RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Depemokimab in Adults With Hypereosinophilic Syndrome (HES)

Quick Facts

Study Start:2022-09-06
Study Completion:2026-03-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05334368

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants who are greater than or equal (\>=) 40 kilogram (kg) at Screening Visit 1.
  2. * Participants who have a documented diagnosis of HES prior to Visit 2.
  3. * A history of 2 or more HES flares within the past 12 months prior to Visit 1.
  4. * 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 (%).
  5. * Capable of giving signed informed consent.
  1. * 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.
  2. * Participants with chronic or ongoing active infections requiring systemic treatment or a pre-existing parasitic infestation within 6 months prior to Visit 1.
  3. * 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.
  4. * Participants with a history of or current lymphoma.
  5. * 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.
  6. * 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.
  7. * Cirrhosis or current unstable liver or biliary disease per investigator assessment.
  8. * Participants who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment.
  9. * Participants with current diagnosis of vasculitis.
  10. * Hypereosinophila with no clinical symptoms and/or proof of organ dysfunction.
  11. * Clinical diagnosis of Eosinophilic granulomatosis with polyangiitis (EGPA).
  12. * Participants with an allergy/ intolerance to a monoclonal antibody or biologic, or any of the excipients of the investigational product.
  13. * Participants who have a previous documented failure with anti-interleukin (IL)-5/5R therapy.
  14. * Participants who have received monoclonal antibodies (mAb) within 30 days or 5 half-lives, whichever is longer, prior to Visit 1.
  15. * Participants who test positive for the FIP1L1-PDGFRα fusion gene.
  16. * 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.
  17. * Participants who are not responsive to OCS based on clinical response or blood eosinophil counts in the opinion of the Investigator.
  18. * Participants who are pregnant or breastfeeding.

Contacts and Locations

Study Contact

US GSK Clinical Trials Call Center
CONTACT
877-379-3718
GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center
CONTACT
+44 (0) 20 89904466
GSKClinicalSupportHD@gsk.com

Principal Investigator

GSK Clinical Trials
STUDY_DIRECTOR
GlaxoSmithKline

Study Locations (Sites)

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
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

Collaborators and Investigators

Sponsor: GlaxoSmithKline

  • GSK Clinical Trials, STUDY_DIRECTOR, GlaxoSmithKline

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-06
Study Completion Date2026-03-26

Study Record Updates

Study Start Date2022-09-06
Study Completion Date2026-03-26

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Hypereosinophilic Syndrome