NCT00968110

Xolair Treatment for Milk Allergic Children

Xolair (Omalizumab) Enhances Oral Tolerance Induction in Milk Allergic Children

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot feasibility study, using Xolair pretreatment for oral milk desensitization. The major assessment will be safety, and the investigators will evaluate for any type of reaction, including allergic reactions that occur during the course of the study.

Detailed description

Our hypothesis is that pretreatment with anti-IgE mAb will greatly reduce the side effects and allergic reactions that occur during oral desensitization to foods and will enhance the development of oral tolerance in patients with severe milk allergy. Once desensitized to milk, children will be able to tolerate milk in a Double Blind Placebo Controlled Food Challenge. The study will also evaluate whether Xolair provides a robust durability of tolerance once administration of Xolair is terminated. We will examine the specific immunological mechanisms that mediate oral tolerance in children undergoing oral milk desensitization The trial will be conducted in three parts: (1) pre-treatment with Xolair for 8 weeks, (2) oral desensitization to cow's milk from weeks 9-16 and continued treatment with Xolair for 8 weeks, and (3) double blind placebo controlled food challenge to milk.

Conditions

• Milk Allergy

Interventions

Type	Name	Description
DRUG	omalizumab	Dosing table established for omalizumab

Timeline

• Start date: 2009-03-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2009-08-28
• Last updated: 2018-10-02

Locations

2 sites across 1 country: United States