Peanut Allergy Clinical Trial
— V712-103Official title:
An Open-label Phase I Study to Assess the Biological Potency of Peanut Allergen Extract in Adolescent and Adult Peanut Allergic Subjects
Verified date | July 2019 |
Source | DBV Technologies |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 27 |
Est. completion date | June 29, 2018 |
Est. primary completion date | June 29, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 50 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Colorado | Aurora | Colorado |
United States | Arkansas Children's Hospital | Little Rock | Arkansas |
Lead Sponsor | Collaborator |
---|---|
DBV Technologies |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biological potency of the In-House Reference peanut proteins extract (DBV712-IHRP) in arbitrary Biological Units (BU) | 1 day to 2 weeks | ||
Secondary | Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) | Throughout the study (1 day to 2 weeks) |
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