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COMPLETED
NCT05590585
PHASE4

Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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

Official title: An Open-Label Single-Arm Study of Dupilumab in Adolescent and Adult Skin of Color Patients With Moderate-to-Severe Atopic Dermatitis

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2023-01-11

Completion Date

2024-11-14

Last Updated

2026-05-27

Healthy Volunteers

No

Interventions

DRUG

dupilumab

Administered by subcutaneous (SC) injection once every 2 weeks (Q2W) following a loading dose

OTHER

Topical emollient (moisturizer)

Moisturizer should be applied twice daily, as per physician's recommendation, as defined in protocol.

Locations (30)

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