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Ethnic Differences in Mechanisms of Action of Dupilumab

NCT05268107 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-11-06

No results posted yet for this study

Summary

Previous research has shown that Asian and African Americans are more likely to develop atopic dermatitis (AD) than their Caucasian counterparts. However, limited information is known about AD in Asian and African American populations because most molecular studies have focused on Caucasians with AD.

This trial will determine differences in inflammatory responses to dupilumab between Caucasian, Asian, and African American patients with AD.

The central hypothesis of this study is that ethnic differences in both immune and stromal cells contribute to variability in AD presentation and response to anti-interleukin-4 receptor (IL-4R) inhibition with dupilumab.

Conditions

Interventions

DRUG

Dupilumab

Patients will be treated with dupilumab for 4 months (standard FDA-approved dosing of 600 mg subcutaneously at baseline/week 0, followed by 300 mg every 2 weeks). Skin biopsies will be assessed at baseline (lesional and non-lesional), week 2 (lesional), and week 16 (lesional). In addition, blood will be obtained at baseline and week 16.

Sponsors & Collaborators

Principal Investigators

  • Johann Gudjonsson, MD · University of Michigan

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-25
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05268107 on ClinicalTrials.gov