Oral Immunotherapy for Wheat Allergy

Phase 1

Completed

Brief Summary: 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.

Detailed Description: Food allergy affects 6-8 percent of children in the United States. Wheat is one of the eight most common foods inducing allergic reactions in the US. Current treatment for food allergy is complete avoidance of the food and to carry antihistamines and self-injectable epinephrine if an accidental reaction occurs. However, accidental exposure to allergens in processed foods may be difficult to avoid. Currently, several therapeutic strategies are being investigated to prevent and treat food allergies. Since immunotherapy injections for food allergy are associated with a high rate of allergic reactions, alternate approaches to treatment are needed. Oral (by mouth) immunotherapy (OIT) is one approach that has been tried in some studies in the treatment of food allergies. The intent of the study is to examine the clinical effects and safety of wheat OIT. This study will last 2 years. All eligible subjects will receive a wheat oral food challenge (OFC). Those who react to 1923mg or less of vital wheat gluten will be randomized to Wheat OIT or a placebo. All eligible and enrolled subjects will have a 1-year and 2-year OFC. Placebo subjects will crossover to Wheat OIT at the 1-year time point. At selected visits, blood and urine collection, physical examination, prick skin tests, and atopic dermatitis and asthma evaluations will occur.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Wheat OIT	Wheat OIT	Active treatment participants receive Vital Wheat Gluten, and have up to four oral food challenges as directed by the protocol.
Placebo	Wheat OIT	Placebo for Vital Wheat Gluten followed by crossover to open-label active therapy (Vital Wheat Gluten), and up to three oral food challenges as directed by the protocol.

Primary Outcome Measures

Name	Time	Method
The Percentage of Desensitized Participants as Measured by the Ability to Consume at Least 4443 mg of Wheat Protein During a 7443 mg Wheat Protein Oral Food Challenge (OFC) Performed 1 Year After Initiating Treatment.	1 Year	Determine in wheat allergic children, whether relative to placebo, daily oral administration of Vital Wheat Gluten escalated to a maximum of 2035 mg/day of Vital Wheat Gluten increases desensitization as measured by consuming without dose limiting symptoms 4443 mg of wheat protein on a 7443 mg wheat protein OFC performed 1 year after initiating treatment.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Who Successfully Consume a Wheat Protein Oral Food Challenge	8 to 10 weeks after passing the 2 Year OFC	The number of subjects who successfully consume a 7443 mg wheat protein oral food challenge (OFC) 8-10 weeks after therapy discontinuation and after passing the 7443 mg wheat protein OFC at the 2 year time point.This OFC will only be administered to subjects in the initial active treatment group.
Number of Subjects Who Achieve the Targeted Maintenance Dose of Wheat OIT	44 Weeks	The number of subjects who achieve the targeted maintenance dose of wheat OIT during the desensitization phase of the study. For Wheat OIT group, reached target dose of 2035 mg wheat powder/1445 mg wheat protein. For placebo group, reached target dose of 2035 mg placebo powder.
Number of Subjects That Achieve Desensitization in the Placebo Cross Over Group	2 Years	The number of subjects that achieve desensitization in the placebo cross over group after 1 year of dosing. Able to consume at least 4443 mg wheat protein on the Week 52 Crossover OFC (4443 mg wheat protein is the amount that was used for the primary endpoint).
Incidence of All Serious Adverse Events During the Study.	1 year and 2 Years

Locations (4): Ann & Robert H. Lurie Children's Hospital of Chicago
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Chicago, Illinois, United States
Johns Hopkins University School of Medicine
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Baltimore, Maryland, United States
Stanford University School of Medicine
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Stanford, California, United States
Icahn School of Medicine at Mount Sinai
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New York, New York, United States