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    Summary
    EudraCT Number:2022-002390-28
    Sponsor's Protocol Code Number:INSPIRE
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-07-26
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGreece - EOF
    A.2EudraCT number2022-002390-28
    A.3Full title of the trial
    IMMUNOTHERAPY NAVIGATED BY SERUM PRESEPSIN FOR INFECTIONS OF THE RESPIRATORY TRACT: THE INSPIRE DOUBLE-BLIND, RANDOMIZED, PHASE IIa EXPLORATORY TRIAL
    ΑΝΟΣΟΘΕΡΑΠΕΙΑ ΠΛΟΗΓΟΥΜΕΝΗ ΑΠΟ ΤΗΝ ΠΡΕΣΗΨΙΝΗ ΤΟΥ ΟΡΟΥ ΣΤΙΣ ΛΟΙΜΩΞΕΙΣ ΤΟΥ ΑΝΑΠΝΕΥΣΤΙΚΟΥ: Η ΔΙΠΛΑ-ΤΥΦΛΗ, ΤΥΧΑΙΟΠΟΙΗΜΕΝΗ, ΔΙΕΡΕΥΝΗΤΙΚΗ ΜΕΛΕΤΗ ΦΑΣΗΣ ΙΙa INSPIRE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    THERAPY WITH ANAKINRA TO PREVENT ORGAN FAILURE FROM SEVERE BACTERIAL PNEUMONIA
    Η ΘΕΡΑΠΕΙΑ ΜΕ ANAKINRA ΓΙΑ ΤΗΝ ΑΠΟΤΡΟΠΗ ΟΡΓΑΝΙΚΗΣ ΑΝΕΠΑΡΚΕΙΑΣ ΑΠΟ ΣΟΒΑΡΗ ΒΑΚΤΗΡΙΑΚΗ ΠΝΕΥΜΟΝΙΑ
    A.3.2Name or abbreviated title of the trial where available
    INSPIRE
    A.4.1Sponsor's protocol code numberINSPIRE
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHellenic Institute for the Study of Sepsis
    B.1.3.4CountryGreece
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHellenic Institute for the Study of Sepsis
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHellenic Institute for the Study of Sepsis
    B.5.2Functional name of contact pointPresident of the Board
    B.5.3 Address:
    B.5.3.1Street Address17, Laodikeias str.
    B.5.3.2Town/ cityAthens
    B.5.3.3Post code11528
    B.5.3.4CountryGreece
    B.5.4Telephone number00302107480662
    B.5.6E-mailhiss@sepsis.gr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Kineret
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrum
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAnakinra
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAnakinra
    D.3.9.1CAS number 143090-92-0
    D.3.9.4EV Substance CodeSUB05500MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    community-acquired pneumonia, hospital-acquired pneumonia
    πνευμονία της κοινότητας/ενδονοσοκομειακή πνευμονία
    E.1.1.1Medical condition in easily understood language
    severe bacterial lung infection with high risk of causing organ dysfunction
    σοβαρή βακτηριακή λοίμωξη του πνεύμονα με μεγάλο κίνδυνο εξέλιξης σε οργανική δυσλειτουργία
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10010120
    E.1.2Term Community acquired pneumonia
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076918
    E.1.2Term Hospital acquired pneumonia
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The INSPIRE study is an exploratory, randomised, phase IIa clinical trial which aims to evaluate the potential benefit of presepsin-guided anakinra therapy as an adjuvant to the standard of care treatment in patients with community-acquired pneumonia or hospital-acquired pneumonia by preventing the development of organ dysfunction as defined by changes in SOFA score by day 7.
    Η μελέτη INSPIRE είναι μία διερευνητική, τυχαιοποιημένη κλινική δοκιμή φάσης ΙΙa που έχει ως σκοπό να αξιολογήσει τo όφελος της προσθήκης του φαρμάκου anakinra, η οποία καθοδηγείται από το βιοδείκτη πρεσηψίνη (presepsin) στην καθιερωμένη αγωγή των ασθενών με πνευμονία της κοινότητας ή ενδονοσοκομειακή πνευμονία προς αποτροπή της ανάπτυξης οργανικής δυσλειτουργίας όπως καθορίζεται από μεταβολές της βαθμολογίας SOFA μετά από 7 ημέρες.
