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)

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) - Evaluation of the Efficacy and Safety of Benralizumab in patients with HES

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54266

Enrollment

Registered

2021-11-03

Start date

2023-01-13

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypereosinophilic Syndrome

Interventions

The Treatment options includes: - Treatment with 1 investigational product

Benrazilumab vs placebo See Protocol V6.0 Part 6 Study Treatment

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * 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

Exclusion criteria

Exclusion criteria: * 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

Design outcomes

Primary

Measure	Time frame
Primary endpoint: - To evaluate the effect of benralizumab on the time to first HES worsening/flare For more details, please see Protocol V6.0, part 3 Objectives and Endpoints	—

Secondary

Measure	Time frame
Secundary Endpoints of the Open-Label Treatment: - To evaluate the effect of benralizumab on the time to first haematological relapse - To evaluate the effect of benralizumab on the proportion of patients who experience HES worsening/flare - To evaluate the effect of benralizumab on the proportion of patients with haematologic relapse - To evaluate the effect of benralizumab on the number of patients who maintain AEC < 500 cells/µL for 24 weeks - To evaluate the effect of benralizumab on corticosteroid use - To evaluate the effect of benralizumab on patient-reported measure of fatigue - To evaluate the effect of benralizumab on health status/health-related quality of life (HRQoL) measures For more details, please see Protocol V6.0, part 3 Objectives and Endpoints	—

Measure

Time frame

Secundary Endpoints of the Open-Label Treatment: - To evaluate the effect of benralizumab on the time to first haematological relapse - To evaluate the effect of benralizumab on the proportion of patients who experience HES worsening/flare - To evaluate the effect of benralizumab on the proportion of patients with haematologic relapse - To evaluate the effect of benralizumab on the number of patients who maintain AEC < 500 cells/µL for 24 weeks - To evaluate the effect of benralizumab on corticosteroid use - To evaluate the effect of benralizumab on patient-reported measure of fatigue - To evaluate the effect of benralizumab on health status/health-related quality of life (HRQoL) measures For more details, please see Protocol V6.0, part 3 Objectives and Endpoints

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)