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New drug aims to tame overactive immune response in sepsis

NCT ID NCT06694701

Disease control Sponsor: Hellenic Institute for the Study of Sepsis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests emapalumab, a drug that blocks a protein called interferon-gamma, in 75 adults with sepsis caused by a specific immune overreaction. The goal is to see if the drug can reduce organ failure, measured by a drop in the SOFA score. Participants are in ICUs across Greece and receive either emapalumab or a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Emapalumab (a drug that blocks interferon-gamma, a protein involved in inflammation)
What this could lead to
If it works, this could point toward a targeted treatment for a specific type of sepsis, potentially reducing organ failure and improving survival in ICU patients.
What could go wrong
This is an early phase 2 trial with only 75 participants, so results may not apply to all sepsis patients. The drug may not improve outcomes or could cause side effects like increased infection risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Provide written informed consent * Adults (≥18 years) of male or female sex * Diagnosis of community-acquired pneumonia (CAP), hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), intrabdominal infection (IAI), acute pyelonephritis (AP), primary bloodstream infection (BSI) and viral respiratory infections. * Sepsis defined by the Sepsis-3 definitions. This is defined as any new infection which is accompanied by an increase of the total baseline SOFA score by at least 2 points. The total baseline SOFA score is calculated by the medical comorbidities and by the evaluation of clinical variables before the sepsis episode in the case of hospital-acquired sepsis. In the case of patients with unknown baseline SOFA score, sepsis is defined as any new infection accompanied by total SOFA score 2 or more. * Willingness to use effective contraceptive methods during the period from the start of the study drug to 6 months after the administration of the last dose of the study drug, in patients of reproductive age. * Serological documentation of IDS defined as detectable blood IFNγ and CXCL9 more than 2,200 pg/ml. IFNγ and CXCL9 are measured in the central study lab by an enzyme immunosorbent assay. * Absence of sepsis-induced immunoparalysis (SII). This is defined as ≥8000 of HLA-DR receptors on CD45/CD14-monocytes measured by flow-cytometry in the central lab using the BD™ fluorescence assay9. Exclusion Criteria: * Body weight more than 104 kg * Intake of any other biological during the last 30 days prior screening except for the intake of anakinra or tocilizumab for patients with active infection by SARS-CoV-2 * Intake of any Janus kinase inhibitors during the last 30 days prior screening except for the intake of baricitinib for patients with active infection by SARS-CoV-2 * Known active infection by Mycobacterium tuberculosis or other mycobacteria. These patients may be enrolled in the trial if treatment against infection by Mycobacterium tuberculosis or other mycobacteria has been initiated * Known active infection by VZV (varicella zoster virus) or by Histoplasma capsulatum or by Leishmania spp. These patients may be enrolled in the trial if treatment against infection by VZV or Histoplasma capsulatum has been initiated * Known active infection by the hepatitis B virus, by the hepatitis C virus and by cytomegalovirus * Vaccination the last 12 weeks before screening with BCG vaccine * Vaccination with any live or attenuated live vaccine (other than BCG) the last 12 weeks before screening * Known allergy or hypersensitivity reactions to emapalumab * Patients living with the human immunodeficiency virus (HIV) * Patients with stage IV solid or hematologic malignancy * Patients with neutropenia (less than 1,000 neutrophils/mm3) * Patients transplanted for solid organ or stem cells * Pregnancy or lactation * Participation in any other interventional trial the last 28 days prior to day 1

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Conditions

The condition(s) this trial relates to.

Infections infectious disease with sepsis Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sepsis

Contacts and locations

Locations

  • 1st Department of Internal Medicine, Thriasio Elefsis General Hospital

    Elefsina, Attica, Greece

  • 1st Intensive Care Unit, G. Papanikolaou Thessaloniki General Hospital

    Thessaloniki, 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

  • Clinic of Intensive Care and Pulmonary Diseases, Aghioi Anargyroi Kifissia General Oncologic Hospital

    Kifissia, Attica, Greece

  • Department of Anesthesiology and Intensive Care, AHEPA Thessaloniki University General Hospital

    Thessaloniki, 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, 424 General Military Training Hospital

    Thessaloniki, Greece

  • Intensive Care Unit, Aghios Dimitrios Thessaloniki General Hospital

    Thessaloniki, Greece

  • Intensive Care Unit, Alexandroupolis University General Hospital

    Alexandroupoli, Greece

  • Intensive Care Unit, Asklipieio Voulas General Hospital

    Athens, Greece

  • Intensive Care Unit, G. Gennimatas Thessaloniki General Hospital

    Thessaloniki, Greece

  • Intensive Care Unit, Ippokrateio Athens General Hospital

    Athens, Greece

  • Intensive Care Unit, Ippokrateio Thessaloniki General Hospital

    Thessaloniki, Greece

  • Intensive Care Unit, Korgialeneio-Benakeio HRC Athens General Hospital

    Athens, Greece

  • Intensive Care Unit, Laiko Athens General Hospital

    Athens, Greece

  • Intensive Care Unit, Papageorgiou Thessaloniki General Hospital

    Thessaloniki, Greece

  • Intensive Care Unit, Patras University General Hospital

    Pátrai, Greece

  • Intensive Care Unit, Theageneio Thessaloniki Cancer Hospital

    Thessaloniki, Greece

  • Intensive Care Unit, University General Hospital of Heraklion

    Heraklion, Crete, 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

More trials for these conditions

Other studies related to the condition(s) this trial covers.