A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)

The study is a Phase II, dose-ranging, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of a single subcutaneously administered omalizumab dose as add-on therapy for the treatment of adolescent and adult patients 12-75 years old who have been diagnosed with CIU and remain symptomatic despite treatment with therapeutic doses of an H1 antihistamine. The study will enroll approximately 76 patients at approximately 45 study centers in the United States and Germany.

Inclusion Criteria:

• CIU diagnosis > 3 months (by history)
• No underlying etiology clearly defined for urticaria (main manifestation cannot be physical urticaria)

Exclusion Criteria:

• Pregnant, breastfeeding, or women not taking contraception
• Patients < 40kg
• Treatment with any investigational agent within 30 days of screening
• Recent history of drug or alcohol abuse
• Atopic dermatitis or other skin disease associated with pruritus
• Clinically relevant major systemic disease (making interpretation of the study results difficult)
• Previously treated with omalizumab (< 12 months since last injection)
• Patients may not take during treatment period or have been taking within the past 3 months any of the following medications/treatments: regular (daily/every other day) hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, IVIG, or plasmapheresis
• Patients may not have been taking doxepin within the past 6 weeks regular (daily/every other day).