At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 616 enrolled
Drug / intervention
Omalizumab +1 moredrug
Likely dose
Omalizumab 0.016 mg/kgfrom 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 24-week, Phase III Randomized, Double-blind, Placebocontrolled, Parallel-group, Multicenter Study of Xolair® (Omalizumab) in Patients With Moderate to Severe Persistent Allergic Asthma Who Remain Not Adequately Controlled Despite GINA (2009) Step 4 Therapy
In Brief
A Phase 3 clinical trial evaluating Omalizumab and Placebo for Persistent Allergic Asthma. Completed, enrolled 616 participants across 39 sites.
Detailed Summary
This study will assess the efficacy, safety and tolerability of omalizumab, compared to placebo in 18 to 75 year old Chinese patients with moderate to severe persistent allergic asthma who have inadequate asthma control despite treatment according to GINA (2009) Step 4 therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPersistent Allergic Asthma
CountriesChina
CollaboratorsGenentech, Inc.
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2010
First PostedSep 2010
Primary CompletionOct 2013
TodayJul 2026
First PostedSep 16, 2010
Enrollment StartSep 1, 2010
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 15.8 years ago
Interventions
Omalizumabdrug
The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
Placebodrug
The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.