At a glance
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A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Xolair® (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)
In Brief
A Phase 3 clinical trial evaluating Omalizumab and Placebo for Chronic Idiopathic Urticaria. Completed, enrolled 319 participants across 66 sites in 8 countries.
Detailed Summary
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-dose H1 antihistamine treatment.
Study Details
Timeline
Interventions
Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.
Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.