This is a 52-week, randomized, placebo-controlled, double-blind, parallel group, multicenter study of depemokimab in adults with uncontrolled HES receiving standard of care (SoC) therapy. The study will recruit patients with a confirmed diagnosis of HES and who are on stable HES therapy for at least 4 weeks prior to randomization (Visit 2). Eligible participants must have uncontrolled HES with a history of repeated flare (≥2 flares in the previous 12 months) and blood eosinophil count of ≥1,000 cells/ microliter (μL) during Screening. Historical HES flares are defined as documented HES-related worsening of clinical symptoms or blood eosinophil counts requiring an escalation in therapy. Participants who meet the inclusion and exclusion criteria will be randomized in a 2:1 ratio to receive either depemokimab or placebo while continuing their SoC HES therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
123
Depemokimab will be administered.
Matching placebo will be administered.
GSK Investigational Site
San Diego, California, United States
RECRUITINGGSK Investigational Site
Atlanta, Georgia, United States
RECRUITINGGSK Investigational Site
Boston, Massachusetts, United States
RECRUITINGGSK Investigational Site
Southfield, Michigan, United States
Frequency of HES flares
A HES flare is defined as either: a HES-related clinical manifestation based on a physician documented change in clinical signs or symptoms resulting in the need for the following : An increase in the maintenance systemic corticosteroid dose by at least 10 mg/day (prednisone/prednisolone equivalent) for at least 5 days, and/or an increase in or addition of any cytotoxic and/or immunosuppressive HES therapy. OR 2 or more courses of blinded active oral corticosteroid (OCS) during the intervention period. The frequency of HES flares will be calculated for each participant as the number of unique starting dates for HES flares.
Time frame: Up to 52 weeks
Time to first HES flare
The time to first HES flare will be calculated from the date of first dose of study intervention and the start date of the HES flare. Time to the first HES flare will be assessed and reported in days.
Time frame: Up to 52 weeks
Number of participants with at least one HES flare during the 52-week study intervention period
Time frame: Up to 52 weeks
Change from Baseline to Week 52 in weekly average score of Brief Fatigue Inventory (BFI) item 3 (worst fatigue in last 24 hours)
The BFI is a tool developed for the rapid assessment of fatigue severity for use in both clinical Screening and clinical trials. The BFI has 9 items. The participant should rate their average and worst fatigue levels over the previous 24 hours using a numeric rating scale anchored with 0 (no fatigue/interference) and 10 (as bad as you can imagine/completely interferes) numeric rating scales
Time frame: Baseline and up to Week 52
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GSK Investigational Site
Rochester, Minnesota, United States
WITHDRAWNGSK Investigational Site
Manhasset, New York, United States
COMPLETEDGSK Investigational Site
Cincinnati, Ohio, United States
RECRUITINGGSK Investigational Site
Columbus, Ohio, United States
RECRUITINGGSK Investigational Site
Charleston, South Carolina, United States
RECRUITINGGSK Investigational Site
Nashville, Tennessee, United States
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