Ethnic Differences in Mechanisms of Action of Dupilumab
University of Michigan
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugDupilumab
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.
Location
- University of MichiganAnn Arbor, Michigan