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

July 25, 2019 updated by: DBV Technologies

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DBV712 Solution for Skin Prick Test
DBV712 In-House Reference Skin Prick Test preparation
Drug: DBV712 IHRP
DBV712 Solution for Skin Prick Test

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)
Time Frame: Throughout the study (1 day to 2 weeks)
Throughout the study (1 day to 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DBV Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2017

Primary Completion (Actual)

June 29, 2018

Study Completion (Actual)

June 29, 2018

Study Registration Dates

First Submitted

November 21, 2017

First Submitted That Met QC Criteria

November 22, 2017

First Posted (Actual)

November 24, 2017

Study Record Updates

Last Update Posted (Actual)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 25, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIOPOT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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