Molecular Signatures of Cutaneous Dupilumab Response
- Registration Number
- NCT05858619
- Lead Sponsor
- University of California, San Francisco
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
- 18 years of age or older
- atopic dermatitis with a EASI (Eczema Area and Severity Index (EASI)) score of ≥7
- Known pregnancy
- Known immunodeficiencies
- Known parasitic infection -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description dupilumab treatment Dupilumab Treatment with IL4RA inhibitor
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of California, San Francisco
🇺🇸San Francisco, California, United States