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

Sponsor

UMC Utrecht (Other)

Overall Status

Terminated

CT.gov ID

NCT04462055

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Food Allergy

Detailed Description

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

3 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2019

Actual Primary Completion Date :

Jul 1, 2022

Actual Study Completion Date :

Jul 1, 2022

Outcome Measures

Primary Outcome Measures

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 [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.]
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.

Secondary Outcome Measures

To evaluate the effect of Dupilumab on food allergy related quality of life [Before the first food challenge and 3 months after the second food challenge during their visit conform Bioday protocol.]
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'.
To evaluate the effect of Dupilumab on the level of specific IgE (sIgE) antibodies [sIgE in blood will be measured every three months during dupilumab treatment]
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
To evaluate the effect of Dupilumab on the biological activity of IgE for peanut and hazelnut and measurement of biomarkers profile [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)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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