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    Summary
    EudraCT Number:2019-001078-27
    Sponsor's Protocol Code Number:BAY1097761/19999
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-10-21
    Trial results View 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-001078-27
    A.3Full title of the trial
    Safety and efficacy of inhaled pegylated adrenomedullin (PEG-ADM) in patients suffering from Acute Respiratory Distress Syndrome (ARDS): a double-blind, randomized, placebo-controlled, multicenter Phase 2a/b clinical trial
    Sicurezza ed efficacia dell’adrenomedullina PEGilata (PEG-ADM) per inalazione in pazienti affetti da Sindrome da Distress Respiratorio Acuto (ARDS): studio clinico in doppio cieco, randomizzato, controllato verso placebo, multicentrico di fase 2a/b.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This study collects information on the safety of inhaled pegylated adrenomedullin (PEG-ADM), how the drug is tolerated and how it effects patients suffering from a type of lung failure that cause fluid to build up in the lungs making breathing difficult (ARDS)
    Sicurezza ed efficacia di PEG-ADM per inalazione nell’ARDS: studio clinico in doppio cieco, randomizzato, controllato verso placebo, multicentrico di fase 2a/b.
    A.3.2Name or abbreviated title of the trial where available
    SEAL Trial
    Studio SEAL
    A.4.1Sponsor's protocol code numberBAY1097761/19999
    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 SponsorBAYER AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBAYER AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street Addressna
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number004930300139003
    B.5.5Fax number004930300139003
    B.5.6E-mailclinical-trials-contact@bayer.com
    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 No
    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 nameBAY 1097761 liofilizzato per inalazione
    D.3.2Product code [BAY 1097761]
    D.3.4Pharmaceutical form Powder for nebuliser solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1432735-93-7
    D.3.9.2Current sponsor codeBAY 1097761
    D.3.9.4EV Substance CodePEG-ADM
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number960
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    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 No
    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 placeboPowder for nebuliser solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute respiratory distress syndrome (ARDS)
    Sindrome da Distress Respiratorio Acuto (ARDS)
    E.1.1.1Medical condition in easily understood language
    A type of lung failure that cause fluid to build up in the lungs making breathing difficult
    Condizione infiammatoria dei polmoni che porta a gravi difficoltà respiratorie
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10001052
    E.1.2Term Acute respiratory distress syndrome
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate safety and efficacy of inhaled PEG-ADM in ARDS
    Valutare la sicurezza e l’efficacia di PEG-ADM per inalazione nell’ARDS
    E.2.2Secondary objectives of the trial
    NA
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. =18 years of age at the time of inclusion into study.
    2. Invasively mechanically ventilated ARDS patients (diagnosed
    according to Berlin definition of ARDS, including PEEP of =5 cm H²O, Xray
    (or CT scan) indicative of ARDS: bilateral opacities not fully
    explained by cardiac failure, fluid overload, lobar/lung collapse,
    effusions or nodules).
    3. Initial diagnosis of mild, moderate or severe ARDS prior to study
    inclusion, with acute onset of ARDS within 1 week after suspected
    trigger factor of
    a. Pneumonia
    b. Aspiration
    c. Sepsis
    d. Pancreatitis
    4. Prior to randomization, hypoxemia with PaO²:FiO² =300 mmHg
    continuously observed for a period of =4 hours (with values of =2
    arterial blood gas [ABG] analyses during that time, with the last value
    obtained timely (generally =3 hours) prior to randomization), under
    ventilation with minimum PEEP =8 cm H²O.
    5. Time from first meeting the last diagnostic ARDS criterion (Berlin
    criteria) to randomization must be =48 hours.
    6. For Study Part A: ARDS patients for whom measurements of extravascular
    lung water are regarded as medically indicated by the treating
    physician, and these measurements are planned as part of their clinical care, from Study Day 1 up to Study Day 7 (if then still intubated).
    7. Male and non-pregnant female
    8. Informed consent of capable patient or, in case of patient being
    incapable of giving informed consent, consent for study inclusion will be
    sought according to applicable laws and regulations.
    I partecipanti sono ritenuti eleggibili per lo studio soltanto se si applicano tutti i seguenti criteri:
    Età
    1. Età = 18 anni alla data dell’inclusione nello studio.
    Tipologia di partecipante e caratteristiche della malattia
    2. Pazienti con ARDS sottoposti a ventilazione meccanica invasiva (diagnosi formulata secondo la definizione di ARDS di Berlino, compreso un valore di PEEP =5 cm H2O, riscontro radiografico (o TAC) di ARDS: opacità bilaterali non completamente spiegate da insufficienza cardiaca, sovraccarico di fluidi, collasso lobare/polmonare, versamenti o noduli).
