A Study of the Efficacy and Safety of Omalizumab (Xolair) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment

Conditions

• Chronic Idiopathic Urticaria

Eligibility Criteria

Sex

ALL

Age

12 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Omalizumab — DRUG
  Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.
• Placebo — DRUG
  Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.

Study Details

The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety 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 refractory CIU and who remain symptomatic despite standard-dose H1 antihistamine treatment.

Key Dates

Start date

Feb 28, 2011

Status verified

Nov 2013

Primary completion

Oct 31, 2012

Completion

Oct 31, 2012

Study Design

Enrollment

319 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
• Experimental: Omalizumab 75 mg
  Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
• Experimental: Omalizumab 150 mg
  Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
• Experimental: Omalizumab 300 mg
  Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.

Primary Outcome Measure

Change From Baseline to Week 12 in the Weekly Itch Severity Score [ Time Frame: Baseline to Week 12 ]

Locations (40)