Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial (NCT05334368)
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Depemokimab in Adults With Hypereosinophilic Syndrome (HES)
๐ฉบ Plain-English Summary (8th-Grade Level)
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 (โฅ2 flares in the previous 12 months) and blood eosinophil count of โฅ1,000 cells/ microliter (ฮผL) 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.
Who can join: Review the eligibility criteria below.
Location: GSK Investigational Site โ San Diego, California
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (92 Sites)
Showing the first 25 of 92 sites.
- GSK Investigational Site โ San Diego, California
- GSK Investigational Site โ Atlanta, Georgia
- GSK Investigational Site โ Boston, Massachusetts
- GSK Investigational Site โ Southfield, Michigan
- GSK Investigational Site โ Rochester, Minnesota
- GSK Investigational Site โ Manhasset, New York
- GSK Investigational Site โ Cincinnati, Ohio
- GSK Investigational Site โ Columbus, Ohio
- GSK Investigational Site โ Charleston, South Carolina
- GSK Investigational Site โ Nashville, Tennessee
- GSK Investigational Site โ Salt Lake City, Utah
- GSK Investigational Site โ Buenos Aires,
- GSK Investigational Site โ Florida,
- GSK Investigational Site โ La Plata,
- GSK Investigational Site โ Mar del Plata,
- GSK Investigational Site โ Quilmes,
- GSK Investigational Site โ Garran, Australian Capital Territory
- GSK Investigational Site โ Brussels,
- GSK Investigational Site โ Porto Alegre, Rio Grande do Sul
- GSK Investigational Site โ Blumenau,
- GSK Investigational Site โ Rio de Janeiro,
- GSK Investigational Site โ Sorocaba,
- GSK Investigational Site โ Ottawa, Ontario
- GSK Investigational Site โ Toronto, Ontario
- GSK Investigational Site โ Beijing,
๐ Contact the Study Coordinator
Phone: (877) 379-3718
Email: GSKClinicalSupportHD@gsk.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.