Molecular Signatures of Cutaneous Dupilumab Response
Overview
- Phase
- Phase 4
- Intervention
- Dupilumab
- Conditions
- Atopic Dermatitis
- Sponsor
- University of California, San Francisco
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change in Eczema Area and Severity Index (EASI) score from baseline to 8-12 weeks
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years of age or older
- •atopic dermatitis with a EASI (Eczema Area and Severity Index (EASI)) score of ≥7
Exclusion Criteria
- •Known pregnancy
- •Known immunodeficiencies
- •Known parasitic infection -
Arms & Interventions
dupilumab treatment
Treatment with IL4RA inhibitor
Intervention: Dupilumab
Outcomes
Primary Outcomes
Change in Eczema Area and Severity Index (EASI) score from baseline to 8-12 weeks
Time Frame: 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.