Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.

Monitoring Response to Therapy in Atopic Dermatitis Patients Treated With Dupilumab Using Noninvasive Reflectance Confocal Microscopy and Optical Coherence Tomography

The study is trying to answer the following question: "Can we use non-invasive imaging to evaluate the response of atopic dermatitis (eczema) to Dupixent (dupilumab)?"

Participating in this research will allow the subject to undergo a noninvasive imaging alternative to conventional monitoring in response to a biologic. Normally, subjects would undergo a clinical examination, serial photography, and possible biopsies to assess the progression of the disease. This study will get rid of the need for a biopsy but will require multiple scans with non-invasive imaging. This research examines a new approach to monitoring response to a biologic drug used for atopic dermatitis, and can also, be used to grade disease severity without the need for a biopsy.

Inclusion Criteria:

• ≥18 years of age
• Atopic dermatitis (AD) affecting ≥10% body surface area (BSA) at baseline
• IGA score ≥3, on the IGA scale of 0-4 at baseline
• Eczema Area and Severity Index (EASI) score of ≥16 at baseline

Exclusion Criteria:

• Prior treatment with Dupilumab (REGN668/SAR231893)
• Treatment with TCS or topical calcineurin inhibitors (TCI) within 2 weeks before the baseline visit
• Bodyweight <30 kg (65lb) at Baseline
• Known or suspected immunodeficiency including human immunodeficiency virus (HIV) infection
• Pregnancy, breastfeeding or planning to become pregnant or breastfeed during the study