Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial
NCT ID: NCT05334368
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
123 participants
INTERVENTIONAL
2022-09-06
2028-12-19
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Depemokimab
All participants in this arm will receive depemokimab.
Depemokimab
Depemokimab will be administered.
Placebo
All participants in this arm will receive placebo.
Placebo
Matching placebo will be administered.
Interventions
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Depemokimab
Depemokimab will be administered.
Placebo
Matching placebo will be administered.
Eligibility Criteria
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Inclusion Criteria
* Participants who have a documented diagnosis of HES prior to Visit 2.
* A history of 2 or more HES flares within the past 12 months prior to Visit 1.
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: a) woman of non-childbearing potential (WONCBP) Or b) woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\<) 1 percentage (%).
* Capable of giving signed informed consent.
Exclusion Criteria
* Participants with chronic or ongoing active infections requiring systemic treatment or a pre-existing parasitic infestation within 6 months prior to Visit 1.
* Participants with a known immunodeficiency (e.g., Human Immunodeficiency Virus \[HIV\]), other than that explained by the use of OCS or other therapy taken for HES.
* Participants with a history of or current lymphoma.
* Participants with current malignancy or previous history of cancer in remission for less than 5 years prior to Visit 1. Participants that had localized carcinoma (i.e., basal or squamous cell) of the skin which was resected for cure will not be excluded.
* Participants with a haematologic malignancy with hypereosinophilia in which HES is not the primary diagnosis, e.g., chronic myeloid leukaemia, myelodysplastic syndrome, chronic eosinophilic leukaemia-not otherwise specified.
* Cirrhosis or current unstable liver or biliary disease per investigator assessment.
* Participants who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment.
* Participants with current diagnosis of vasculitis.
* Hypereosinophila with no clinical symptoms and/or proof of organ dysfunction.
* Clinical diagnosis of Eosinophilic granulomatosis with polyangiitis (EGPA).
* Participants with an allergy/ intolerance to a monoclonal antibody or biologic, or any of the excipients of the investigational product.
* Participants who have a previous documented failure with anti-interleukin (IL)-5/5R therapy.
* Participants who have received monoclonal antibodies (mAb) within 30 days or 5 half-lives, whichever is longer, prior to Visit 1.
* Participants who test positive for the FIP1L1-PDGFRα fusion gene.
* QT interval corrected for heart rate according to Fridericia's formula (QTcF) ≥450 milliseconds (msec) or QTcF ≥480 msec for participants with Bundle Branch Block at Screening Visit 1.
* Participants who are not responsive to OCS based on clinical response or blood eosinophil counts in the opinion of the Investigator.
* Participants who are pregnant or breastfeeding.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
Atlanta, Georgia, United States
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Boston, Massachusetts, United States
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Southfield, Michigan, United States
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Rochester, Minnesota, United States
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Manhasset, New York, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Charleston, South Carolina, United States
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Nashville, Tennessee, United States
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Salt Lake City, Utah, United States
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Buenos Aires, , Argentina
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Florida, , Argentina
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La Plata, , Argentina
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Mar del Plata, , Argentina
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Quilmes, , Argentina
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Garran, Australian Capital Territory, Australia
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Brussels, , Belgium
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Porto Alegre, Rio Grande do Sul, Brazil
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Blumenau, , Brazil
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Rio de Janeiro, , Brazil
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Sorocaba, , Brazil
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Beijing, , China
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Changsha, , China
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Guangzhou, , China
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Guangzhou, , China
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Harbin, , China
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Nanchang, , China
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Shanghai, , China
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Suzhou, , China
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Wuhan, , China
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Brno - Bohunice, , Czechia
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Hradec Králové, , Czechia
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Prague, , Czechia
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Ústí nad Labem, , Czechia
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Odense C, , Denmark
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Bad Bramstedt, , Germany
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Mannheim, , Germany
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Athens, , Greece
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Rio Patras, , Greece
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Pokfulam, , Hong Kong
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Bologna, , Italy
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Catania, , Italy
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Milan, , Italy
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Napoli, , Italy
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Novara, , Italy
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Pavia, , Italy
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Roma, , Italy
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Treviso, , Italy
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Verona, , Italy
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Aomori, , Japan
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Aomori, , Japan
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Chiba, , Japan
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Gifu, , Japan
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Hyōgo, , Japan
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Kanagawa, , Japan
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Miyagi, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Wakayama, , Japan
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Yamanashi, , Japan
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Guadalajara, , Mexico
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Monterrey, , Mexico
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Veracruz, , Mexico
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Chęciny, , Poland
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Lodz, , Poland
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Gwangju, , South Korea
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Jeonju, , South Korea
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Kangwondo, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon Kyunggi-do, , South Korea
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Barcelona, , Spain
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Granada, , Spain
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Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Pozuelo de AlarcOn Madr, , Spain
GSK Investigational Site
Salamanca, , Spain
GSK Investigational Site
Valencia, , Spain
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Zaragoza, , Spain
GSK Investigational Site
Leicester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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217013
Identifier Type: -
Identifier Source: org_study_id
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