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)
Omalizumab
+ Placebo
Chronic Urticaria+9
+ Chronic Disease
+ Hypersensitivity
Treatment Study
Summary
Study start date: February 1, 2011
Actual date on which the first participant was enrolled.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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.319 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 12 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
25% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives