Status:
RECRUITING
Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hypereosinophilic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 19 2028
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT05334368
Start Date
September 6 2022
End Date
December 19 2028
Last Update
November 25 2025
Active Locations (91)
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1
GSK Investigational Site
San Diego, California, United States, 920237
2
GSK Investigational Site
Atlanta, Georgia, United States, 30322
3
GSK Investigational Site
Boston, Massachusetts, United States, 02111
4
GSK Investigational Site
Southfield, Michigan, United States, 48075