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)

Chronic Idiopathic Urticaria Clinical Trial

Official title: A Phase III, Multicenter, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria 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-dosed H1 antihistamine treatment.

Clinical Trial Description

The trial incorporated a Type I error control plan, as follows:

The testing of the primary endpoint was conducted in the following hierarchical order. A p-value that is less than 0.05 can only be claimed statistically significant if statistical significance has been 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

A hierarchical analysis of the secondary endpoints was performed for each dose found to be significant in the primary endpoint. A p-value that is less than 0.05 can only be claimed statistically significant if statistical significance has been claimed at the previous stage.

• Stage 1: Change from baseline in Urticaria Activity Score (UAS7) at Week 12

• Stage 2: Change from baseline in the weekly number of hives score at Week 12

• Stage 3: Time to weekly itch severity score Minimally Important Difference (MID) response at Week 12

• Stage 4: Proportion of patients with UAS7 ≤ 6 at Week 12

• Stage 5: Proportion of weekly itch severity score MID Responders at Week 12

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

• Stage 7: Change from baseline in overall Dermatology Life Quality Index (DLQI) score at Week 12

• Stage 8: Proportion of angioedema-free days from Week 4 to Week 12 ;

Study Design

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

Related Conditions & MeSH terms

• Chronic Idiopathic Urticaria
• Urticaria

• NCT number: NCT01292473
• Study type: Interventional
• Source: Genentech, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: March 2011
• Completion date: June 2012