Overview

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

Status:
Completed

Trial end date:
2012-10-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 3

Details

Lead Sponsor:

Genentech, Inc.

Treatments:

Histamine Antagonists
Histamine H1 Antagonists
Omalizumab