Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT00260702
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Omalizumab to Treat Hyper-IgE (Job's) Syndrome
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
Pilot Study of Omalizumab (Xolair) in Hyper IgE (Job's) Syndrome
Status:
COMPLETED
Status Verified Date:
2010-03-15
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
The hyper-IgE syndromes (HIES) are disorder characterized by markedly elevated serum IgE levels, eosinophilia, dermatitis, and recurrent skin and lung infections. The autosomal dominant form of HIES, Job's syndrome, is also characterized by skeletal abnormalities and lung cysts, and is caused primarily by a mutation in the STAT3 gene. The most common allergic or atopic symptoms seen in HIES include a characteristic rash and bronchial hyper-responsiveness. The rash tends to respond to systemic antimicrobials, topical antiseptics, mad steroids. It is unclear what the role, if any, IgE plays in the pathogenesis of these allergic (and perhaps non-allergic) phenotypes.
Omalizumab is a humanized monoclonal antibody specific for the FcepsilonRI portion of IgE that does not cross-link IgE. It has been used for amelioration of severe asthma and food allergies, and is being studied in a number of other allergic diseases. This study aims to determine whether administration of omalizumab is safe in patients with HIES, effective in inducing FcepsilonRI downregulation, and in reducing some of the cutaneous and/or respiratory symptoms associated with HIES. It also aims to determine whether the present maximum indicated dose has any effect on patients with HIES who have greater than indicated IgE levels. Finally, it aims to assess the safety and pharmacodynamic profile of increased doses of omalizumab likely to be required in most patients with HIES.
Omalizumab is a humanized monoclonal antibody specific for the FcepsilonRI portion of IgE that does not cross-link IgE. It has been used for amelioration of severe asthma and food allergies, and is being studied in a number of other allergic diseases. This study aims to determine whether administration of omalizumab is safe in patients with HIES, effective in inducing FcepsilonRI downregulation, and in reducing some of the cutaneous and/or respiratory symptoms associated with HIES. It also aims to determine whether the present maximum indicated dose has any effect on patients with HIES who have greater than indicated IgE levels. Finally, it aims to assess the safety and pharmacodynamic profile of increased doses of omalizumab likely to be required in most patients with HIES.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 06-I-0032 | None | None | View |