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    EudraCT Number:2017-003855-47
    Sponsor's Protocol Code Number:AP301-II-002
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-01-16
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2017-003855-47
    A.3Full title of the trial
    Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability oedema in patients with moderate-to-severe ARDS - a randomised, placebo-controlled, double-blind trial
    Bewertung der Sicherheit und vorläufgien Wirksamkeit sequenziell ansteigender Dosierungen von Solnatide zur Behandlung des pulmonalen Permeabilitätsödems bei Patienten mit mäßigem bis schwerem akutem Atemnotsyndrom (ARDS) – eine randomisierte, Placebo kontrollierte Doppelblindstudie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability oedema in patients with moderate-to-severe ARDS - a randomised, placebo-controlled, double-blind trial
    Bewertung der Sicherheit und vorläufgien Wirksamkeit sequenziell ansteigender Dosierungen von Solnatide zur Behandlung des pulmonalen Permeabilitätsödems bei Patienten mit mäßigem bis schwerem akutem Atemnotsyndrom (ARDS) – eine randomisierte, Placebo kontrollierte Doppelblindstudie
    A.4.1Sponsor's protocol code numberAP301-II-002
    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 SponsorApeptico Forschung und Entwicklung GmbH
    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 supportApeptico Forschung und Entwicklung GmbH
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationApeptico Forschung und Entwicklung GmbH
    B.5.2Functional name of contact pointProf. Dr. Bernhard Fischer
    B.5.3 Address:
    B.5.3.1Street AddressMariahilfer Straße 136, Top 1.15
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1150
    B.5.4Telephone number00436641432919
    B.5.5Fax number0043664330337795
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/677
    D.3 Description of the IMP
    D.3.1Product nameSolnatide
    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 259206-53-06
    D.3.9.2Current sponsor codeAP301
    D.3.9.3Other descriptive namehuman tumour necrosis factor alpha-derived peptide Cys-Gly-Gln-Arg-Glu-Thr-Pro-Glu-Gly-Ala-Glu-Ala-Lys-Pro-Trp-Tyr-Cys
    D.3.9.4EV Substance CodeSUB120783
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 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 placeboSolvent for...
    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
    pulmonary permeability oedema in patients with moderate-to-severe ARDS
    E.1.1.1Medical condition in easily understood language
    Acute Lung Injury
    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 LLT
    E.1.2Classification code 10003083
    E.1.2Term ARDS
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10037423
    E.1.2Term Pulmonary oedema
    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 assess the local and systemic safety of 7 days orally inhaled sequential multiple ascending doses of solnatide in patients with pulmonary permeability oedema and moderate-to-severe ARDS.
    Bewertung der lokalen und systemischen Sicherheit einer siebentägigen, oralen Inhalation sequenziell ansteigender Dosierungen von Solnatide zur Behandlung des pulmonalen Permeabilitätsödems bei Patienten mit mäßigem bis schwerem ARDS.
    E.2.2Secondary objectives of the trial
    To review potential efficacy endpoints for a future phase III pivotal trial.
    To assess plasma level of orally inhaled solnatide in selected patients.
    Identifizierung möglicher Parameter zur Wirksamkeitsbewertung im Rahmen einer zukünftigen Phase III Zulassungsstudie.
