Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial
Status:
Not yet recruiting
Trial end date:
2025-05-30
Target enrollment:
Participant gender:
Summary
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.