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

Food Allergy Clinical Trial

— PRROTECT  

Official title:

Phase 2 Study of Omalizumab in Oral Peanut Desensitization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781637
• Other study ID #: Peanut 002
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2013
• Est. completion date: May 31, 2022

Study information

• Verified date: February 2023
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 31, 2022
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity
• Peanut Allergy
• Peanut Hypersensitivity

Intervention

Drug:
• Omalizumab
subcutaneous injection
• placebo
subcutaneous injection

Locations

Country	Name	City	State
United States	Division of Immunology, Children's Hospital Boston	Boston	Massachusetts
United States	Lurie Children's Hospital	Chicago	Illinois
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Stanford University	Stanford	California

Sponsors (4)

Lead Sponsor	Collaborator
Boston Children's Hospital	Ann & Robert H Lurie Children's Hospital of Chicago, Children's Hospital of Philadelphia, Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo		6 weeks after last dose of omalizumab/placebo
Secondary	Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo		12 weeks after last dose of omalizumab/placebo