Hypereosinophilic Syndrome (HES)
Conditions
Brief summary
"Time to first HES worsening/flare - Population b: Full analysis set - Intercurrent event strategy b: Included in analysis regardless of treatment discontinuation (treatment policy) - Population-level summary: Hazard ratio (HES worsening/flare: HES clinical manifestations or lab abnormalities that result in an increase/burst of oral corticosteroids (OCS) ≥10 mg/day for at least 2 days OR an increase, or addition of new cytotoxic and/or immunosuppressive therapy, OR hospitalization)"
Detailed description
"DB treatment period: - Key: Proportion of patients who experience an HES worsening/flare during the DB period - Key: Number of HES worsenings/flares (annualised rate/year) during the DB period - Key: Time to first haematologic relapse (AEC ≥ 1000 cells/μL) during the DB period - Key: Fatigue severity (PROMIS fatigue short form 7a) at Week 24 - Proportion of patients who: - have haematologic relapse during the DB period - have AEC < 500 cells/μL for 24 weeks - require an increase in [...], "OLE treatment period: - Proportion of patients who experience an HES worsening/flare - Annualized rate of HES worsening/flare - Fatigue (PROMIS fatigue short form 7a) - Safety and tolerability will be evaluated in terms of AEs, vital signs and clinical laboratory assessments - Serum benralizumab concentrations, anti-benralizumab antibodies and nAbs - HES symptom questionnaire - HRQoL (SF-36v2)"
Interventions
DRUGBenralizumab Placebo for clinical trials is a sterile liquid solution presented in an accessorized prefilled syringe (APFS) for subcutaneous injection. Please refer to the IMPD documentation enclosed.
DRUGPlacebo
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| "Time to first HES worsening/flare - Population b: Full analysis set - Intercurrent event strategy b: Included in analysis regardless of treatment discontinuation (treatment policy) - Population-level summary: Hazard ratio (HES worsening/flare: HES clinical manifestations or lab abnormalities that result in an increase/burst of oral corticosteroids (OCS) ≥10 mg/day for at least 2 days OR an increase, or addition of new cytotoxic and/or immunosuppressive therapy, OR hospitalization)" | — |
Secondary
| Measure | Time frame |
|---|---|
| "DB treatment period: - Key: Proportion of patients who experience an HES worsening/flare during the DB period - Key: Number of HES worsenings/flares (annualised rate/year) during the DB period - Key: Time to first haematologic relapse (AEC ≥ 1000 cells/μL) during the DB period - Key: Fatigue severity (PROMIS fatigue short form 7a) at Week 24 - Proportion of patients who: - have haematologic relapse during the DB period - have AEC < 500 cells/μL for 24 weeks - require an increase in [...], "OLE treatment period: - Proportion of patients who experience an HES worsening/flare - Annualized rate of HES worsening/flare - Fatigue (PROMIS fatigue short form 7a) - Safety and tolerability will be evaluated in terms of AEs, vital signs and clinical laboratory assessments - Serum benralizumab concentrations, anti-benralizumab antibodies and nAbs - HES symptom questionnaire - HRQoL (SF-36v2)" | — |
Countries
Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Poland, Spain
Outcome results
None listed