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

Phase 1

Completed

• Conditions: Peanut Allergy
• Interventions: Drug: DBV712 IHRP

• Registration Number: NCT03352726
• Lead Sponsor: DBV Technologies

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-11-22
• Study Start: 2017-11-24
• Study First Posted: 2017-11-24
• Primary Completion: 2018-06-29
• Study Completion: 2018-06-29
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DBV712 Solution for Skin Prick Test	DBV712 IHRP	DBV712 In-House Reference Skin Prick Test preparation

Primary Outcome Measures

Name	Time	Method
Biological potency of the In-House Reference peanut proteins extract (DBV712-IHRP) in arbitrary Biological Units (BU)	1 day to 2 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)	Throughout the study (1 day to 2 weeks)

Trial Locations

Locations (2)

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States