Natron

• Research type

  Research Study

• Full title

  A Multicentre, Randomised, Double-blind, Parallel-group,Placebo-controlled, 24-week Phase 3 Study with an Open-labelExtension to Evaluate the Efficacy and Safety of Benralizumab inPatients with Hypereosinophilic Syndrome (HES)

• IRAS ID

  1007682

• Contact name

  Marnie Duncan

• Contact email

  marnie.duncan@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2019-002039-27

• Research summary

  This study to learn more about benralizumab and evaluate its potential effect in treatment of HES.
  HES (Hypereosinophilic Syndrome) is a disease characterized by high levels of eosinophils (a particular type of white blood cell) in the blood and a build-up of eosinophils in some organs and tissues (like skin, heart, lungs, intestines or others) causing their dysfunction.

  Benralizumab is an antibody (i.e. biologic drug) that has been made to reduce the number of eosinophils in the body. A previous benralizumab HES study showed that benralizumab may reduce eosinophils in blood and tissues in patients with severe HES that is not well controlled by standard of care medications.

  The purpose of this study is to see if benralizumab, given as injections under the skin, can help control HES better if it is added to available standard of care HES medications.

  This is a multicentre, randomised, Double Blind, parallel-group, placebo-controlled, 24-week Phase 3 study to compare the efficacy and safety of benralizumab 30 mg versus placebo administered by sub cutaneous injection every 4 weeks in patients with HES.
  This study comprises 2 distinct periods (together defined as the ‘main study’): A 24-week Double Blind 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 Extension treatment period, during which all patients will receive benralizumab.

  Patients will be on the study for at least 18 months and will undergo a number of tests and procedures such as blood tests, physical assessments, echocardiogram, urine sampling, tissue biopsy, electrocardiogram, spirometry, assessment for steroid responsiveness, questionnaires.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  23/WM/0133

• Date of REC Opinion

  5 Sep 2023

• REC opinion

  Further Information Favourable Opinion