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

NCT04191304 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2026-04-02

No results posted yet for this 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.

Conditions

  • Hypereosinophilic Syndrome

Interventions

BIOLOGICAL

Benralizumab

Benralizumab solution for injection in an accessorised prefilled syringe (APFS) will be administered subcutaneously (SC) every 4 weeks

BIOLOGICAL

Placebo

Matching placebo solution for injection in an APFS will be administered SC every 4 weeks

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-20
Primary Completion
2025-05-07
Completion
2027-02-28
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • China
  • Denmark
  • France
  • Germany
  • India
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Poland
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04191304 on ClinicalTrials.gov