EMBRACE

Ongoing study

Official Study Title
EMapalumaB treatment foR Anticipated Clinical benefit in sepsis driven by the Interferon-Gamma Endotype (The EMBRACE trial)

Brief Description
In a recent analysis of 5,503 patients with sepsis meeting the Sepsis-3 definitions and coming from Germany, Greece and Italy randomized into one discovery set and one validation set, it was found that one endotype driven by IFNγ (interferon-gamma) (IFNγ-Drive Sepsis, IDS) is prevailing in almost 20% of patients. The presence of IDS is an independent risk for 28-day mortality irrespective of the type of infection, comorbidities, organ dysfunctions and the isolated pathogen. 28-day mortality is 40 to 43%. The EMBRACE trial investigates if treatment with emapalumab, a monoclonal antibody which neutralizes IFNγ activity, may improve the outcome of patients with sepsis driven by the IDS endotype. EMBRACE also aims to identify the best dosing regimen of emapalumab for the management of IDS.

Details
Status: Recruiting
Study Type: Interventional (Clinical Trial)
Study phase: IIa
Study sites: 24 sites in Greece
Target of enrolment: 75 participants

ClinicalTrials.gov Identifier: NCT06694701
EU Trial (CTIS) Number: 2024-515255-38-00

Study Start: March 12th, 2025

Condition/Disease studied: Infections; Severe Infections
Keywords: Severe infections; IFNγ; IFNγ-Drive Sepsis; emapalumab; interferon-gamma

Connect to the EMBRACE trial portal