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
Condition: Chronic Idiopathic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: Omalizumab; Placebo
Intervention description: Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.; Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.
Intervention MeSH terms: Omalizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 319.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      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-dose H1 antihistamine treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU)
             refractory to H1 antihistamines at the time of randomization.

        Exclusion Criteria:

          -  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.