Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)



Status:Enrolling by invitation
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:Any - 17
Updated:3/27/2019
Start Date:October 15, 2015
End Date:November 16, 2023

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An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Dupilumab in Patients ≥6 Months to <18 Years of Age With Atopic Dermatitis

The primary objective of the study is to assess the long-term safety of dupilumab in
pediatric participants with AD.

The secondary objectives of the study are:

- To assess the long-term efficacy of dupilumab in pediatric participants with AD

- To assess the trough concentrations of functional dupilumab in serum and the
immunogenicity in pediatric participants with AD after re-treatment with dupilumab.


Key Inclusion Criteria:

1. Participated in a prior dupilumab study in pediatric patients with AD and adequately
completed the visits and assessments required for both the treatment and follow-up periods,
as defined in the prior study protocol

Key Exclusion Criteria:

1. Patients who, during their participation in a prior dupilumab study developed an
adverse event (AE) or serious adverse event (SAE) deemed related to study drug which
could indicate that continued treatment with study drug may present an unreasonable
risk for the patient

2. Patients, who during the participation in a prior Dupilumab study, developed an AE
that was deemed related to study drug and led to study treatment discontinuation,
which in the opinion of the investigator or medical monitor could indicate that
continued treatment with study drug may present an unreasonable risk for the patient

3. Treatment with an investigational drug, other than dupilumab, within 8 weeks or within
5 half-lives (if known), whichever is longer, before the baseline visit

4. Having used immunosuppressive/immunomodulating drugs within 4 weeks before the
baseline visit

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

6. Diagnosed active endoparasitic infections or at high risk of these infections

7. Severe concomitant illness(es) that, in the investigator's judgment, would adversely
affect the patient's participation in the study.

Note: Other protocol defined Inclusion / Exclusion criteria may apply
We found this trial at
48
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Rockville, Maryland 20850
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Bakersfield, California
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Bellaire, Texas 77401
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Birmingham, Alabama
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Boston, Massachusetts
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Boston, MA
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Calgary,
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Centennial, Colorado
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Chapel Hill, North Carolina
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Chicago, Illinois
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Chicago, IL
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Columbus, Georgia
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Coral Gables, Florida 33134
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Corning, New York 14830
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Denver, Colorado 80206
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Evansville, Indiana 47713
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Evansville, IN
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Forest Hills, New York 11375
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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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Gahanna, Ohio 43230
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Gilbert, Arizona 85234
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Greer, South Carolina
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Indianapolis, Indiana 46256
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Indianapolis, IN
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Long Beach, California
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Los Angeles, California
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Macon, Georgia 31217
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Mission Viejo, California 92691
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New York, New York
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Norfolk, Virginia 23502
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North Charleston, South Carolina
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Orange, California 92868
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Palo Alto, California
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Philadelphia, Pennsylvania 19104
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Plainfield, Indiana 46168
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Plymouth, Minnesota 55441
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Plymouth, MN
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Portland, OR
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Rochester, New York
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Rolling Hills Estates, California 90274
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Saint Louis, Missouri
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San Antonio, Texas
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San Diego, California
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Sandy Springs, Georgia 30328
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Santa Rosa, California
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Seattle, Washington 98105
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Skokie, Illinois 60077
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Tacoma, Washington 98405
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Tampa, Florida
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Tulsa, Oklahoma
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Washington, District of Columbia 20016
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Ypsilanti, Michigan 48197
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