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Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial

CompletedPhase 4

Sponsor: Regeneron Pharmaceuticals

Conditions: Moderate-to-Severe Atopic Dermatitis, Atopic Eczema

Interventions: dupilumab, Topical emollient (moisturizer)

Countries: United States

The study is focused on skin of color participants who have moderate-to-severe atopic dermatitis. Atopic dermatitis, also referred to as eczema, is a condition that causes the skin to become itchy, dry, and cracked. From the previous studies on the study drug, it is seen that the study drug has an acceptable safety and effectiveness in participants with atopic dermatitis. The aim of this study is to get additional information on the safety and effectiveness of the study drug, particularly the information on aspects of atopic dermatitis in skin of color participants. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in your blood at different times * How much the study drug improves quality of life and mental health

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

1. Skin of color, defined as Fitzpatrick skin type ≥4 at screening visit
2. Diagnosis of moderate-to-severe atopic dermatitis (AD) that cannot be adequately controlled with topical AD medications, as defined in protocol
3. Has applied a stable dose of topical emollient (moisturizer) twice daily as per physician recommendation starting at screening visit

Key Exclusion Criteria:

1. Self-reported Caucasian or White race
2. Adolescent body weight less than 30 kg at screening
3. Prior use of dupilumab within 6 months of screening
4. Concomitant skin diseases or other pigmentary disorder that could confound AD assessments
5. Current or prior use, within 12 weeks before the screening visit, of phototherapy or tanning beds
6. Active helminthic infections; suspected or high risk of helminthic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before baseline
7. Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 7 days prior to baseline
8. Planned or anticipated use of any prohibited medications and procedures, as defined in protocol
9. Has received a COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study drug

NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply

Locations (30)

Birmingham, Alabama, United States
Birmingham, Alabama, United States
Montgomery, Alabama, United States
Fremont, California, United States
San Diego, California, United States
San Francisco, California, United States
San Francisco, California, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Glenn Dale, Maryland, United States
Rockville, Maryland, United States
Dearborn, Michigan, United States
Troy, Michigan, United States
St Louis, Missouri, United States
Atlantic Highlands, New Jersey, United States
Brooklyn, New York, United States
Elmhurst, New York, United States
New York, New York, United States
The Bronx, New York, United States
Durham, North Carolina, United States
Portland, Oregon, United States
North Charleston, South Carolina, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States