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NCT05334368 · ClinicalTrials.gov registry record · Phase 3
Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial
A Phase 3 study of Hypereosinophilic Syndrome, sponsored by GlaxoSmithKline.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 123
- Enrollment target
- 20
- Study locations
NCT05334368: Recruiting Phase 3 study of Hypereosinophilic Syndrome, sponsored by GlaxoSmithKline.
NCT05334368 is a Phase 3 study of Hypereosinophilic Syndrome that is actively recruiting participants, run by GlaxoSmithKline. The registered enrollment target is 123 participants, roughly in line with the 116-participant average among 7 other Hypereosinophilic Syndrome trials with a reported enrollment target. The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05334368, a Phase 3 study of Hypereosinophilic Syndrome, is actively recruiting participants, sponsored by GlaxoSmithKline.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 123 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Depemokimab
Study Locations (20)
Other
- GSK Investigational Site - Buenos Aires
- GSK Investigational Site - Florida
- GSK Investigational Site - La Plata
- GSK Investigational Site - Mar del Plata
- GSK Investigational Site - Quilmes
- GSK Investigational Site - Brussels
- GSK Investigational Site - Blumenau
Ohio
- GSK Investigational Site - Cincinnati
- GSK Investigational Site - Columbus
California
- GSK Investigational Site - San Diego
Georgia
- GSK Investigational Site - Atlanta
Massachusetts
- GSK Investigational Site - Boston
Michigan
- GSK Investigational Site - Southfield
Minnesota
- GSK Investigational Site - Rochester
New York
- GSK Investigational Site - Manhasset
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2022-09-06 |
| Est. Completion | 2028-12-19 |
| Phase | Phase 3 |
What NCT05334368 shows while recruiting
NCT05334368 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 116-participant average among 7 other Hypereosinophilic Syndrome trials with a reported enrollment target.
The record links to 1 condition, with Hypereosinophilic Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05334368 names 20 study sites across 13 states, led by Other, Ohio, California.
Frequently Asked Questions
What is clinical trial NCT05334368 about?
NCT05334368 is a clinical study titled "Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial". 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 leas...
What is the current status of trial NCT05334368?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 123 participants. The study started on 2022-09-06. Estimated completion is 2028-12-19.
What conditions does trial NCT05334368 study?
This clinical trial studies the following conditions: Hypereosinophilic Syndrome.
What interventions are being tested in trial NCT05334368?
The interventions under investigation include: Placebo (OTHER), Depemokimab (DRUG).
Who is sponsoring clinical trial NCT05334368?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05334368 being conducted?
This trial has 20 study locations across California, Georgia, Massachusetts, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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