At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 323 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Placebo and Omalizumab for Chronic Idiopathic Urticaria. Completed, enrolled 323 participants across 61 sites in 8 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Idiopathic Urticaria
CountriesDenmark, France, Germany, Italy, Poland, Spain, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2011
Enrollment StartMar 2011
Primary CompletionJun 2012
TodayJul 2026
First PostedFeb 9, 2011
Enrollment StartMar 1, 2011
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.4 years ago
Interventions
Placebodrug
Placebo was supplied lyophilized in vials.
Omalizumabdrug
Omalizumab was supplied lyophilized in vials.