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

NCT04462055 | Terminated DMC

• 1 other identifier: 19-197
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy

Keywords

Dupilumab; Food allergy; Atopic Dermatitis; BioDay Registry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

• 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

• 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)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

AD patients with moderate to severe AD who are indicated for treatment with dupilumab and have comorbid food allergy

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Centre Utrecht

Utrecht, 3584 CX, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Food Hypersensitivity; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: July 8, 2020
• Study Start: May 1, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)