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
sites
Bellaire, Texas 77401
1354
mi
from 91732
Bellaire, TX
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Bakersfield, California
106
mi
from 91732
Bakersfield, CA
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Birmingham, Alabama
1785
mi
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Birmingham, AL
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Boston, Massachusetts
2578
mi
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Boston, MA
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1189
mi
from 91732
Calgary,
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Centennial, Colorado
818
mi
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Centennial, CO
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Chapel Hill, North Carolina
1991
mi
from 91732
Chapel Hill, NC
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Chicago, Illinois
1728
mi
from 91732
Chicago, IL
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Columbus, Georgia
1902
mi
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Columbus, GA
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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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Evansville, Indiana 47713
1715
mi
from 91732
Evansville, IN
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Forest Hills, New York 11375
2441
mi
from 91732
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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Gahanna, Ohio 43230
1967
mi
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Gahanna, OH
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Gilbert, Arizona 85234
363
mi
from 91732
Gilbert, AZ
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Greer, South Carolina
2027
mi
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Greer, SC
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Indianapolis, Indiana 46256
1800
mi
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Indianapolis, IN
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Long Beach, California
23
mi
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Long Beach, CA
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Los Angeles, California
13
mi
from 91732
Los Angeles, CA
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Macon, Georgia 31217
1974
mi
from 91732
Macon, GA
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Mission Viejo, California 92691
37
mi
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Mission Viejo, CA
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New York, New York
2432
mi
from 91732
New York, NY
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Norfolk, Virginia 23502
2341
mi
from 91732
Norfolk, VA
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North Charleston, South Carolina
2179
mi
from 91732
North Charleston, SC
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Orange, California 92868
21
mi
from 91732
Orange, CA
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Palo Alto, California
328
mi
from 91732
Palo Alto, CA
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Philadelphia, Pennsylvania 19104
2373
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from 91732
Philadelphia, PA
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Plainfield, Indiana 46168
1779
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from 91732
Plainfield, IN
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Plymouth, Minnesota 55441
1502
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from 91732
Plymouth, MN
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828
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Portland, OR
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Rochester, New York
2245
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Rochester, NY
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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
mi
from 91732
Rolling Hills Estates, CA
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Saint Louis, Missouri
1573
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Saint Louis, MO
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San Antonio, Texas
1188
mi
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San Antonio, TX
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San Diego, California
105
mi
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San Diego, CA
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Sandy Springs, Georgia 30328
1917
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Sandy Springs, GA
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Santa Rosa, California
399
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Santa Rosa, CA
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Seattle, Washington 98105
964
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Seattle, WA
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Skokie, Illinois 60077
1724
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Skokie, IL
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Tacoma, Washington 98405
939
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Tacoma, WA
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Tampa, Florida
2136
mi
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Tampa, FL
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Tulsa, Oklahoma
1250
mi
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Tulsa, OK
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Washington, District of Columbia 20016
2278
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Washington,
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Ypsilanti, Michigan 48197
1937
mi
from 91732
Ypsilanti, MI
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