Who is eligible for clinical trial NCT05268107?

Participants must meet protocol criteria for Atopic Dermatitis. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05268107 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-11-04

Ethnic Differences in Mechanisms of Action of Dupilumab (NCT05268107)

🟢 Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: University of Michigan

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (21 items).

Location: University of Michigan — Ann Arbor, Michigan

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Established diagnosis of AD for at least 2 years before the screening visit and confirmed according to the American Academy of Dermatology Consensus Criteria at the time of the screening visit
Moderate-to-severe AD with involvement \> 10% of body-surface-area (BSA) and investigator global assessment (IGA) score 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the screening and baseline visits
Female subjects of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to commit to true abstinence throughout the study and for 12 weeks after the last study drug injection or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection
Subject willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Body weight less than 30 kilogram
Subjects meeting 1 or more of the following criteria at screening or baseline:
Had an exacerbation of asthma requiring hospitalization in the preceding 12 months.
Reporting asthma that has not been well-controlled (ie, symptoms occurring on \>2 days per week, nighttime awakenings 2 or more times per week, or some interference with normal activities) during the preceding 3 months
Asthma Control Test (ACT) \< 19 (only for subjects with a history of asthma).
Subjects with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis.
Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit.
Confirmed or suspected coronavirus disease 2019 (COVID-19) infection within 4 weeks before the screening or baseline visit
Received COVID-19 vaccination within 4 weeks before baseline visit
Previous treatment with dupilumab
Pregnant women (positive serum pregnancy test result at the screening visit or positive urine pregnancy test at the baseline visit), breastfeeding women, or women planning a pregnancy during the clinical study

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Michigan — Ann Arbor, Michigan

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