Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Depemokimab in Adults With Hypereosinophilic Syndrome (HES)
Led by GlaxoSmithKline · Updated on 2025-11-25
123
Participants Needed
91
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying depemokimab in adults with uncontrolled Hypereosinophilic Syndrome (HES) who are already receiving standard treatment. This phase 3, randomized, placebo-controlled, double-blind, parallel group, multicenter trial focuses on patients with a confirmed HES diagnosis, a history of at least two flares in the past year, and a high blood eosinophil count. The study aims to evaluate the frequency of HES flares over 52 weeks while maintaining participants on stable therapy. Participants will be randomly assigned in a 2:1 ratio to receive either depemokimab or a placebo, in addition to their existing standard of care treatment. The study lasts 52 weeks, during which participants continue their usual HES therapy alongside the study drug or placebo. The trial is designed to assess safety and efficacy with careful monitoring throughout. During the study, participants will undergo regular assessments including monitoring of HES flare frequency, time to first flare, and fatigue levels using the Brief Fatigue Inventory. Researchers will track clinical symptoms, blood eosinophil counts, and any adverse events. The total participation time is up to 52 weeks, with ongoing safety evaluations to understand the impact of depemokimab compared to placebo.
CONDITIONS
Brief Title
Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants who weigh at least 40 kilograms at Screening Visit 1.
- Participants with a documented diagnosis of Hypereosinophilic Syndrome before Visit 2.
- History of two or more HES flares within the 12 months before Visit 1.
- Female participants must not be pregnant or breastfeeding and either be of non-childbearing potential or use a highly effective contraceptive method with less than 1% failure rate.
- Capable of providing signed informed consent.
You will not qualify if you...
- Participants with HES symptoms that may pose unacceptable risks or affect study results as judged by the investigator.
- Participants with chronic or ongoing active infections needing systemic treatment or parasitic infestation within 6 months before Visit 1.
- Participants with known immunodeficiency except due to HES treatment.
- Participants with history or current lymphoma.
- Participants with current cancer or cancer remission less than 5 years, except resected localized skin carcinoma.
- Participants with blood cancers where HES is not the primary diagnosis.
- Participants with cirrhosis or unstable liver/biliary disease.
- Participants with severe uncontrolled cardiovascular disease.
- Participants diagnosed with vasculitis.
- Participants with hypereosinophilia without symptoms or organ dysfunction.
- Participants diagnosed with Eosinophilic granulomatosis with polyangiitis (EGPA).
- Participants allergic or intolerant to monoclonal antibodies or study product components.
- Participants with previous failure using anti-IL-5/5R therapy.
- Participants who received monoclonal antibodies within 30 days or 5 half-lives before Visit 1.
- Participants positive for the FIP1L1-PDGFRα fusion gene.
- Participants with prolonged QTcF interval at Screening Visit 1.
- Participants not responding to corticosteroid therapy as judged by the investigator.
- Pregnant or breastfeeding participants.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants receive depemokimab or placebo to evaluate the efficacy and safety in treating Hypereosinophilic Syndrome.
Regular visits during the 52-week treatment period
Trial Site Locations
Total: 91 locations
1
GSK Investigational Site
San Diego, California, United States, 920237
Actively Recruiting
2
GSK Investigational Site
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
GSK Investigational Site
Boston, Massachusetts, United States, 02111
Actively Recruiting
4
GSK Investigational Site
Southfield, Michigan, United States, 48075
Withdrawn
5
GSK Investigational Site
Rochester, Minnesota, United States, 55905
Withdrawn
6
GSK Investigational Site
Manhasset, New York, United States, 11030
Completed
7
GSK Investigational Site
Cincinnati, Ohio, United States, 45229
Actively Recruiting
8
GSK Investigational Site
Columbus, Ohio, United States, 43212
Actively Recruiting
9
GSK Investigational Site
Charleston, South Carolina, United States, 29425
Actively Recruiting
10
GSK Investigational Site
Nashville, Tennessee, United States, 37208
Completed
11
GSK Investigational Site
Salt Lake City, Utah, United States, 84132
Actively Recruiting
12
GSK Investigational Site
Buenos Aires, Argentina, C1425BEN
Actively Recruiting
13
GSK Investigational Site
Florida, Argentina, 1602
Actively Recruiting
14
GSK Investigational Site
La Plata, Argentina, B1900
Actively Recruiting
15
GSK Investigational Site
Mar del Plata, Argentina, 7600
Actively Recruiting
16
GSK Investigational Site
Quilmes, Argentina, 1878
Actively Recruiting
17
GSK Investigational Site
Garran, Australian Capital Territory, Australia, 2606
Completed
18
GSK Investigational Site
Brussels, Belgium, 1070
Actively Recruiting
19
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Actively Recruiting
20
GSK Investigational Site
