Clinical trial • Phase II • Infectious Disease|Respiratory
EMAPALUMAB for Sepsis
Phase II trial of EMAPALUMAB for Sepsis.
Overview
- Trial Therapeutic Area
- Infectious Disease|Respiratory
- Trial Disease
- Sepsis
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody|Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 02-07-2024
- First CTIS Authorization Date
- 21-10-2024
Trial design
Sodium Chloride Injection/ DEMO 0,9% w/v (placebo) administered by intravenous infusion; product record lists dose units ml with max daily amount 250 ml, max total amount 2250 ml, max treatment period 28 days.-controlled Phase II trial across 29 sites in Greece.
- Comparator
- Sodium Chloride Injection/ DEMO 0,9% w/v (placebo) administered by intravenous infusion; product record lists dose units ml with max daily amount 250 ml, max total amount 2250 ml, max treatment period 28 days.
- Biomarker Stratified
- True, biomarkers: blood IFNγ and CXCL9; IDS defined as detectable IFNγ and CXCL9 >2,200 pg/ml (patients must have serological documentation of IDS).
- Target Sample Size
- 75
- Trial Duration For Participant
- 28
Eligibility
Recruits 75 Vulnerable population flag selected in the registry. Inclusion requires "Provide written informed consent" and participants are adults (≥18 years). Subject information and informed consent forms are available in Greek and English (multiple ICF documents listed). No explicit statement in the provided data about assent or legally authorised representative/proxy consent procedures is available..
- Pregnancy Exclusion
- Pregnancy or lactation
- Vulnerable Population
- Vulnerable population flag selected in the registry. Inclusion requires "Provide written informed consent" and participants are adults (≥18 years). Subject information and informed consent forms are available in Greek and English (multiple ICF documents listed). No explicit statement in the provided data about assent or legally authorised representative/proxy consent procedures is available.
Inclusion criteria
- {"criterion_text":"- Provide written informed consent\n- Adults (≥18 years) of male or female sex\n- 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.\n- 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.\n- 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.\n- 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\n- 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 assay."}
Exclusion criteria
- {"criterion_text":"- 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\n- Participation in any other interventional trial the last 28 days prior to day 0\n- 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\n- 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\n- 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.\n- Vaccination the last 12 weeks before screening with BCG vaccine\n- Body weight more than 125 kg\n- Vaccination with any live or attenuated live vaccine (other than BCG) the last 12 weeks before screening\n- Known allergy or hypersensitivity reactions to emapalumab\n- Patients living with the human immunodeficiency virus (HIV)\n- Patients with stage IV solid or hematologic malignancy\n- Known active infection by the hepatitis B virus, by the hepatitis C virus and by cytomegalovirus\n- Patients with neutropenia (less than 1,000 neutrophils/mm3)\n- Patients transplanted for solid organ or stem cells\n- Pregnancy or lactation"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The study primary endpoint is the decrease of SOFA score by the end-of-treatment (EOT). This is defined as either a) at least 1.4 points decrease of mean SOFA score calculated between days 1 and EOT from SOFA score of day 0; OR b) at least 2 points decrease of SOFA at EOT from day 0.","definition_or_measurement_approach":"Decrease in SOFA score measured from day 0 to EOT. Option (a) compares the mean SOFA between days 1 and EOT vs day 0 (≥1.4 point decrease) or (b) absolute decrease of ≥2 points at EOT versus day 0."}
- {"endpoint_text":"- Patients dying before the EOT are considered not meeting the primary endpoint. EOT is defined as the day of end of treatment of the study drug for each of the study participants. For patients requiring dosing by day 27, the decrease of the SOFA score is evaluated on day 28.","definition_or_measurement_approach":"Deaths prior to EOT count as failure to meet the primary endpoint. EOT defined as day of end of study drug treatment; for patients dosed through day 27 the SOFA change is assessed on day 28."}
Secondary endpoints
- {"endpoint_text":"- The number of doses required in each group to achieve the SOFA score response by the EOT","definition_or_measurement_approach":"Count of administered doses per group required to meet the SOFA response criteria by EOT."}
- {"endpoint_text":"- 28-day mortality","definition_or_measurement_approach":"All-cause mortality measured at 28 days."}
Recruitment
- Planned Sample Size
- 75
- Recruitment Window Months
- 24
- Consent Approach
- Written informed consent is required (inclusion criterion: "Provide written informed consent"). Participants are adults (≥18 years). Subject information and informed consent forms are available in Greek and English (multiple ICF documents listed). The provided data does not specify proxy consent, assent, or other language versions beyond Greek and English.
