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

• Status: Active, not recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Collaborators: Ann & Robert H Lurie Children's Hospital of Chicago; Children's Hospital of Philadelphia; Stanford University
• Treatments: Omalizumab

Criteria

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.