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    Summary
    EudraCT Number:2016-003883-38
    Sponsor's Protocol Code Number:ADR-02
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-03
    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 ConcernedGermany - PEI
    A.2EudraCT number2016-003883-38
    A.3Full title of the trial
    A Double-Blind, Placebo-Controlled, Randomized, Multicenter, Proof of Concept and Dose-Finding Phase II Clinical Trial to Investigate the Safety, Tolerability and Efficacy of ADRECIZUMAB in Patients with Septic Shock and Elevated Adrenomedullin
    Doppelblinde, placebokontrollierte, randomisierte, multizentrische, klinische Machbarkeits- und Dosisfindungsstudie der Phase II zur Untersuchung von Sicherheit, Verträglichkeit und Wirksamkeit von ADRECIZUMAB bei Patienten mit septischem Schock und erhöhtem Adrenomedullin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial comparing Standard Treatment in the ICU with ADRECIZUMAB Treatment in patients with septic shock and elevated Adrenomedullin
    Studie zum Vergleich der Standardbehandlung von Patienten mit septischem Schock und erhöhtem Adrenomedullin auf der Intensivstation mit der Therapie von ADRECIZUMAB
    A.3.2Name or abbreviated title of the trial where available
    AdrenOSS-2
    A.4.1Sponsor's protocol code numberADR-02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03085758
    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 SponsorAdrenomed 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 supportAdrenomed AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAdrenomed AG
    B.5.2Functional name of contact pointClinical Development
    B.5.3 Address:
    B.5.3.1Street AddressNeuendorfstraße 15a
    B.5.3.2Town/ cityHennigsdorf
    B.5.3.3Post code16761
    B.5.3.4CountryGermany
    B.5.4Telephone number+4933022056532
    B.5.5Fax number+4933022077815
    B.5.6E-mailjzimmermann@adrenomed.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 nameAdrecizumab
    D.3.2Product code HAM8101
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    Intravenous use
    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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Septic Shock
    Septischer Schock
    E.1.1.1Medical condition in easily understood language
    A life-threatening organ dysfunction due to dysregulated host response to a proven or suspected infection
    Eine lebensbedrohliche Organfunktionsstörung infolge einer fehlgesteuerten Reaktion des Wirts auf eine nachgewiesene oder vermutete Infektion
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10040070
    E.1.2Term Septic shock
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the safety and tolerability of ADRECIZUMAB in patients with early septic shock and elevated bio-ADM (concentration of > 70 pg/ml) in treatment arm A (2 mg/kg) and in treatment arm B (4 mg/kg) over the 90 days study period.

    Untersuchung der Sicherheit und Verträglichkeit von ADRECIZUMAB bei Patienten mit einem septischen Schock im Frühstadium und erhöhtem Bio-ADM (Konzentration von >70 pg/ml) in Behandlungsarm A (2 mg/kg) und in Behandlungsarm B (4 mg/kg) über die Studiendauer von 90 Tagen
    E.2.2Secondary objectives of the trial
    •To obtain first data on efficacy of ADRECIZUMAB in patients with early septic shock and a bio-ADM concentration of > 70 pg/ml in the treatment arms compared with placebo.
    •To study the PK of free-ADRECIZUMAB
    • Erhebung erster Daten über die Wirksamkeit von ADRECIZUMAB bei Patienten mit einem septischen Schock im Frühstadium und einer Bio-ADM-Konzentration von >70 pg/ml in den Behandlungsarmen im Vergleich zu Placebo.
    • Untersuchung der PK von freiem ADRECIZUMAB
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent by patient or legally designated representative
    (according to country – specific regulations)
    2. Male and female patient, age ≥ 18 years
    3. Body weight 50 kg – 120 kg
    4. Bio-ADM concentration > 70 pg/ml
    5. Patient with early septic shock (start of vasopressor therapy
    < 12 hours)
    6. Women of childbearing potential must have a negative pregnancy serum or urine pregnancy test before randomization
    7. Highly effective method of contraception must be maintained for 6 months after study start by women of childbearing potential and sexually active men.
