Clinical trial NCT04462055: Effectiveness of Dupilumab in Food Allergic Patients With Moderate to Severe Atopic Dermatitis
Official title: Effectiveness of Dupilumab in Food Allergic Patients With Moderate to Severe Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Food Allergy
Keywords: Dupilumab
Food allergy
Atopic Dermatitis
BioDay Registry
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 3
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 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:
measure: To evaluate the effect of Dupilumab on food allergy related quality of life
timeFrame: Before the first food challenge and 3 months after the second food challenge during their visit conform Bioday protocol.
measure: To evaluate the effect of Dupilumab on the level of specific IgE (sIgE) antibodies
timeFrame: sIgE in blood will be measured every three months during dupilumab treatment
measure: To evaluate the effect of Dupilumab on the biological activity of IgE for peanut and hazelnut and measurement of biomarkers profile
timeFrame: 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)
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Centre Utrecht
Study officials:
References: