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    Summary
    EudraCT Number:2013-001037-40
    Sponsor's Protocol Code Number:IFX-1-P2.1
    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:2013-08-13
    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 number2013-001037-40
    A.3Full title of the trial
    A phase II randomized, placebo-controlled, double-blind, dose controlled trial in patients suffering from early, newly developing abdominal or pulmonary derived septic organ dysfunction to evaluate safety, pharmacokinetics, pharmacodynamics and to estimate efficacy of the new humanized monoclonal i.v. administered antibody CaCP29
    Eine randomisierte, placebokontrollierte, doppelblinde, dosiskontrollierte Phase II Studie für Patienten, die an neueinsetzendem abdominellem oder pulmonalen septischem Organversagen leiden, zur Evaluation der Sicherheit, Pharmakokinetik, Pharmakodynamik und zur Abschätzung der Wirksamkeit des i.v. verabreichten neuen humanisierten monoklonalen Antikörpers CaCP29
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II randomized, placebo-controlled, double-blind, dose controlled trial in patients suffering from early, newly developing abdominal or pulmonary derived septic organ dysfunction to evaluate safety, pharmacokinetics, pharmacodynamics and to estimate efficacy of the new humanized monoclonal i.v. administered antibody CaCP29
    Eine randomisierte, placebokontrollierte, doppelblinde, dosiskontrollierte Phase II Studie für Patienten, die an neueinsetzendem abdominellem oder pulmonalen septischem Organversagen leiden, zur Evaluation der Sicherheit, Pharmakokinetik, Pharmakodynamik und zur Abschätzung der Wirksamkeit des i.v. verabreichten neuen humanisierten monoklonalen Antikörpers CaCP29
    A.3.2Name or abbreviated title of the trial where available
    SCIENS
    A.4.1Sponsor's protocol code numberIFX-1-P2.1
    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 SponsorInflaRx GmbH
    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 supportInflaRx GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZKS Leipzig - KKS
    B.5.2Functional name of contact pointTrial Coordination
    B.5.3 Address:
    B.5.3.1Street AddressHaertelstr. 16-18
    B.5.3.2Town/ cityLeipzig
    B.5.3.3Post code04107
    B.5.3.4CountryGermany
    B.5.4Telephone number493419716154
    B.5.5Fax number493419716259
    B.5.6E-mailSCIENS@zks.uni-leipzig.de
    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 nameCaCP29
    D.3.2Product code CaCP29
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot applicable
    D.3.9.2Current sponsor codeIFX-1 (former code: CaCP29)
    D.3.9.3Other descriptive namechimeric monoclonal antibody, IgG4 subtype
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 organ dysfunction
    septisches Organversagen
    E.1.1.1Medical condition in easily understood language
    septic organ dysfunction
    septisches Organversagen
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10040047
    E.1.2Term Sepsis
    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
    The primary objective of this trial is to characterize the safety and tolerability of three dose regimens of CaCP29 and also to perform an assessment of the pharmacokinetics and pharmacodynamics of CaCP29.
    Das primäre Ziel der Studie ist es, drei Dosisregime der Therapie mit CaCP29 auf Sicherheit, Toleranz, Pharmakokinetik und Pharmakodynamik zu analysieren.
    E.2.2Secondary objectives of the trial
    Secondary objectives are the preliminary assessment of the efficacy of CaCP29 on clinical surrogate endpoints (e.g., SOFA score, length of ICU stay, duration of renal replacement therapy and mechanical ventilation), the evaluation of differences between patients with abdominal or pulmonary infections on biochemical and morbidity endpoints and to generate data for PK/PD modeling.
    Die sekundären Ziele der Studie sind die Analyse der Wirksamkeit auf klinische Surrogatparameter (bspw. SOFA-Score, Aufenthalt auf der Intensivstation, Dauer der Nierenersatztherapie und der mechanischen Beatmung), Evaluation der Unterschiede von biochemischen und Krankheitsparametern zwischen Patienten mit abdominieller und pulmonalen Infektionen sowie die Generierung von Daten für PK/PD-Modellierung.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients ≥ 18 years old
    2. Written informed consent
    3. Occurrence of at least two criteria of a systemic inflammatory response syndrome (SIRS)
    4. Suspected or confirmed abdominal or pulmonary infection
    5. Broad spectrum i.v. antimicrobial therapy to treat abdominal or pulmonary infection which is also effective against N. meningitidis
    6. At least one organ dysfunction due to sepsis
    7. A reasonable likelihood that administration of study drug can be started within 3.5 hours after start of screening process.
    E.4Principal exclusion criteria
    1. Sepsis of other primary cause than pulmonary or abdominal source
    2. Weight > 130 kg
    3. Any other disease and condition that is likely to interfere with evaluation of study product, outcome assessment or satisfactory conduct of the study
    a. Infection where guidelines recommend a longer duration (i.e. more than 2 weeks) of antimicrobial therapy
    b. meningitis
    c. Life expectancy less than 6 months due to concomitant diseases
    d. Significant hepatic impairment
    e. Active hepatitis
    f. Severe congestive heart failure
    g. Severe central neurological impairment
    h. Cardiopulmonary resuscitation in the 4 weeks prior to screening
    4. Patients receiving the following concomitant medication within 14 days prior to screening:
    a. Calcineurin inhibitors
    b. Proliferation inhibitors
    c. Anti-metabolites
    d. High dose corticosteroids
    5. Patients receiving high dose immunoglobulins (e.g., IVIG, Pentaglobin®) within 3 months prior to screening
    6. Neutrocytopenia
    6. General criteria
    a. Pregnant or breast-feeding women
    b. Women with childbearing potential (defined as within two years of their last menstruation) not willing to practice appropriate contraceptive measures (e.g., implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy, abstinence) while participating in the trial
    c. Participation in any interventional clinical trial within the last 3 months
    d. Prior participation in this clinical trial
    e. Patient is chronically bed-bound prior to the onset of sepsis
    f. Known intravenous drug abuse
    f. Employee at the study site, or spouse/partner or relative of any study staff
    h. No commitment to full aggressive life support
    E.5 End points
    E.5.1Primary end point(s)
    Endpoints for Pharmacokinetics and Pharmacodynamics:
    One of the primary objectives of the clinical trial is to evaluate pharmacokinetics (PK) and pharmacodynamics (PD) of treatment with CaCP29 in patients with abdominal or pulmonary derived septic organ dysfunction. PK and PD will be analyzed by the following endpoints. Sample size and power calculation are based on effects on plasma concentration of C5a.

