Ireland
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Active, not recruiting Phase 3

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

NCT05334368 · tracked via the Priya Life Science Japan tracker
Phase
Phase 3
Started
2022-09-06
Last updated
2026-10-13

Condition(s) studied

Hypereosinophilic Syndrome

Investigational drug(s) / intervention(s)

Depemokimab →Placebo

Depemokimab: Depemokimab will be administered.

Placebo: Matching placebo will be administered.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Frequency of HES flares — Up to 52 weeks
    A HES flare is defined as either: a HES-related clinical manifestation based on a physician documented change in clinical signs or symptoms resulting in the need for the following : An increase in the maintenance systemic corticosteroid dose by at least 10 mg/day (prednisone/prednisolone equivalent) for at least 5 days, and/or an increase in or addition of any cytotoxic and/or immunosuppressive HES therapy. OR 2 or more courses of blinded active oral corticosteroid (OCS) during the intervention period. The frequency of HES flares will be calculated for each participant as the number of unique starting dates for HES flares.

Trial sites (60)

FacilityCityRegionStatus
GSK Investigational Site San Diego California
GSK Investigational Site Atlanta Georgia
GSK Investigational Site Manhasset New York
GSK Investigational Site Columbus Ohio
GSK Investigational Site Nashville Tennessee
GSK Investigational Site 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
GSK Investigational Site Porto Alegre Rio Grande do Sul
GSK Investigational Site Blumenau Brazil
GSK Investigational Site Rio de Janeiro Brazil
GSK Investigational Site Sorocaba Brazil
GSK Investigational Site Ottawa Ontario
GSK Investigational Site Toronto Ontario
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
GSK Investigational Site Roma Italy
GSK Investigational Site Aomori Japan
GSK Investigational Site Chiba Japan
GSK Investigational Site Gifu Japan
GSK Investigational Site Hyōgo Japan
GSK Investigational Site Miyagi Japan
GSK Investigational Site Tokyo Japan
GSK Investigational Site Tokyo Japan
GSK Investigational Site Wakayama Japan
GSK Investigational Site Yamanashi Japan

+ 20 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05334368 on ClinicalTrials.gov ↗ ← All trials in Japan