Actively Recruiting
Ethnic Differences in Mechanisms of Action of Dupilumab
Led by University of Michigan · Updated on 2025-11-06
30
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Ethnic Differences in Mechanisms of Action of Dupilumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Established diagnosis of atopic dermatitis for at least 2 years confirmed by American Academy of Dermatology criteria
- Moderate-to-severe atopic dermatitis involving more than 10% of body surface area
- Investigator global assessment score of 3 (moderate) at screening and baseline visits
- Female participants of childbearing potential must agree to abstinence or use approved contraception during the study and for 12 weeks after last dose
- Willingness and ability to comply with all study procedures and time commitments
You will not qualify if you...
- Body weight less than 30 kilograms
- Recent asthma exacerbation requiring hospitalization within 12 months
- Poorly controlled asthma symptoms in the past 3 months or low Asthma Control Test score if history of asthma
- History of chronic obstructive pulmonary disease or chronic bronchitis
- Skin infection within 1 week before baseline or infection requiring treatment within 2 weeks before baseline
- Confirmed or suspected COVID-19 infection within 4 weeks before screening or baseline
- COVID-19 vaccination within 4 weeks before baseline
- Previous treatment with dupilumab
- Pregnancy, breastfeeding, or planning pregnancy during the study
- History of lymphoproliferative disease or malignancy within 5 years except certain treated skin or cervical cancers
- Hypersensitivity to immunoglobulin products or lidocaine
- Known active or latent tuberculosis infection
- Known or suspected immunosuppression or frequent severe infections
- History or presence of confounding skin conditions such as psoriasis or cutaneous T-cell lymphoma
- Planned major surgery during the study
- Participation in another drug or device study within 8 weeks prior to screening
- History of alcohol or substance abuse within 6 months
- History of poor wound healing or keloid formation
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
N
Nicole Nechiporchik
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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