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

Conditions

• Hypereosinophilic Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Depemokimab — DRUG
  Depemokimab will be administered.
• Placebo — OTHER
  Matching placebo will be administered.

Study Details

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 Dates

Start date

Sep 6, 2022

Status verified

Nov 2025

Primary completion

Dec 19, 2028

Completion

Dec 19, 2028

Study Design

Enrollment

123 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Depemokimab
  All participants in this arm will receive depemokimab.
• Placebo Comparator: Placebo
  All participants in this arm will receive placebo.

Primary Outcome Measure

Frequency of HES flares [ Time Frame: Up to 52 weeks ]

Central Contacts

• US GSK Clinical Trials Call Center
  877-379-3718
  [email protected]
• EU GSK Clinical Trials Call Center
  +44 (0) 20 89904466
  [email protected]

Locations (11)

Find similar trials in San Diego, CA

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