This study will evaluate the safety and effectiveness of a laboratory-made antibody called
omalizumab in patients with Job's syndrome, or hyper-IgE syndrome (HIES). Patients with HIES
have very high levels of IgE antibody, a protein made by white blood cells. IgE plays an
important role in starting allergic reactions in the body and may be related to some HIES
symptoms, such as skin rashes and asthma. Patients also have frequent lung infections, easily
broken bones and other symptoms. Omalizumab, which is approved to treat allergic asthma, is
directed against IgE. This study will see if blocking IgE with omalizumab in HIES patients is
safe and if it can reduce patients' IgE count. It will also look at how the body handles
omalizumab and how it affects patients' symptoms.
Patients 6 years of age or older with HIES may be eligible for this study. Each candidate is
screened with a medical history, physical examination, skin examination and blood test.
Participants receive an injection of omalizumab under the skin once every 2 weeks for 6
doses. At the time of each injection, patients are examined by a doctor, answer questions
about their symptoms and have a blood sample drawn. After the sixth dose, patients have a
physical examination, blood tests, skin examination and lung function tests. At follow-up
visits scheduled 2, 4 and 6 months after the last dose of omalizumab, patients have a
physical examination, answer questions about their symptoms, and have a blood sample drawn.
Patients who show a significant response to omalizumab stay off the drug for 3 months after
the last dose and then discuss with their study doctor and referring doctor about continuing
the medicine.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)