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    Summary
    EudraCT Number:2021-005059-35
    Sponsor's Protocol Code Number:TMP-2204-2021-47
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2024-11-05
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2021-005059-35
    A.3Full title of the trial
    Potential of FX06 to improve disease severity in Acute Respiratory Distress Syndrome patients (Ixion 2.0)
    Potențialul FX06 de îmbunătățire a severității bolii la pacienți cu sindrom de detresă respiratorie acută (Ixion 2.0)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    study to improve disease severity of patients with ARDS by treatment with FX06
    A.3.2Name or abbreviated title of the trial where available
    IXION
    A.4.1Sponsor's protocol code numberTMP-2204-2021-47
    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 SponsorF4Pharma GmbH i.G.
    B.1.3.4CountryAustria
    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 supportEU
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFraunhofer ITMP
    B.5.2Functional name of contact pointClinical Research
    B.5.3 Address:
    B.5.3.1Street AddressTheodor-Stern-Kai 7
    B.5.3.2Town/ cityFrankfurt
    B.5.3.3Post code60596
    B.5.3.4CountryGermany
    B.5.4Telephone number0049696301 80221
    B.5.6E-mailClincialResearch@itmp.fraunhofer.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 nameFX06
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFX06
    D.3.9.2Current sponsor codeFX06
    D.3.9.3Other descriptive nameFX06
    D.3.9.4EV Substance CodeSUB26822
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 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 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 placeboInjection
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    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)
    E.1.1.1Medical condition in easily understood language
    mild to moderate ARDS
    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 24.0
    E.1.2Level LLT
    E.1.2Classification code 10085269
    E.1.2Term ARDS disease progression
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    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 is to demonstrate a difference in the time to initial unassisted breathing (UAB) in patients receiving FX06 compared to patients receiving placebo until day 28.

    • Time to initial unassisted breathing (UAB) until day 28 in both treatment groups
    Unassisted breathing is defined as:
    Without invasive ventilation for 48h consecutively for patients with invasive ventilation at BL and neither invasive nor non-invasive ventilation (including HFNO) for 48h consecutively for patients with non-invasive ventilation (including HFNO) at BL.
    Continuous or bilevel positive airway pressure (CPAP, BIPAP) solely for sleep-disordered breathing management is not defined as assisted breathing. Also, non-mechanical oxygen supplementation will not be defined as assisted breathing.
    E.2.2Secondary objectives of the trial
    - Disease progression/improvement based on Berlin Definition
    - Proportion of patients with respiratory support
    - days with ventilation and ventialtor-free days
    - days on ECMO
    - patients alive and UAB
    - patients that achieved initial UAB
    - patients achieving extubation
    - patients that needed intubation
    - patients returning to assisted breathing or mechanical ventilation
    - patients needing catecholamine hemodynamic support
    - patients receiving kinetic therapy
    - Lung function (e.g. PaO2, FiO2, Horowitz Index, pCO2, LPEEP, Pinsp, FiO2, vasodilator use, high-flow oxygen, oxygen saturation)
    - inflammation markers and their change and normalization
    - Mortality rate
    - Survival censored
    - normal and pathological capillary refill time
    - Length of hospital and ICU stay
    - Location where patients have been discharged to
    - Subgroup analysis by concomitant medication, age, sex, and ARDS cause
    - AEs/SAEs, type, severity and their relatedness to IMP
    - injection-related AEs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Hospitalised patients with mild to moderate ARDS according to the Berlin Definition of ARDS or patients with assisted breathing (without the use of PEEP) and high oxygen demand (e.g., HFNO ≥ 30 L/min) who fulfil the other criteria of the Berlin Definition of ARDS (modified Berlin criteria) (for clarification see Table 1)
    2. Patients ≥ 18 years
    3. Randomization within 48h of ARDS diagnosis
    4. Written informed consent obtained prior to the initiation of any protocol-required procedures by the patient or his/her legal representative
    5. Patients or their legal representatives able to understand the requirements of the study and give written informed consent
    E.4Principal exclusion criteria
    1. >48 hours of invasive mechanical ventilation before randomization
    2. Severe ARDS according to the Berlin Definition
    3. Evidence of other significant uncontrolled concomitant diseases or serious and/or uncontrolled diseases with a bad prognosis that are likely to interfere with the evaluation of the patient’s safety and with the study outcome as judged by the treating physician, e.g.:
    o Other severe advanced or chronic lung diseases (e.g., COPD Gold ≥ 3, severe silicosis)
    o Acute respiratory failure due to cardiac failure (NYHA ≥ III) or fluid overload
    o Advanced hepatic insufficiency or severe liver disease (e.g., liver cirrhosis CHILD C)
    o Use of chronic (> 3 months) long-term oxygen therapy before randomization
    o Exacerbation of asthma
    o Septic shock
    4. Any contraindications to use the IMP (e.g., allergy or intolerance against the IMP or its ingredients)
    5. Is currently being detained in an institution by a governmental or judicial order
    6. Do not intubate order
    7. Women pregnant or breastfeeding
    8. Males or females of reproductive potential not willing to use effective contraception for the duration of the study period (defined as PEARL index –1 - e.g., contraceptive pill, IUD or true sexual abstinence, bilateral tubal occlusion or male partner with vasectomy; also see chapter 19.2 for guidance)
    9. Current participation in another interventional clinical trial with IMP or participation within the last 30 days
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to demonstrate a difference in the time to initial unassisted breathing (UAB) in patients receiving FX06 compared to patients receiving placebo until day 28.

