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

Use our guide to learn which trials are right for you!

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
Evansville, Indiana 47713
280
mi
from 43215
Evansville, IN
Click here to add this to my saved trials
Bakersfield, California
1980
mi
from 43215
Bakersfield, CA
Click here to add this to my saved trials
Bellaire, Texas 77401
997
mi
from 43215
Bellaire, TX
Click here to add this to my saved trials
Birmingham, Alabama
491
mi
from 43215
Birmingham, AL
Click here to add this to my saved trials
Boston, Massachusetts
643
mi
from 43215
Boston, MA
Click here to add this to my saved trials
1670
mi
from 43215
Calgary,
Click here to add this to my saved trials
Centennial, Colorado
1157
mi
from 43215
Centennial, CO
Click here to add this to my saved trials
Chapel Hill, North Carolina
278
mi
from 43215
Chapel Hill, NC
Click here to add this to my saved trials
Chicago, Illinois
274
mi
from 43215
Chicago, IL
Click here to add this to my saved trials
Columbus, Georgia
529
mi
from 43215
Columbus, GA
Click here to add this to my saved trials
Coral Gables, Florida 33134
994
mi
from 43215
Coral Gables, FL
Click here to add this to my saved trials
Corning, New York 14830
345
mi
from 43215
Corning, NY
Click here to add this to my saved trials
Denver, Colorado 80206
1160
mi
from 43215
Denver, CO
Click here to add this to my saved trials
Forest Hills, New York 11375
485
mi
from 43215
Forest Hills, NY
Click here to add this to my saved trials
Fort Smith, Arkansas 72916
697
mi
from 43215
Fort Smith, AR
Click here to add this to my saved trials
938
mi
from 43215
Fort Worth, TX
Click here to add this to my saved trials
Gahanna, Ohio 43230
8
mi
from 43215
Gahanna, OH
Click here to add this to my saved trials
Gilbert, Arizona 85234
1647
mi
from 43215
Gilbert, AZ
Click here to add this to my saved trials
Greer, South Carolina
350
mi
from 43215
Greer, SC
Click here to add this to my saved trials
Indianapolis, Indiana 46256
158
mi
from 43215
Indianapolis, IN
Click here to add this to my saved trials
Long Beach, California
1977
mi
from 43215
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California
1972
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
Macon, Georgia 31217
493
mi
from 43215
Macon, GA
Click here to add this to my saved trials
Mission Viejo, California 92691
1953
mi
from 43215
Mission Viejo, CA
Click here to add this to my saved trials
New York, New York
477
mi
from 43215
New York, NY
Click here to add this to my saved trials
Norfolk, Virginia 23502
426
mi
from 43215
Norfolk, VA
Click here to add this to my saved trials
North Charleston, South Carolina
516
mi
from 43215
North Charleston, SC
Click here to add this to my saved trials
Orange, California 92868
1959
mi
from 43215
Orange, CA
Click here to add this to my saved trials
Palo Alto, California
2099
mi
from 43215
Palo Alto, CA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
414
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
Plainfield, Indiana 46168
179
mi
from 43215
Plainfield, IN
Click here to add this to my saved trials
Plymouth, Minnesota 55441
633
mi
from 43215
Plymouth, MN
Click here to add this to my saved trials
2026
mi
from 43215
Portland, OR
Click here to add this to my saved trials
Rochester, New York
356
mi
from 43215
Rochester, NY
Click here to add this to my saved trials
Rockville, Maryland 20850
318
mi
from 43215
Rockville, MD
Click here to add this to my saved trials
Rolling Hills Estates, California 90274
1985
mi
from 43215
Rolling Hills Estates, CA
Click here to add this to my saved trials
Saint Louis, Missouri
394
mi
from 43215
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas
1138
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
San Diego, California
1951
mi
from 43215
San Diego, CA
Click here to add this to my saved trials
Sandy Springs, Georgia 30328
424
mi
from 43215
Sandy Springs, GA
Click here to add this to my saved trials
Santa Rosa, California
2109
mi
from 43215
Santa Rosa, CA
Click here to add this to my saved trials
Seattle, Washington 98105
2004
mi
from 43215
Seattle, WA
Click here to add this to my saved trials
Skokie, Illinois 60077
285
mi
from 43215
Skokie, IL
Click here to add this to my saved trials
Tacoma, Washington 98405
2013
mi
from 43215
Tacoma, WA
Click here to add this to my saved trials
Tampa, Florida
830
mi
from 43215
Tampa, FL
Click here to add this to my saved trials
Tulsa, Oklahoma
752
mi
from 43215
Tulsa, OK
Click here to add this to my saved trials
Washington, District of Columbia 20016
324
mi
from 43215
Washington,
Click here to add this to my saved trials
Ypsilanti, Michigan 48197
160
mi
from 43215
Ypsilanti, MI
Click here to add this to my saved trials