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

Conditions

• Atopic Eczema
• Moderate-to-Severe Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• dupilumab — DRUG
  Administered by subcutaneous (SC) injection once every 2 weeks (Q2W) following a loading dose
• Topical emollient (moisturizer) — OTHER
  Moisturizer should be applied twice daily, as per physician's recommendation, as defined in protocol.

Study Details

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

Key Dates

Start date

Jan 11, 2023

Status verified

May 2026

Primary completion

Nov 14, 2024

Completion

Nov 14, 2024

Study Design

Enrollment

124 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: dupilumab
  Adolescents and adults will receive 1 of 2 dose regimens based on age and body weight

Primary Outcome Measure

Percentage of Participants With ≥75% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-75) [ Time Frame: Week 24 ]

Locations (30)

Find similar trials in Birmingham, AL