NCT05334368

Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Depemokimab in Adults With Hypereosinophilic Syndrome (HES)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 123 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypereosinophilic Syndrome

Interventions

Type	Name	Description
DRUG	Depemokimab	Depemokimab will be administered.
OTHER	Placebo	Matching placebo will be administered.

Timeline

• Start date: 2022-09-06
• Primary completion: 2028-12-19
• Completion: 2028-12-19
• First posted: 2022-04-19
• Last updated: 2025-11-25

Locations

91 sites across 21 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, Denmark, Germany, Greece, Hong Kong, Israel, Italy, Japan, Mexico, Poland, Romania, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study