Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients

Summary

This was a 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 participants 12 - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.

Timeline

Start

2014-12

Primary completion

2015-12

Completion

2015-12

Outcome

Met primary endpoint

registry Omalizumab 300 mg vs Placebo; p <0.001; Mean Difference (Net) -3.70 (95% CI -5.310 to -2.098) NCT02329223 ↗

registry Omalizumab 150 mg vs Placebo; p = 0.006; Mean Difference (Net) -2.29 (95% CI -3.921 to -0.654) NCT02329223 ↗

Drugs

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

Indications