Geography
- Total Number Of Sites
- 29
- Total Number Of Participants
- 75
Greece
- Earliest CTIS Part Ii Submission Date
- 12-09-2024
- Latest Decision Or Authorization Date
- 20-10-2025
- Processing Time Days
- 403
- Number Of Sites
- 29
- Number Of Participants
- 75
Sites
- Site Name
- Thoracic General Hospital Of Athens I Sotiria
- Department Name
- New Multivalent Intensive Care Unit
- Principal Investigator Name
- Maria Daganou
- Principal Investigator Email
- mdaganou@hotmail.com
- Contact Person Name
- Maria Daganou
- Contact Person Email
- mdaganou@hotmail.com
- Site Name
- Ippokratio General Hospital Of Thessaloniki
- Department Name
- Intensive Care Unit
- Principal Investigator Name
- Eleni Mouloudi
- Principal Investigator Email
- elmoulou@yahoo.gr
- Contact Person Name
- Eleni Mouloudi
- Contact Person Email
- elmoulou@yahoo.gr
- Site Name
- 424 Military General Training Hospital
- Department Name
- Intensive Care Unit
- Principal Investigator Name
- Ioannis Katsiadramis
- Principal Investigator Email
- ikatsiadramis@yahoo.gr
- Contact Person Name
- Ioannis Katsiadramis
- Contact Person Email
- ikatsiadramis@yahoo.gr
- Site Name
- Thoracic General Hospital Of Athens I Sotiria
- Department Name
- 1st Department of Internal and Pulmonary Medicine
- Principal Investigator Name
- Nikoleta Rovina
- Principal Investigator Email
- nikrovina@med.uoa.gr
- Contact Person Name
- Nikoleta Rovina
- Contact Person Email
- nikrovina@med.uoa.gr
- Site Name
- General Hospital Of Eleusina Thriasio
- Department Name
- 1st Department of Internal Medicine
- Principal Investigator Name
- Styliani Sympardi
- Principal Investigator Email
- lianasympa@hotmail.com
- Contact Person Name
- Styliani Sympardi
- Contact Person Email
- lianasympa@hotmail.com
- Site Name
- Ippokratio General Hospital Of Thessaloniki
- Department Name
- 2nd Propaedeutic Department of Internal Medicine
- Principal Investigator Name
- Michail Doumas
- Principal Investigator Email
- michalisdoumas@yahoo.co.uk
- Contact Person Name
- Michail Doumas
- Contact Person Email
- michalisdoumas@yahoo.co.uk
- Site Name
- General Hospital Of Thessaloniki Papageorgiou
- Department Name
- Intensive Care Unit
- Principal Investigator Name
- Domniki Liatsi
- Principal Investigator Email
- domliatsi@yahoo.gr
- Contact Person Name
- Domniki Liatsi
- Contact Person Email
- domliatsi@yahoo.gr
- Site Name
- Thoracic General Hospital Of Athens I Sotiria
- Department Name
- 1st Department of Internal and Pulmonary Medicine
- Principal Investigator Name
- Zafeiria Mastora
- Principal Investigator Email
- nikrovina@med.uoa.gr
- Contact Person Name
- Zafeiria Mastora
- Contact Person Email
- nikrovina@med.uoa.gr
- Site Name
- University General Hospital Of Ioannina
- Department Name
- Intensive Care Unit
- Principal Investigator Name
- Ioannis Koulouras
- Principal Investigator Email
- vpkoulouras@yahoo.gr
- Contact Person Name
- Ioannis Koulouras
- Contact Person Email
- vpkoulouras@yahoo.gr
- Site Name
- Kat Attica General Hospital
- Department Name
- Intensive Care Unit I
- Principal Investigator Name
- Maria Theodorakopoulou
- Principal Investigator Email
- mariatheodor10@gmail.com
- Contact Person Name
- Maria Theodorakopoulou
- Contact Person Email
- mariatheodor10@gmail.com
- Site Name
- Theageneio Cancer Hospital
- Department Name
- Intensive Care Unit
- Principal Investigator Name
- Souzana Anisoglou
- Principal Investigator Email
- souzanis@freemail.gr
- Contact Person Name
- Souzana Anisoglou
- Contact Person Email
- souzanis@freemail.gr
- Site Name
- General Hospital Of Athens Korgialenio Benakio H.R.C.
