A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)



Status:Archived
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:February 2011

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A Phase III, Multicenter, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)


The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled,
parallel-group study to evaluate the efficacy and safety of omalizumab administered
subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged
12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite
standard-dosed H1 antihistamine treatment.



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1 Boston Medical Center Pl
Boston, Massachusetts 02118
617.638.8000
Boston Med Center Boston Medical Center (BMC) is a 496-bed academic medical center located in...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28203
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East Providence, Rhode Island 02915
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York, Pennsylvania 17405
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