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Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial — PRROTECT  

Food Allergy Clinical Trial

Official title:
Phase 2 Study of Omalizumab in Oral Peanut Desensitization

Clinical Trial Summary

The investigators will perform a double blind, placebo controlled clinical trial with Xolair (omalizumab) at four centers to safely and rapidly desensitize patients with severe peanut allergy. The investigators will determine if pretreatment with anti-IgE mAb (Xolair/omalizumab) can greatly reduce allergic reactions and allow for faster and safer desensitization.

Clinical Trial Description

36 subjects will receive Xolair, and 8 subjects will receive placebo. The study will occur at 4 sites: Boston Children's Hospital, Children's Hospital of Philadelphia, Stanford University and Lurie Children's Hospital. Patients will be pre-treated with Xolair or placebo before rapid oral peanut desensitization. Patients will continue to receive Xolair during the 8 subsequent weeks of desensitization, receiving their final dose of Xolair one week after reaching the highest tolerated dose of peanut. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01781637
Study type Interventional
Source Boston Children's Hospital
Contact
Status Completed
Phase Phase 1/Phase 2
Start date January 2013
Completion date May 31, 2022
View Details
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