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Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial
Sponsor: GlaxoSmithKline
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.
Official title: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Depemokimab in Adults With Hypereosinophilic Syndrome (HES)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2022-09-06
Completion Date
2027-10-29
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Depemokimab
Depemokimab will be administered.
Placebo
Matching placebo will be administered.
Locations (60)
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Manhasset, New York, United States
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Columbus, Ohio, United States
GSK Investigational Site
Nashville, Tennessee, United States
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Buenos Aires, Argentina
GSK Investigational Site
Florida, Argentina
GSK Investigational Site
La Plata, Argentina
GSK Investigational Site
Mar del Plata, Argentina
GSK Investigational Site
Quilmes, Argentina
GSK Investigational Site
Garran, Australian Capital Territory, Australia
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil
GSK Investigational Site
Blumenau, Brazil
GSK Investigational Site
Rio de Janeiro, Brazil
GSK Investigational Site
Sorocaba, Brazil
GSK Investigational Site
Ottawa, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Beijing, China
GSK Investigational Site
Changsha, China
GSK Investigational Site
Guangzhou, China
GSK Investigational Site
Guangzhou, China
GSK Investigational Site
Nanchang, China
GSK Investigational Site
Shanghai, China
GSK Investigational Site
Suzhou, China
GSK Investigational Site
Wuhan, China
GSK Investigational Site
Brno-Bohunice, Czechia
GSK Investigational Site
Prague, Czechia
GSK Investigational Site
Mannheim, Germany
GSK Investigational Site
Catania, Italy
GSK Investigational Site
Novara, Italy
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Roma, Italy
GSK Investigational Site
Aomori, Japan
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Chiba, Japan
GSK Investigational Site
Gifu, Japan
GSK Investigational Site
Hyōgo, Japan
GSK Investigational Site
Miyagi, Japan
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Tokyo, Japan
GSK Investigational Site
Tokyo, Japan
GSK Investigational Site
Wakayama, Japan
GSK Investigational Site
Yamanashi, Japan
GSK Investigational Site
Guadalajara, Mexico
GSK Investigational Site
Monterrey, Mexico
GSK Investigational Site
Veracruz, Mexico
GSK Investigational Site
Chęciny, Poland
GSK Investigational Site
Lodz, Poland
GSK Investigational Site
Bucharest, Romania
GSK Investigational Site
Bucharest, Romania
GSK Investigational Site
Cluj-Napoca, Romania
GSK Investigational Site
Gwangju, South Korea
GSK Investigational Site
Jeonju, South Korea
GSK Investigational Site
Kangwondo, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Suwon Kyunggi-do, South Korea
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Valencia, Spain
GSK Investigational Site
Leicester, Leicestershire, United Kingdom