Peanut Oral Immunotherapy and Anti-Immunoglobulin E (IgE) for Peanut Allergy

Completed · Phase 1/Phase 2

Conditions studied: Peanut Hypersensitivity

In brief

The purpose of this study is to determine whether the addition of anti-IgE treatment will make peanut oral immunotherapy safer, more tolerable, and more effective in treating peanut allergy.

Key facts

Study ID

NCT00932282

Run by

University of North Carolina, Chapel Hill

People needed

13

Starts

2009-07-01

Expected to finish

2015-08-01

Last updated by the study team

2018-03-01

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 12 years and above 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] > 5 kUA/L
• A history of significant clinical symptoms (urticaria, angioedema, rhinorrhea, nasal congestion, pruritis, sneezing, abdominal pain, emesis, diarrhea, wheezing, shortness of breath, lip/tongue swelling, throat itching, throat swelling, impending sense of doom) occurring within 60 minutes after ingesting peanuts
• Provide signed informed consent
• Women who are sexually active, must agree to use appropriate contraceptive measures for the duration of the study and for 9 months afterwards

You may not qualify if…

• History of severe anaphylaxis to peanut or omalizumab 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 oat or wheat (because of potential cross contamination with oat) food allergy will be excluded
• 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)
• History of other serious underlying disease (i.e., heart disease, diabetes, etc.)
• Women who are pregnant or nursing

Where it is running

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

Full record on ClinicalTrials.gov

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