    8. No care limitation
    1. Schriftliche Einwilligung des Patienten oder gesetzlichen Vertreters (gemäß den länderspezifischen Bestimmungen)
    2. Männliche und weibliche Patienten im Alter ab 18 Jahren
    3. Körpergewicht 50 kg – 120 kg
    4. Bio-ADM-Konzentration >70 pg/ml
    5. Patient mit einem septischen Schock im Frühstadium (Beginn der Vasopressor-Therapie vor < 12 Stunden)
    6. Frauen im gebärfähigen Alter müssen vor Randomisierung einen negativen Serum- oder Urintest vorweisen
    7.Gebärfähige Frauen und sexuell aktive Männer müssen ab Studienbeginn 6 Monate lang eine hochwirksame Methode zur Empfängnisverhütung anwenden.
    8.Keine Pflegeeinschränkung
    E.4Principal exclusion criteria
    1. Moribund
    2. Pre-existing unstable condition (e.g. a recent cerebral hemorrhage or infarct, a recent acute unstable myocardial infarction (all < 3 months), congestive heart failure – NYHA Class IV)
    3. Patients that required cardiopulmonary resuscitation in the last 4 weeks prior to evaluation for enrollment
    4. Severe COPD with chronic oxygen need at home (GOLD IV)
    5. Any organ or bone marrow transplant within the past 24 weeks
    6. Uncontrolled serious hemorrhage (≥ 2 units of blood / platelets in the previous 24 hrs.). Patients may be considered for enrollment if bleeding has stopped and patient is otherwise qualified
    7. Uncontrolled hematological / oncological malignancies
    8. Absolute neutropenia < 500 per µL
    9. Severe chronic liver disease (Child-Pugh C)
    10. Systemic fungal infection or active tuberculosis
    11. Neuromuscular disorders that impact breathing / spontaneous ventilation
    12. Burns > 30% of body surface
    13. Plasmapheresis
    14. Breastfeeding women
    15. Participation in a clinical trial involving another investigational drug within 4 weeks prior to inclusion
    16. Unwilling or unable to be fully evaluated for all follow-up visits
    1. Moribunder Patient
    2. Vorbestehende instabile Erkrankung (z. B. kürzliche Hirnblutung oder Infarkt, ein kürzlich stattgehabter akuter, instabiler Myokardinfarkt (alle vor < 3 Monaten), Herzinsuffizienz – NYHA-Klasse IV)
    3. Patienten, die in den 4 Wochen vor der Einschlussuntersuchung reanimiert wurden
    4. Schwere COPD mit chronischem Sauerstoffbedarf zu Hause (GOLD IV)
    5. Organ- oder Knochenmarktransplantation innerhalb der vergangenen 24 Wochen
    6. Unkontrollierte, schwerwiegende Blutung (≥ 2 Blut-/Thrombozyten-einheiten in den vergangenen 24 Std.). Die Patienten kommen für einen Einschluss in Frage, wenn die Blutung gestillt ist und der Patient ansonsten qualifiziert ist
    7. Unkontrolliertes hämatologisches/onkologisches Malignom
    8. Absolute Neutropenie <500 pro µl
    9. Schwere chronische Lebererkrankung (Child-Pugh C)
    10. Systemische Pilzinfektion oder aktive Tuberkulose
    11. Neuromuskuläre Erkrankung mit Beeinträchtigung der Atmung/Spontanatmung
    12. Verbrennungen von >30 % der Körperoberfläche
    13. Plasmapherese
    14. Stillende Frauen
    15. Teilnahme an einer klinischen Studie mit einem anderen Prüfpräparat in den letzten 4 Wochen vor dem Einschluss
    16. Der Patient ist nicht bereit oder nicht in der Lage, bei allen Nachbeobachtungsterminen vollständig beurteilt zu werden
    E.5 End points
    E.5.1Primary end point(s)
    • Mortality
    • Interruption of infusion
    • Severity and frequency of treatment-emergent adverse Events
    • Mortalität
    • Unterbrechung der Infusion
    • Schweregrad und Häufigkeit behandlungsbedingter unerwünschter Ereignisse
    E.5.1.1Timepoint(s) of evaluation of this end point
    •Primary efficacy endpoint:
    Sepsis Support Index (SSI) defined as: days with organ support or dead within 14 days follow up.

