Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260702
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-12-01
Brief Title:
Omalizumab to Treat Hyper-IgE Jobs Syndrome
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pilot Study of Omalizumab Xolair in Hyper IgE Jobs 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 Jobs 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 Jobs 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 andor 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 andor 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-I-0032 | None | None | None |