NCT05590585CompletedPhase 4
Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial
An Open-Label Single-Arm Study of Dupilumab in Adolescent and Adult Skin of Color Patients With Moderate-to-Severe Atopic Dermatitis
Source: ClinicalTrials.gov · Last updated 27 May 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 124 (actual)
- First submitted
- 18 Oct 2022
- Start date
- 11 Jan 2023
- Primary completion date
- 14 Nov 2024
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05590585
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 124
- From 11 Jan 2023 to the primary completion date, 14 Nov 2024
- 30 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Lab values
- Active helminthic infections; suspected or high risk of helminthic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before baseline
Other
- Self-reported Caucasian or White race
- Adolescent body weight less than 30 kg at screening
Who the study is looking for
- 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
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Atlanta Biomedical Clinical Research LLC Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Advanced Medical Research, PC Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Rao Dermatology Coordinator of this site? Confirm its status | Atlantic Highlands | United States | Unknown status |
| The University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Total Skin & Beauty Dermatology Center Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| SUNY Downstate Medical Center Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| Northwestern Memorial Hospital Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Wayne State University Physician Group Dermatology Coordinator of this site? Confirm its status | Dearborn | United States | Unknown status |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| NYC Health + Hospital , Elmhurst Hospital Center Coordinator of this site? Confirm its status | Elmhurst | United States | Unknown status |
| Center For Dermatology Clinical Research, Inc. Coordinator of this site? Confirm its status | Fremont | United States | Unknown status |
| Callender Dermatology and Cosmetic Center Coordinator of this site? Confirm its status | Glenn Dale | United States | Unknown status |
| Center for Clinical Studies, LTD. LLP Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Heights Dermatology & Aesthetic Center - Heights Location Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Skin and Cancer Associates, LLP Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| University of Miami Miller School of Medicine Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Century Research LLC Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| C2 Research Center, LLC Coordinator of this site? Confirm its status | Montgomery | United States | Unknown status |
| Markowitz Medical Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| National Allergy and Asthma Research, LLC Coordinator of this site? Confirm its status | North Charleston | United States | Unknown status |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Dermatology and Skin Cancer Specialists, LLC dba US Dermatology Partners Coordinator of this site? Confirm its status | Rockville | United States | Unknown status |
| Texas Dermatology and Laser Specialists Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| RFSA Dermatology Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| UCSD/ Rady Children's Hospital Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| UCSF Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| SF Research Institute Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Philip Fried, MD PLLC Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Revival Research Institute, LLC Coordinator of this site? Confirm its status | Troy | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.