Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczem… (NCT05590585) | Clinical Trial Compass
CompletedPhase 4
Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial
United States124 participantsStarted 2023-01-11
Plain-language summary
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
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
✓. Skin of color, defined as Fitzpatrick skin type ≥4 at screening visit
✓. Diagnosis of moderate-to-severe atopic dermatitis (AD) that cannot be adequately controlled with topical AD medications, as defined in protocol
✓. Has applied a stable dose of topical emollient (moisturizer) twice daily as per physician recommendation starting at screening visit
Exclusion criteria
✕. Self-reported Caucasian or White race
✕. Adolescent body weight less than 30 kg at screening
✕. Prior use of dupilumab within 6 months of screening
✕. Concomitant skin diseases or other pigmentary disorder that could confound AD assessments
✕. Current or prior use, within 12 weeks before the screening visit, of phototherapy or tanning beds
✕. Active helminthic infections; suspected or high risk of helminthic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before baseline
What they're measuring
1
Percentage of Participants With ≥75% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-75)