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NCT04191304 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Hypereosinophilic Syndrome, sponsored by AstraZeneca.

Active
Registry status
Phase 3
Development phase
134
Enrollment target
20
Study locations

NCT04191304 is a Phase 3 study of Hypereosinophilic Syndrome that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 134 participants, above the 114-participant average among 7 other Hypereosinophilic Syndrome trials with a reported enrollment target (18% higher). The trial reports 20 study locations across 8 states.

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The verdict

NCT04191304, a Phase 3 study of Hypereosinophilic Syndrome, is active but no longer recruiting, sponsored by AstraZeneca.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
134 participants
Enrollment target
20
Study locations

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 Studied

Hypereosinophilic Syndrome

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL Benralizumab

Study Locations (20)

Other

  • Research Site - Rosario
  • Research Site - Innsbruck
  • Research Site - Brussels
  • Research Site - Edegem
  • Research Site - Chengdu
  • Research Site - Tianjin
  • Research Site - Xiamen
  • Research Site - Zhengzhou
  • Research Site - København Ø
  • Research Site - Lille
  • Research Site - Pessac
  • Research Site - Strasbourg

Ohio

  • Research Site - Cleveland
  • Research Site - Columbus

California

  • Research Site - La Jolla

Georgia

  • Research Site - Atlanta

Maryland

  • Research Site - Bethesda

Michigan

  • Research Site - Ann Arbor

North Carolina

  • Research Site - Durham

Utah

  • Research Site - Salt Lake City

Trial Details

FieldValue
Enrollment Target 134 participants
Start Date 2020-07-20
Est. Completion 2026-12-30
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04191304

The ClinicalTrials.gov registry entry for NCT04191304 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 114-participant average among 7 other Hypereosinophilic Syndrome trials with a reported enrollment target (18% higher). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hypereosinophilic Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04191304 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, Ohio, California.

Frequently Asked Questions

What is clinical trial NCT04191304 about?

NCT04191304 is a clinical study titled "A Phase III Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES)". 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 peri...

What is the current status of trial NCT04191304?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 134 participants. The study started on 2020-07-20. Estimated completion is 2026-12-30.

What conditions does trial NCT04191304 study?

This clinical trial studies the following conditions: Hypereosinophilic Syndrome.

What interventions are being tested in trial NCT04191304?

The interventions under investigation include: Placebo (BIOLOGICAL), Benralizumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT04191304?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04191304 being conducted?

This trial has 20 study locations across California, Georgia, Maryland, Michigan, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.