Study Description
Brief 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
Condition or Disease
Moderate-to-Severe Atopic Dermatitis
Atopic Eczema
Study Design
| Study Type: | Interventional (Clinical Trial) |
| Estimated Enrollment: | 120 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-Label Single-Arm Study of Dupilumab in Adolescent and Adult Skin of Color Patients With Moderate-to-Severe Atopic Dermatitis |
| Actual Study Start Date: | January 11, 2023 |
| Estimated Primary Completion Date: | July 23, 2025 |
| Estimated Study Completion Date: | July 23, 2025 |
Eligibility Criteria
| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
- Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 7 days prior to baseline
- Planned or anticipated use of any prohibited medications and procedures, as defined in protocol
- 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