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

UMC Utrecht

Status: Terminated

Conditions: Food Allergy

Study type: Observational

Funder types: Other

Identifiers

NCT04462055

19-197

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. AD patients with moderate to severe AD who are indicated for treatment with dupilumab
2. 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
3. Positive double-blind placebo-controlled Food Challenge (DBPCFC) with an eliciting dose before the last dose
4. Signed Bioday informed consent from subjects

Exclusion criteria

1. Subjects reacting objectively to the placebo at screening.
2. Subjects in whom DBCPFC is contra-indicated or in whom DBPCFC is not reliable