Ethnic Differences in Mechanisms of Action of Dupilumab
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of Michigan
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ Body weight less than 30 kilogram
- ✕ Subjects meeting 1 or more of the following criteria at screening or baseline:
- ✕ 1. Had an exacerbation of asthma requiring hospitalization in the preceding 12 months.
- ✕ 2. 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
- ✕ 3. Asthma Control Test (ACT) \< 19 (only for subjects with a history of asthma).
- ✕ 4. 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
Where it's recruiting
Ann Arbor
Source: ClinicalTrials.gov · NCT05268107 · last updated 2025-11-06