NCT00866788

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

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Idiopathic Urticaria

Interventions

Type	Name	Description
DRUG	omalizumab	Administered by subcutaneous injection
DRUG	placebo	Participants received a single subcutaneous placebo injection on Day 0 of the study.
DRUG	H1 antihistamines	Patients received one of the following: Cetirizine 10 mg once per day (QD), Levocetirizine dihydrochloride 5 mg QD, Fexofenadine 60 mg twice per day or 180 mg QD, Loratadine 10 mg QD or Desloratadine 5 mg QD
DRUG	Diphenhydramine	Diphenhydramine was provided and used on an as-needed basis (25 mg per dose)

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2009-03-23
• Last updated: 2017-07-11
• Results posted: 2011-09-09