    E.2.2Secondary objectives of the trial
    Not applicable
    Δεν εφαρμόζεται
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age equal to or above 18 years
    2. Male or female gender
    3. In case of women of reproductive age, willingness to use dual contraceptive method during the study period
    4. Written informed consent provided by the patient. For subjects without decision-making capacity, informed consent must be obtained from a legally designated representative following the national legislation in the Member State where the trial is planned
    5. Community-acquired pneumonia or hospital-acquired pneumonia
    6. qSOFA score equal to 1
    7. Serum presepsin > 350 pg/ml
    1. Ηλικία ίση ή άνω των 18 ετών
    2. Και τα δύο φύλα
    3. Για γυναίκες αναπαραγωγικής ηλικίας, πρέπει να είναι πρόθυμες να χρησιμοποιήσουν διπλή αντισυλληπτική μέθοδο κατά τη διάρκεια της μελέτης
    4. Έγγραφη συναίνεση μετά από ενημέρωση που παρέχεται από τον ασθενή ή από νόμιμο εκπρόσωπο σε περίπτωση που ο ασθενής δεν είναι δυνατό να συναινέσει σύμφωνα με την εθνική νομοθεσία
    5. Πνευμονία της κοινότητας ή ενδονοσκομειακή πνευμονία
    6. Βαθμολογία qSOFA ίση με 1
    7. Πρεσηψίνη ορού > 350 pg/ml
    E.4Principal exclusion criteria
    • Age below 18 years
    • Denial of written informed consent
    • Any stage IV malignancy
    • Any do not resuscitate decision
    • Patients with PaO2/FiO2 less than 150 necessitating non-invasive ventilation or mechanical ventilation
    • Hospitalization in Intensive Care Unit
    • Known hypersensitivity to anakinra
    • Oral or IV intake of corticosteroids at a daily dose equal to or greater than 0.4 mg/kg prednisone for a period greater than the last 15 days
    • qSOFA score 0, 2 or 3
    • Any anti-cytokine biological treatment for the last one month
    • Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study
    • Participation in any other interventional trial
    • Ηλικία κάτω των 18 ετών
    • Άρνηση έγγραφης συναίνεσης
    • Κακοήθεια σταδίου IV
    • Απόφαση μη ανάνηψης
    • Ασθενείς με λόγο PaO2/FiO2 μικρότερο από 150 που χρήζουν μη επεμβατικού αερισμού ή μηχανικού αερισμού
    • Νοσηλεία σε Μονάδα Εντατικής Θεραπείας
    • Γνωστή υπερευαισθησία στο anakinra
    • Λήψη κορτικοστεροιειδών από του στόματος ή ενδοφλέβια σε ημερήσια δόση μεγαλύτερη από 0,4 mg/kg ισοδύναμου πρεδνιζόνης για τις τελευταίες 15 ημέρες
    • Βαθμολογία qSOFA 0, 2 ή 3
    • Θεραπεία κατά κυτταροκινών τον τελευταίο μήνα
    • Εγκυμοσύνη ή γαλουχία. Προκειμένου για γυναίκες αναπαραγωγικής ηλικίας προ της εισαγωγής στη μελέτη θα διενεργείται τεστ κύησης ούρων προς αποκλεισμό εγκυμοσύνης
    • Συμμετοχή σε άλλη παρεμβατική μελέτη
    E.5 End points
    E.5.1Primary end point(s)
    Τhe progression into organ dysfunction. This is a composite endpoint. Patients who meet any of the following are considered to meet this endpoint: i) increase of SOFA score by 2 or more points from day 1 (before start of the study drug) until day 7; ii) death by day 90.
    Η εκδήλωση οργανικής δυσλειτουργίας. Πρόκειται για σύνθετο καταληκτικό σημείο το οποίο ορίζεται ως η εκδήλωση οποιουδήποτε εκ των κάτωθι: i) αύξηση στη βαθμολογία SOFA κατά τουλάχιστον 2 μονάδες από την ημέρα 1 (πριν την έναρξη του φαρμάκου μελέτης) μέχρι την ημέρα 7, και ii) θάνατος μέχρι την ημέρα 90.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 7
    Day 90
    Ημέρα 7
    Ημέρα 90
    E.5.2Secondary end point(s)
    •Change of SOFA score over all days of follow-up
    •Incidence of specific organ dysfunction by day 28
    •Time until discharge from hospital
    •Mortality by day 28
    •Mortality by day 90
    •Time until attenuation of sepsis-induced inflammation as defined by PCT measurements
    •Change of presepsin from baseline until day 10
    •Comparison of change of cytokine function and endothelial dysfunction markers from baseline by days 4 and 7
    •Comparative progression into organ dysfunction (defined as in the primary endpoint) between patients who failed screening because of presepsin 350 pg/ml or less and patients who were enrolled in the study and were allocated to Treatment Arm 1
    •Comparative 28-day mortality between patients who failed screening because of presepsin 350 pg/ml or less and patients who were enrolled in the study and were allocated to Treatment Arm 1
    •Μεταβολές στη βαθμολογία SOFA σε όλη τη διάρκεια της παρακολούθησης
    •Η επίπτωση συγκεκριμένης δυσλειτουργίας οργάνου μέχρι την ημέρα 28
    •Ο χρόνος μέχρι την έξοδο από το νοσοκομείο
    •Θνητότητα μέχρι την ημέρα 28
    •Θνητότητα μέχρι την ημέρα 90
    •Ο χρόνος μέχρι την ύφεση της φλεγμονής που αποδίδεται στη σήψη όπως ορίζεται από τη μεταβολή στις τιμές της προκαλσιτονίνης
    •Μεταβολές στα επίπεδα πρεσηψίνης καθημερινά για 10 ημέρες
    •Μεταβολή των επιπέδων των κυτταροκινών και των δεικτών ενδοθηλιακής δυσλειτουργίας από τη ημέρα 1 (πριν την έναρξη του φαρμάκου μελέτης) μέχρι τις ημέρες 4 και 7
    •Σύγκριση της εκδήλωσης οργανικής δυσλειτουργίας μεταξύ ασθενών που δεν εντάσσονται στη μελέτη λόγω τιμών πρεσηψίνης 350 pg/ml ή λιγότερο και ασθενών που τυχαιοποιούνται στην ομάδα της εικονικής θεραπείας
    •Σύγκριση της θνητότητας μέχρι την ημέρα 28 μεταξύ ασθενών που δεν εντάσσονται λόγω τιμών πρεσηψίνης 350 pg/ml ή λιγότερο και ασθενών που τυχαιοποιούνται στην ομάδα της εικονικής θεραπείας
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 4, 7, 10, 28, 90 and by hospital discharge
    Ημέρες 4, 7, 10, 28, 90 και κατά την έξοδο από το νοσοκομείο
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Δεν εφαρμόζεται
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-10
    P. End of Trial
    P.End of Trial StatusOngoing
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