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

Last updated: December 9, 2024
Sponsor: Regeneron Pharmaceuticals
Overall Status: Completed

Phase

4

Condition

Dermatitis, Atopic

Allergies & Asthma

Hives (Urticaria)

Treatment

dupilumab

Topical emollient (moisturizer)

Clinical Study ID

NCT05590585
R668-AD-2217
  • Ages > 12
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Skin of color, defined as Fitzpatrick skin type ≥4 at screening visit

  2. Diagnosis of moderate-to-severe atopic dermatitis (AD) that cannot be adequatelycontrolled with topical AD medications, as defined in protocol

  3. Has applied a stable dose of topical emollient (moisturizer) twice daily as perphysician recommendation starting at screening visit

Exclusion

Key Exclusion Criteria:

  1. Self-reported Caucasian or White race

  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 ADassessments

  5. Current or prior use, within 12 weeks before the screening visit, of phototherapy ortanning beds

  6. Active helminthic infections; suspected or high risk of helminthic infection, unlessclinical and (if necessary) laboratory assessments have ruled out active infectionbefore 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 definedin protocol

  9. Has received a COVID-19 vaccination within 1 week of planned start of studymedication or for which the planned COVID-19 vaccinations would not be completed 1week prior to start of study drug

NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply

Study Design

Total Participants: 124
Treatment Group(s): 2
Primary Treatment: dupilumab
Phase: 4
Study Start date:
January 11, 2023
Estimated Completion Date:
November 14, 2024

Connect with a study center

  • The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • The University Of Alabama At Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Total Skin & Beauty Dermatology Center

    Birmingham, Alabama 35203
    United States

    Site Not Available

  • C2 Research Center, LLC

    Montgomery, Alabama 36117
    United States

    Site Not Available

  • Center for Dermatology Clinical Research, inc.

    Fremont, California 94538
    United States

    Site Not Available

  • The Regents of the University of California on behalf of its San Diego campus

    La Jolla, California 92093
    United States

    Site Not Available

  • UCSD/ Rady Children's Hospital

    San Diego, California 92123
    United States

    Site Not Available

  • SF Research Institute

    San Francisco, California 94127
    United States

    Site Not Available

  • UCSF

    San Francisco, California 94118
    United States

    Site Not Available

  • Century Research LLC

    Miami, Florida 33173
    United States

    Site Not Available

  • Skin and Cancer Associates, LLP

    Miami, Florida 33137
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

  • University of Miami Miller School of Medicine

    Miami, Florida 33136
    United States

    Site Not Available

  • Advanced Medical Research PC

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Atlanta Biomedical Clinical Research LLC

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Callender Center for clinical Research

    Glenn Dale, Maryland 20769
    United States

    Active - Recruiting

  • Callender Dermatology and Cosmetic Center

    Glenn Dale, Maryland 20769
    United States

    Site Not Available

  • Dermatology and Skin Cancer Specialists, LLC dba US Dermatology Partners

    Rockville, Maryland 20850
    United States

    Site Not Available

  • US Dermatology Partners DBA DermAssociates, PC

    Rockville, Maryland 20850
    United States

    Active - Recruiting

  • Wayne State Dermatology

    Dearborn, Michigan 48124
    United States

    Site Not Available

  • Wayne State University Physician Group Dermatology

    Dearborn, Michigan 48126
    United States

    Site Not Available

  • A Comprehensive Dermatology Center

    Troy, Michigan 48084
    United States

    Site Not Available

  • Revival Research Institute , LLC

    Troy, Michigan 48084
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Rao Dermatology

    Atlantic Highlands, New Jersey 07716
    United States

    Site Not Available

  • Philip Fried, MD PLLC

    Bronx, New York 10463
    United States

    Site Not Available

  • SUNY Downstate Medical Center

    Brooklyn, New York 11203
    United States

    Site Not Available

  • NYC Health + Hospital , Elmhurst Hospital Center

    Elmhurst, New York 11373
    United States

    Site Not Available

  • Northwell Health

    New Hyde Park, New York 11042
    United States

    Site Not Available

  • Markowitz Medical

    New York, New York 10128
    United States

    Site Not Available

  • Duke University (School of Medicine)

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • National Allergy and Asthma Research, LLC.

    North Charleston, South Carolina 29420
    United States

    Site Not Available

  • Alpesh D Desai, DO PLLC

    Houston, Texas 77008
    United States

    Active - Recruiting

  • Center for Clinical Studies, LTD.LLP

    Houston, Texas 77004
    United States

    Site Not Available

  • Heights Dermatology & Aesthetic Center - Heights Location

    Houston, Texas 77008
    United States

    Site Not Available

  • RFSA Dermatology

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas 78218
    United States

    Site Not Available

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