drugset / Trial / NCT02329223

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

NCT02329223

Phase 3 Completed 218 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

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

Drugs

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