Conditions: Chronic Idiopathic Urticaria
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 323
Healthy volunteers: no

Brief 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

Arms:
arm 1: Placebo subcutaneously (sc) every 4 weeks arm 2: Omalizumab 75 mg sc every 4 weeks arm 3: Omalizumab 150 mg sc every 4 weeks arm 4: Omalizumab 300 mg sc every 4 weeks.

Interventions: intervention 1: Placebo intervention 2: Omalizumab
Intervention descriptions: intervention 1: Placebo was supplied lyophilized in vials. intervention 2: Omalizumab was supplied lyophilized in vials.

Protocol document: