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

Study acronym: DESTINY
StatusActive, Not Recruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Enrollment reduced 11% 123 → 109 participants
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Record History

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  1. Enrollment closed, study ongoing Show 5 more changesShow less
    • Trial sites reduced: 93 → 60 locations
    • Enrollment target: estimated 109 to confirmed 110
    • Primary and study completion dates: Nov 24, 2027 to Oct 29, 2027
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 2 of 3 entries
  2. Primary completion moved earlier from Dec 19, 2028 to Nov 24, 2027
    • Enrollment reduced: 123 → 109 participants
    • Study completion moved earlier from Jul 16, 2032 to Nov 24, 2027
    • Study sites: 92 to 93
    v15
  3. Study completion pushed from Dec 19, 2028 to Jul 16, 2032
    • Study sites: 91 to 92
    v14
  4. Primary completion date: Nov 2, 2026 to Dec 19, 2028
    • Study sites: 78 to 91
    • Study completion date: Nov 30, 2026 to Dec 19, 2028
    v13
  5. Enrollment target: 120 to 123
    • Study sites: 75 to 78
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary completion date: Feb 26, 2026 to Nov 2, 2026
    • Study sites: 87 to 75
    • Study completion date: Mar 26, 2026 to Nov 30, 2026
    v11
  2. Study sites: 89 to 87v10
  3. Study sites: 90 to 89v9
  4. Study sites: 91 to 90v8
  5. Primary completion date: May 2, 2025 to Feb 26, 2026
    • Study sites: 19 to 91
    • Study completion date: May 30, 2025 to Mar 26, 2026
    v7
  6. Re-verified, no change to tracked fieldsv6
  7. Study Status, Referencesv5
  8. Study sites: 12 to 19v4
  9. Study sites: 2 to 12v3
  10. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 11, 2022 to Sep 6, 2022
    • Study sites: 0 to 2
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
GlaxoSmithKline
246 trials monitored
See 20 trials at risk
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.
Trial Details
NCT Number NCT05334368
Lead Sponsor GlaxoSmithKline
Conditions
(from sponsor)		 Hypereosinophilic Syndrome
Related terms Hypereosinophilic Syndrome
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov