OIT and Xolair® (Omalizumab) in Cow's Milk Allergy
Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
Food allergy affects up to 4% of the U.S. population and is most common in young children.
Milk allergy is the most common cause of food allergy in infants and young children, and
usually develops in the first year of life. There is no treatment for food allergy and the
current standard of care for milk-allergic individuals is the avoidance of milk-containing
products. Research is underway to identify potential therapeutic strategies to reduce or
eliminate the adverse effects experienced by milk-allergic individuals when they consume
milk-containing products.
Several studies have suggested that milk-allergic children who receive milk protein oral
immunotherapy (OIT) may become desensitized to milk, resulting in short term protection
against accidental ingestion of milk products. However, these children did not develop
"tolerance," which is long term protection even after milk immunotherapy is stopped. A
potential strategy to induce tolerance to milk uses milk in combination with Xolair®
(omalizumab). Xolair consists of anti-IgE molecules that attach to IgE, the major antibody
involved in allergic reactions. The goal of this clinical trial is to see whether Xolair® in
combination with milk protein OIT is safer and more effective than OIT alone in inducing
tolerance to milk and milk products. Participants will be administered a double blind,
placebo controlled milk challenge at various time points in the study. If desensitization is
achieved participants will be tested for tolerance at a certain time point after stopping
treatment.
Phase:
Phase 2
Details
Lead Sponsor:
Hugh A Sampson, MD
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)