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    Summary
    EudraCT Number:2018-003146-17
    Sponsor's Protocol Code Number:QGC001-2QG4
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-02-04
    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 - BfArM
    A.2EudraCT number2018-003146-17
    A.3Full title of the trial
    A Phase 2, Double-blind, Active-controlled, Dose-titrating Efficacy and Safety Study of Firibastat (QGC001) Compared to Ramipril Administered Orally, Twice Daily, Over 12 Weeks to Prevent Left Ventricular Dysfunction after Acute Myocardial Infarction
    Eine doppelblinde, aktiv kontrollierte Dosistitrationsstudie der Phase 2 zur Beurteilung der Wirksamkeit und Sicherheit von Firibastat (QGC001) im Vergleich zu Ramipril zweimal täglich oral über 12 Wochen zur Prävention von linksventrikulärer Dysfunktion nach akutem Myokardinfarkt.

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Quantum Genomics Firibastat (QGC001) or Ramipril after Acute Myocardial Infarction for Prevention of Left Ventricular Dysfunction (QUORUM)
    Firibastat (QGC001) von Quantum Genomics oder Ramipril nach akutem Myokardinfarkt zur Prävention von linksventrikulärer Dysfunktion (QUORUM)
    A.4.1Sponsor's protocol code numberQGC001-2QG4
    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 SponsorQuantum Genomics
    B.1.3.4CountryFrance
    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 supportQuantum Genomics
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuantum Genomics
    B.5.2Functional name of contact pointMedical Project Manager
    B.5.3 Address:
    B.5.3.1Street Address33 rue Marbeuf
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.6E-mailstephanie.desbrandes@quantum-genomics.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 nameFiribastat
    D.3.2Product code QGC001
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFiribastat
    D.3.9.1CAS number 648927-86-0
    D.3.9.2Current sponsor codeQGC001
    D.3.9.4EV Substance CodeSUB33157
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 2
    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 nameFiribastat
    D.3.2Product code QGC001
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFiribastat
    D.3.9.1CAS number 648927-86-0
    D.3.9.2Current sponsor codeQGC001
    D.3.9.4EV Substance CodeSUB33157
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Triatec®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi SPA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRAMIPRIL
    D.3.9.1CAS number 87333-19-5
    D.3.9.4EV Substance CodeSUB10248MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of left ventricular dysfunction after acute anterior myocardial infarction
    E.1.1.1Medical condition in easily understood language
    Prevention of left ventricular dysfunction after acute anterior myocardial infarction
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparison of the effects of twice daily (bis in die [BID]) oral administration of 2 doses of firibastat to those of BID oral administration of ramipril on the change from Baseline in left ventricular ejection fraction (LVEF) assessed by cardiac magnetic resonance imaging (CMRI) on Day 84
    E.2.2Secondary objectives of the trial
    To compare the effects of BID administration of firibastat and ramipril on:
    - the change from Baseline to Day 84 in left-ventricle end-diastolic and end-systolic volumes assessed by CMRI
    - the change from Baseline to Day 84 in average peak of longitudinal and
    circumferential strain (assessed by CMRI) in the infarcted segments
    - infarct mass (assessed by CMRI) at Day 84
    - major cardiac event (MACE): combined clinical endpoint of cardiovascular death, myocardial infarction (MI), and cardiac hospitalization over 84 days
    - the change from Baseline to Day 84 in N-terminal pro b-type natriuretic peptide (NT proBNP), procollagen type III aminoterminal peptide (PIIINP), and C reactive protein (CRP)
    - the slope of decrease in copeptin blood level change between Baseline and Day 84.

    To compare the safety of firibastat and ramipril
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must provide signed written informed consent. Important Note: Subject must be willing and able to give informed consent for participation in the study.
    2. Men and women >= 18 years of age at Screening.
    3. Diagnosis of first acute anterior MI (ST-elevation myocardial infarction) defined as chest pain >30 minutes and ST elevation ≥0.2 mV in at least 2 consecutive electrocardiogram (ECG) leads in the anterior area (DI, aVL, V1-V6).
    4. Primary PCI of the index-MI-related artery within 24 hours after the MI.
    5. Women of childbearing potential and non-surgically sterile male subjects who are sexually active must agree to use an approved highly effective form of contraception from the time of informed consent until 30 days post-dose. Approved forms of contraception include hormonal intrauterine devices, hormonal contraceptives (oral birth control pills, depot, patch, or injectable), together with supplementary double-barrier methods such as condoms or diaphragms with spermicidal gel or foam.
