Ethnic Differences in Mechanisms of Action of Dupilumab

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT05268107
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 25, 2023
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Dupilumab
    The 3 groups of patients (Asian, African American, and Caucasian) will all receive the same intervention.

Primary Outcome Measure

Difference in inflammatory response to dupilumab between Caucasian, Asian and African American patients with atopic dermatitis as measured by change in expression of interleukin4 (IL4) from week 0 to 2. [ Time Frame: Week 0, week 2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Nicole Nechiporchik
[email protected]
734-936-7519

Find similar trials in Ann Arbor, MI

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
University of Michigan· Ann Arbor, MI

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