Active — Not RecruitingPhase 3

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

United States134 participantsStarted 2020-07-20

Plain-language 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.

Who can participate

Age range12 Years – 130 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Provision of the signed and dated written informed consent of the patient or the patient's legally authorised representative, and informed assent from the patient (per local regulations) prior to any mandatory study-specific procedures, sampling, and analyses
✓. Males and females 12 years of age and older at the time of signing the ICF
✓. Documented diagnosis of HES (history of persistent eosinophilia \> 1500 cells/μL without secondary cause on 2 examinations \[interval ≥ 1 month; Valent et al 2012\] and evidence of end organ manifestations attributable to the eosinophilia)
✓. Documented negative testing for the FIP1L1-PDGFRA fusion tyrosine kinase gene translocation
✓. Stable HES treatment dose(s) and regimen for ≥ 4 weeks at the time of Visit 1
✓. Signs or symptoms of HES worsening/flare and/or laboratory abnormalities indicative of HES worsening/flare (other than isolated eosinophilia) at Visit 1 OR a documented history of 2 or more HES worsening/flares within 12 months prior to Visit 1 requiring an escalation in therapy
✓. AEC ≥ 1000 cells/μL at Visit 1 (assessed by local laboratory)
✓. Corticosteroid responsiveness defined as an AEC \< 1000 cells/μL after a 2-day course of OCS (prednisone/prednisolone) 1 mg/kg/day at Visit 2 (assessed by local laboratory). Other OCSs in equivalent doses are permitted

What they're measuring

Time to first HES worsening/flare

Timeframe: Up to 24 weeks

Trial details

NCT IDNCT04191304

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-07

View on ClinicalTrials.gov More Hypereosinophilic Syndrome trials

Plain-language summary

Who can participate

Age range12 Years – 130 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Provision of the signed and dated written informed consent of the patient or the patient's legally authorised representative, and informed assent from the patient (per local regulations) prior to any mandatory study-specific procedures, sampling, and analyses
✓. Males and females 12 years of age and older at the time of signing the ICF
✓. Documented diagnosis of HES (history of persistent eosinophilia \> 1500 cells/μL without secondary cause on 2 examinations \[interval ≥ 1 month; Valent et al 2012\] and evidence of end organ manifestations attributable to the eosinophilia)
✓. Documented negative testing for the FIP1L1-PDGFRA fusion tyrosine kinase gene translocation
✓. Stable HES treatment dose(s) and regimen for ≥ 4 weeks at the time of Visit 1
✓. Signs or symptoms of HES worsening/flare and/or laboratory abnormalities indicative of HES worsening/flare (other than isolated eosinophilia) at Visit 1 OR a documented history of 2 or more HES worsening/flares within 12 months prior to Visit 1 requiring an escalation in therapy
✓. AEC ≥ 1000 cells/μL at Visit 1 (assessed by local laboratory)
✓. Corticosteroid responsiveness defined as an AEC \< 1000 cells/μL after a 2-day course of OCS (prednisone/prednisolone) 1 mg/kg/day at Visit 2 (assessed by local laboratory). Other OCSs in equivalent doses are permitted

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria