Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial
NCT ID: NCT05590585
Last Updated: 2026-01-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
124 participants
INTERVENTIONAL
2023-01-11
2024-11-14
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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dupilumab
Adolescents and adults will receive 1 of 2 dose regimens based on age and body weight
dupilumab
Administered by subcutaneous (SC) injection once every 2 weeks (Q2W) following a loading dose
Topical emollient (moisturizer)
Moisturizer should be applied twice daily, as per physician's recommendation, as defined in protocol.
Interventions
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dupilumab
Administered by subcutaneous (SC) injection once every 2 weeks (Q2W) following a loading dose
Topical emollient (moisturizer)
Moisturizer should be applied twice daily, as per physician's recommendation, as defined in protocol.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
12 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Total Skin & Beauty Dermatology Center
Birmingham, Alabama, United States
The University Of Alabama At Birmingham
Birmingham, Alabama, United States
C2 Research Center, LLC
Montgomery, Alabama, United States
Center for Dermatology Clinical Research, inc.
Fremont, California, United States
UCSD/ Rady Children's Hospital
San Diego, California, United States
UCSF
San Francisco, California, United States
SF Research Institute
San Francisco, California, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Skin and Cancer Associates, LLP
Miami, Florida, United States
Century Research LLC
Miami, Florida, United States
Advanced Medical Research PC
Atlanta, Georgia, United States
Atlanta Biomedical Clinical Research LLC
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Callender Dermatology and Cosmetic Center
Glenn Dale, Maryland, United States
Dermatology and Skin Cancer Specialists, LLC dba US Dermatology Partners
Rockville, Maryland, United States
Wayne State University Physician Group Dermatology
Dearborn, Michigan, United States
Revival Research Institute , LLC
Troy, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Rao Dermatology
Atlantic Highlands, New Jersey, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
NYC Health + Hospital , Elmhurst Hospital Center
Elmhurst, New York, United States
Markowitz Medical
New York, New York, United States
Philip Fried, MD PLLC
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
National Allergy and Asthma Research, LLC.
North Charleston, South Carolina, United States
Center for Clinical Studies, LTD.LLP
Houston, Texas, United States
Heights Dermatology & Aesthetic Center - Heights Location
Houston, Texas, United States
RFSA Dermatology
San Antonio, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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R668-AD-2217
Identifier Type: -
Identifier Source: org_study_id
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