- Department Name
- Intensive Care Unit
- Principal Investigator Name
- Maria Patrani
- Principal Investigator Email
- mpatrani@gmail.com
- Contact Person Name
- Maria Patrani
- Contact Person Email
- mpatrani@gmail.com
- Site Name
- General Hospital Of Thessaloniki O Agios Dimitrios
- Department Name
- Intensive Care Unit
- Principal Investigator Name
- Glykeria Vlachogianni
- Principal Investigator Email
- glykav@otenet.gr
- Contact Person Name
- Glykeria Vlachogianni
- Contact Person Email
- glykav@otenet.gr
- Site Name
- University General Hospital Attikon
- Department Name
- 4th Department of Internal Medicine
- Principal Investigator Name
- Evangelos Giamarellos-Bourboulis
- Principal Investigator Email
- egiamarel@med.uoa.gr
- Contact Person Name
- Evangelos Giamarellos-Bourboulis
- Contact Person Email
- egiamarel@med.uoa.gr
- Site Name
- University General Hospital Of Alexandroupoli
- Department Name
- Intensive Care Unit
- Principal Investigator Name
- Vasileios Papaioannou
- Principal Investigator Email
- vapapa@med.duth.gr
- Contact Person Name
- Vasileios Papaioannou
- Contact Person Email
- vapapa@med.duth.gr
- Site Name
- University General Hospital Of Alexandroupoli
- Department Name
- 2nd Department of Internal Medicine
- Principal Investigator Name
- Periklis Panagopoulos
- Principal Investigator Email
- ppanago@med.duth.gr
- Contact Person Name
- Periklis Panagopoulos
- Contact Person Email
- ppanago@med.duth.gr
- Site Name
- General Hospital Of Thessloniki G Gennimatas
- Department Name
- Intensive Care Unit
- Principal Investigator Name
- Eleni Antoniadou
- Principal Investigator Email
- eleni.antoniadou@gmail.com
- Contact Person Name
- Eleni Antoniadou
- Contact Person Email
- eleni.antoniadou@gmail.com
- Site Name
- Asklepieion Voulas General Hospital
- Department Name
- Intensive Care Unit
- Principal Investigator Name
- Aikaterini Ioakeimidou
- Principal Investigator Email
- katioakim@gmail.com
- Contact Person Name
- Aikaterini Ioakeimidou
- Contact Person Email
- katioakim@gmail.com
- Site Name
- General University Hospital Of Patras
- Department Name
- Intensive Care Unit
- Principal Investigator Name
- Vasileios Karamouzos
- Principal Investigator Email
- vkaramouzos@hotmail.com
- Contact Person Name
- Vasileios Karamouzos
- Contact Person Email
- vkaramouzos@hotmail.com
- Site Name
- University General Hospital Of Heraklion
- Department Name
- Intensive Care Unit
- Principal Investigator Name
- Evmorfia Kondyli
- Principal Investigator Email
- kondylie@uoc.gr
- Contact Person Name
- Evmorfia Kondyli
- Contact Person Email
- kondylie@uoc.gr
- Site Name
- Hippokration Hospital
- Department Name
- Intensive Care Unit
- Principal Investigator Name
- Georgios Kofinas
- Principal Investigator Email
- georgekofinas@gmail.com
- Contact Person Name
- Georgios Kofinas
- Contact Person Email
- georgekofinas@gmail.com
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- Intensive Care Unit
- Principal Investigator Name
- Elissavet Paramythiotou
- Principal Investigator Email
