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Emapalumab Treatment For Anticipated Clinical Benefit In Sepsis Driven By The Interferon-Gamma Endotype (The EMBRACE Trial)
Sponsor: Hellenic Institute for the Study of Sepsis
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2025-03-22
Completion Date
2026-11
Last Updated
2025-11-19
Healthy Volunteers
No
Conditions
Interventions
Emapalumab-Izsg
The drug is administered at a dose of 6mg/kg of body weight on day 0 and repeated dosing of 3mg/kg of body weight is provisioned for days 3, 6, 9, 12, 15, 19, 23 and 27 provided that the stopping rule does not apply.
Emapalumab-Izsg
The drug is administered at a dose of 6mg/kg of body weight on day 0, 6mg/kg of body weight on day 3, 6mg/kg of body weight on day 6 and repeated dosing of 3mg/kg of body weight is provisioned for days 9, 12, 15, 19, 23 and 27 provided that the stopping rule does not apply.
Placebo
250ml of 0.9% sodium chloride. The drug is administered on day 0 and repeated dosing is provisioned for days 3, 6, 9, 12, 15, 19, 23 and 27 provided that the stopping rule does not apply
Locations (24)
1st Department of Internal Medicine, Thriasio Elefsis General Hospital
Elefsina, Attica, Greece
Clinic of Intensive Care and Pulmonary Diseases, Aghioi Anargyroi Kifissia General Oncologic Hospital
Kifissia, Attica, Greece
Intensive Care Unit, University General Hospital of Heraklion
Heraklion, Crete, Greece
Intensive Care Unit, Alexandroupolis University General Hospital
Alexandroupoli, Greece
3rd University Department of Internal Medicine, Sotiria Chest Diseases Athens General Hospital
Athens, Greece
4th Department of Internal Medicine, ATTIKON University General Hospital
Athens, Greece
Intensive Care Unit I, KAT Attica General Hospital
Athens, Greece
Intensive Care Unit of 1st University Department Respiratory Medicine, Sotiria Chest Diseases Athens General Hospital
Athens, Greece
Intensive Care Unit of Center for Respiratory Failure, Sotiria Chest Diseases Athens General Hospital
Athens, Greece
Intensive Care Unit, Asklipieio Voulas General Hospital
Athens, Greece
Intensive Care Unit, Ippokrateio Athens General Hospital
Athens, Greece
Intensive Care Unit, Korgialeneio-Benakeio HRC Athens General Hospital
Athens, Greece
Intensive Care Unit, Laiko Athens General Hospital
Athens, Greece
New Multivalent Intensive Care Unit, Sotiria Chest Diseases Athens General Hospital
Athens, Greece
Ηigh Dependency Unit of Department of Clinical Therapeutics, Alexandra Athens General Hospital
Athens, Greece
Intensive Care Unit, Patras University General Hospital
Pátrai, Greece
1st Intensive Care Unit, G. Papanikolaou Thessaloniki General Hospital
Thessaloniki, Greece
Department of Anesthesiology and Intensive Care, AHEPA Thessaloniki University General Hospital
Thessaloniki, Greece
Intensive Care Unit, 424 General Military Training Hospital
Thessaloniki, Greece
Intensive Care Unit, Aghios Dimitrios Thessaloniki General Hospital
Thessaloniki, Greece
Intensive Care Unit, G. Gennimatas Thessaloniki General Hospital
Thessaloniki, Greece
Intensive Care Unit, Ippokrateio Thessaloniki General Hospital
Thessaloniki, Greece
Intensive Care Unit, Papageorgiou Thessaloniki General Hospital
Thessaloniki, Greece
Intensive Care Unit, Theageneio Thessaloniki Cancer Hospital
Thessaloniki, Greece