    Beurteilung des Plasmaspiegels von oral inhaliertem Solnatide bei ausgewählten Patienten.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The study will enrol patients with pulmonary permeability oedema (EVLWI ≥ 10) and moderate to severe ARDS admitted to an Intensive Care Unit (ICU) and under mechanical ventilation*. To be eligible to participate in this study, an individual must meet all the following criteria:
    1. Informed consent (for details see Section 10.1.1)
    2. Male or female ≥18 years of age
    3. Patient has been admitted to an ICU, is mechanically ventilated (according to the ventilation and weaning protocol as outlined in the study protocol) and stable in this condition for at least 8 hours
    4. Moderate and severe ARDS diagnosis as defined by the Berlin Definition:
    • Onset of ARDS within 1 week of a known clinical insult or new or worsening respiratory symptoms
    • Bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules
    • Respiratory failure not fully explained by cardiac failure or fluid overload (origin of oedema)
    • PaO2/FiO2 ≤ 200 mm Hg with Positive End-Expiratory Pressure (PEEP) ≥5 cm H2O
    5. Verified ARDS diagnosis (moderate or sever according to BERLIN Definition) not older than 48 hours
    6. Extravascular lung water index (EVLWI) ≥ 10 mL/PBW, as assessed with a validated bedside measurement (single indicator transpulmonary thermodilution measurement with the PiCCO system)
    7. Patient who meets criteria for extensive hemodynamic monitoring as per international intensive-care medicine standards

    Es werden mechanisch beatmete Intensivpatienten mit einem pulmonalen Permeabilitätsödem (EVLWI ≥ 10) und mäßigem bis schwerem ARDS in die Studie aufgenommen. Um in die Studie aufgenommen zu werden, muss ein Patient sämtliche nachfolgend genannten Kriterien erfüllen:
    1. Einverständniserklärung (Einzelheiten s. Abschnitt 10.1.1)
    2. Männlich oder weiblich ≥ 18 Jahre
    3. Mechanisch beatmeter Intensivpatient (s. Beatmungsproto-koll im Prüfplan) mindestens acht Stunden in stabilem Zu-stand
    4. Diagnose eines mäßigen bis schweren ARDS gemäß der Berlin Definition:
    • Beginn des ARDS innerhalb von 1 Woche nach einem bekannten klinischen Insult oder neu aufgetretene bzw. Verschlechterung vorhandener respiratorischer Symptome
    • Bilaterale Verdichtungen in der Röntgen-Thorax-Aufnahme oder Computertomographie, die nicht auf Effusionen, Lungenversagen oder Knoten zurückgeführt werden können
    • Atemnot kann nicht auf das Vorhandensein eines kardialen Lungenödems oder einer Überwässerung zurückgeführt werden
    • Quotient des arteriellen Sauerstoffpartialdrucks (PaO2)/inspiratorischer Sauerstoffkonzentration (FiO2) ≤ 200 mmHg, bei einem positiven endexpiratorischen Druck (PEEP) ≥ 5 cm H2O
    5. Bestätigte Diagnose des ARDS (mittel oder schwer gemäß BERLIN Definition) nicht älter als 48 Stunden
    6. Extravaskulärer-Lungenwasserindex (EVLWI) ≥ 10 mL/ PBW, gemessen anhand der alleinigen transpulmonalen Thermodilution mit Hilfe des PiCCO Systems
    7. Patient erfüllt die Kriterien für ein extensives hämo-dynamisches Monitoring gemäß internationalen, intensiv-medizinischen Standards
    E.4Principal exclusion criteria
    1. History of clinically relevant allergies or idiosyncrasies to solnatide
    2. Known use of any other investigational or non-registered drug within 30 days prior to study enrollment
    3. Severe state of septic shock with a Mean Arterial Pressure (MAP) ≤ 65 mm Hg and serum lactate level > 4 mmol/L (36 mg/dL) despite adequate volume resuscitation
    4. An underlying clinical condition that, in the opinion of the Investigator, would make it very unlikely for the patient to be successfully weaned from ventilation due to severe underlying diseases (e.g. severe malnutrition, severe neurological diseases, pulmonary fibrosis or COPD)
    5. Extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support
    6. Neutrophil count < 0.3 x 10^9/L
    7. Cancer treatment (chemotherapy or biological) or therapy with other immunosuppressive agents for organ transplantation within 2 weeks
    8. Cachexia (BMI < 18.5 kg/m2)
    9. Cardiogenic pulmonary edema diagnosed by echocardiography or pulmonary artery catheter
    10. Skin burns involving more than 15% of body surface
    11. Subjects who are extremely unlikely to survive more than 48 hours due to the acute conditions of the patient in the opinion of the Investigator
    12. Subjects transferred from a hospital not participating in this study who are already planned to be re-transferred during the observation period
