Q4883g: Omalizumab compared with placebo in patients with CIU

• Research type

  Research Study

• Full title

  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

• IRAS ID

  74025

• Contact name

  Clive Grattan

• Sponsor organisation

  Genentech Inc.

• Eudract number

  2010-022784-35

• ISRCTN Number

  Isrctn

• Research summary

  This is a Phase III double-blind, placebo-controlled, parallel-group study that looks at ascertaining the safety and efficacy of omalizumab administered subcutaneouslyas additional therapy for the treatment of adolescent and adult patients (aged 12-75 years old), who have been diagnosed with chronic idiopatic urticaria but 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 (leukotriene receptor antagonists).The study will enroll approximately 320 patients (240 in the omalizumab [300-mg] arm and 80 in the placebo arm) at approximately 70 study sites. The study will consist of three distinct study periods over a time-period of 42 weeks. The screening period of 2 weeks, followed by treatment period of 24 weeks and follow up period of 16 weeks. Patients will not take the study treatment in the follow up period (week 25 to 42). The end of the study is defined as the last enrolled patient??s last visit.

• REC name

  London - Central Research Ethics Committee

• REC reference

  11/LO/0530

• Date of REC Opinion

  8 Aug 2011

• REC opinion

  Further Information Favourable Opinion