CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Peanut Oral Immunotherapy +1 moredrug
Likely dose
Peanut Oral Immunotherapy 0.2mgfrom 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.

Search/NCT00932282
NCT00932282Phase 2Completed
CompareCT.gov

Peanut OIT & Anti-IgE: Peanut Oral Immunotherapy and Anti-IgE Treatment for Peanut Allergy {NIH R21 Combined Peanut Oral Immunotherapy and Anti-IgE: Mechanistic Studies}

University of North Carolina, Chapel Hill·interventional·Posted Jul 3, 2009·Updated Mar 1, 2018

In Brief

A Phase 2 clinical trial evaluating Peanut Oral Immunotherapy and Omalizumab for Peanut Hypersensitivity. Completed, enrolled 13 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether the addition of anti-IgE treatment will make peanut oral immunotherapy safer, more tolerable, and more effective in treating peanut allergy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeanut Hypersensitivity
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 3, 2009
Enrollment StartJul 1, 2009
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 17.0 years ago

Interventions

Peanut Oral Immunotherapydrug

Peanut flour taken by mouth, given every day. Dose ranges from 0.2mg of peanut flour to 8000mg of peanut flour during the maintenance phase.

Omalizumabdrug

Omalizumab (anti-IgE) will be given for 4 months prior to starting oral immunotherapy. The medication is given as a subcutaneous injection with dose based on total IgE levels and weight at the beginning of the study. This medication is given for a total of 10 months.