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NCT03352726 Clinical Trial

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

Peanut Allergy Clinical Trial

— V712-103  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03352726
Other study ID # BIOPOT
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 24, 2017
Est. completion date June 29, 2018

Study information
Verified date July 2019
Source DBV Technologies
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date June 29, 2018
Est. primary completion date June 29, 2018
Accepts healthy volunteers No
Gender All
Age group 12 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DBV712 IHRP
DBV712 Solution for Skin Prick Test

Locations
Country Name City State
United States Children's Hospital Colorado Aurora Colorado
United States Arkansas Children's Hospital Little Rock Arkansas

Sponsors (1)
Lead Sponsor Collaborator
DBV Technologies

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Biological potency of the In-House Reference peanut proteins extract (DBV712-IHRP) in arbitrary Biological Units (BU) 1 day to 2 weeks
Secondary Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) Throughout the study (1 day to 2 weeks)
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