- lparamyth61@hotmail.com
- Contact Person Name
- Elissavet Paramythiotou
- Contact Person Email
- lparamyth61@hotmail.com
- Site Name
- Geniko Nosokomeio Thessalonikis George Papanikolaou
- Department Name
- 1st Intensive Care Unit
- Principal Investigator Name
- Athina Lavrentieva
- Principal Investigator Email
- alavrenti@gmail.com
- Contact Person Name
- Athina Lavrentieva
- Contact Person Email
- alavrenti@gmail.com
- Site Name
- General Hospital Of Thessaloniki Papageorgiou
- Department Name
- 3rd Department of Internal Medicine
- Principal Investigator Name
- Vasileios Kotsis
- Principal Investigator Email
- vkotsis@auth.gr
- Contact Person Name
- Vasileios Kotsis
- Contact Person Email
- vkotsis@auth.gr
- Site Name
- Thoracic General Hospital Of Athens I Sotiria
- Department Name
- 3rd Department of Internal Medicine
- Principal Investigator Name
- Garifalia Poulakou
- Principal Investigator Email
- gpoulakou@gmail.com
- Contact Person Name
- Garifalia Poulakou
- Contact Person Email
- gpoulakou@gmail.com
- Site Name
- Sismanogleio General Hospital
- Department Name
- Intensive Care Unit
- Principal Investigator Name
- Aikaterini Sakagianni
- Principal Investigator Email
- sakagianni@sismanoglio.gr
- Contact Person Name
- Aikaterini Sakagianni
- Contact Person Email
- sakagianni@sismanoglio.gr
- Site Name
- Alexandra Hospital
- Department Name
- Ηigh Dependency Unit of Department of Clinical Therapeutics
- Principal Investigator Name
- Georgios Dimopoulos
- Principal Investigator Email
- gdimop@med.uoa.gr
- Contact Person Name
- Georgios Dimopoulos
- Contact Person Email
- gdimop@med.uoa.gr
- Site Name
- University General Hospital Of Thessaloniki Ahepa
- Department Name
- Department of Anesthesiology and Intensive Care
- Principal Investigator Name
- Eleni Argyriadou
- Principal Investigator Email
- argiriadouhelena@hotmail.gr
- Contact Person Name
- Eleni Argyriadou
- Contact Person Email
- argiriadouhelena@hotmail.gr
- Site Name
- General Oncological Hospital Of Kifissia Agioi Anargyroi
- Department Name
- Clinic of Intensive Care and Pulmonary Diseases
- Principal Investigator Name
- Pavlos Myrianthefs
- Principal Investigator Email
- pmiriant@nurs.uoa.gr
- Contact Person Name
- Pavlos Myrianthefs
- Contact Person Email
- pmiriant@nurs.uoa.gr
Sponsor
Primary sponsor
- Full Name
- Hellenic Institute For The Study Of Sepsis
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Greece
Investigational products
- Investigational Product Name
- EMAPALUMAB
- Active Substance
- EMAPALUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- No marketing authorisation number recorded
- Orphan Designation
- Yes
- Maximum Dose
- Max daily 10 mg/kg; max total 37 mg/kg
- Investigational Product Name
- Sodium Chloride Injection/ DEMO 0,9% w/v
- Active Substance
- SODIUM CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- Marketing authorisation: 24901/09 (Greece)
- Maximum Dose
- Max daily 250 ml; max total 2250 ml
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