At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 46 enrolled
Drug / intervention
Wheat OITdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Oral Immunotherapy for Wheat Allergy
In Brief
A Phase 2 clinical trial evaluating Wheat OIT for Wheat Allergy. Completed, enrolled 46 participants across 4 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWheat Allergy
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartOct 2013
First PostedNov 2013
Primary CompletionNov 2015
Study CompletionApr 2017
TodayJul 2026
First PostedNov 11, 2013
Enrollment StartOct 1, 2013
Primary CompletionNov 1, 2015
Study CompletionApr 13, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.6 years ago
Interventions
Wheat OITdrug
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.