Safety, Pharmacokinetics and Efficacy of Dupilumab in Patients ≥6 Months to <6 Years With Severe Atopic Dermatitis (Liberty AD PRESCHOOL)



Status:Recruiting
Conditions:Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:Any - 5
Updated:12/5/2018
Start Date:November 30, 2017
End Date:November 2, 2021
Contact:Clinical Trials Administrator
Email:clinicaltrials@regeneron.com
Phone:844-734-6643

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

A Phase 2/3 Study Investigating the Pharmacokinetics, Safety, and Efficacy of Dupilumab in Patients Aged ≥6 Months to <6 Years With Severe Atopic Dermatitis

This study is a 2-part (parts A and B) phase 2/3 study to evaluate the safety,
pharmacokinetics (PK) and efficacy of dupilumab in participants 6 months to less than 6 years
of age with severe atopic dermatitis (AD).

1. Part A (open-label, single-ascending-dose, sequential cohort phase 2 study):

- Primary objective is to characterize the safety and PK of dupilumab administered as
a single dose in pediatric participants, 6 months to less than 6 years of age, with
severe AD.

- Secondary objective is to evaluate the efficacy and immunogenicity of a single dose
of dupilumab in participants 6 months to less than 6 years of age with severe AD

2. Part B (randomized, double-blind, parallel-group, placebo-controlled phase 3 study):

- Primary objective is to demonstrate the efficacy of multiple doses of dupilumab
over 16 weeks of treatment when administered concomitantly with topical
corticosteroids (TCS) in pediatric participants, 6 months to less than 6 years of
age, with severe AD.

- Secondary objective is to assess the safety and immunogenicity of multiple doses of
dupilumab over 16 weeks of treatment when administered concomitantly with TCS in
participants 6 months to less than 6 years of age with severe AD

Key Inclusion Criteria

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

2. Participants with documented recent history (within 6 months before the screening
visit) of inadequate response to topical AD medication(s)

3. IGA = 4 at screening and baseline visits

4. EASI ≥21 at screening and baseline visits

5. Body Surface Area (BSA) ≥15% at screening and baseline visits

Key Exclusion Criteria

1. Participation in a prior dupilumab clinical study

2. History of important side effects of medium potency topical corticosteroids (only
applicable for part B of the study)

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

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

5. Active chronic or acute infection requiring treatment with systemic antibiotics,
antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit.

6. Known history of human immunodeficiency virus (HIV) infection or HIV seropositivity at
the screening visit

7. History of malignancy at any time before the baseline visit

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

9. 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 apply
We found this trial at
23
sites
Minneapolis, Minnesota
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Ann Arbor, Michigan 48103
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Birmingham, Alabama
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boston, Massachusetts
?
mi
from
Boston, MA
Click here to add this to my saved trials
Centennial, Colorado
?
mi
from
Centennial, CO
Click here to add this to my saved trials
Charleston, South Carolina
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Chicago, Illinois
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Columbus, Georgia
?
mi
from
Columbus, GA
Click here to add this to my saved trials
Coral Gables, Florida 33134
?
mi
from
Coral Gables, FL
Click here to add this to my saved trials
Forest Hills, New York 11375
?
mi
from
Forest Hills, NY
Click here to add this to my saved trials
Lebanon, New Hampshire
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
Los Angeles, California
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Macon, Georgia 31217
?
mi
from
Macon, GA
Click here to add this to my saved trials
Muenster, North Rhine-Westphal 48149
?
mi
from
Muenster,
Click here to add this to my saved trials
Norfolk, Virginia 23502
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Orange, California 92868
?
mi
from
Orange, CA
Click here to add this to my saved trials
Palo Alto, California
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
Saint Louis, Missouri
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Tacoma, Washington 98405
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Tampa, Florida
?
mi
from
Tampa, FL
Click here to add this to my saved trials