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

Primary Purpose

Peanut Allergy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

DBV712 IHRP

About this trial

This is an interventional other trial for Peanut Allergy focused on measuring EPIT, Epicutaneous, Immunotherapy, Viaskin

Eligibility Criteria

12 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arkansas Children's Hospital
Children's Hospital Colorado

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DBV712 Solution for Skin Prick Test

Arm Description

DBV712 In-House Reference Skin Prick Test preparation

Outcomes

Primary Outcome Measures

Biological potency of the In-House Reference peanut proteins extract (DBV712-IHRP) in arbitrary Biological Units (BU)

Secondary Outcome Measures

Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)

Full Information

NCT ID

NCT03352726

First Posted

November 21, 2017

Last Updated

July 25, 2019

Sponsor

DBV Technologies

1. Study Identification

Unique Protocol Identification Number

NCT03352726

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

November 24, 2017 (Actual)

Primary Completion Date

June 29, 2018 (Actual)

Study Completion Date

June 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

DBV Technologies

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peanut Allergy

Keywords

EPIT, Epicutaneous, Immunotherapy, Viaskin

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DBV712 Solution for Skin Prick Test

Arm Type

Experimental

Arm Description

DBV712 In-House Reference Skin Prick Test preparation

Intervention Type

Drug

Intervention Name(s)

DBV712 IHRP

Intervention Description

DBV712 Solution for Skin Prick Test

Primary Outcome Measure Information:

Title

Biological potency of the In-House Reference peanut proteins extract (DBV712-IHRP) in arbitrary Biological Units (BU)

Time Frame

1 day to 2 weeks

Secondary Outcome Measure Information:

Title

Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)

Time Frame

Throughout the study (1 day to 2 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Arkansas Children's Hospital

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72202

Country

United States

Facility Name

Children's Hospital Colorado

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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