Oral Immunotherapy for Wheat Allergy

NCT01980992 | Completed Phase 1 Results DMC

• 2 other identifiers: GCO 11-0197FAI001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

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.

Conditions

Wheat Allergy

Keywords

Food Allergy; Wheat Allergy; Oral Immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  1 Year

Secondary Outcomes (4)

• Number of Subjects Who Successfully Consume a Wheat Protein Oral Food Challenge

  8 to 10 weeks after passing the 2 Year OFC

• Number of Subjects Who Achieve the Targeted Maintenance Dose of Wheat OIT

  44 Weeks

• Number of Subjects That Achieve Desensitization in the Placebo Cross Over Group

  2 Years

• Incidence of All Serious Adverse Events During the Study.

  1 year and 2 Years

Study Arms (2)

Wheat OIT

ACTIVE COMPARATOR

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

Drug: Wheat OIT

Placebo

PLACEBO COMPARATOR

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.

Drug: Wheat OIT

Interventions

Wheat OIT 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.

Also known as: Vital Wheat Gluten

Placebo; Wheat OIT

Eligibility Criteria

• Age: 4 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Hugh A Sampson, MD: lead

Study Sites (4)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 100029, United States

Location

MeSH Terms

Conditions

Wheat Hypersensitivity; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Hugh A. Sampson
• Organization: Icahn School of Medicine at Mount Sinai

hugh.sampson@mssm.edu

212-659-9426

Study Officials

• Hugh A Sampson, MD

  Icahn School of Medicine at Mount Sinai

  STUDY CHAIR

• Hugh A Sampson, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dean for Translational Biomedical Sciences, Director, Jaffe Food Allergy Institute

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 11, 2013
• Study Start: October 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: April 13, 2017
• Last Updated: August 14, 2020
• Results First Posted: March 31, 2017

Record last verified: 2020-08

Locations

US (4)