    6. Women of childbearing potential must have a negative serum pregnancy test result at the Screening Visit.
    E.4Principal exclusion criteria
    1. Body mass index >45 kg/m².
    2. Subject is hemodynamically unstable or has cardiogenic shock.
    3. Subjects with clinical signs of HF (Kilipp III and IV corresponding to severe HF).
    4. Systolic blood pressure <100 mmHg at Inclusion Visit.
    5. Early primary PCI of the index-MI-related artery performed within 3 hours after MI. Important Note: the time of the PCI MUST NOT be delayed because of the protocol, if PCI is performed within 3 hours after MI, the patient is not eligible.
    6. Subjects who require treated with angiotensin-converting-enzyme inhibitor (ACE-I), angiotensin-receptor blocker (ARB), or sacubitril/valsartan after to the index magnetic resonance imaging. Note: if treatment was for HTN, ACE-I/ARB should be stopped, right before index magnetic resonance imaging, and, if necessary, another therapeutic class can be prescribed for HTN. If the ACE-I/ARB was prescribed for congestive HF, the subject is not considered eligible; if the ACE-I/ARB prescribed for another reason cannot be stopped, the subject is not eligible for study inclusion.
    7. Subjects scheduled for implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy, or pacemaker within the next 3 months. If an ICD is indicated for ventricular arrhythmia during the course of the study, a life vest, when possible, should be prescribed and the ICD scheduled after study completion.
    8. Subjects with any contraindication related to the CMRI procedure (devices or metal foreign bodies, including pacemaker, defibrillator) including severe claustrophobia according to the lists/safety rules of the local MRI departments.
    9. Female who is breast-feeding, pregnant, or planning to become pregnant during the study.
    10. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
    11. Alkaline phosphatase >3 x upper limit of normal (ULN), total bilirubin 1.5 ULN, or direct bilirubin >ULN in subjects with Gilbert's syndrome at the Screening Visit.
    12. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at the Screening Visit.
    13. History of any blood disorder, other than sickle cell trait, causing hemolysis or unstable red blood cells (e.g., malaria, babesiosis, hemolytic anemia, thalassemia, or sickle cell anemia).
    14. Clinical evidence of thyroid disease, thyroid hormone therapy that is not stable >=4 weeks prior to Screening, or a thyroid-stimulating hormone (TSH) level <0.75 x lower limit of normal or >1.5 x ULN.
    15. History of alcohol or drug abuse within the 3 months prior to the Screening Visit that would interfere with study participation or lead to decreased compliance with study procedures or IP intake in the investigator’s opinion.
    16. Participation in another clinical study involving an investigational drug within 30 days prior to Screening, or if a subject plans to participate in another clinical study within 30 days of discontinuation of the IP.
    17. Any condition that in the opinion of the investigator would interfere with study participation, may pose a risk to the subject, or would make study participation not in the best interest of the subject.
    18. Subjects with a life expectancy of less than 1 year per investigator’s discretion.
    19. Any subject who, in the opinion of the investigator, will not be able to follow the protocol.
    20. Subjects with an history of documented allergic reactions.
    21. Subjects with Diabetes insipidus.
    The contraindications of Ramipril as given in the summary of product characteristics must be checked before any inclusion to ensure that the subject has no contraindication to the administration of Ramipril; otherwise the subject should be excluded from the study.
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline to Day 84 in LVEF assessed by CMRI (centralized reading)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 84
    E.5.2Secondary end point(s)
    - Change from Baseline to Day 84 in left-ventricular end-diastolic and end-systolic volumes assessed by CMRI
    - Change from Baseline to Day 84 in average peak of longitudinal and circumferential strain in the infarcted segments assessed by CMRI
    - Infarct mass at EOT (Day 84) assessed by CMRI
    - MACE (i.e., cardiovascular deaths, new MIs, and cardiac hospitalizations) as adjudicated by an independent committee
    - Change from Baseline in NT-proBNP, PIIINP, and CRP levels to Day 84
    - Slope of decrease in copeptin over time
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 84
    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.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) Yes
    E.8.2.2Placebo No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Russian Federation
    France
    Germany
    Hungary
    Poland
    Slovakia
    Spain
    United Kingdom
    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
    LPLV
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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: 147
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 147
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state62
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 270
    F.4.2.2In the whole clinical trial 294
    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)
    After the end of the study, each subject will be treated according to standard clinical practice.
    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 Decision2019-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-07-08
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