Oral Immunotherapy (OIT) for Peanut Allergy

• Status: Completed
• Trial end date: 2016-12-12
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill

Criteria

Inclusion Criteria:

• Age 1- 6 years all of either sex, any race, any ethnicity at the time of the initial visit

• The presence of IgE specific to peanuts (a positive skin prick test to peanuts (diameter of wheal >3.0 mm) and a positive in vitro IgE [CAP-FEIA] > 7 kUA/L

• A history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts

• Provide signed informed consent

Exclusion Criteria:

• History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or oxygen saturation < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence)

• 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

• Poor control or persistent activation of atopic dermatitis

• Moderate to severe persistent asthma

• 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 oral food challenges (OFCs)