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

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Clinical Trials Administrator; Phone Number: 844-734-6643; Email: clinicaltrials@regeneron.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • The University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35203
      • Recruiting
      • Total Skin & Beauty Dermatology Center
    • Montgomery, Alabama, United States, 36117
      • Recruiting
      • C2 Research Center, Llc
  • California
    • Fremont, California, United States, 94538
      • Recruiting
      • Center For Dermatology Clinical Research, Inc.
    • San Diego, California, United States, 92123
      • Recruiting
      • UCSD/ Rady Children's Hospital
    • San Francisco, California, United States, 94118
      • Recruiting
      • UCSF
    • San Francisco, California, United States, 94127
      • Recruiting
      • SF Research Institute
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami Miller School of Medicine
    • Miami, Florida, United States, 33137
      • Recruiting
      • Skin and Cancer Associates, LLP
    • Miami, Florida, United States, 33173
      • Terminated
      • Century Research LLC
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Recruiting
      • Advanced Medical Research Pc
    • Atlanta, Georgia, United States, 30331
      • Recruiting
      • Atlanta Biomedical Clinical Research LLC
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Memorial Hospital
  • Maryland
    • Glenn Dale, Maryland, United States, 20769
      • Recruiting
      • Callender Dermatology and Cosmetic Center
    • Rockville, Maryland, United States, 20850
      • Recruiting
      • Dermatology and Skin Cancer Specialists, LLC dba US Dermatology Partners
  • Michigan
    • Dearborn, Michigan, United States, 48126
      • Recruiting
      • Wayne State University Physician Group Dermatology
    • Troy, Michigan, United States, 48084
      • Recruiting
      • Revival Research Institute , LLC
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
  • New Jersey
    • Atlantic Highlands, New Jersey, United States, 07716
      • Recruiting
      • Rao Dermatology
  • New York
    • Bronx, New York, United States, 10463
      • Recruiting
      • Philip Fried, MD PLLC
    • Brooklyn, New York, United States, 11203
      • Recruiting
      • SUNY Downstate Medical Center
    • Elmhurst, New York, United States, 11373
      • Recruiting
      • NYC Health + Hospital , Elmhurst Hospital Center
    • New York, New York, United States, 10128
      • Recruiting
      • Markowitz Medical
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
  • South Carolina
    • North Charleston, South Carolina, United States, 29420
      • Recruiting
      • National Allergy and Asthma Research, LLC.
  • Texas
    • Houston, Texas, United States, 77004
      • Recruiting
      • Center for Clinical Studies, LTD.LLP
    • Houston, Texas, United States, 77008
      • Recruiting
      • Heights Dermatology & Aesthetic Center - Heights Location
    • San Antonio, Texas, United States, 78218
      • Recruiting
      • Texas Dermatology and Laser Specialists
    • San Antonio, Texas, United States, 78213
      • Recruiting
      • 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
Proportion of participants with eczema area and severity index (EASI)-75	EASI is a composite index measuring the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. EASI-75 is ≥75% reduction from baseline in EASI.	At Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with Investigator's Global Assessment (IGA) = 0 to 1	IGA is an assessment scale used to determine severity of 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.	Each Visit, Baseline Through Week 24
Percent change from baseline in EASI	EASI is a composite index measuring the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.	Each Visit, Baseline Through Week 24
Absolute change from baseline in EASI	EASI is a composite index measuring the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.	Each Visit, Baseline Through Week 24
Proportion of participants with EASI-50	EASI is a composite index measuring the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. EASI-50 is ≥50% reduction from baseline in EASI	Each Visit, Baseline Through Week 24
Proportion of participants with EASI-75	EASI is a composite index measuring the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. EASI-75 is ≥75% reduction from baseline in EASI	Each Visit, Baseline Through Week 24
Proportion of participants with EASI-90	EASI is a composite index measuring the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. EASI-90 is ≥90% reduction from baseline in EASI	Each Visit, Baseline Through Week 24
Percent change from baseline in total SCORing atopic dermatitis (AD) (SCORAD) component scores	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).	Each Visit, Baseline Through Week 24
Proportion of participants with 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.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). SCORAD-50 is ≥50% reduction in SCORAD	Each Visit, Baseline Through Week 24
Proportion of participants with improvement (reduction) of weekly average of daily Peak Pruritus (PP) Numerical Rating Scale (NRS) ≥3 from baseline	Peak Pruritus NRS is a simple assessment tool that participants will use to report the average intensity of their pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable)	Each Visit, Baseline Through Week 24
Proportion of participants with improvement (reduction) of weekly average of daily PP NRS ≥4	Peak Pruritus NRS is a simple assessment tool that participants will use to report the average intensity of their pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable)	Each Visit, Baseline Through Week 24
Percent change from baseline in weekly average of daily PP NRS	Peak Pruritus NRS is a simple assessment tool that participants will use to report the average intensity of their pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable)	Each Visit, Baseline Through Week 24
Absolute change from baseline in weekly average of daily PP NRS	Peak Pruritus NRS is a simple assessment tool that participants will use to report the average intensity of their pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable)	Each Visit, Baseline Through Week 24
Change from baseline in percent body surface area (BSA)	BSA affected by AD will be assessed for each section of the body using the rule of nines (the possible highest score for each region is: head and neck [9%], interior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) and will be reported as a percentage of all major body sections combined.	Each Visit, Baseline Through Week 24
Change from baseline in health-related quality of life (QOL) as measured by Dermatology Life Quality Index (DLQI; age ≥16)	DLQI 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 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.	Each Visit, Baseline Through Week 24
Change from baseline in health-related QOL as measured by Children's Dermatology Life Quality Index (CDLQI; age <16)	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 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL in children.	Each Visit, Baseline Through Week 24
Change from baseline in Patient Oriented Eczema Measure (POEM)	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) (high score indicative of poor quality of life [QOL]).	Each Visit, Baseline Through Week 24
Change from baseline in Hospital Anxiety and Depression Scale (HADS)	HADS is a 14-item questionnaire, (7)for anxiety and (7) for depression symptoms; possible scores range from 0 to 21 for each subscale. The following cut-off scores are recommended for both subscales: 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.	Each Visit, Baseline Through Week 24
Change from baseline in Skin Pain NRS (SP NRS)	SP NRS Scale is an assessment tool used to report the intensity of a patient's pain. Patients will select the number between 0 and 10 that fits best to their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain possible).	Each Visit, From Baseline Through Week 24
Change from baseline in weekly average Sleep Quality NRS	Sleep Quality NRS is an 11-point scale (0 to 10) in which 0 indicates worst possible sleep while 10 indicates best possible sleep.	Each Visit, Baseline Through Week 24
Proportion of 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.	Each Visit, Through Week 24
Proportion 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.	Each Visit, Through Week 24
Proportion of participants who rate 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 since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change"	Each Visit, Through Week 24
Proportion of participants who rate their eczema symptoms in PGIC as "Much better" or "Moderately better"	The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change"	Each Visit, Through Week 24
Incidence of non-herpetic skin infection treatment-emergent adverse events (TEAEs)	TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.	Through Last Study Visit, at Week 24
Change in total and allergen-specific immunoglobulin (E) IgEs		Baseline to Weeks 4, 12 and 24
Percent change in total and allergen-specific IgEs		Baseline to Weeks 4, 12 and 24
Trough concentration of functional dupilumab in serum		At Baseline, Week 12 and Week 24

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Estimated): July 23, 2025
• Study Completion (Estimated): July 23, 2025

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): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Pruritus; Eczematous Lesions
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Dermatologic Agents; Emollients
• 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