Atopic Dermatitis
Conditions
Brief summary
This study examines the effect of IL4RA blockade with dupilumab on the immune cells of atopic dermatitis skin lesions.
Detailed description
This is a one-arm, open-label study to examine the effect of dupilumab. Dupilumab is a FDA-approved medication for the treatment of atopic dermatitis. This study will examine how dupilumab affects immune cells within atopic dermatitis skin lesions. Fifteen subjects with moderate to severe atopic dermatitis will be enrolled. Biopsy samples will be collected and undergo molecular profiling to correlate profiles with and to predict dupilumab treatment response.
Interventions
DRUGDupilumab
dupilumab 600 mg injection initially and then 300 mg every other week
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older 2. atopic dermatitis with a EASI (Eczema Area and Severity Index (EASI)) score of ≥7
Exclusion criteria
1. Known pregnancy 2. Known immunodeficiencies 3. Known parasitic infection -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Eczema Area and Severity Index (EASI) score from baseline to 8-12 weeks | baseline and 8-12 weeks | Change in EASI score from baseline to 8-12 weeks. Scores range from 0 to 72, with higher scores indicating more severity. |
Countries
United States
Contacts
CONTACTJeffrey Cheng, MD, PhD
PRINCIPAL_INVESTIGATORJeffrey Cheng, MD, PhD
University of California, San Francisco
PRINCIPAL_INVESTIGATORRaymond Cho, MD, PhD
University of California, San Francisco
Outcome results
None listed