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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Hypereosinophilic Syndrome

In brief

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.

Key facts

Study ID

NCT05334368

Run by

GlaxoSmithKline

People needed

123

Starts

2022-09-06

Expected to finish

2032-07-16

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Harbin, China (enrolling)
• GSK Investigational Site — Nanchang, China (enrolling)
• GSK Investigational Site — Changsha, China (enrolling)
• GSK Investigational Site — Guangzhou, China (enrolling)
• GSK Investigational Site — Boston, Massachusetts, United States (enrolling)
• GSK Investigational Site — Cincinnati, Ohio, United States (enrolling)
• GSK Investigational Site — San Diego, California, United States (enrolling)
• GSK Investigational Site — Charleston, South Carolina, United States (enrolling)
• GSK Investigational Site — Guangzhou, China (enrolling)
• GSK Investigational Site — Salt Lake City, Utah, United States (enrolling)
• GSK Investigational Site — Buenos Aires, Argentina (enrolling)
• GSK Investigational Site — Florida, Argentina (enrolling)
• GSK Investigational Site — La Plata, Argentina (enrolling)
• GSK Investigational Site — Mar del Plata, Argentina (enrolling)
• GSK Investigational Site — Quilmes, Argentina (enrolling)
• GSK Investigational Site — Columbus, Ohio, United States (enrolling)
• GSK Investigational Site — Brussels, Belgium (enrolling)
• GSK Investigational Site — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
• GSK Investigational Site — Blumenau, Brazil (enrolling)
• GSK Investigational Site — Rio de Janeiro, Brazil (enrolling)
• GSK Investigational Site — Sorocaba, Brazil (enrolling)
• GSK Investigational Site — Ottawa, Ontario, Canada (enrolling)
• GSK Investigational Site — Toronto, Ontario, Canada (enrolling)
• GSK Investigational Site — Beijing, China (enrolling)
• GSK Investigational Site — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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