Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.

Study Overview
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Brief Summary
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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)?

Detailed Description
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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.

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

Conditions
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Eczema, Atopic Dermatitis

Intervention / Treatment
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* Drug: Dupilumab
* Device: Optical Coherence Tomography
* Device: Reflectance confocal microscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dupixent<br>Patients will receive initial dose of 600 mg (two 300 mg injections in different injection sites), followed by 300 mg given every other week for 16 weeks. Patients will self-administer by subcutaneous injection at home, instructions will be provided at first visit. | Drug: Dupilumab<br>* IL-4 antagonist to improve moderate-severe atopic dermatitis<br>* Other names: Dupixent;Device: Optical Coherence Tomography<br>* OCT is a noninvasive imaging device that can be used to monitor inflammatory skin disorders.<br>* Other names: OCT;Device: Reflectance confocal microscopy<br>* RCM is a noninvasive imaging device, with resolution approaching that of histology, which can monitor structural changes in the epidermis and superficial dermis, monitor inflammatory cells, and can overcome the limitations of a traditional biopsy.<br>* Other names: RCM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eczema Area and Severity Index (EASI) | The Eczema Area and Severity Index (EASI) is a tool used to measure the extent (area) and severity of atopic eczema, ranging 0-72, 0 being least severe and 72 being most severe. | Baseline to 16 weeks | 
| Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) | Investigator will use the Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) a tool used to measure the severity of atopic eczema, ranging 0-4, 0 is clear and 4 is most severe. | Baseline to 16 weeks | 
| Noninvasive Imaging (clinical response) with Reflectance Confocal Microscopy (RCM) | Reflectance Confocal Microscopy (RCM) is a noninvasive imaging device that can be used to monitor the severity of inflammatory skin disorders without the need for a biopsy. RCM can visualize cells with a resolution comparable to a light microscope, allowing the investigators to identify the degree of inflammation and damage to the skin. An overall disease severity score ranging from 0-3 (0=none, 1=mild, 2= moderate, 3=severe) will use aggregates of the following *features: Spongiosis Parakeratosis Epidermal thickness Quality of honeycomb structure of the stratum spinosum Appearance of the dermal-epidermal junction Appearance of the superficial dermis Recognition of the dermal papilla Caliber of blood vessels Presence of inflammatory cells Grading will be scored (0=none, 1=mild, 2= moderate, 3=severe), a greater numerical score indicates more advanced disease. | Baseline to 16 weeks | 
| Noninvasive Imaging (clinical response) with Optical Coherence Tomography (OCT) | Optical Coherence Tomography (OCT) is a noninvasive imaging device that can be used to monitor the severity of inflammatory skin disorders without the need for a biopsy. OCT can detect deep structures in the skin, identify areas of inflammation, and determine the thickness of the skin. These measures will be consolidated to a severity score ranging 0-3, (0= no disease, 3= severe disease) and will be tracked throughout the duration of the study. The following features will be aggregated to form an Optical Coherence Tomography-severity-score: Change in the epidermal thickness Changes in anatomy or appearance of the dermo-epidermal junction and the dermis. Changes in vascular flow patterns, including the number and density of vessels in skin using the dynamic feature of Optical Coherence Tomography Grading will be scored 0=none, 1=mild, 2= moderate, 3=severe | Baseline to 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dermatitis, Dupilumab, Inflammatory Skin Diseases, itch relief, biologic