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

NCT03346434

CompletedPhase 2, Phase 3

Sponsor: Regeneron Pharmaceuticals

Conditions: Dermatitis, Atopic

Interventions: Dupilumab, Matching placebo

Countries: United States, Germany, Poland, United Kingdom

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 moderate-to-severe atopic dermatitis (AD).

Eligibility overview

Sex: ALL

Age: 6 Months to 5 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria

* Diagnosis of atopic dermatitis (AD) according to the American Academy of Dermatology consensus criteria at the screening visit
* Participants with documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s)
* IGA score at screening and baseline visits
* part A: IGA = 4
* part B: IGA ≥3
* EASI score at screening and baseline visits
* part A: EASI ≥21
* part B: EASI ≥16
* Body Surface Area (BSA) involvement at screening and baseline visits
* part A: ≥15%
* part B: ≥10%
* At least 11 (of a total of 14\*) applications of a topical emollient (moisturizer) during the 7 consecutive days immediately before the baseline visit (not including the day of randomization) (for part B of the study only)
* Baseline worst scratch/itch score weekly average score for maximum scratch/itch intensity ≥4 (for part B of the study only)
* At least 11 (of a total of 14) daily applications of low potency TCS during the 2-week TCS standardization period (beginning on day -14) leading up to the baseline visit (for part B of the study only).

Key Exclusion Criteria

* Prior treatment with dupilumab
* History of important side effects of low potency topical corticosteroids (only applicable for part B of the study)
* Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit
* Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
* Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit.
* Known or suspected immunodeficiency, known history of human immunodeficiency virus (HIV) infection or HIV seropositivity at the screening visit, established diagnosis of HBV infection or HBV seropositivity at screening, established diagnosis of HCV infection or HCV seropositivity at screening
* History of malignancy at any time before the baseline visit
* Diagnosed active endoparasitic infections or at high risk of these infections
* Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study
* Body weight \<5 kg or ≥30 kg at baseline (only applicable part B of the study)

Note: Other protocol defined Inclusion/ Exclusion criteria apply

Locations (48)

Birmingham, Alabama, United States
Gilbert, Arizona, United States
Long Beach, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
Rolling Hills Estates, California, United States
San Diego, California, United States
Washington D.C., District of Columbia, United States
Coral Gables, Florida, United States
Tampa, Florida, United States
Columbus, Georgia, United States
Macon, Georgia, United States
Sandy Springs, Georgia, United States
Chicago, Illinois, United States
Rockville, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Ypsilanti, Michigan, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Hackensack, New Jersey, United States
Forest Hills, New York, United States
New York, New York, United States
Rochester, New York, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
North Charleston, South Carolina, United States
Austin, Texas, United States
San Antonio, Texas, United States
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