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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
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

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Atlanta Biomedical Clinical Research LLC
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Advanced Medical Research, PC
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Rao Dermatology
Coordinator of this site? Confirm its status
Atlantic HighlandsUnited StatesUnknown status
The University of Alabama at Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
Total Skin & Beauty Dermatology Center
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
SUNY Downstate Medical Center
Coordinator of this site? Confirm its status
BrooklynUnited StatesUnknown status
Northwestern Memorial Hospital
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Wayne State University Physician Group Dermatology
Coordinator of this site? Confirm its status
DearbornUnited StatesUnknown status
Duke University Medical Center
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DurhamUnited StatesUnknown status
NYC Health + Hospital , Elmhurst Hospital Center
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ElmhurstUnited StatesUnknown status
Center For Dermatology Clinical Research, Inc.
Coordinator of this site? Confirm its status
FremontUnited StatesUnknown status
Callender Dermatology and Cosmetic Center
Coordinator of this site? Confirm its status
Glenn DaleUnited StatesUnknown status
Center for Clinical Studies, LTD. LLP
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Heights Dermatology & Aesthetic Center - Heights Location
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HoustonUnited StatesUnknown status
Skin and Cancer Associates, LLP
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MiamiUnited StatesUnknown status
University of Miami Miller School of Medicine
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MiamiUnited StatesUnknown status
Century Research LLC
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MiamiUnited StatesUnknown status
C2 Research Center, LLC
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MontgomeryUnited StatesUnknown status
Markowitz Medical
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New YorkUnited StatesUnknown status
National Allergy and Asthma Research, LLC
Coordinator of this site? Confirm its status
North CharlestonUnited StatesUnknown status
Oregon Health Science University
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status
Dermatology and Skin Cancer Specialists, LLC dba US Dermatology Partners
Coordinator of this site? Confirm its status
RockvilleUnited StatesUnknown status
Texas Dermatology and Laser Specialists
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San AntonioUnited StatesUnknown status
RFSA Dermatology
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San AntonioUnited StatesUnknown status
UCSD/ Rady Children's Hospital
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San DiegoUnited StatesUnknown status
UCSF
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San FranciscoUnited StatesUnknown status
SF Research Institute
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San FranciscoUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
Philip Fried, MD PLLC
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The BronxUnited StatesUnknown status
Revival Research Institute, LLC
Coordinator of this site? Confirm its status
TroyUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.