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NCT05334368PHASE3Recruiting

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

GlaxoSmithKline

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

Inclusion Criteria: * Participants who are greater than or equal (\>=) 40 kilogram (kg) at Screening Visit 1. * 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 HES disease manifestations which in the opinion of the investigator may put the participant at unacceptable risk from study participation or confound interpretation of efficacy or safety data. * 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.

Interventions

DRUG

Depemokimab

OTHER

Placebo

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Conditions

Hypereosinophilic Syndrome

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

GSK Investigational Site

Brussels, 1070

Belgium

GSK Investigational Site

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

GSK Investigational Site

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

GSK Investigational Site

Brno-Bohunice, 625 00

Czechia

GSK Investigational Site

Hradec Králové, 500 05

Czechia

GSK Investigational Site

Prague, 14059

Czechia

GSK Investigational Site

Ústí nad Labem, 40113

Czechia

GSK Investigational Site

Odense C, 5000

Denmark

GSK Investigational Site

Bad Bramstedt, 24576

Germany

GSK Investigational Site

Mannheim, 68167

Germany

GSK Investigational Site

Athens, 10676

Greece

GSK Investigational Site

Rio Patras, 26054

Greece

GSK Investigational Site

Pokfulam,

Hong Kong

GSK Investigational Site

Ramat Gan, 52621

Israel

GSK Investigational Site

Tel Aviv, 64239

Israel

GSK Investigational Site

Bologna, 40138

Italy

GSK Investigational Site

Catania, 95123

Italy

GSK Investigational Site

Milan, 20132

Italy

GSK Investigational Site

Naples, 80131

Italy

GSK Investigational Site

Novara, 28100

Italy

GSK Investigational Site

Pavia, 27100

Italy

GSK Investigational Site

Roma, 00168

Italy

GSK Investigational Site

Treviso, 31100

Italy

GSK Investigational Site

Verona, 37134

Italy

GSK Investigational Site

Aomori, 030-8553

Japan

GSK Investigational Site

Aomori, 036-8563

Japan

GSK Investigational Site

Chiba, 272-8516

Japan

GSK Investigational Site

Gifu, 509-6134

Japan

GSK Investigational Site

Hyōgo, 670-8540

Japan

GSK Investigational Site

Kanagawa, 259-1143

Japan

GSK Investigational Site

Miyagi, 980-8574

Japan

GSK Investigational Site

Tokyo, 105-8471

Japan

GSK Investigational Site

Tokyo, 142-8666

Japan

GSK Investigational Site

Wakayama, 641-8509

Japan

GSK Investigational Site

Yamanashi, 409-3898

Japan

GSK Investigational Site

Guadalajara, 44130

Mexico

GSK Investigational Site

Monterrey, 64060

Mexico

GSK Investigational Site

Veracruz, 94534

Mexico

GSK Investigational Site

Chęciny, 26-060

Poland

GSK Investigational Site

Lodz, 90-153

Poland

GSK Investigational Site

Bucharest, 020125

Romania

GSK Investigational Site

Bucharest, 31281

Romania

GSK Investigational Site

Cluj-Napoca, 400124

Romania

GSK Investigational Site

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