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

Chronic Idiopathic Urticaria Clinical Trial

Official title: A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Xolair® (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Type I Error Rate Control Plan

Primary Outcome Measure

In order to maintain an overall type I error rate of 0.05 (2-sided) across the 3 omalizumab dose levels, the testing of the primary Outcome Measure was conducted in the following hierarchical order. A p-value < 0.05 is only considered statistically significant if statistical significance was claimed at the previous stage.

• Stage 1: Omalizumab 300-mg group vs. placebo

• Stage 2: Omalizumab 150-mg group vs. placebo

• Stage 3: Omalizumab 75-mg group vs. placebo

Secondary Outcome Measures

A hierarchical analysis of the following secondary Outcome Measures was performed for each dose found to be significant in the primary Outcome Measure. A p-value < 0.05 is only considered statistically significant if statistical significance was claimed at the previous stage.

• Stage 1: Change from baseline to Week 12 in the urticaria activity score over 7 days (UAS7)

• Stage 2: Change from Baseline to Week 12 in the weekly number of hives score

• Stage 3: Time to minimally important difference (MID) response in the weekly itch severity score by Week 12

• Stage 4: Percentage of participants with a UAS7 score ≤ 6 at Week 12

• Stage 5: Percentage of weekly itch severity score MID responders at Week 12

• Stage 6: Change from Baseline to Week 12 in the weekly size of the largest hive score

• Stage 7: Change from Baseline in the overall dermatology life quality index (DLQI) score at Week 12

• Stage 8: Change from Baseline in the overall dermatology life quality index (DLQI) score at Week 12

• Stage 9: Percentage of complete responders (UAS7 = 0) at Week 12 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Idiopathic Urticaria
• Urticaria

• NCT number: NCT01287117
• Study type: Interventional
• Source: Genentech, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: February 2011
• Completion date: October 2012