An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)

An Exploratory, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy of Multiple Doses of Omalizumab in Cystic Fibrosis Complicated by Allergic Bronchopulmonary Aspergillosis (ABPA)

This study will evaluate the safety and efficacy of omalizumab for the treatment of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with Cystic Fibrosis aged 12 years and older.

Inclusion Criteria:

• Diagnosis of Cystic Fibrosis complicated by Allergic Bronchopulmonary Aspergillosis (ABPA)
• Oral corticosteroid use for ABPA flare
• Age 12 years and older (except for Italy; ≥ 18 years)
• Total serum IgE levels ≥ 500 IU/mL

Exclusion Criteria:

• History of cancer in the last 10 years.
• History of severe allergic reactions
• Pregnant and lactating women
• Prior use of Xolair

Other protocol-defined inclusion/exclusion criteria may apply.