    3. Diagnosi iniziale di ARDS lieve, moderata o grave prima dell’inclusione nello studio con manifestazione acuta di ARDS entro 1 settimana dal sospetto fattore scatenante di:
    a. Polmonite
    b. Aspirazione
    c. Sepsi
    d. Pancreatite
    4. Prima della randomizzazione, ipossiemia con PaO2:FiO2 =300 mmHg osservata per un periodo continuativo =4 ore (con =2 valori di emogasanalisi arteriosa [ABG] durante questo intervallo, con l’ultimo valore ottenuto tempestivamente (in generale =3 ore) prima della randomizzazione), in ventilazione con PEEP minima =8 cm H2O (e considerando la strategia di ventilazione raccomandata durante questo periodo, come descritto nel paragrafo 8.11).
    5. Il tempo tra il riscontro iniziale dell’ultimo criterio diagnostico di ARDS (criteri di Berlino) e la randomizzazione deve essere =48 ore.
    6. Per la Parte A dello studio: pazienti con ARDS per i quali il medico curante ritiene indicata a livello clinico la misurazione del volume di acqua extravascolare polmonare e per i quali tali misurazioni sono previste nell’ambito dell’assistenza clinica tra il giorno 1 e il giorno 7 dello studio (se ancora intubati).
    Sesso
    7. Soggetti di sesso maschile e femminile non in gravidanza
    Poiché la popolazione reclutata è gravemente malata, ventilata meccanicamente in modo invasivo e pertanto considerata in astinenza da rapporti sessuali durante il periodo di trattamento, la necessità di consulenza in materia di contraccezione durante tale periodo è ritenuta molto improbabile. A discrezione dello sperimentatore, la consulenza per l’uso di adeguati metodi contraccettivi sarà fornita ai partecipanti che abbiano ripreso conoscenza e che possono essere sessualmente attivi entro i 30 giorni precedenti il termine del trattamento.
    Consenso informato
    8. Il consenso informato del paziente capace o, in caso di paziente incapace di fornire il consenso informato, il consenso per l’inclusione nello studio dovrà essere ottenuto nel rispetto delle leggi e normative applicabili.
    E.4Principal exclusion criteria
    1. Any value of a PaO²:FiO² ratio >300 mmHg within a time interval of 4
    hours before randomization
    2. Rescue therapy (e.g. inhalation of nitric oxide gas and/or inhalation of
    prostacyclin analogues, or ECMO/ECCO2R) already initiated at screening
    and/or Study Day 1 (prior to first dose of the study intervention)
    3. Moribund participants not expected to survive 24 hours (clinical
    decision)
    4. Expected duration of invasive mechanical ventilation less than 48
    hours (clinical decision)
    5. History of co-morbidities requiring long-term/home oxygen use (e.g.
    severe chronic obstructive pulmonary disease [COPD], pulmonary
    fibrosis) or non-invasive ventilation (except for sleep apnea
    management), or making weaning per se improbable (e.g. ALS, muscular
    dystrophy)
    6. Smoke inhalation injury, extensive burns or trauma/head injury as
    concomitant condition
    7. History of pneumectomy, lung lobectomy or lung transplant
    8. Diffuse alveolar hemorrhage from vasculitis
    9. Current lung malignancy (incl. lung metastasis), or other malignancy
    requiring chemotherapy or radiation within the last month
    10. Chronic kidney disease with a history of renal replacement therapy
    (e.g. dialysis)
    11. Chronic liver disease Child-Pugh Class C
    12. Chronic heart failure NYHA IV
    13. Known hypersensitivity to polyethylenglycol (PEG, Macrogol)
    14. Participation in other interventional studies involving
    pharmacological interventions, or biological or cell therapy
    interventions.
    I partecipanti sono esclusi dallo studio qualora si applichi uno qualsiasi dei seguenti criteri:

    Condizioni mediche
    1. Qualunque valore del rapporto PaO2:FiO2 >300 mmHg entro un intervallo di tempo di 4 ore precedenti la randomizzazione
    2. Terapia di salvataggio (ad esempio inalazione di ossido nitrico e/o inalazione di analoghi delle prostacicline, o ECMO/ECCO2R[rimozione extracorporea di CO2]) già avviata in sede di screening e/o il giorno 1 dello studio (prima della prima dose del trattamento in studio)
    3. Partecipanti moribondi per cui non si preveda una sopravvivenza superiore alle 24 ore (decisione clinica)
    4. Durata prevista della ventilazione meccanica invasiva inferiore a 48 ore (decisione clinica)
    5. Anamnesi di co-morbilità che richiedono l’impiego di ossigeno a lungo termine/a domicilio (per esempio, broncopneumopatia cronica ostruttiva [BPCO], fibrosi polmonare) o ventilazione non invasiva (se non per la gestione dell’apnea del sonno) o che rendono lo svezzamento di per sé improbabile (per esempio SLA o distrofia muscolare)
    6. Danno da inalazione di fumi, ustioni estese o lesioni da trauma/craniche come condizioni concomitanti
    7. Anamnesi di pneumectomia, lobectomia polmonare o trapianto di polmone
    8. Emorragia alveolare diffusa dovuta a vasculite
    9. Cancro polmonare presente (compresa metastasi del polmone) o altra malignità che abbia richiesto trattamento con chemioterapia o radioterapia nel corso dell’ultimo mese
    10. Malattia renale cronica con anamnesi di terapia renale sostitutiva (per esempio, dialisi)
    11. Malattia epatica cronica (Classe C Child-Pugh)
    12. Insufficienza cardiaca cronica (Classe IV NYHA)
    13. Ipersensibilità nota al polietilenglicole (PEG, macrogol)
    Esperienza in studio clinico precedente/concomitante
    14. Intenzione di partecipare o partecipazione precedente (nei 30 giorni precedenti il giorno 1 dello studio) ad altri studi interventistici comprendenti interventi farmacologici o interventi con terapia biologica o cellulare. La partecipazione ad altri studi interventistici, che studiano le modifiche dei regimi terapeutici di supporto o obiettivi simili, è possibile se l’intervento in questione viene considerato non pregiudizievole per la valutazione dei risultati o delle raccomandazioni terapeutiche di supporto descritte in questo protocollo. Lo sperimentatore e il promotore valuteranno le implicazioni di tale studio; in assenza di accordo reciproco, il paziente deve essere escluso.
