NCT01264939

A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 336 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is a global Phase III, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the safety and efficacy 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 chronic idiopathic urticaria (CIU) who remain symptomatic despite standard-dosed H1 antihistamine treatment (including doses up to 4 times above the approved dose level), H2 blockers, and/or leukotriene receptor antagonists (LTRA).

Conditions

• Chronic Idiopathic Urticaria

Interventions

Type	Name	Description
DRUG	Omalizumab	Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.
DRUG	Placebo	Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.
DRUG	H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist	Participants were required to maintain stable doses of their pre-randomization combination therapy with an H1 antihistamine and either an H2 blocker or leukotriene receptor antagonist, or all 3 drugs in combination, throughout the 24-week treatment period and 16-week follow-up period of the 40-week study.
DRUG	Diphenhydramine	Participants were provided with diphenhydramine 25 mg for itch relief on an as-needed basis, up to a maximum of 3 doses within 24 hours for the duration of the 40-week study.

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2010-12-22
• Last updated: 2013-11-26
• Results posted: 2013-11-26

Locations

73 sites across 8 countries: United States, Australia, Germany, New Zealand, Poland, Singapore, Switzerland, United Kingdom