administered concomitantly with
TCS in patients ≥6 years to <12 years of age with severe AD.


Key Inclusion Criteria:

1. Diagnosis of AD according to the American Academy of Dermatology consensus criteria
(Eichenfield 2003) at screening visit

2. Chronic AD diagnosed at least 1 year prior to the screening visit

3. IGA = 4 at screening and baseline visits

4. EASI ≥21 at the screening and baseline visits

5. BSA ≥15% at screening and baseline visits

6. Documented recent history (within 6 months before the baseline visit) of inadequate
response to topical AD medication(s)

7. At least 11 (of a total of 14) applications of a stable dose of topical emollient
(moisturizer) twice daily during the 7 consecutive days immediately before the
baseline visit

Key Exclusion Criteria:

1. Participation in a prior dupilumab clinical study

2. Treatment with a systemic investigational drug before the baseline visit

3. Treatment with a topical investigational drug within 2 weeks prior to the baseline
visit

4. Treatment with crisabarole within 2 weeks prior to the baseline visit

5. History of important side effects of medium potency topical corticosteroids (e.g,
intolerance to treatment, hypersensitivity reactions, significant skin atrophy,
systemic effects), as assessed by the investigator or patient's treating physician

6. Treatment with a topical calcineurin inhibitor (TCI) within 2 weeks prior to the
baseline visit

7. Having used any of the following treatments within 4 weeks before the baseline visit,
or any condition that, in the opinion of the investigator, is likely to require such
treatment(s) during the first 4 weeks of study treatment:

1. Immunosuppressive/immunomodulating drugs (e.g, systemic corticosteroids,
cyclosporine, mycophenolate-mofetil, interferon gamma, Janus kinase inhibitors,
azathioprine, methotrexate, etc.)

2. Phototherapy for AD

8. Treatment with biologics, as follows:

1. Any cell-depleting agents including but not limited to rituximab:

within 6 months before the baseline visit, or until lymphocyte and CD 19+
lymphocyte count returns to normal, whichever is longer

2. Other biologics: within 5 half-lives (if known) or 16 weeks before the baseline
visit, whichever is longer

9. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit

10. Body weight <15 kg at baseline

Note: Other Inclusion/ Exclusion criteria apply
We found this trial at
30
sites
Philadelphia, Pennsylvania 19104
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Bakersfield, California
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Bakersfield, CA
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Bellaire, Texas 77401
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Bellaire, TX
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Birmingham, Alabama
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Birmingham, AL
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Calgary,
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Charleston, South Carolina
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Charleston, SC
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Chicago, Illinois
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Chicago, IL
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Coral Gables, Florida 33134
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Coral Gables, FL
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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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Gahanna, Ohio 43230
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Gahanna, OH
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Gilbert, Arizona 85234
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Gilbert, AZ
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Long Beach, California
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Long Beach, CA
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Macon, Georgia 31217
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Macon, GA
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Minneapolis, Minnesota
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Minneapolis, MN
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Mission Viejo, California 92691
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Mission Viejo, 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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North Charleston, South Carolina
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North Charleston, SC
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Portland, OR
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Rochester, New York
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Rochester, NY
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Rockville, Maryland 20850
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Rockville, MD
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Rolling Hills Estates, California 90274
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Rolling Hills Estates, CA
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Saint Louis, Missouri
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Saint Louis, MO
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San Antonio, Texas
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San Antonio, TX
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San Diego, California
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San Diego, CA
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Sandy Springs, Georgia 30328
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Sandy Springs, GA
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Tampa, Florida
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Tampa, FL
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Ypsilanti, Michigan 48197
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Ypsilanti, MI
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