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

NCT06694701 Phase 2 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Hellenic Institute for the Study of Sepsis
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	75
Start date	2025-03-22
Completion	2026-11

Conditions

• Sepsis

Interventions

• Emapalumab-Izsg
• Emapalumab-Izsg
• Placebo

Primary outcomes

• Decrease of SOFA score by the end-of-treatment — From enrollment to the end of treatment of the study drug for each of the study participants, ranging from 2 to 29 days.
  The study primary endpoint is the decrease of SOFA score by the end-of-treatment (EOT). This is defined as either a) at least 1.4 points decrease of mean SOFA score calculated between days 1 and EOT from SOFA score of day 0; OR b) at least 2 points decrease of SOFA at EOT from day 0.

Countries

Greece