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

Boston Children's Hospital36 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Peanut Allergy Food Allergy

Interventions

OmalizumabDRUG

subcutaneous injection

placeboDRUG

subcutaneous injection

Eligibility

Sex: ALLMin age: 7 YearsMax age: 25 Years

Medical Language ↔ Plain English

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.

Locations (4)

Stanford University

Stanford, California, United States

Lurie Children's Hospital

Chicago, Illinois, United States

Division of Immunology, Children's Hospital Boston

Boston, Massachusetts, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo

Time frame: 6 weeks after last dose of omalizumab/placebo

Secondary Outcomes

Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo

Time frame: 12 weeks after last dose of omalizumab/placebo

Data from ClinicalTrials.gov

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