A Study to Assess the Biological Potency of Peanut Allergen Extract in Adolescent and Adult Peanut Allergic Subjects

An Open-label Phase I Study to Assess the Biological Potency of Peanut Allergen Extract in Adolescent and Adult Peanut Allergic Subjects

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.

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