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Emapalumab Treatment For Anticipated Clinical Benefit In Sepsis Driven By The Interferon-Gamma Endotype (The EMBRACE Trial)

Study acronym: EMBRACE
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Study sites revised (24)
    v9
  2. Site details revised at 9 of 24 sitesv8
  3. Site details revised at 24 of 24 sitesv7
  4. Site details revised at 2 of 24 sitesv6
  5. Start date changed from estimate of Mar 2025 to Mar 22, 2025
    • Site details revised at 1 of 24 sites
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 2025 to Mar 2025
    • Site details revised at 24 of 24 sites
    v4
  2. Start date: Nov 2024 to Jan 2025
    • Eligibility criteria expanded, about 6 words
    • Study description shortened, about 1 word
    v3
  3. Study sites: 1 to 24v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
EMBRACE is a double-blind, randomized, placebo-controlled, phase IIa study that will be conducted in multiple Intensive Care Units (ICUs) and departments of Internal Medicine across Greece. It aims to investigate if treatment with emapalumab, a monoclonal antibody which blocks IFNγ, may improve the outcome of patients with sepsis driven by the IDS (endotype of IFNγ-driven sepsis) endotype. EMBRACE also aims to identify the best dosing regimen of emapalumab for the management of IDS.
Trial Details
NCT Number NCT06694701
Lead Sponsor Hellenic Institute for the Study of Sepsis
Conditions
(from sponsor)		 Sepsis
Related terms Infections, Sepsis
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov