This is a multicentre, randomised, double-blind (DB), parallel-group, placebo-controlled,
24-week Phase 3 study to compare the efficacy and safety of benralizumab versus placebo
administered by SC injection Q4W in patients with hypereosinophilic syndrome (HES). This
study comprises 2 distinct periods (together defined as the 'main study'): A 24-week, DB
treatment period, during which patients will be randomised to receive either benralizumab or
placebo, in addition to prior stable HES background therapy, and an open-label (OLE)
treatment period, during which all patients will receive benralizumab. Patients will not
continue to be recruited after 47 patients have had their first HES worsening/flare.The
primary database lock (DBL) will occur when at least 47 patients have had their first HES
worsening/flare event and all randomised patients have been followed up for the 24-week DB
treatment period. The target patient population is male and female patients 12 years of age
and older with symptomatic active HES. Approximately 120 eligible patients will be randomised
at a 1:1 ratio to receive either benralizumab or matching placebo.
Clinical Study Identifier
Last Modified on
10 December 2020
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