    • Time to initial unassisted breathing (UAB) until day 28 in both treatment groups
    Unassisted breathing is defined as:
    Without invasive ventilation for 48h consecutively for patients with invasive ventilation at BL and neither invasive nor non-invasive ventilation (including HFNO) for 48h consecutively for patients with non-invasive ventilation (including HFNO) at BL.
    Continuous or bilevel positive airway pressure (CPAP, BIPAP) solely for sleep-disordered breathing management is not defined as assisted breathing. Also, non-mechanical oxygen supplementation will not be defined as assisted breathing.
    E.5.1.1Timepoint(s) of evaluation of this end point
    BL until day 28
    E.5.2Secondary end point(s)
    Secondary objectives and endpoints:
    Assessment and treatment comparison of the following objectives at all available visits and time points between the FX06 and placebo group:

    • Disease progression/improvement
    - Proportion of patients with improved or worsened disease state compared to baseline based on Berlin Definition (mild, moderate, severe, or no ARDS)
    - Proportion of patients with each Berlin Definition classification (mild, moderate, severe, or no ARDS)
    - Proportion of patients with respiratory support (non-invasive, invasive, ECMO, HFNO, low flow oxygen, non-mechanical oxygen supplementation)
    - Number of days with ventilation (invasive vs non-invasive ventilation (incl. HFNO)) until day 28 and day 60
    - Number of days on ECMO unitl day 28 and day 60
    - Number of ventilator-free days until day 28
    - Number and proportion of patients alive and breathing without assistance at day 28 and day 60
    - Proportion of patients that achieved initial UAB within 28 days
    -Proportion of patients achieving extubation until day 28 and day 60 (for those patients intubated at BL)
    - Proportion of patients that needed intubation (invasive ventilation) until day 28 (for those patients that were not intubated at BL)
    - Proportion of patients returning to assisted breathing or mechanical ventilation (after achievement of initial UAB as defined above)
    - Proportion of patients needing catecholamine hemodynamic support to achieve target blood pressure and cumulative dosage of catecholamine drugs
    - Proportion of patients receiving kinetic therapy to improve pulmonary function and cumulative duration of prone positioning up to day 28

    • Lung function (partial oxygen pressure in the blood, fraction of inspired oxygen, Horowitz index) at BL, D3, D6, D10 and D28
    - Absolute PaO2 (mmHg) values
    - Absolute FiO2 (mmHg, fraction of inspired oxygen)
    - Horowitz Index (mmHg) and change to BL
    - pCO2 value and change to baseline
    - Lung compliance (ml/cm H2O) and change to BL
    - Respiratory minute volume and change to baseline
    - Absolute and relative change in applied Positive-End-Expiratory Pressure (PEEP)
    - Absolute and relative change in applied inspiratory pressure support (Pinsp)
    - Absolute and relative change in applied flow-rate and FiO2 when using high-flow oxygen therapy
    -Proportion of patients using pulmonary vasodilators (eg. nitric oxide or prostaglandin)
    - Proportion of patients reaching > 92% oxygen saturation under room air

    For respiratory parameters the worst value over 24h at the respective day will be documented for the study

    • Systemic inflammation (changes and normalisation in troponin, procalcitonin, CRP, leukocyte count, ferritin, D-dimers, lactate, lactate dehydrogenase, albumin, IL-6)
    - Concentration of blood parameters and their change to BL
    - Proportion of patients with normalized systemic inflammation (for each inflammation parameter)

    • Survival / Mortality
    - Mortality rate at day 28 and day 60
    - Survival censored at day 28 and day 60

    • Capillary refill time
    - Proportion of patients with normal and pathological capillary refill time at baseline (as pathological: ≥2 s or normal: <2 s) and change to BL

    • Duration of hospital and ICU stay
    - Length of hospital and ICU stay until day 28 or until day 60
    - Proportion of patients that have been discharged from the hospital and/or the ICU until day 28 and day 60
    - Location where patients have been discharged to (if applicable; e.g. home, rehabilitation centre)

    • Subgroup analysis by concomitant medication, age, sex, and ARDS cause
    - Proportion of patients with a specific type of concomitant medication (e.g., antibiotics, corticosteroids, antibody therapy, etc.), by age group, by sex, and by ARDS cause
    - Comparison of patients with different concomitant medications, age groups, sex, and ARDS cause in terms of safety events and efficacy parameters
    Safety
    • Safety parameters (evaluated for safety set)
    - Number of adverse events and serious adverse events
    - Type and severity (mild, moderate, severe) of all adverse events
    - (s)AEs and their relatedness to treatment
    - Mean number per patient and total number of injection-related (s)AEs within 1 h after injection of IMP
    E.5.2.1Timepoint(s) of evaluation of this end point
    BL, day 28, day 60 and day 3, day 6 and day 10
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    data base hard lock
    In order to fulfil sponsor obligations (ICH E6[R2]) by monitoring and source data verification at site to confirm data integrity and patient safety the definition LVLS/LPLV cannot be used as end of trial. The access to hospitals and isolated departments as ICUs are hindered to avoid spreading of various potential infections. Therefore, site monitoring visits and site data corrections within eCRF may only be performed significantly after LVLS/LPLV.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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: 217
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    patients under ventilation not able to give their consent personally will only be included in this trial if the legal representative signs the consent form prepared for this case
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 263
    F.4.2.2In the whole clinical trial 263
    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 (Standard of Care)
    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 Decision2023-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-09
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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