A Phase III Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES)

Study Summary

This is a multicentre, randomised, double-blind (DB), parallel-group, placebo-controlled, 24-week Phase III 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 their prior stable HES background therapy, and an open-label extension (OLE) period, during which all patients will receive benralizumab. The primary database lock (DBL) will occur when approximately 38 patients have had their first HES worsening/flare event during the DB treatment period and all randomised patients have had the opportunity to be followed up for the 24-week DB treatment period. A patient must complete the 24-week DB treatment period on investigational product (IP) to be eligible to enter the OLE treatment period. The final DBL will occur after the last patient completes the OLE.

Primary Outcome

The time to first HES worsening/flare is calculated as: start date of the first HES worsening - date of randomisation + 1. For participants who do not experience a HES worsening/flare, the time to first HES worsening/flare is right censored at the end of the DB period corresponding to the earliest date (date of the first of Benra open label dose, study day 183, date of last contact, and data cut-off date). The number of participants with events and censored observations is presented.

Conditions Studied

Interventions

• BIOLOGICAL Placebo
• BIOLOGICAL Benralizumab

Study Locations (20)