Blumenau, Brazil, 89030-101
Actively Recruiting
21
GSK Investigational Site
Rio de Janeiro, Brazil, 21.941-913
Actively Recruiting
22
GSK Investigational Site
Sorocaba, Brazil, 18040-425
Actively Recruiting
23
GSK Investigational Site
Ottawa, Ontario, Canada, K1H 1E4
Actively Recruiting
24
GSK Investigational Site
Toronto, Ontario, Canada, M5G 1X5
Actively Recruiting
25
GSK Investigational Site
Beijing, China, 100730
Actively Recruiting
26
GSK Investigational Site
Changsha, China, 410008
Actively Recruiting
27
GSK Investigational Site
Guangzhou, China, 510080
Actively Recruiting
28
GSK Investigational Site
Guangzhou, China, 510515
Actively Recruiting
29
GSK Investigational Site
Harbin, China, 150010
Actively Recruiting
30
GSK Investigational Site
Nanchang, China, 330006
Actively Recruiting
31
GSK Investigational Site
Shanghai, China, 200025
Actively Recruiting
32
GSK Investigational Site
Suzhou, China, 215006
Actively Recruiting
33
GSK Investigational Site
Wuhan, China, 430022
Actively Recruiting
34
GSK Investigational Site
Brno-Bohunice, Czechia, 625 00
Actively Recruiting
35
GSK Investigational Site
Hradec Králové, Czechia, 500 05
Actively Recruiting
36
GSK Investigational Site
Prague, Czechia, 14059
Actively Recruiting
37
GSK Investigational Site
Ústí nad Labem, Czechia, 40113
Actively Recruiting
38
GSK Investigational Site
Odense C, Denmark, 5000
Actively Recruiting
39
GSK Investigational Site
Bad Bramstedt, Germany, 24576
Actively Recruiting
40
GSK Investigational Site
Mannheim, Germany, 68167
Actively Recruiting
41
GSK Investigational Site
Athens, Greece, 10676
Actively Recruiting
42
GSK Investigational Site
Rio Patras, Greece, 26054
Withdrawn
43
GSK Investigational Site
Pokfulam, Hong Kong
Actively Recruiting
44
GSK Investigational Site
Ramat Gan, Israel, 52621
Actively Recruiting
45
GSK Investigational Site
Tel Aviv, Israel, 64239
Actively Recruiting
46
GSK Investigational Site
Bologna, Italy, 40138
Actively Recruiting
47
GSK Investigational Site
Catania, Italy, 95123
Actively Recruiting
48
GSK Investigational Site
Milan, Italy, 20132
Actively Recruiting
49
GSK Investigational Site
Naples, Italy, 80131
Actively Recruiting
50
GSK Investigational Site
Novara, Italy, 28100
Actively Recruiting
51
GSK Investigational Site
Pavia, Italy, 27100
Actively Recruiting
52
GSK Investigational Site
Roma, Italy, 00168
Actively Recruiting
53
GSK Investigational Site
Treviso, Italy, 31100
Actively Recruiting
54
GSK Investigational Site
Verona, Italy, 37134
Actively Recruiting
55
GSK Investigational Site
Aomori, Japan, 030-8553
Actively Recruiting
56
GSK Investigational Site
Aomori, Japan, 036-8563
Actively Recruiting
57
GSK Investigational Site
Chiba, Japan, 272-8516
Actively Recruiting
58
GSK Investigational Site
Gifu, Japan, 509-6134
Actively Recruiting
59
GSK Investigational Site
Hyōgo, Japan, 670-8540
Actively Recruiting
60
GSK Investigational Site
Kanagawa, Japan, 259-1143
Actively Recruiting
61
GSK Investigational Site
Miyagi, Japan, 980-8574
Actively Recruiting
62
GSK Investigational Site
Tokyo, Japan, 105-8471
Actively Recruiting
63
GSK Investigational Site
Tokyo, Japan, 142-8666
Actively Recruiting
64
GSK Investigational Site
Wakayama, Japan, 641-8509
Actively Recruiting
65
GSK Investigational Site
Yamanashi, Japan, 409-3898
Actively Recruiting
66
GSK Investigational Site
Guadalajara, Mexico, 44130
Actively Recruiting
67
GSK Investigational Site
Monterrey, Mexico, 64060
Actively Recruiting
68
GSK Investigational Site
Veracruz, Mexico, 94534
Actively Recruiting
69
GSK Investigational Site
Chęciny, Poland, 26-060
Actively Recruiting
70
GSK Investigational Site
Lodz, Poland, 90-153
Actively Recruiting
71
GSK Investigational Site
Bucharest, Romania, 31281
Actively Recruiting
72
GSK Investigational Site
Cluj-Napoca, Romania, 400124
Actively Recruiting
73
GSK Investigational Site
Gwangju, South Korea, 61469
Actively Recruiting
74
GSK Investigational Site
Jeonju, South Korea, 561-712
Actively Recruiting
75
GSK Investigational Site
Kangwondo, South Korea, 26426
Actively Recruiting
76
GSK Investigational Site
Seoul, South Korea, 03722
Actively Recruiting
77
GSK Investigational Site
Seoul, South Korea, 06351
Actively Recruiting
78
GSK Investigational Site
Seoul, South Korea, 06591
Actively Recruiting
79
GSK Investigational Site
Seoul, South Korea, 110-744
Actively Recruiting
80
GSK Investigational Site
Seoul, South Korea, 136-705
Actively Recruiting
81
GSK Investigational Site
Seoul, South Korea, 138-736
Actively Recruiting
82
GSK Investigational Site
Suwon Kyunggi-do, South Korea, 16499
Actively Recruiting
83
GSK Investigational Site
Barcelona, Spain, 08036
Actively Recruiting
84
GSK Investigational Site
Granada, Spain, 18014
Actively Recruiting
85
GSK Investigational Site
Madrid, Spain, 28008
Actively Recruiting
86
GSK Investigational Site
Madrid, Spain, 28031
Actively Recruiting
87
GSK Investigational Site
Pozuelo de AlarcOn Madr, Spain, 28223
Actively Recruiting
88
GSK Investigational Site
Salamanca, Spain, 37007
Actively Recruiting
89
GSK Investigational Site
Valencia, Spain, 46026
Actively Recruiting
90
GSK Investigational Site
Zaragoza, Spain, 50009
Actively Recruiting
91
GSK Investigational Site
Leicester, United Kingdom, LE3 9QP
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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