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

• Status: Completed
• Trial end date: 2018-06-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: DBV Technologies

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