Effectiveness of Dupilumab in Food Allergic Patients With Moderate to Severe Atopic Dermatitis

Study Overview
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Brief Summary
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This study evaluates the effectiveness of Dupilumab in food allergic patients with moderate to severe Atopic Dermatitis (AD). Included patients participated in the BioDay Registry.

Detailed Description
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The positive results of the dupilumab studies in AD, asthma and nasal polyposis with chronic sinusitis validate the fundamental role for IL-4 and IL-13 in the pathogenesis of these diseases, and add to the possibility that these cytokines are also critically involved in other related allergic/atopic (type 2 immune) diseases that are often co-morbidly associated with AD, such as food allergy.

Official Title
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Effectiveness of Dupilumab in Food Allergic Patients With Moderate to Severe Atopic Dermatitis

Conditions
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Food Allergy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AD patients with moderate to severe AD who are indicated for treatment with dupilumab Peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy allergic subjects, with a well-documented medical history of reactions after ingestion.Peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy specific immunoglobulin E (IgE) level (Phadia CAP-system) higher than 0.35 kU/L or a skin prick test of at least 3 mm Positive double-blind placebo-controlled Food Challenge (DBPCFC) with an eliciting dose before the last dose Signed Bioday informed consent from subjects Exclusion Criteria: Subjects reacting objectively to the placebo at screening. Subjects in whom DBCPFC is contra-indicated or in whom DBPCFC is not reliable

Ages Eligible for Study
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Minimum Age: 12 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of Dupilumab on change in clinical eliciting dose (i.e. lowest dose causing an allergic reaction) in subjects with peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy | AD patients with moderate to severe AD who are indicated for treatment with dupilumab and have symptomatic food allergy to peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy will be included. | Each subject will undergo two oral food challenges: one at screening and one during dupilumab treatment with a treatment duration of at least 28 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of Dupilumab on food allergy related quality of life | The food allergy related quality of life will be measured with the Food allergy Quality of Life Questionnaire adult form (FAQLQ-AF) The FAQLQ-AF assesses health-related quality of life (HRQL) and contains a total of 29 items. The total FAQLQ-AF score is the mean score of all items with a range of 1 'no impairment' to 7 'maximal impairment'. | Before the first food challenge and 3 months after the second food challenge during their visit conform Bioday protocol. | 
| To evaluate the effect of Dupilumab on the level of specific IgE (sIgE) antibodies | sIgE in blood will be measured using the ImmunoCAP system (Thermofisher, Uppsala, Sweden). Levels of ≥ 0.35 kU/L will be considered positive. Depending on the food the following will be tested: peanut: extract, Ara h 2, 6; hazelnut: extract, cor a 1, 9, 14; walnut: extract; cow's milk: extract; hen's egg: extract; soybean: extract | sIgE in blood will be measured every three months during dupilumab treatment | 
| To evaluate the effect of Dupilumab on the biological activity of IgE for peanut and hazelnut and measurement of biomarkers profile | For patients treated with Dupilumab left over serum is stored except as the patient objects. Patients treated with Dupilumab asked to participate to the biobank eczema and/or biobank acute inflammation. | The basophil activation test and the measurement of biomarkers on Luminex at baseline and after at least 28 weeks of dupilumab treatment (e.g. at time of second challenge) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dupilumab, Food allergy, Atopic Dermatitis, BioDay Registry