    13. Subjects who are not expected to survive the next month because of an underlying uncorrectable medical condition or a do not resuscitate order
    14. Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test
    1. Anamnese klinisch relevanter Allergien oder Unverträglich-
    keiten gegenüber Solnatide
    2. Anwendung sonstiger Prüfmedikation oder nicht zugelassener
    Medikamente innerhalb von 30 Tagen vor Aufnahme in die
    3. Zustand eines schweren septischen Schocks mit einem
    Mittleren arteriellen Druck ≤ 65 mm Hg und einer Laktat-
    konzentration im Serum ˃ 4 mmol/L (36 mg/dL) trotz ausreich-
    endner Volumensubstitution
    4. Klinische Anzeichen für das Vorhandensein einer schwer-
    wiegenden Grunderkrankung, z.B. erhebliche Mangeler-
    nährung, schwere neurologische Erkrankungen, pulmonale
    Fibrose oder COPD, wodurch nach Ansicht des Prüfarztes eine
    Erfolgreiche Entwöhnung von der mechanischen Beatmung un-
    wahrscheinlich ist
    5. Extrakorporale Membranoxygenierung, Hochfrequenzbe-
    atmung oder andere Form einer extrakorporalen Lungen-
    6. Neutrophilenzahl: < 0.3 x 10^9/L
    7. Onkotherapie (chemisch oder biologisch) oder eine Behandlung
    mit Immunsupressiva zur Organtransplantation innerhalb von 2
    8. Kachexie (BMI < 18.5 kg/m2)
    9. Vorhandensein eines kardialen Lungenödems, diagnostiziert
    mittels Echokardiographie oder Pulmonalarterienkatheter
    10. Hautverbrennungen von mehr als 15% der Körperoberfläche
    11. Patienten, die aufgrund akuter Probleme nach Ansicht des
    Prüfarztes mit großer Wahrscheinlichkeit nicht länger als 48
    Stunden überleben werden
    12. Patienten, die von einem nicht an der Studie teilnehmenden
    Krankenhaus überwiesen wurden und bereits während der
    Beobachtungsphase zurückverlegt werden sollen
    13. Patienten, die aufgrund einer unheilbaren Erkrankung oder
    einer Patientenverfügung die kommenden Monate voraus-
    sichtlich nicht überleben werden
    14. Schwangere oder stillende Frauen oder solche, bei denen ein
    positives bzw. nicht eindeutiges Resultat eines Schwanger-
    schaftstests vorliegt
    E.5 End points
    E.5.1Primary end point(s)
    Safety will be assessed by a review of mortality, the incidence of adverse events and serious adverse events, as well as by analysis of relevant laboratory data and ECG.
    Safety parameters
    • Drug-related adverse events (through day 14)
    • All adverse events through day 28
    • All-cause deaths through day 28
    • Vital signs daily through day 14 (heart rate, systolic and diastolic blood pressure, and body temperature)
    • ECG parameters including heart rate PQ, QRS, QT and QTc intervals through day 7
    • Clinical laboratory assessments (haematology, clinical chemistry, blood gases and urine analysis) daily through day 14
    • 24-hour fluid balance through day 7
    • Hemodynamic parameters: mean arterial pressure, pulmonary blood volume (PBV), cardiac index and cardiac output assessed at screening and daily until end of treatment
    • Need for vasoactive drugs assessed at screening and daily until end of treatment
    Preliminary efficacy parameters
    • Change from baseline to day 7 in EVLWI and pulmonary vascular permeability index (PVPI) as assessed with a validated bedside measurement (single indicator transpulmonary thermodilution measurement with the PiCCO system)
    • Lung compliance through day 14, if patient is mechanical ventilated (controlled mechanical ventilation)
    • Murray lung injury score (LIS) through day 7 if chest x-ray is available
    • Oxygenation ratio (PaO2/FiO2 ratio) assessed through day 7
    • Ventilation parameters: ventilatory plateau pressure, tidal volume (Vt), positive end expiratory pressure (PEEP), respiratory rate, FiO2, peak inspiratory pressure (PIP), mean airway pressure, peak airway pressure (Ppeak), ventilation mode through day 14, if patient is mechanical ventilated (controlled mechanical ventilation, assisted breathing, non-invasive ventilation)
    • Driving pressure (Pplat -PEEP) through Day 14
    • Spontaneous breathing trial
    • Time to extubation through day 28
    • Ventilator-free days (VFD) (corresponding with the standardized ventilation and weaning protocol) through day 28
    • Days of hospitalization through day 28, defined as the difference between the date of discharge and the date of randomization. Days of outpatient hospitalization will not be included.
