Status:
TERMINATED
Effectiveness of Dupilumab in Food Allergic Patients With Moderate to Severe Atopic Dermatitis
Lead Sponsor:
UMC Utrecht
Conditions:
Food Allergy
Eligibility:
All Genders
12+ years
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.
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 t...
Eligibility Criteria
Inclusion
- 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
- Subjects reacting objectively to the placebo at screening.
- Subjects in whom DBCPFC is contra-indicated or in whom DBPCFC is not reliable
Key Trial Info
Start Date :
May 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04462055
Start Date
May 1 2019
End Date
July 1 2022
Last Update
July 29 2022
Active Locations (1)
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1
University Medical Centre Utrecht
Utrecht, Netherlands, 3584 CX