Peanut Allergy
Conditions
Keywords
EPIT, Epicutaneous, Immunotherapy, Viaskin
Brief summary
The study aims to assess the biological potency of the In-House Reference Preparation (IHRP) of peanut allergens extract by a quantitative Skin Prick Test (SPT) method in peanut-allergic subjects.
Interventions
DRUGDBV712 IHRP
DBV712 Solution for Skin Prick Test
Sponsors
DBV Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Male or female subjects aged between 12-50 years * Physician-diagnosed peanut allergy * Subject currently following a strict peanut-free diet * Documented history of positive test to peanut-specific IgE (ImmunoCAP system) \>0.7 kU/L * Positive peanut SPT with a largest wheal diameter ≥ 8 mm Main
Exclusion criteria
* Uncontrolled asthma * Peanut allergen immunotherapy whatever the route, either ongoing or previously started and having lasted more than one month (\>30 days) * Topical use of steroids within the past 14 days prior to the Screening SPT * Inability to discontinue short-acting antihistamines * Atopic dermatitis, eczema or urticaria on the areas to be tested
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biological potency of the In-House Reference peanut proteins extract (DBV712-IHRP) in arbitrary Biological Units (BU) | 1 day to 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) | Throughout the study (1 day to 2 weeks) |
Countries
United States
Outcome results
None listed