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

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.

Timeline

Start

2020-07-20

Primary completion

2025-05-07

Completion

2027-02-28

Publications

• Ogbogu PU, Roufosse F, Akuthota P, Kuna P, Groh M, Reiter A, Yokota A, Siddiqui SH, Mutsaers PGNJ, Li B, Khoury P, Bahadori LM, Bednarczyk A, Bouma G, Brooks LG, Ferreira J, Grindebacke H, Ho CN, Jain P, Palmer RL, Jison ML, Klion AD; NATRON study group. Benralizumab versus placebo for hypereosinophilic syndrome: a randomized, placebo-controlled phase 3 trial. Nat Med. 2026 Jun;32(6):2017-2025. doi: 10.1038/s41591-026-04315-8. Epub 2026 Mar 31.

Drugs

Indications