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ACTIVE NOT RECRUITING
NCT06694701
PHASE2

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

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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.

DRUG

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