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Study on Emapalumab for Patients with Sepsis Linked to Interferon-Gamma

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as sepsis, which is a serious illness caused by the body's response to an infection. The study is investigating a treatment using a medication called emapalumab. Emapalumab is a type of medicine known as a monoclonal antibody, which works by blocking a substance in the body called interferon-gamma (IFNγ). This trial is specifically looking at a form of sepsis driven by the IFNγ endotype, which is a particular pattern of the disease that affects a small percentage of patients.

The purpose of the study is to see if emapalumab can improve the health outcomes of patients with this specific type of sepsis. Participants in the study will receive emapalumab through an intravenous infusion, which means the medicine is given directly into a vein. The study will also use a placebo for comparison. The treatment period will last up to 28 days, during which the effects of the medication will be closely monitored. The study aims to find the best dosing regimen of emapalumab for managing this type of sepsis.

In addition to emapalumab, the study will use sodium chloride injection, which is a common solution used in medical treatments. The trial will help determine if emapalumab can reduce the severity of sepsis symptoms and improve patient outcomes. The findings from this study could lead to better treatment options for patients with sepsis driven by the IFNγ endotype.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be required to provide written informed consent. This means you agree to participate after understanding the details of the study.

    You must be an adult, 18 years or older, and have a diagnosis of certain infections such as community-acquired pneumonia or sepsis, as defined by specific medical criteria.

  2. Step 2

    Initial assessment

    A blood test will be conducted to confirm the presence of interferon-gamma and CXCL9 at specific levels. These are substances in the blood that help determine if you have a particular type of sepsis.

    Your medical history and current health status will be reviewed to ensure you meet all the criteria for participation.

  3. Step 3

    Treatment phase

    You will receive the study medication, emapalumab, through an intravenous infusion. This means the medication will be administered directly into your vein.

    The dosage and frequency of the medication will be determined by the study team based on your specific needs and response to treatment.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, your health will be closely monitored. This includes regular assessments of your SOFA score, which is a measure used to track your condition.

    The primary goal is to observe a decrease in your SOFA score by the end of the treatment period, which indicates an improvement in your condition.

  5. Step 5

    End of treatment

    The end of treatment is defined individually for each participant. For those requiring dosing by day 27, the evaluation will occur on day 28.

    Your participation in the trial will conclude after the final assessments are completed, and you will be informed of the results.

Who can join the trial?

7 criteria

  • Provide written informed consent, which means you agree to participate in the study after being informed about it.
  • Be an adult, which means you are 18 years or older, and can be of any gender.
  • Have a diagnosis of certain infections, such as community-acquired pneumonia (CAP), hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), intra-abdominal infection (IAI), acute pyelonephritis (AP), primary bloodstream infection (BSI), or viral respiratory infections.
  • Have sepsis as defined by the Sepsis-3 definitions. This means you have a new infection that causes an increase in your SOFA score by at least 2 points. The SOFA score is a way doctors measure how well your organs are working.
  • Have serological documentation of IDS, which means your blood tests show certain levels of IFNγ and CXCL9, measured in a central study lab.
  • Be willing to use effective contraceptive methods from the start of the study drug to 6 months after the last dose, if you are of reproductive age.
  • Do not have sepsis-induced immunoparalysis (SII), which means your blood tests show a certain number of HLA-DR receptors on specific immune cells, measured in a central lab.

Who cannot join the trial?

5 criteria

  • Patients who do not have **sepsis**. Sepsis is a serious condition where the body has an extreme response to an infection.
  • Patients who do not have the **IDS endotype**. IDS stands for IFNγ-Drive Sepsis, which is a specific type of sepsis.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial group.
  • Patients who are not considered part of a vulnerable population.
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Investigated drugs

Emapalumab is a type of medication known as a monoclonal antibody. It works by blocking a substance in the body called interferon-gamma (IFNγ). In this clinical trial, emapalumab is being tested to see if it can help patients with a specific type of sepsis, which is a serious infection that can lead to organ failure. This type of sepsis is driven by high levels of IFNγ, and emapalumab aims to improve the health outcomes of these patients by reducing the harmful effects of IFNγ. The trial is also trying to find the best way to use emapalumab for treating this condition.

What is already known about the treatment

Emapalumab – Emapalumab is administered as an injection, typically given into a vein. It is currently being studied in clinical trials for its potential benefits in treating sepsis, a severe infection that can lead to organ failure. The main therapeutic use of emapalumab in this context is to help patients with a specific type of sepsis driven by a protein called interferon-gamma. At the molecular level, emapalumab works by blocking interferon-gamma, which is thought to contribute to the harmful effects of this type of sepsis. It is classified as a monoclonal antibody, a type of medication designed to target specific proteins in the body.

Investigated diseases

Sepsis – Sepsis is a severe and potentially life-threatening condition that arises when the body's response to infection causes injury to its own tissues and organs. It begins with an infection that can originate in any part of the body, such as the lungs, urinary tract, skin, or gastrointestinal tract. As the infection progresses, the immune system releases chemicals into the bloodstream to fight the infection, which can trigger widespread inflammation. This inflammation can lead to a cascade of changes that damage multiple organ systems, causing them to fail. The progression of sepsis can be rapid, and it may lead to septic shock, characterized by a significant drop in blood pressure that can result in severe organ dysfunction. Early recognition and management are crucial to prevent further complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515255-38-00Protocol codeEMBRACEEstimated enrolment75 patientsSponsorHellenic Institute For The Study Of Sepsis

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).