MedTrace Logo

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

NCT05590585 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2026-01-02

Study results available
· View outcomes & findings →

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-11
Primary Completion
2024-11-14
Completion
2024-11-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05590585 on ClinicalTrials.gov