View Clinical Trial (Medical Research Study)

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Sympto

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Conditions:		Chronic Idiopathic Urticaria
Purpose:		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.
Study Summary:
Criteria:		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
NCT ID:		NCT01287117
Primary Contact:		Study Director Karin Rosen, M.D., Ph.D. Genentech Robert Biaggi Email: biaggi.robert@gene.com
Backup Contact:		N/A
Location Contact:		Springfield, Illinois 62703 United States There is no listed contact information for this specific location. Site Status: Recruiting

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