Phase 4
N=124
Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial
Moderate-to-Severe Atopic Dermatitis · Atopic Eczema
Bottom Line
View on ClinicalTrials.gov: NCT05590585 ↗Enrolled (actual)
124
Serious AEs
5.7%
Results posted
Jan 2026
Primary outcome: Primary: Percentage of Participants With ≥75% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-75) — 76.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- dupilumab (Drug); Topical emollient (moisturizer) (Other)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With ≥75% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-75) |
76.0 | — |
| SECONDARY Percentage of Participants With an Investigator's Global Assessment (IGA) Score 0 to 1 |
0.9; 6.8; 15.9; 25.9; 35.2; 45.4 | — |
| SECONDARY Percent Change From Baseline in EASI Score |
-25.929; -46.092; -67.270; -70.999; -73.276; -79.185 | — |
| SECONDARY Change From Baseline in EASI Score |
-7.105; -12.097; -17.779; -18.475; -19.460; -20.985 | — |
| SECONDARY Percentage of Participants With ≥50% Reduction From Baseline in EASI Score (EASI-50) |
17.2; 47.9; 77.9; 84.3; 84.3; 89.7 | — |
| SECONDARY Percentage of Participants With ≥75% Reduction From Baseline in EASI Score (EASI-75) |
3.4; 23.1; 50.4; 56.5; 63.9; 74.2 | — |
| SECONDARY Percentage of Participants With ≥90% Reduction From Baseline in EASI Score (EASI-90) |
0.9; 5.1; 15.0; 27.8; 38.9; 41.2 | — |
| SECONDARY Percent Change From Baseline in Total Scoring Atopic Dermatitis (SCORAD) Score |
-18.5; -30.2; -44.4; -50.5; -53.2; -55.6 | — |
| SECONDARY Percentage of Participants With ≥50% Reduction From Baseline in SCORAD Score (SCORAD-50) |
9.1; 16.2; 39.3; 52.9; 59.8; 68.1 | — |
| SECONDARY Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily Peak Pruritus (PP) Numerical Rating Scale (NRS) Score ≥3 |
14.3; 31.6; 48.2; 54.6; 64.8; 68.0 | — |
| SECONDARY Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily PP NRS Score ≥4 |
8.4; 19.7; 32.5; 38.9; 44.4; 47.6 | — |
| SECONDARY Percent Change From Baseline in Weekly Average of Daily PP NRS Score |
-16.253; -28.672; -41.010; -45.944; -52.706; -54.138 | — |
| SECONDARY Change From Baseline in Weekly Average of Daily PP NRS Score |
-1.234; -2.058; -2.939; -3.237; -3.741; -3.823 | — |
| SECONDARY Percent Change From Baseline in Percent Body Surface Area (BSA) |
-17.91; -31.07; -53.09; -60.04; -64.65; -71.03 | — |
| SECONDARY Change From Baseline in Health-related Quality of Life (QOL) as Measured by Dermatology Life Quality Index (DLQI; Age ≥16) Score |
-4.5; -5.6; -6.7; -7.6; -7.6; -8.5 | — |
| SECONDARY Change From Baseline in Health-related QOL as Measured by Children's Dermatology Life Quality Index (CDLQI; Age <16) Score |
-4.2; -5.0; -5.1; -6.3; -8.5; -8.6 | — |
| SECONDARY Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score |
-5.6; -8.3; -10.3; -11.0; -11.2; -11.3 | — |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score |
-1.8; -2.3; -2.8; -3.7; -3.4; -3.4 | — |
| SECONDARY Change From Baseline in Skin Pain NRS (SP NRS) Score |
-2.3; -2.6; -3.2; -3.3; -3.0; -3.0 | — |
| SECONDARY Change From Baseline in Weekly Average Sleep Quality NRS Score |
0.473; 0.910; 1.204; 1.281; 1.239; 1.045 | — |
| SECONDARY Percentage of Participants With Patient Global Impression of Disease (PGID) Response as No Symptoms |
4.0; 4.0; 14.6; 10.0; 12.0; 14.3 | — |
| SECONDARY Percentage of Participants With PGID Response as No Symptoms or Mild Symptoms |
26.7; 46.0; 59.4; 65.6; 68.5; 64.3 | — |
| SECONDARY Percentage of Participants Who Rated Their Eczema Symptoms in the Patient Global Impression of Change (PGIC) as "Much Better" |
15.8; 23.7; 44.1; 45.6; 50.5; 55.2 | — |
| SECONDARY Percentage of Participants Who Rated Their Eczema Symptoms in the PGIC as "Moderately Better" |
14.0; 27.2; 23.4; 28.2; 27.6; 25.0 | — |
| SECONDARY Number of Participants With Non-herpetic Skin Infection Treatment-emergent Adverse Events (TEAEs) |
1 | — |
| SECONDARY Change From Baseline in Total Immunoglobulin (E) IgE |
-493.277; -2284.021; -3177.471 | — |
| SECONDARY Percent Change From Baseline in Total IgE |
-6.277; -39.703; -50.375 | — |
| SECONDARY Trough Concentration of Functional Dupilumab in Serum |
40.8; 43.9; 43.9; 49.6 | — |
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
Key Inclusion Criteria
- 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
Key Exclusion Criteria
- 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
NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply
Data sourced from ClinicalTrials.gov (NCT05590585). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.