    • ICU days through day 28. ICU days is defined as the number of calendar days a patient was in the ICU until completion of day 28.
    Plasma concentration of solnatide in selected patients
    Plasma concentrations of solnatide.
    Die Bewertung der Sicherheit erfolgt anhand der Sterblichkeitsrate, der Inzidenz von unerwünschten und schwerwiegenden uner-wünschten Ereignissen sowie der Analyse relevanter Laborwerte und des EKG.
    • Nebenwirkungen (bis einschließlich Tag 14)
    • Sämtliche unerwünschten Ereignisse (bis einschließlich Tag 28)
    • Sämtliche Todesfälle bis einschließlich Tag 28
    • Vitalzeichen bis einschließlich Tag 14 (Puls, systolischer und diastolischer Blutdruck sowie Körpertemperatur)
    • EKG Parameter einschl. Puls, PQ, QRS, QT und QTc Intervall bis einschließlich Tag 7
    • Klinische Laborwerte (Hämatologie, klinische Chemie, Blutgase und Urinanalyse) bis einschließlich Tag 14
    • 24 Stunden Flüssigkeitshaushalt bis einschließlich Tag 7
    • Hämodynamische Parameter (durchschnittlicher arterieller Druck, Lungenblutvolumen, Herzindex und Herzminutenvolumen) werden beim Screening sowie täglich bis zum Ende der Behand-lung bestimmt
    • Bedarf an vasoaktiven Medikamenten wird vom Screening bis zum Ende der Behandlung täglich bestimmt

    Vorläufige Wirksamkeitsparameter
    • Bestimmung der Änderung von EVLWI und des pulmonalvaskulären Permeabilitätsindex (PVPI) von Behand-lungsbeginn bis Tag 7 anhand der alleinigen transpulmonalen Thermodilution mit Hilfe des PiCCO Systems
    • Bestimmung der Lungencompliance bis einschließlich Tag 14, falls der Patient mechanisch beatmet wird (kontrollierte mechanische Beatmung, unterstützte Atmung, nicht-invasive Beatmung)
    • Bestimmung des Murray Lungenschädigungsindex (LIS) bis einschließlich Tag 7, falls eine Röntgen-Thorax Aufnahme vorliegt
    • Bestimmung des Oxygenierungsindex (PaO2/FiO2) bis ein-schließlich Tag 7
    • Beatmungsparameter: Beatmungsplateaudruck, Atemzugvolu-men (Vt), positive endexpiratorischer Druck (PEEP), Atemfrequenz, inspiratorische Sauerstoffkonzentration (FiO2), maximaler Inspirationsdruck, mittlerer Atemwegsdruck, maxi-maler Atemwegsdruck (Ppeak), Art der Beatmung bis einschließ-lich Tag 14, falls ein Patient mechanisch beatmet wird (kontrollierte mechanische Beatmung, unterstützte Atmung, nicht-invasive Beatmung)
    • Druckamplitude (Pplat -PEEP) bis einschließlich Tag 14
    • Spontanatmungsversuch
    • Zeitraum bis zur Extubation bis einschließlich Tag 28
    • Anzahl der beatmungsfreien Tage (entsprechend dem Standardbeatmungs- und Weaning Protokoll) bis einschließlich Tag 28
    • Verweildauer im Krankenhaus (Tage) bis einschließlich Tag 28, definiert als Differenz zwischen Entlassungstag und dem Tag der Randomisierung. Tage eines ambulanten Krankenhausaufent-halts werden nicht berücksichtigt.
    • Verweildauer auf der Intensivstation (Kalendertage) bis ein-schließlich Tag 28
    Plasmakonzentration von Solnatide bei ausgewählten Patienten
    Plasmakonzentrationen von Solnatide.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to day 7 respectivly da 28 (+7)
    E.5.2Secondary end point(s)
    not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    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 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. 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 trial4
    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 EEA6
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    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: 40
    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 Yes
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    F.4.2.2In the whole clinical trial 95
    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)
    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 Decision2018-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-24
    P. End of Trial
    P.End of Trial StatusOngoing
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