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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Peanut Allergy, Food Allergy

In brief

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.

Key facts

Study ID

NCT01781637

Run by

Boston Children's Hospital

People needed

36

Starts

2013-01-01

Expected to finish

2022-05-31

Last updated by the study team

2023-02-21

Who can join

Age: 7 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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