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

Treatment with an investigational agent within 30 days prior to screening.

Weight \< 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.

Intravenous (IV) immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to screening.

Regular (daily/every other day) doxepin (oral) use within 6 weeks prior to screening.

Any H2 antihistamine use within 7 days prior to screening.

Any leukotriene receptor antagonist (LTRA) (montelukast or zafirlukast) within 7 days prior to screening.

Any H1 antihistamines at greater than approved doses within 3 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 follicle-stimulating hormone (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.

What this study is about