Phase 2
N=46
Oral Immunotherapy for Wheat Allergy
Wheat Allergy
Bottom Line
View on ClinicalTrials.gov: NCT01980992 ↗Enrolled (actual)
46
Serious AEs
5.6%
Results posted
Mar 2017
Primary outcome: Primary: 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. — 0; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Wheat OIT (Drug)
- Age
- Pediatric, Adult · 4+ yrs
- Sex
- All
- Sponsor
- Hugh A Sampson, MD
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
0; 12 | — |
| SECONDARY Number of Subjects Who Successfully Consume a Wheat Protein Oral Food Challenge |
0; 3 | — |
| SECONDARY Number of Subjects Who Achieve the Targeted Maintenance Dose of Wheat OIT |
21; 19 | — |
| SECONDARY Number of Subjects That Achieve Desensitization in the Placebo Cross Over Group |
14 | — |
| SECONDARY Incidence of All Serious Adverse Events During the Study. |
0; 3; 1; 1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01980992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.