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

Phase 1

Completed

• Conditions: Peanut Allergy; Food Allergy
• Interventions: Drug: placebo; Drug: Omalizumab

• Registration Number: NCT01781637
• Lead Sponsor: Boston Children's Hospital

Brief 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-30
• Study First Submitted QC: 2013-01-31
• Study First Posted: 2013-02-01
• Primary Completion: 2015-10
• Results First Submitted: 2017-03-23
• Results First Submitted QC: 2017-03-23
• Results First Posted: 2017-05-03
• Study Completion: 2022-05-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Moderate to severe peanut allergy-sensitive subjects between the ages of 7 to 25 years old.
• Sensitivity to peanut allergen will be documented by a positive skin prick test result (6 mm diameter wheal or greater)
• ImmunoCAP IgE level to peanut > 10 kU/L.
• Sensitivity to peanut allergen based on a double-blind placebo-controlled oral food challenge (DBPCFC) at maximum of cumulative 175 mg of peanut protein dose.

Exclusion Criteria

• Subjects with a total IgE at screening of < 50 kU/L > 2,000 kU/L.
• Positive reaction to the placebo on DBPCFC.
• Previous reaction to omalizumab.
• Subjects having a history of severe anaphylaxis to peanut requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma, or gastrointestinal or gastroesophageal disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	Patients will receive placebo.
omalizumab group	Omalizumab	Patients will receive omalizumab.

Primary Outcome Measures

Name	Time	Method
Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo	6 weeks after last dose of omalizumab/placebo

Secondary Outcome Measures

Name	Time	Method
Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo	12 weeks after last dose of omalizumab/placebo

Trial Locations

Locations (4)

Lurie Children's Hospital; 🇺🇸 Chicago, Illinois, United States

Stanford University; 🇺🇸 Stanford, California, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Division of Immunology, Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States