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

Conditions

• Chronic Idiopathic Urticaria

Eligibility Criteria

Sex

ALL

Age

12 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Placebo was supplied lyophilized in vials.
• Omalizumab — DRUG
  Omalizumab was supplied lyophilized in vials.

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-dosed H1 antihistamine treatment.

Key Dates

Start date

Mar 31, 2011

Status verified

Oct 2013

Primary completion

Jun 30, 2012

Completion

Jun 30, 2012

Study Design

Enrollment

323 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Placebo
  Placebo subcutaneously (sc) every 4 weeks
• Experimental: Omalizumab 75 mg
  Omalizumab 75 mg sc every 4 weeks
• Experimental: Omalizumab 150 mg
  Omalizumab 150 mg sc every 4 weeks
• Experimental: Omalizumab 300 mg
  Omalizumab 300 mg sc every 4 weeks.

Primary Outcome Measure

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

Locations (36)