Oral Immunotherapy for Wheat Allergy

NCT ID: NCT01980992

Last Updated: 2020-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-04-13

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.

Conditions

Wheat Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Wheat OIT

Active treatment participants receive Vital Wheat Gluten, and have up to four oral food challenges as directed by the protocol.

Group Type: ACTIVE_COMPARATOR

Wheat OIT

Intervention Type: DRUG

Vital Wheat Gluten dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses.

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Wheat OIT

Intervention Type: DRUG

Vital Wheat Gluten dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses.

Interventions

Wheat OIT

Vital Wheat Gluten dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses.

Intervention Type: DRUG

Other Intervention Names

Vital Wheat Gluten

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hugh A Sampson, MD

OTHER

Sponsor Role: lead

Responsible Party

Hugh A Sampson, MD

Dean for Translational Biomedical Sciences, Director, Jaffe Food Allergy Institute

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hugh A Sampson, MD

Role: STUDY_CHAIR

Icahn School of Medicine at Mount Sinai

Hugh A Sampson, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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

Countries

United States

Other Identifiers

FAI001

Identifier Type: OTHER

Identifier Source: secondary_id

GCO 11-0197

Identifier Type: -

Identifier Source: org_study_id