Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial
Condition(s) studied
Investigational drug(s) / intervention(s)
Depemokimab: Depemokimab will be administered.
Placebo: Matching placebo will be administered.
Study 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.
Eligibility
Primary outcome measure(s)
- Frequency of HES flares — Up to 52 weeks
A HES flare is defined as either: a HES-related clinical manifestation based on a physician documented change in clinical signs or symptoms resulting in the need for the following : An increase in the maintenance systemic corticosteroid dose by at least 10 mg/day (prednisone/prednisolone equivalent) for at least 5 days, and/or an increase in or addition of any cytotoxic and/or immunosuppressive HES therapy. OR 2 or more courses of blinded active oral corticosteroid (OCS) during the intervention period. The frequency of HES flares will be calculated for each participant as the number of unique starting dates for HES flares.
Trial sites (93)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | San Diego | California | Recruiting |
| GSK Investigational Site | Atlanta | Georgia | Completed |
| GSK Investigational Site | Boston | Massachusetts | Recruiting |
| GSK Investigational Site | Southfield | Michigan | Withdrawn |
| GSK Investigational Site | Rochester | Minnesota | Withdrawn |
| GSK Investigational Site | Manhasset | New York | Completed |
| GSK Investigational Site | Cincinnati | Ohio | Recruiting |
| GSK Investigational Site | Columbus | Ohio | Recruiting |
| GSK Investigational Site | Charleston | South Carolina | Recruiting |
| GSK Investigational Site | Nashville | Tennessee | Completed |
| GSK Investigational Site | Salt Lake City | Utah | Recruiting |
| GSK Investigational Site | Buenos Aires | Argentina | Recruiting |
| GSK Investigational Site | Florida | Argentina | Recruiting |
| GSK Investigational Site | La Plata | Argentina | Recruiting |
| GSK Investigational Site | Mar del Plata | Argentina | Recruiting |
| GSK Investigational Site | Quilmes | Argentina | Recruiting |
| GSK Investigational Site | Garran | Australian Capital Territory | Completed |
| GSK Investigational Site | Brussels | Belgium | Recruiting |
| GSK Investigational Site | Porto Alegre | Rio Grande do Sul | Recruiting |
| GSK Investigational Site | Blumenau | Brazil | Recruiting |
| GSK Investigational Site | Rio de Janeiro | Brazil | Recruiting |
| GSK Investigational Site | Sorocaba | Brazil | Recruiting |
| GSK Investigational Site | Ottawa | Ontario | Recruiting |
| GSK Investigational Site | Toronto | Ontario | Recruiting |
| GSK Investigational Site | Beijing | China | Recruiting |
| GSK Investigational Site | Changsha | China | Recruiting |
| GSK Investigational Site | Guangzhou | China | Recruiting |
| GSK Investigational Site | Guangzhou | China | Recruiting |
| GSK Investigational Site | Guangzhou | China | Recruiting |
| GSK Investigational Site | Harbin | China | Recruiting |
| GSK Investigational Site | Nanchang | China | Recruiting |
| GSK Investigational Site | Shanghai | China | Recruiting |
| GSK Investigational Site | Suzhou | China | Recruiting |
| GSK Investigational Site | Wuhan | China | Recruiting |
| GSK Investigational Site | Brno-Bohunice | Czechia | Recruiting |
| GSK Investigational Site | Hradec Králové | Czechia | Recruiting |
| GSK Investigational Site | Prague | Czechia | Recruiting |
| GSK Investigational Site | Ústí nad Labem | Czechia | Recruiting |
| GSK Investigational Site | Odense C | Denmark | Recruiting |
| GSK Investigational Site | Bad Bramstedt | Germany | Recruiting |
+ 53 more sites — see the full list on the official registry below.
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05334368 on ClinicalTrials.gov ↗ ← All trials in Italy