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

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ClinicalTrials.gov Identifier: NCT03352726
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
DBV Technologies

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.

Condition or disease Intervention/treatment Phase
Peanut Allergy Drug: DBV712 IHRP Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open-label Phase I Study to Assess the Biological Potency of Peanut Allergen Extract in Adolescent and Adult Peanut Allergic Subjects
Actual Study Start Date : November 24, 2017
Estimated Primary Completion Date : February 28, 2018
Estimated Study Completion Date : February 28, 2018

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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) [ Time Frame: Throughout the study (1 day to 2 weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352726


Locations
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Perry, MD    501-364-1060    PerryTamaraT@uams.edu   
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Greenhawt, MD    720-777-2575    Matthew.Greenhawt@childrenscolorado.org   
Sponsors and Collaborators
DBV Technologies

Responsible Party: DBV Technologies
ClinicalTrials.gov Identifier: NCT03352726     History of Changes
Other Study ID Numbers: BIOPOT
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by DBV Technologies:
EPIT
Epicutaneous
Immunotherapy
Viaskin

Additional relevant MeSH terms:
Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases