Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial
Start Date
9/6/2022
Completion Date
7/16/2032
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Depemokimab
Placebo
Conditions
Locations
GSK Investigational Site
San Diego, California 920237
United States
GSK Investigational Site
Atlanta, Georgia 30322
United States
GSK Investigational Site
Boston, Massachusetts 02111
United States
GSK Investigational Site
Southfield, Michigan 48075
United States
GSK Investigational Site
Rochester, Minnesota 55905
United States
GSK Investigational Site
Manhasset, New York 11030
United States
GSK Investigational Site
Cincinnati, Ohio 45229
United States
GSK Investigational Site
Columbus, Ohio 43212
United States
GSK Investigational Site
Charleston, South Carolina 29425
United States
GSK Investigational Site
Nashville, Tennessee 37208
United States
GSK Investigational Site
Salt Lake City, Utah 84132
United States
GSK Investigational Site
Buenos Aires, C1425BEN
Argentina
GSK Investigational Site
Florida, 1602
Argentina
GSK Investigational Site
La Plata, B1900
Argentina
GSK Investigational Site
Mar del Plata, 7600
Argentina
GSK Investigational Site
Quilmes, 1878
Argentina
GSK Investigational Site
Garran, Australian Capital Territory 2606
Australia
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Brussels, 1070
Belgium
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Porto Alegre, Rio Grande do Sul 90035-903
Brazil
GSK Investigational Site
Blumenau, 89030-101
Brazil
GSK Investigational Site
Rio de Janeiro, 21.941-913
Brazil
GSK Investigational Site
Sorocaba, 18040-425
Brazil
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Ottawa, Ontario K1H 1E4
Canada
GSK Investigational Site
Toronto, Ontario M5G 1X5
Canada
GSK Investigational Site
Beijing, 100730
China
GSK Investigational Site
Changsha, 410008
China
GSK Investigational Site
Guangzhou, 510080
China
GSK Investigational Site
Guangzhou, 510515
China
GSK Investigational Site
Harbin, 150010
China
GSK Investigational Site
Nanchang, 330006
China
GSK Investigational Site
Shanghai, 200025
China
GSK Investigational Site
Suzhou, 215006
China
GSK Investigational Site
Wuhan, 430022
China
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Brno-Bohunice, 625 00
Czechia
GSK Investigational Site
Hradec Králové, 500 05
Czechia
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Prague, 14059
Czechia
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Ústí nad Labem, 40113
Czechia
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Odense C, 5000
Denmark
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Bad Bramstedt, 24576
Germany
GSK Investigational Site
Mannheim, 68167
Germany
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Athens, 10676
Greece
GSK Investigational Site
Rio Patras, 26054
Greece
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Pokfulam,
Hong Kong
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Ramat Gan, 52621
Israel
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Tel Aviv, 64239
Israel
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Bologna, 40138
Italy
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Catania, 95123
Italy
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Milan, 20132
Italy
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Naples, 80131
Italy
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Novara, 28100
Italy
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Pavia, 27100
Italy
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Roma, 00168
Italy
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Treviso, 31100
Italy
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Verona, 37134
Italy
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Aomori, 030-8553
Japan
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Aomori, 036-8563
Japan
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Chiba, 272-8516
Japan
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Gifu, 509-6134
Japan
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Hyōgo, 670-8540
Japan
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Kanagawa, 259-1143
Japan
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Miyagi, 980-8574
Japan
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Tokyo, 105-8471
Japan
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Tokyo, 142-8666
Japan
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Wakayama, 641-8509
Japan
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Yamanashi, 409-3898
Japan
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Guadalajara, 44130
Mexico
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Monterrey, 64060
Mexico
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Veracruz, 94534
Mexico
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Chęciny, 26-060
Poland
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Lodz, 90-153
Poland
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Bucharest, 020125
Romania
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Bucharest, 31281
Romania
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Cluj-Napoca, 400124
Romania
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Gwangju, 61469
South Korea
GSK Investigational Site
Jeonju, 561-712
South Korea
GSK Investigational Site
Kangwondo, 26426
South Korea
GSK Investigational Site
Seoul, 03722
South Korea
GSK Investigational Site
Seoul, 06351
South Korea
GSK Investigational Site
Seoul, 06591
South Korea
GSK Investigational Site
Seoul, 110-744
South Korea
GSK Investigational Site
Seoul, 136-705
South Korea
GSK Investigational Site
Seoul, 138-736
South Korea
GSK Investigational Site
Suwon Kyunggi-do, 16499
South Korea
GSK Investigational Site
Barcelona, 08036
Spain
GSK Investigational Site
Granada, 18014
Spain
GSK Investigational Site
Madrid, 28008
Spain
GSK Investigational Site
Madrid, 28031
Spain
GSK Investigational Site
Pozuelo de AlarcOn Madr, 28223
Spain
GSK Investigational Site
Salamanca, 37007
Spain
GSK Investigational Site
Valencia, 46026
Spain
GSK Investigational Site
Zaragoza, 50009
Spain
GSK Investigational Site
Leicester, LE3 9QP
United Kingdom