Dupilumab In Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-seVere Eczema tRial

• Status: Not yet recruiting
• Trial end date: 2025-07-23
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is:

• To describe further the efficacy of dupilumab on extent and severity of eczematous lesions in skin of color participants, at least (≥)12 years old, with moderate-to-severe atopic dermatitis (AD)

The secondary objectives of the study are:

• To describe further the efficacy of dupilumab on pruritus and other AD symptoms in skin of color participants, ≥12 years old, with moderate-to-severe AD

• To describe further the efficacy of dupilumab on measures of mental health (anxiety and depression) and quality of life (QOL) in skin of color participants, ≥12 years old, with moderate-to-severe AD

• To describe further the safety of dupilumab administered to skin of color participants, ≥12 years old, with moderate-to-severe AD

• To assess dupilumab modulation of type 2 biomarkers in skin of color participants, ≥12 years old, with moderate-to-severe AD

• To evaluate further the systemic exposure of dupilumab in skin of color participants, ≥12 years old, with moderate-to-severe AD

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Collaborator: Sanofi
• Treatments: Emollients

Criteria

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