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A Study to Assess the Biological Potency of Peanut Allergen Extract in Adolescent and Adult Peanut Allergic Subjects

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 12 Years - 50 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03352726
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

DBV Technologies
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Peanut Allergy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Arkansas Children's Hospital, Little Rock, Arkansas

Status

Recruiting

Address

Arkansas Children's Hospital

Little Rock, Arkansas, 72202

Site Contact

Perry, MD

PerryTamaraT@uams.edu

501-364-1060

Children's Hospital Colorado, Aurora, Colorado

Status

Recruiting

Address

Children's Hospital Colorado

Aurora, Colorado, 80045

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