Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment

A Phase IV, Multicenter, Single-arm and Open-label Study With Omalizumab (Xolair®) in Chronic Spontaneous Urticaria (CSU) Patients Who Remain Symptomatic Despite Antihistamine (H1) Treatment

Evaluate the proportion of patients with an urticaria control test [UCT] score of greater than or equal to 12 at Week 12.

Inclusion Criteria:

• Male or female patients aged between 18 and 75 years.
• Diagnosis of CSU for ≥ 6 months and an inadequate response to nsH1 antihistamines at the time of the request, as defined by the following:
• The presence of itch and hives for > 6 consecutive weeks at any time prior to enrollment, despite current use of H1 antihistamine therapy during this time period.
• Weekly UAS7 score (range 0 to 42) 16 and UCT score (range 0 to 16) < 8 prior to enrollment (Day 1)
• Current use of an H1 antihistamine for CSU on the day of the initial visit and Day
• Informed consent

Exclusion Criteria:

• Treatment with an investigational agent within 30 days before enrollment.
• Routine (daily or every other day during 5 or more consecutive days) doses of the following medications within 30 days prior to Day -7: systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide.
• Intravenous (i.v.) immunoglobulin G or plasmapheresis within 30 days prior to Day -7
• Regular (daily/every other day) doxepin (oral) use within 14 days prior to Day -7.
• Any H2 antihistamine use within 7 days prior to Day -7.
• Any leukotriene receptor antagonist (LTRA) (montelukast or zafirlukast) within 7 days prior to Day 7.
• Concomitant use of cyclosporine or any other immunosuppressive agent.
• Hypersensitivity to omalizumab or any component of the formulation.
• History of anaphylactic shock.