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

NCT05590585 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: R668-AD-2217
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 30

Brief 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

Conditions

Moderate-to-Severe Atopic Dermatitis; Atopic Eczema

Keywords

Eczematous Lesions; Pruritus

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With ≥75% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-75)

  The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 24.

  Week 24

Secondary Outcomes (27)

• Percentage of Participants With an Investigator's Global Assessment (IGA) Score 0 to 1

  Weeks 2, 4, 8, 12, 16, 20, and 24

• Percent Change From Baseline in EASI Score

  Weeks 2, 4, 8, 12, 16, 20, and 24

• Change From Baseline in EASI Score

  Weeks 2, 4, 8, 12, 16, 20, and 24

• Percentage of Participants With ≥50% Reduction From Baseline in EASI Score (EASI-50)

  Weeks 2, 4, 8, 12, 16, 20, and 24

• Percentage of Participants With ≥75% Reduction From Baseline in EASI Score (EASI-75)

  Weeks 2, 4, 8, 12, 16, 20, and 24

Study Arms (1)

dupilumab

EXPERIMENTAL

Adolescents and adults will receive 1 of 2 dose regimens based on age and body weight

Drug: dupilumab; Other: Topical emollient (moisturizer)

Interventions

dupilumab DRUG

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

Also known as: Dupixent®, R668, SAR231893

dupilumab

Topical emollient (moisturizer) OTHER

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

dupilumab

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Self-reported Caucasian or White race
• Adolescent body weight less than 30 kg at screening
• 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
• Active helminthic infections; suspected or high risk of helminthic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before baseline
• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (30)

Total Skin & Beauty Dermatology Center

Birmingham, Alabama, 35203, United States

Location

The University Of Alabama At Birmingham

Birmingham, Alabama, 35233, United States

Location

C2 Research Center, LLC

Montgomery, Alabama, 36117, United States

Location

Center for Dermatology Clinical Research, inc.

Fremont, California, 94538, United States

Location

UCSD/ Rady Children's Hospital

San Diego, California, 92123, United States

Location

UCSF

San Francisco, California, 94118, United States

Location

SF Research Institute

San Francisco, California, 94127, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Skin and Cancer Associates, LLP

Miami, Florida, 33137, United States

Location

Century Research LLC

Miami, Florida, 33173, United States

Location

Advanced Medical Research PC

Atlanta, Georgia, 30328, United States

Location

Atlanta Biomedical Clinical Research LLC

Atlanta, Georgia, 30331, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Callender Dermatology and Cosmetic Center

Glenn Dale, Maryland, 20769, United States

Location

Dermatology and Skin Cancer Specialists, LLC dba US Dermatology Partners

Rockville, Maryland, 20850, United States

Location

Wayne State University Physician Group Dermatology

Dearborn, Michigan, 48126, United States

Location

Revival Research Institute , LLC

Troy, Michigan, 48084, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Rao Dermatology

Atlantic Highlands, New Jersey, 07716, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

NYC Health + Hospital , Elmhurst Hospital Center

Elmhurst, New York, 11373, United States

Location

Markowitz Medical

New York, New York, 10128, United States

Location

Philip Fried, MD PLLC

The Bronx, New York, 10463, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

National Allergy and Asthma Research, LLC.

North Charleston, South Carolina, 29420, United States

Location

Center for Clinical Studies, LTD.LLP

Houston, Texas, 77004, United States

Location

Heights Dermatology & Aesthetic Center - Heights Location

Houston, Texas, 77008, United States

Location

RFSA Dermatology

San Antonio, Texas, 78213, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Pruritus

Interventions

dupilumab; Emollients

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dermatologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: January 11, 2023
• Primary Completion: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: January 2, 2026
• Results First Posted: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (30)