    Pharmacokinetics:
    The PK is measured by plasma concentration of CaCP29 which is determined several times after administration of CaCP29.
    Analysis of plasma concentration of CaCP29 will comprise the following measures:
    - Plasma concentration at each time point
    - Maximum observed concentration (Cmax) per infusion
    - Concentration measured immediately before next dosing (Ctrough)
    - Area under the curve of plasma concentration per infusion
    - Mean concentration per infusion
    - Terminal phase half-life

    Pharmacodynamics:
    PD is primarily measured by plasma concentration of free, detectable C5a which is determined several times after administration of CaCP29.

    Plasma concentration of free, detectable C5a will be described by:
    - Plasma concentration of free C5a at each time point
    - Relative change of plasma concentration of free detectable C5a at each time point compared to baseline

    Secondly, pharmacodynamics is investigated by description of:
    - Bioactivity of CaCP29 at time points where the plasma concentration of CaCP29 is above 7.3 µg/mL
    - Complement activation: plasma levels of C3a, C3, C5b-9 at each time point measured, serum levels of CH50 at each time point measured
    - Cytokine: plasma levels of IL-6, IL-8, IL-10, INF-γ, TNF-α at each time point measured

    Anti-drug Antibody:
    The development of anti-drug antibodies will be described by:
    - Number of patients with detection of anti-drug antibody (ADA)
    - Number of patients with detection of ADA at each time point measured

