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

Atopic Eczema Clinical Trial

— DISCOVER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05590585
• Other study ID #: R668-AD-2217
• Status: Recruiting
• Phase: Phase 4
• Start date: January 11, 2023
• Est. completion date: July 23, 2025

Study information

• Verified date: January 2024
• Source: Regeneron Pharmaceuticals
• Contact: Clinical Trials Administrator
• Phone: 844-734-6643
• Email: clinicaltrials[@]regeneron.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 23, 2025
• Est. primary completion date: July 23, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Eczema
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Moderate-to-Severe Atopic Dermatitis

Intervention

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

Country	Name	City	State
United States	Advanced Medical Research PC	Atlanta	Georgia
United States	Atlanta Biomedical Clinical Research LLC	Atlanta	Georgia
United States	Rao Dermatology	Atlantic Highlands	New Jersey
United States	The University Of Alabama At Birmingham	Birmingham	Alabama
United States	Total Skin & Beauty Dermatology Center	Birmingham	Alabama
United States	Philip Fried, MD PLLC	Bronx	New York
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Wayne State University Physician Group Dermatology	Dearborn	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	NYC Health + Hospital , Elmhurst Hospital Center	Elmhurst	New York
United States	Center for Dermatology Clinical Research, inc.	Fremont	California
United States	Callender Dermatology and Cosmetic Center	Glenn Dale	Maryland
United States	Center for Clinical Studies, LTD.LLP	Houston	Texas
United States	Heights Dermatology & Aesthetic Center - Heights Location	Houston	Texas
United States	Century Research LLC	Miami	Florida
United States	Skin and Cancer Associates, LLP	Miami	Florida
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	C2 Research Center, LLC	Montgomery	Alabama
United States	Markowitz Medical	New York	New York
United States	National Allergy and Asthma Research, LLC.	North Charleston	South Carolina
United States	Oregon Health & Science University	Portland	Oregon
United States	Dermatology and Skin Cancer Specialists, LLC dba US Dermatology Partners	Rockville	Maryland
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	RFSA Dermatology	San Antonio	Texas
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
United States	UCSD/ Rady Children's Hospital	San Diego	California
United States	SF Research Institute	San Francisco	California
United States	UCSF	San Francisco	California
United States	Revival Research Institute , LLC	Troy	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in total and allergen-specific immunoglobulin (E) IgEs		Baseline to Weeks 4, 12 and 24
Secondary	Percent change in total and allergen-specific IgEs		Baseline to Weeks 4, 12 and 24
Secondary	Trough concentration of functional dupilumab in serum		At Baseline, Week 12 and Week 24