A Multicentre, Randomised, Double-blind, Parallel-group, Placebo controlled, 24-week Phase 3 Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients with Hypereosinophilic Syndrome (HES)
- Conditions
- Hypereosinophilic Syndrome10047954
- Registration Number
- NL-OMON54266
- Lead Sponsor
- Astra Zeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 3
* Adults with documented diagnosis of HES
* 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.
* At least one flare within the past 12 months must not be related to a
decrease in HES therapy during the 4 weeks prior to the flare.
For more details, see protocol section 5.1
* Life-threatening HES and/or HES complication(s) as judged by the Investigator
* Current malignancy, or history of malignancy
* A history of known immunodeficiency disorder other than that explained by the
use of OCS or other therapy taken for HES. Positive human immunodeficiency
virus (HIV) test.
For more details, see protocol Section 5.2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br><br /><br>- To evaluate the effect of benralizumab on the time to first HES<br /><br>worsening/flare<br /><br><br /><br><br /><br>For more details, please see Protocol V6.0, part 3 Objectives and Endpoints</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundary Endpoints of the Open-Label Treatment: - To evaluate the effect of<br /><br>benralizumab on the time to first haematological relapse - To evaluate the<br /><br>effect of benralizumab on the proportion of patients who experience HES<br /><br>worsening/flare - To evaluate the effect of benralizumab on the proportion of<br /><br>patients with haematologic relapse - To evaluate the effect of benralizumab on<br /><br>the number of patients who maintain AEC < 500 cells/µL for 24 weeks - To<br /><br>evaluate the effect of benralizumab on corticosteroid use - To evaluate the<br /><br>effect of benralizumab on patient-reported measure of fatigue - To evaluate the<br /><br>effect of benralizumab on health status/health-related quality of life (HRQoL)<br /><br>measures For more details, please see Protocol V6.0, part 3 Objectives and<br /><br>Endpoints</p><br>