Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130234
Status:
COMPLETED
Last Update Posted:
2008-05-07
First Post:
2005-08-12
Brief Title:
Effect of Anti-IgE in Chronic Urticaria
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Effect of Anti-IgE in Chronic Urticaria
Status:
COMPLETED
Status Verified Date:
2008-05
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 is being done to find out if a drug called Xolair omalizumab an anti-IgE antibody is safe and effective for people with chronic urticaria hives with persistent symptoms in spite of taking antihistamines
Detailed Description:
Omalizumab Xolair is a recombinant humanized monoclonal antibody that binds specifically to the FcEpsilonR1 binding site on human IgE The binding of omalizumab inhibits the ability of IgE to bind to basophils or mast cells Free IgE levels fall by 89 and 98 over 16 and 24 weeks of therapy respectively Busse 2001 Total IgE levels rise in patients treated with omalizumab though almost all IgE is bound and thus inactive Omalizumab has also been shown to decrease expression of the FcEpsilonR1 receptor on both basophils and mast cells Beck et al 2004 Omalizumab recently received FDA approval for the treatment of moderate to severe persistent allergic asthma in pediatric 12 years of age and above and adult patients Studies have also shown efficacy in the treatment of allergic rhinitis and similar anti-IgE compounds have been efficacious as food allergy therapeutics Casale 2001 and Leung 2003
Given the efficacy of omalizumab in the treatment of moderate to severe allergic asthma the researchers will conduct a double-blind study to evaluate the safety and efficacy of omalizumab in a small number of patients with chronic urticaria with persistent symptoms in spite of background antihistamine therapy Omalizumab is currently not indicated for patients with chronic urticaria The primary hypothesis is that omalizumab will lead to a reduction in serum IgE levels and blood basophil high affinity IgE receptor expression in subjects with chronic idiopathic urticaria Additionally clinical outcomes such as quality of life symptoms scores and medication use will be explored This study should allow for further understanding of the role IgE plays in chronic urticaria
Given the efficacy of omalizumab in the treatment of moderate to severe allergic asthma the researchers will conduct a double-blind study to evaluate the safety and efficacy of omalizumab in a small number of patients with chronic urticaria with persistent symptoms in spite of background antihistamine therapy Omalizumab is currently not indicated for patients with chronic urticaria The primary hypothesis is that omalizumab will lead to a reduction in serum IgE levels and blood basophil high affinity IgE receptor expression in subjects with chronic idiopathic urticaria Additionally clinical outcomes such as quality of life symptoms scores and medication use will be explored This study should allow for further understanding of the role IgE plays in chronic urticaria
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