    E.5 End points
    E.5.1Primary end point(s)
    Part B only: Ventilator-free survival (VFS, proportion of participants alive and off invasive mechanical ventilation) at study day 28
    Parte B: sopravvivenza (VFS) senza ventilatore al giorno 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 28
    giorno 28
    E.5.2Secondary end point(s)
    Part A only:
    1. Clinical Utility Index (CUI) based on data from the first week of treatment (change vs. baseline), CUI is derived from
    o Extravascular lung water index (EVLWi)
    o Oxygenation index (OI)
    o Non-pulmonary Sequential Organ Failure Assessment (npSOFA) score
    2.Ventilator-free survival (VFS, proportion of participants alive and off invasive mechanical ventilation) at study day 28
    Part A and Part B:
    3. All-cause mortality at study day 28, study day 60 and study day 90
    4. Proportion of participants who still require invasive mechanical ventilation support at study day 28 and study day 60
    5. Ventilator-free days (VFDs) within study day 28 and study day 60
    6. Ventilator-free survival at study day 60
    7. Integrated analysis on Ventilator-free survival at study day 28 and study day 60, involving all participants from Part A and Part B
    Solo Parte A
    · Indice di utilità clinica (CUI) basato sui dati della prima settimana di trattamento (variazione rispetto al basale). Il CUI è ottenuto da:
    o Acqua ExtraVascolare Polmonare indicizzata (EVLWi)
    o Indice di ossigenazione (OI)
    o punteggio di Valutazione dell'Insufficienza d'Organo Sequenziale non polmonare (npSOFA)
    · Sopravvivenza senza ventilatore (VFS, percentuale di partecipanti in vita e senza ventilazione meccanica invasiva) al giorno 28 dello studio
    Parte A e Parte B
    · Mortalità per tutte le cause al giorno 28, al giorno 60 e al giorno 90 dello studio
    · Percentuale di partecipanti che necessitano ancora del supporto della ventilazione meccanica invasiva al giorno 28 e al giorno 60 dello studio
    · Giorni liberi dal ventilatore (VFD) entro il giorno 28 e il giorno 60 dello studio
    · Sopravvivenza senza ventilatore al giorno 60 dello studio
    · Analisi integrata sulla sopravvivenza senza ventilatore al giorno 28 e 60 dello studio estesa a tutti i partecipanti della Parte A e della Parte B.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. during the first week of the study
    2. at study day 28
    3. at study day 28, study day 60 and study day 90
    4 at study day 28 and study day 60
    5. within study day 28 and study day 60
    6. at study day 60
    7. at study day 28 and study day 60
    1. prima settimana di studio
    2. giorno 28
    3. giorno 28, giorno 60, giorno 90
    4 giorno 28, giorno 60
    5. entro giorno 28 e giorno 60
    6. giorno 60
    7. giorno 28, giorno 60
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    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 trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Canada
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Greece
    Hungary
    Israel
    Italy
    Japan
    Netherlands
    Portugal
    Romania
    Russian Federation
    Slovakia
    Switzerland
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial 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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 166
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Eligible patients for this study suffer from ARDS and are invasively mechanically ventilated, hence many will also be sedated. Patients will be in severe distress due to dyspnea; hypotonia in case concomitant sepsis with limited cognitive functioning
    I pazienti eleggibili in questo studio soffrono di ARDS e sono invasivamente ventilati in modo meccanico e spesso sedati. I pazienti saranno in grave difficoltà a causa di dispnea; ipotonia in caso di sepsi con limitate funzioni cognitive
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 466
    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)
    NA
    NA
    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 Decision2020-07-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-03-01
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