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A Phase III Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES)
NCT04191304 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2020-07-20 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 3 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,053 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04191304 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, Ohio, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04191304?
The interventions under investigation include: Placebo (BIOLOGICAL), Benralizumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04191304?
This trial is sponsored by AstraZeneca, which has 1,053 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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