NCT01781637

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

Phase 2 Study of Omalizumab in Oral Peanut Desensitization

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 7 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Peanut Allergy
• Food Allergy

Interventions

Type	Name	Description
DRUG	Omalizumab	subcutaneous injection
DRUG	placebo	subcutaneous injection

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-10-01
• Completion: 2022-05-31
• First posted: 2013-02-01
• Last updated: 2023-02-21
• Results posted: 2017-05-03

Locations

4 sites across 1 country: United States