Oral Immunotherapy for Wheat Allergy

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Wheat Allergy

In brief

This study is being done to learn about the medical effects, the safety, and the immunologic effects of Wheat Oral Immunotherapy (OIT) treatment. The goal of the study is to find out whether subjects can develop the ability to eat wheat (the food allergen) regularly without allergic symptoms after stopping the study treatment.

Key facts

Study ID

NCT01980992

Run by

Hugh A Sampson, MD

People needed

46

Starts

2013-10-01

Expected to finish

2017-04-13

Last updated by the study team

2020-08-14

Who can join

Age: 4 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 4-30 years either sex, any race, any ethnicity
• Positive Prick Skin Test to wheat greater than 3mm compared to control and/or a wheat specific IgE >= 0.35 kUA/L
• Positive baseline challenge to wheat (<= 1923 mg of vital wheat gluten)
• Written informed consent from subject and/or parent/guardian
• Written assent from all subjects as appropriate
• All females of child bearing age must be using appropriate birth control

You may not qualify if…

• History of anaphylaxis to wheat resulting in hypotension, neurological compromise or mechanical ventilation
• Known allergy to corn
• Known celiac disease
• Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)
• Active eosinophilic gastrointestinal disease in the past two years
• Participation in any interventional study for the treatment of food allergy in the past 6 months
• Subject is on "build-up phase" of immunotherapy (i.e., has not reached maintenance dosing). Subjects tolerating maintenance allergen immunotherapy can be enrolled.
• Severe asthma, uncontrolled mild or moderate asthma. More information on this criterion can be found in the protocol.
• A burst of oral, IM or IV steroids of more than 2 days for an indication other than asthma in the past 1 month
• Inability to discontinue antihistamines for initial day escalation, skin testing or OFC
• Use of omalizumab or other non-traditional forms of allergen immunotherapy or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year
• Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
• Use of investigational drug within 90 days or plan to use investigational drug during the study period
• Pregnancy or lactation

Where it is running

• Stanford University School of Medicine — Stanford, California, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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