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

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

Outcome

Met primary endpoint

registry analysis (superiority test); Omalizumab 300mg vs Placebo; p <0.001; Mean Difference (Net) -4.23 (95% CI -5.70 to -2.77); Mixed Model with Repeated Measures(MMRM) NCT03328897 ↗

Publications

Bi XD, Lu BZ, Pan XX, Liu S, Wang JY. Adjunct therapy with probiotics for chronic urticaria in children: randomised placebo-controlled trial. Allergy Asthma Clin Immunol. 2021 Apr 17;17(1):39. doi: 10.1186/s13223-021-00544-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Omalizumab	Monoclonal antibody	150 mg	Subcutaneous
Subject	Omalizumab	Monoclonal antibody	300 mg	Subcutaneous