drugset / Trial / NCT03328897

Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria

NCT03328897

Phase 3 Completed 418 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study was to demonstrate the efficacy and safety of omalizumab, compared with placebo, as an add-on to H1 antihistamines (H1AH) therapy in adult patients suffering from Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite H1AH therapy.

Timeline

Start
2017-04-26
Primary completion
2019-07-23
Completion
2019-09-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Omalizumab Monoclonal antibody 150 mg Subcutaneous
Subject Omalizumab Monoclonal antibody 300 mg Subcutaneous