Status:
COMPLETED
A Study to Assess the Biological Potency of Peanut Allergen Extract in Adolescent and Adult Peanut Allergic Subjects
Lead Sponsor:
DBV Technologies
Conditions:
Peanut Allergy
Eligibility:
All Genders
12-50 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
November 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2018
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03352726
Start Date
November 24 2017
End Date
June 29 2018
Last Update
July 26 2019
Active Locations (2)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045