Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance: The DEVIL Study

Completed · Phase 2

Conditions studied: Food Hypersensitivity

In brief

Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is to produce a new treatment that would benefit young subjects who have recently been diagnosed with peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance).

Key facts

Study ID

NCT00932828

Run by

University of North Carolina, Chapel Hill

People needed

37

Starts

2009-06-22

Expected to finish

2017-02-01

Last updated by the study team

2018-05-24

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 9-36 months of either sex, any race, any ethnicity at the time of the initial visit
• EITHER a positive skin prick test to peanuts or in vitro [CAP-FEIA] peanut immunoglobin E (IgE) level in the blood > 0.35 kU/L PLUS a history of a clinical allergic reaction (defined as significant clinical symptoms occurring within 60 minutes after ingesting peanuts) within 6 months of screening
• OR a positive prick skin test to peanuts and in vitro [CAP-FEIA] peanut IgE level > 5 kU/L when there is no history of allergic reaction and no known peanut exposure
• Provision of signed informed consent
• Development of symptoms characteristic of IgE-mediated food allergy (urticaria, angioedema, respiratory distress/wheeze/cough, vomiting/diarrhea, anaphylaxis) during initial oral food challenge

You may not qualify if…

• History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise
• Currently participating in a study using an investigational new drug
• Participation in any interventional study for the treatment of food allergy in the past 12 months
• Subjects with a known wheat food allergy will be excluded because of cross contamination of oat with wheat
• Severe atopic dermatitis
• Currently being treated with greater than medium daily doses of inhaled corticosteroids, as defined by the National Heart Lung and Blood Institute (NHLBI) guidelines
• Inability to discontinue antihistamines for skin testing and OFCs

Where it is running

• University of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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