Overview

A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)

Status:
Completed

Trial end date:
2010-01-01

Target enrollment:

Participant gender:

Summary

The study is a Phase II, dose-ranging, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of a single subcutaneously administered omalizumab dose as add-on therapy for the treatment of adolescent and adult patients 12-75 years old who have been diagnosed with CIU and remain symptomatic despite treatment with therapeutic doses of an H1 antihistamine. The study will enroll approximately 76 patients at approximately 45 study centers in the United States and Germany.

Phase:

Phase 2

Details

Lead Sponsor:

Genentech, Inc.

Treatments:

Diphenhydramine
Histamine Antagonists
Histamine H1 Antagonists
Omalizumab
Promethazine