Recruiting
Phase 3

Depemokimab

Sponsor:

GlaxoSmithKline

Code:

NCT05334368

Conditions

Hypereosinophilic Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Depemokimab

Placebo

Study Details

Brief 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.

Conditions

Hypereosinophilic Syndrome

Study ID

NCT05334368

Start date

Sep 6, 2022

Status verified date

Sep, 2026

Completion date

Nov 24, 2027

Anticipated

Primary completion date

Nov 24, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

109 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Depemokimab

All participants in this arm will receive depemokimab.

placebo comparator: Placebo

All participants in this arm will receive placebo.

Interventions

Depemokimab

Depemokimab will be administered.

Placebo

Matching placebo will be administered.

Primary outcome measure

  • Frequency of HES flares [ Time Frame: Up to 52 weeks ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

San Diego, California, United States, 920237

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Brian Modena

GSK Investigational Site

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

John Leung

GSK Investigational Site

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Marc Rothenberg

GSK Investigational Site

Recruiting

Columbus, Ohio, United States, 43212

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Casey Curtis

GSK Investigational Site

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Kelli Williams

GSK Investigational Site

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Mili Shum

GSK Investigational Site

Recruiting

Ottawa, Ontario, Canada, K1H 1E4

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Timothy Olynych

GSK Investigational Site

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Hassan Sibai

More Information

Sponsor

GlaxoSmithKline

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Depemokimab
  • Hypereosinophilic Syndrome
  • DESTINY
  • Monoclonal antibody
  • Anti-interleukin -5

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-09-04.