NCT01292473

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)

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Chronic Idiopathic Urticaria

Interventions

Type	Name	Description
DRUG	Placebo	Placebo was supplied lyophilized in vials.
DRUG	Omalizumab	Omalizumab was supplied lyophilized in vials.

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-02-09
• Last updated: 2013-10-11
• Results posted: 2013-09-02

Locations

61 sites across 8 countries: United States, Denmark, France, Germany, Italy, Poland, Spain, Turkey (Türkiye)