AZ NATRON - D3254C00001 (Hypereosinophilic Syndrome) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about benralizumab and evaluate its potential effect in treatment for patients with hypereosinophilic syndrome (HES).

What is the Condition Being Studied?

Hypereosinophilic Syndrome (HES)

Who Can Participate in the Study?

Adults ages 18+ who:

- Have a documented diagnosis of HES

-- History of persistent eosinophilia >1500 cells/microliter (at least 2 examinations, interval of at least 1 month)

-- Secondary cause excluded

-- End organ manifestations attributable to the eosinophilia

- Are FIP1L1-PDGFRA fusion tyrosine kinase gene translocation negative

For more information about who can join this study, contact the study team at

Age Group

What is Involved?

If you choose to join this study, you will:

- Get a random assignment (like a coin flip) to 1 of 2 groups

-- One group will take benralizumab

-- The other group will take a placebo (inactive substance that has no drug in it)

This "blinded" portion of the study will last 24 weeks. After the 24 weeks are done, you will have the option to continue in the study. Everyone who chooses to continue in the study will then get benralizumab no matter which group they were in previously. This extension portion of the study will last one year.

Throughout the study, you will also:

- Have blood draws

- Give urine samples

- Have heart scans (ECG)

- Have breathing tests

- Have physical exams

Study Details

Full Title
A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 24 Week Phase III Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients with Hypereosinophilic Syndrome (HES) D3254C00001
Principal Investigator
Allergy & Immunology Specialist
Protocol Number
IRB: PRO00103948
NCT: NCT04191304
Phase III
Enrollment Status
Open for Enrollment