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

Projekt

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

Automatisch geschlossen · 2012 bis 2013

Anliker Mark

Art

Klinische Forschung

Reichweite

Multizentrisch, KSSG als teilnehmendes Zentrum

Bereiche

Dermatologie | Venerologie | Allergologie

Status

Automatisch geschlossen

Start

2012

Ende

2013

Finanzierungsart

Industrie

Studiendesign

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

Webseite

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

Kurzbeschreibung/Zielsetzung

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.