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

• Change in the Weekly Pruritus Score From Baseline to Week 4 [ Time Frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) ] [ Designated as safety issue: No ]
  The pruritus (itch) score was recorded by participants twice daily (morning and evening) based on the severity of itch over the last 12 hours, using a scale from 0 (none) to 3 (severe). The weekly pruritus score was the sum of average daily pruritus scores over the previous 7 days. The range of the weekly score is 0-21.
• Change in the Weekly Score for Number of Hives From Baseline to Week 4 [ Time Frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) ] [ Designated as safety issue: No ]
  The number of hives was recorded by participants twice daily (morning and evening) using a scale from 0 (no hives) to 3 (more than 12 hives). The weekly score of number of hives was the sum of the average daily scores over the previous 7 days, and ranged from 0 to 21
• Change in the Weekly Score for Sleep Interference From Baseline to Week 4 [ Time Frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) ] [ Designated as safety issue: No ]
  The extent to which hives or itch interfered with participants' sleep was recorded once daily in the patient diary using a scale from 0 (no interference) to 3 (substantial interference, waking often). The weekly score of sleep interference was the sum of the daily scores over the previous 7 days, and ranged from 0 to 21.
• Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4 [ Time Frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) ] [ Designated as safety issue: No ]
  Diphenhydramine 25mg was provided and used on an as-needed basis (maximum 3 times/day) as rescue medication. The weekly score for the amount of rescue medication is the sum of the daily scores for the amount of rescue medication used at each day in the week, and ranged from 0 to 21.
• Number of Patients With Adverse Events by Severity [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

  The severity (i.e. intensity) of each Adverse Event (AE) was graded according to the following scale: Mild: Symptoms causing no or minimal interference with usual social and functional activities. Moderate: Symptoms causing greater than minimal interference with usual social and functional activities. Severe: Symptoms causing inability to perform usual social and functional activities.

  Additional AE data is provided in the AE section below. The terms "severe" and "serious" are not synonymous. Severity refers to the intensity of an AE. A "Serious" AE is defined below.

• Number of Participants With Immunogenicity [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  Immunogenicity was measured by detection of anti-therapeutic antibodies (anti-omalizumab antibodies) using a fragment enzyme-linked immunosorbent assay (ELISA).

• Change in the weekly pruritus score from baseline to the 4th week in the treatment period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Change in the weekly score for number of hives from baseline to the 4th week in the treatment period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Change in the weekly score for the sleep interference from baseline to the 4th week in the treatment period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Change in the amount of rescue medication from baseline to the 4th week in the treatment period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Frequency and severity of treatment emergent adverse events [ Time Frame: Length of study ] [ Designated as safety issue: No ]
• Clinical laboratory measures and vital signs [ Time Frame: Length of study ] [ Designated as safety issue: No ]
• Incidence of immunogenicity [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

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.

• Drug: omalizumab
  Administered by subcutaneous injection
  Other Name: Xolair
• Drug: placebo
  Participants received a single subcutaneous placebo injection on Day 0 of the study.
• Drug: H1 antihistamines
  Patients received one of the following: Cetirizine 10 mg once per day (QD), Levocetirizine dihydrochloride 5 mg QD, Fexofenadine 60 mg twice per day or 180 mg QD, Loratadine 10 mg QD or Desloratadine 5 mg QD
• Drug: Diphenhydramine
  Diphenhydramine was provided and used on an as-needed basis (25 mg per dose)

• Experimental: Omalizumab 75 mg
  Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.).
  Interventions:

  • Drug: omalizumab
  • Drug: H1 antihistamines
  • Drug: Diphenhydramine
• Experimental: Omalizumab 300 mg
  Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
  Interventions:

  • Drug: omalizumab
  • Drug: H1 antihistamines
  • Drug: Diphenhydramine
• Experimental: Omalizumab 600 mg
  Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
  Interventions:

  • Drug: omalizumab
  • Drug: H1 antihistamines
  • Drug: Diphenhydramine
• Placebo Comparator: Placebo
  Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
  Interventions:

  • Drug: omalizumab
  • Drug: placebo
  • Drug: H1 antihistamines
  • Drug: Diphenhydramine

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).