A Study of the Efficacy and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)

• Incidence of adverse events and serious adverse events [ Time Frame: Up to week 40 ] [ Designated as safety issue: No ]
• Severity of adverse events and serious adverse events [ Time Frame: Up to week 40 ] [ Designated as safety issue: No ]

The study is a global 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 patients aged 12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite standard-dosed H1 antihistamine treatment.

• Drug: omalizumab
  Repeating subcutaneous injection
• Drug: placebo
  Repeating subcutaneous injection

• Experimental: A
  Intervention: Drug: omalizumab
• Placebo Comparator: B
  Intervention: Drug: placebo

Inclusion Criteria:

• Diagnosis of CIU/CSU refractory to H1 antihistamines at the time of randomization

Exclusion Criteria:

• Treatment with an investigational agent within 30 days prior to screening
• Weight less than 20 kg (44 lbs)
• Clearly defined underlying etiology for chronic urticarias other than CIU
• Evidence of parasitic infection
• Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or other skin disease associated with itch
• Previous treatment with omalizumab within a year prior to screening
• Routine doses of the following medications within 30 days prior to screening: systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide
• IV immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to screening
• Regular (daily/every other day) doxepin (oral) use within 14 days prior to screening
• Patients with current malignancy, history of malignancy, or currently under work-up for suspected malignancy except non-melanoma skin cancer that has been treated or excised and is considered resolved
• Hypersensitivity to omalizumab or any component of the formulation
• History of anaphylactic shock
• Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic or other pathological conditions that could interfere with the interpretation of the study results and or compromise the safety of the patients
• Evidence of current drug or alcohol abuse
• Nursing women or women of childbearing potential, unless they meet the following definition of post-menopausal: 12 months of natural amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/mL or 6 weeks post surgical bilateral oophorectomy (with or without hysterectomy) or hysterectomy or are using one or more of the following acceptable methods of contraception: surgical sterilization, hormonal contraception, and double-barrier methods