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

NCT ID: NCT03352726

Last Updated: 2019-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-24

Study Completion Date

2018-06-29

Brief Summary

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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

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Conditions

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Peanut Allergy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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DBV712 Solution for Skin Prick Test

DBV712 In-House Reference Skin Prick Test preparation

Group Type EXPERIMENTAL

DBV712 IHRP

Intervention Type DRUG

DBV712 Solution for Skin Prick Test

Interventions

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DBV712 IHRP

DBV712 Solution for Skin Prick Test

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DBV Technologies

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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BIOPOT

Identifier Type: -

Identifier Source: org_study_id

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