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Completed

NCT Number: NCT03352726

A 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.

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Key information

Conditions

Peanut Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nut and Peanut Hypersensitivity Peanut Hypersensitivity

Age range

12 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arkansas Children's Hospital, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DBV712 IHRP

Drug

DBV712 Solution for Skin Prick Test

Primary outcomes

  1. 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 outcomes

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

    Time frame: Throughout the study (1 day to 2 weeks)

Sponsors and collaborators

Lead sponsor

DBV Technologies

Industry

Registry information

Official study title

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

Acronym: V712-103

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 24, 2017
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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