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

Project

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

Automatically Closed · 2012 until 2013

Anliker Mark

Type

Clinical Studies

Range

Multicentric, KSSG as participating partner

Units

Dermatologie | Venerologie | Allergologie

Status

Automatically Closed

Start Date

2012

End Date

2013

Financing

Industry

Study Design

Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Homepage

http://clinicaltrials.gov/ct2/show/NCT01264939

Brief description/objective

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 CIU who remain symptomatic despite standard-dosed H1 antihistamine treatment (including doses up to four times above the approved dose level), H2 blockers, and/or LTRA.