A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria
Status:
Completed
Trial end date:
2017-03-09
Target enrollment:
Participant gender:
Summary
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the
efficacy and safety of subcutaneous (SC) omalizumab (Xolair) as an add-on therapy through 48
weeks for treatment of H1 antihistamine refractory chronic idiopathic urticaria (CIU). After
completing an initial 24-week open-label treatment period with omalizumab 300 milligrams (mg)
every 4 weeks (Q4W), participants responding to omalizumab will be randomized at a 3:2 ratio
(omalizumab:placebo) to either continue omalizumab or be transitioned to placebo for a
further 24 weeks.