A Study to Assess the Biological Potency of Peanut Allergen Extract in Adolescent and Adult Peanut Allergic Subjects (V712-103)

DBV Technologies

Status and phase: Completed; Phase 1

Conditions: Peanut Allergy

Treatments: Drug: DBV712 IHRP

Study type: Interventional

Funder types: Industry

Identifiers

NCT03352726

BIOPOT

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 12 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

DBV712 Solution for Skin Prick Test

Experimental group

Description:

DBV712 In-House Reference Skin Prick Test preparation

Treatment:

Drug: DBV712 IHRP