NCT05590585

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

Conditions

• Moderate-to-Severe Atopic Dermatitis
• Atopic Eczema

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-11
• Primary completion: 2024-11-14
• Completion: 2024-11-14
• First posted: 2022-10-21
• Last updated: 2026-01-02
• Results posted: 2026-01-02

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated drug study