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

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

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

Study Overview

• Status: Completed
• Conditions: Moderate-to-Severe Atopic Dermatitis; Atopic Eczema
• Intervention / Treatment: Drug: dupilumab; Other: Topical emollient (moisturizer)

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • The University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35203
      • Total Skin & Beauty Dermatology Center
    • Montgomery, Alabama, United States, 36117
      • C2 Research Center, LLC
  • California
    • Fremont, California, United States, 94538
      • Center For Dermatology Clinical Research, Inc.
    • San Diego, California, United States, 92123
      • UCSD/ Rady Children's Hospital
    • San Francisco, California, United States, 94118
      • UCSF
    • San Francisco, California, United States, 94127
      • SF Research Institute
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine
    • Miami, Florida, United States, 33173
      • Century Research LLC
    • Miami, Florida, United States, 33137
      • Skin and Cancer Associates, LLP
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Advanced Medical Research PC
    • Atlanta, Georgia, United States, 30331
      • Atlanta Biomedical Clinical Research LLC
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • Maryland
    • Glenn Dale, Maryland, United States, 20769
      • Callender Dermatology and Cosmetic Center
    • Rockville, Maryland, United States, 20850
      • Dermatology and Skin Cancer Specialists, LLC dba US Dermatology Partners
  • Michigan
    • Dearborn, Michigan, United States, 48126
      • Wayne State University Physician Group Dermatology
    • Troy, Michigan, United States, 48084
      • Revival Research Institute , LLC
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New Jersey
    • Atlantic Highlands, New Jersey, United States, 07716
      • Rao Dermatology
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate Medical Center
    • Elmhurst, New York, United States, 11373
      • NYC Health + Hospital , Elmhurst Hospital Center
    • New York, New York, United States, 10128
      • Markowitz Medical
    • The Bronx, New York, United States, 10463
      • Philip Fried, MD PLLC
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • South Carolina
    • North Charleston, South Carolina, United States, 29420
      • National Allergy and Asthma Research, LLC.
  • Texas
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies, LTD.LLP
    • Houston, Texas, United States, 77008
      • Heights Dermatology & Aesthetic Center - Heights Location
    • San Antonio, Texas, United States, 78218
      • Texas Dermatology and Laser Specialists
    • San Antonio, Texas, United States, 78213
      • RFSA Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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

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 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

NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dupilumab; Adolescents and adults will receive 1 of 2 dose regimens based on age and body weight	Drug: dupilumab; Administered by subcutaneous (SC) injection once every 2 weeks (Q2W) following a loading dose; Other Names: SAR231893; Dupixent®; R668; Other: Topical emollient (moisturizer); Moisturizer should be applied twice daily, as per physician's recommendation, as defined in protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With an Investigator's Global Assessment (IGA) Score 0 to 1	IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Percentage of participants with IGA "0" or "1" are reported at each visit.	Weeks 2, 4, 8, 12, 16, 20, and 24
Percent Change From Baseline in EASI Score	The Eczema Area and Severity Index (EASI) score was used to measure the severity and extent of 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.	Weeks 2, 4, 8, 12, 16, 20, and 24
Change From Baseline in EASI Score	The Eczema Area and Severity Index (EASI) score was used to measure the severity and extent of 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.	Weeks 2, 4, 8, 12, 16, 20, and 24
Percentage of Participants With ≥50% Reduction From Baseline in EASI Score (EASI-50)	The EASI score was used to measure the severity and extent of 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-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to the given time point.	Weeks 2, 4, 8, 12, 16, 20, and 24
Percentage of Participants With ≥75% Reduction From Baseline in EASI Score (EASI-75)	The EASI score was used to measure the severity and extent of 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 the given time point.	Weeks 2, 4, 8, 12, 16, 20, and 24
Percentage of Participants With ≥90% Reduction From Baseline in EASI Score (EASI-90)	The EASI score was used to measure the severity and extent of 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-90 responders were the participants who achieved ≥90% overall improvement in EASI score from baseline to the given time point.	Weeks 2, 4, 8, 12, 16, 20, and 24
Percent Change From Baseline in Total Scoring Atopic Dermatitis (SCORAD) Score	The SCORAD index is a clinical tool for assessing the severity of atopic dermatitis. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).	Weeks 2, 4, 8, 12, 16, 20, and 24
Percentage of Participants With ≥50% Reduction From Baseline in SCORAD Score (SCORAD-50)	SCORAD index is a clinical tool for assessing the severity of atopic dermatitis. Extent and intensity of eczema as well as subjective signs insomnia, etc.) were assessed and scored. Total score ranged from 0 (absent disease) to 103 (severe disease). A decrease in score indicated improvement. SCORAD-50 was defined as ≥50% reduction from baseline in SCORAD score.	Weeks 2, 4, 8, 12, 16, 20, and 24
Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily Peak Pruritus (PP) Numerical Rating Scale (NRS) Score ≥3	Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. A decrease in score indicated improvement.	Weeks 2, 4, 8, 12, 16, 20, and 24
Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily PP NRS Score ≥4	Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. A decrease in score indicated improvement.	Weeks 2, 4, 8, 12, 16, 20, and 24
Percent Change From Baseline in Weekly Average of Daily PP NRS Score	Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. A decrease in score indicated improvement.	Weeks 2, 4, 8, 12, 16, 20, and 24
Change From Baseline in Weekly Average of Daily PP NRS Score	Peak Pruritus NRS is an assessment tool used by subjects to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. A decrease in score indicated improvement.	Weeks 2, 4, 8, 12, 16, 20, and 24
Percent Change From Baseline in Percent Body Surface Area (BSA)	BSA affected by AD was assessed for each section of the body using the rule of nines (the possible highest score for each region was: head and neck [9%], interior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). BSA was reported as a percentage of all major body sections combined.	Weeks 2, 4, 8, 12, 16, 20, and 24
Change From Baseline in Health-related Quality of Life (QOL) as Measured by Dermatology Life Quality Index (DLQI; Age ≥16) Score	DLQI is a 10-item, validated questionnaire to assess the impact of AD disease symptoms and treatment on QOL; over the past week, with an overall scoring of 0 (no effect on QoL) to 30 (extremely large effect on QoL). A decrease in score indicated improvement.	Weeks 2, 4, 8, 12, 16, 20, and 24
Change From Baseline in Health-related QOL as Measured by Children's Dermatology Life Quality Index (CDLQI; Age <16) Score	CDLQI is a 10-item, validated questionnaire to assess the impact of AD disease symptoms and treatment on quality of life (QOL); over the past week, with an overall scoring of 0 (no effect on QoL) to 30 (extremely large effect on QoL) in children. A decrease in score indicated improvement.	Weeks 2, 4, 8, 12, 16, 20, and 24
Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score	POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (Higher score indicative of more severe symptoms). Total score was an average of the disease symptoms assessed. A decrease in score indicated improvement.	Weeks 2, 4, 8, 12, 16, 20, and 24
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score	The Hospital Anxiety and Depression Scale (HADS) is a screening tool designed to assess anxiety and depression. The scale consists of 14 items, divided into two subscales: Anxiety (HADS-A): 7 items; Depression (HADS-D): 7 items. The range of the total score is 0-42 (sum of HADS-A and HADS-D), with higher score indicating more severe overall psychological distress. The two subscales can be reported separately, each with a score range of 0-21, with higher score indicating more severe symptoms of anxiety or depression. A decrease in either the total score or a subscale score indicates improvement.	Weeks 2, 4, 8, 12, 16, 20, and 24
Change From Baseline in Skin Pain NRS (SP NRS) Score	SP NRS Scale is an assessment tool used to report the intensity of a participant's pain. Participants selected the number between 0 and 10 that fit best to their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain imaginable). A decrease in score indicated improvement.	Weeks 2, 4, 8, 12, 16, 20, and 24
Change From Baseline in Weekly Average Sleep Quality NRS Score	Sleep Quality NRS is an 11-point scale (0 to 10) in which 0 indicated worst possible sleep while 10 indicated best possible sleep. An increase in score indicated improvement.	Weeks 2, 4, 8, 12, 16, 20, and 24
Percentage of Participants With Patient Global Impression of Disease (PGID) Response as No Symptoms	PGID is a single 1-item questionnaire designed to assess participant's overall impression of disease severity during the past 7 days with a 5-level scale of no symptoms, mild, moderate, severe or very severe. Data are reported for the percentage of participants with a PGID response of "No symptoms" at the specified timepoints.	Weeks 2, 4, 8, 12, 16, 20, and 24
Percentage of Participants With PGID Response as No Symptoms or Mild Symptoms	PGID is a single 1-item questionnaire designed to assess participant's overall impression of disease severity during the past 7 days with a 5-level scale of no symptoms, mild, moderate, severe or very severe. Data are reported for the percentage of participants with a PGID response of "No symptoms" or "Mild symptoms" at the specified timepoints.	Weeks 2, 4, 8, 12, 16, 20, and 24
Percentage of Participants Who Rated Their Eczema Symptoms in the Patient Global Impression of Change (PGIC) as "Much Better"	The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change in eczema symptoms since starting treatment as rated on a 7-point Likert scale anchored by (1) "much better" to (7) "much worse", with (4) = "no change". Data are reported for the percentage of participants who rated their eczema symptoms as "Much better" at the specified timepoints.	Weeks 2, 4, 8, 12, 16, 20, and 24
Percentage of Participants Who Rated Their Eczema Symptoms in the PGIC as "Moderately Better"	The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change in eczema symptoms since starting treatment as rated on a 7-point Likert scale anchored by (1) "much better" to (7) "much worse", with (4) = "no change". Data are reported for the percentage of participants who rated their eczema symptoms as "Moderately better" at the specified timepoints.	Weeks 2, 4, 8, 12, 16, 20, and 24
Number of Participants With Non-herpetic Skin Infection Treatment-emergent Adverse Events (TEAEs)	A TEAE is any untoward medical occurrence in a participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Data are reported for the number of participants with non-herpetic skin infection TEAEs. A summary of all serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.	Day 1 through Week 24
Change From Baseline in Total Immunoglobulin (E) IgE	Serum samples were collected to measure concentrations of IgE.	Weeks 4, 12 and 24
Percent Change From Baseline in Total IgE	Serum samples were collected to measure concentrations of IgE.	Weeks 4, 12 and 24
Trough Concentration of Functional Dupilumab in Serum	Adolescents and adults received 1 of 2 dose regimens based on age and body weight. The trough concentration of functional dupilumab in serum for the 2 dose regimens at the specified time points are presented. Participants treated and had at least one evaluable post-first-dose concentration measurement.	Week 12 and Week 24

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Sanofi
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Publications and helpful links

Helpful Links

• A Plain Language Summary is available on TrialSummaries.com

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Actual): November 14, 2024
• Study Completion (Actual): November 14, 2024

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pruritus; Eczematous Lesions
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Skin Manifestations; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Dermatitis, Atopic; Pruritus; Dermatologic Agents; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Emollients; dupilumab
• Other Study ID Numbers: R668-AD-2217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
• IPD Sharing 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.
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No