    More precisely: In the time frame of 14 day follow-up, each day on support with vasopressor, and/or mechanical ventilation (defined as any ventilation received on this day, independnet from the duration of mechanical ventilation), and/or renal dysfunction (defined as renal SOFA = 4), or not alive, is counted as 1. The sum over the follow-up period is defined as SSI.
    • Primärer Wirksamkeitsendpunkt:
    Sepsis Support Index (SSI), definiert als Tage mit Organunterstützung oder Tod innerhalb von 14 Nachbeobachtungstagen.

    Das heißt: In einem Zeitraum von 14 Nachbeobachtungstagen zählt jeder Tag mit Unterstützung durch Vasopressoren und/oder mechanischer Beatmung (definiert als jede an diesem Tag erhaltene Beatmung unabhängig von der Dauer der mechanischen Beatmung) und/oder Nierenfunktionsstörung (definiert als renaler SOFA-Score = 4) oder nicht am Leben mit 1. Die Summe aus der Nachbeobachtungszeit ist definiert als SSI.
    E.5.2Secondary end point(s)
    • Sepsis Support Index (SSI) defined as: days with organ support or dead within 14 day follow up
    More precisely: In the time frame of 14 day follow-up, each day on support with vasopressor, and/or mechanical ventilation (defined as any ventilation received on this day, independnet from the duration of mechanical ventilation), and/or renal dysfunction (defined as renal SOFA = 4), or not alive, is counted as 1. The sum over the follow up period is defined as SSI
    Sepsis Support Index (SSI), definiert als Tage mit Organunterstützung oder Tod innerhalb von 14 Nachbeobachtungstagen.

    Das heißt: In einem Zeitraum von 14 Nachbeobachtungstagen zählt jeder Tag mit Unterstützung durch Vasopressoren und/oder mechanischer Beatmung (definiert als jede an diesem Tag erhaltene Beatmung unabhängig von der Dauer der mechanischen Beatmung) und/oder Nierenfunktionsstörung (definiert als renaler SOFA-Score = 4) oder nicht am Leben mit 1. Die Summe aus der Nachbeobachtungszeit ist definiert als SSI.
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Sepsis Support Index (SSI) at 28 day follow-up
    • Penalized Sepsis Support Index (pSSI) at 14 and 28 day follow-up
    •Persistent organ dysfunction or death at 14 and 28 day follow-up
    •Day 28 and day 90 mortality rate
    •SSI and pSSI excluding the renal component
    •Individual Sepsis Support Index components with and without mortality
    •Sequential Organ Failure Assessment (SOFA) Score
    • Improvement in renal function as change in penKid and creatinine (day 3 – day 1,day 7 – day 1)
    •Length of stay at ICU/ hospital
    •Changes of functional parameters and other parameters during stay at ICU
    •Vasopressor use (drug,highest/lowest dose, duration)
    •APACHE II
    •Quality of Life by Euro-QoL-5 (day 1, day 28 and day 90)
    •Vital signs (heart rate, blood pressure)
    -Sepsis Support Index (SSI) an Tag 28 der Nachbeobachtung
    -Penalisierter Sepsis Support Index (pSSI) an Tag 14 und 28 der Nach-beobachtung
    -Persistierende Organfunktionsstörung oder Tod an Tag 14 und 28 der Nachbeobachtung
    -Mortalitätsrate an Tag 28 und Tag 90
    -SSI und pSSI ohne Nierenkomponente
    -Einzelne SSI-Komponenten mit und ohne Mortalität
    -Score des Sequential Organ Failure Assessment (SOFA)
    -Verbesserung der Nierenfunktion als Änderung bei penKid und Kreatinin (Tag 3 – Tag 1, Tag 7 – Tag 1)
    -Aufenthaltsdauer Intensivstation/ Krankenhaus
    -Veränderungen bei Funktionsparametern und anderen Parametern während Aufenthalt auf Intensivstation
    -Anwendung von Vasopressoren
    - APACHE II
    -Lebensqualität gemäß Euro-QoL-5(bei Einschluss an Tag 1, Tag 28 und Tag 90)
    -Vitalparameter
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Last visit of the last subject (LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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
    For patients unable to give consent due to an emergency Situation, the patients' relatives or representatives or an independent doctor are informed about the study and give consent. After recovery patients' personal consents will be obtained.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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
    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 Decision2017-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-20
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