    Endpoints of Safety:
    A major objective of this clinical trial is to investigate safety and tolerability of treatment with CaCP29. Safety and tolerability will be primarily described by:
    - Number and percentage of patients with Adverse Events until day 28
    and secondly by
    - Number and percentage of patients with AEs grouped (i) by severity, and (ii) by causal relationship to study medication
    - Number and percentage of patients with serious AEs (SAEs) (i) in total and (ii) grouped by causal relationship to study medication
    - Changes in routine laboratory parameters (electrolytes, blood chemistry, hematology, coagulation, procalcitonin) as compared with baseline assessments
    - Change in vital signs as compared to baseline assessment
    - Change in ECG as compared to baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    The evaluations will be performed at the following timepoints, where some timepoints only apply for one or two of the cohorts: 0h, 2h, 6h, 12h, 14h, 24h, 26h, 48h, 72h, 74h, days 5, 8, 13, 28, hospital discharge
    E.5.2Secondary end point(s)
    Endpoints of Efficacy:
    A secondary object of the trial is to describe efficacy of CaCP29. The following endpoints will be investigated:

    Mortality:
    - 28 day all-cause mortality (number of patients deceased divided by the number of patients with documented survival status at day 28 post randomization)

    Morbidity:
    - Mean SOFA until day 10 (for definition see appendix 17.1 of the trial protocol; for each day, SOFA sub-scores and their sum, the daily SOFA score, will be calculated. Afterwards, mean of all daily SOFA scores until day 10 will be computed. In case of earlier discharge from the ICU, the SOFA at time of discharge will be assumed to be stable and counted as such from day 1 post discharge until day 10 post randomization is reached.)
    - Modified mean SOFA until day 10 (calculated by (i) omitting the Central Nervous System sub-score and (ii) calculating the renal subscore without taking urine output into consideration)
    - Mean SOFA Sub-scores until day 10
    - Days on ICU until day 28, The number of days alive and on ICU will be counted until day 28 post randomization or hospital discharge, whichever occurs first.
    - Hospital length of stay, The number of days until hospital discharge will be counted. Observation period is censored on day 28 post randomization.
    - Number of patients ventilated until day 14, On a single study day, a patient is counted as ventilated if the ventilation lasts for at least three or six hours in case of invasive or non-invasive ventilation, respectively. Observation is censored at hospital discharge.
    - Ventilator-free days until day 14, A day is counted as “ventilator-free day” if the patient is alive and not ventilated (see above).
    - Numbers of patients with renal replacement therapy (RRT) until day 14 , On a single study day, a patient is counted as treated with RRT if the hemofiltration or hemodialysis lasts for at least two hours. Observation is censored at hospital discharge.
    - RRT-free days until day 14, A day is counted as “RRT-free day” if the patient is alive and not treated with RRT.
    The need for renal replacement therapy will be documented at hospital discharge. In case of missing data after hospital discharge before day 14, imputation will be based on this information.
    - Numbers of patients with administration of vasopressor until day 14, Vasopressor: Epinephrine, Norepinephrine, Dobutamine and Vasopressin. Observation is censored at hospital discharge.
    - Vasopressor-free days until day 14, A day is counted as “vasopressor-free day” if the patient is alive and no vasopressor is applied. Observation is censored at hospital discharge.
    - Days without antimicrobial therapy (AMT) until day 14, A day is counted as “AMT free day” if the patient is alive and no AMT is administered. Observation is censored at hospital discharge.

    Fluid balance:
    - Mean daily total fluid intake until day 28 (maximal until ICU discharge)
    - Mean daily total fluid output until day 28 (maximal until ICU discharge)
    - Mean daily fluid balance until day 28 (maximal until ICU discharge)

    Furthermore, the total fluid intake, output and balance of the whole ICU stay (until Day 14 at maximum), i.e. sum of all ICU days, will be described. The results will be stratified by length of ICU day.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The evaluations will be performed at the following timepoints: -3h (before randomization), Baseline, days 1-28 (not all parameter, see trial protocol), hospital discharge
    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 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 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 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 concerned14
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months13
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months13
    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: 37
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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
    Due to the severity of the disease (sepsis), ventilation and sedations a large proportion of patients is likely unable to provide informed consent before the beginning of the trial either in oral or written form.
    Wahrscheinlich wird ein großer Anteil der Patienten aufgrund der Schwere der Erkrankung (Sepsis), Sedierung und mechanischer Beatmung nicht in der Lage sein eine mündliche oder schriftliche Einwilligung zur Teilnahme an der Studie zu äußern.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 72
    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)
    No long term treatment with the IMP is planned.
    Eine Langzeitbehandlung mit dem Prüfprodukt ist nicht vorgesehen.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-29
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