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    Summary
    EudraCT Number:2019-004509-29
    Sponsor's Protocol Code Number:QGC001-3QG1
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-03-02
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-004509-29
    A.3Full title of the trial
    A Phase 3, Double-blind, Placebo-controlled, Efficacy and Safety Study of Firibastat (QGC001) Administered Orally, Twice Daily, Over 12 Weeks in Difficult-to-treat/Resistant Hypertensive Subjects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3, Double-blind, Placebo-controlled, Efficacy and Safety Study of Firibastat (QGC001) Administered Orally, Twice Daily, Over 12 Weeks in Difficult-to-treat/Resistant Hypertensive Subjects
    A.3.2Name or abbreviated title of the trial where available
    Firibastat in treatment-RESistant Hypertension (FRESH)
    A.4.1Sponsor's protocol code numberQGC001-3QG1
    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 pointBruno Besse
    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.5.4Telephone number33185347770
    B.5.5Fax number33185347778
    B.5.6E-mailbruno.besse@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
    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.3.9.3Other descriptive nameFIRIBASTAT
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of hypertension (HTN) in difficult-to-treat and/or treatment resistant
    patients
    E.1.1.1Medical condition in easily understood language
    Treatment of high blood pressure in difficult-to-treat and/or treatment resistant
    patients
    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
    The primary objective is to assess the effects of administration of firibastat (QGC001) 500 mg oral (po) twice daily (bis in die [bid]) on blood pressure (BP) over 12 weeks in subjects with uncontrolled primary HTN despite being treated with at least 2 classes of antihypertensive therapies, including a diuretic, at the maximum tolerated doses (MTDs) (defined as difficult-to-treat or resistant patients). The secondary objective is to assess the safety of firibastat (QGC001).
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the safety of firibastat (QGC001).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to understand, and willing to provide written informed consent and able to comply with the study procedures and restrictions.
    2. Men and women ≥18 years of age at Screening
    3. Diagnosis of primary HTN for at least 6 months prior to Screening and:
    • Currently treated with at least 2 antihypertensive classes of drug, including a diuretic, at the MTDs (ie, the subject can tolerate the dose and has had no intolerable AEs), with no change (drug, regimen, and
    dose) for at least 6 weeks and with medication adherence >80% during the Run-in Period.
    • Have a systolic AOBP between 140 mmHg and 170 mmHg (inclusive) at Screening while on their current chronic antihypertensive treatments.
    • Have a successful ABPM measurement according to the criteria in Section 6.2.2.1, with a mean systolic daytime ABP >135 mmHg after the
    Run-in Period while on their current chronic antihypertensive treatments.
    4. Women of childbearing potential and nonsurgically 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 postdose. Approved forms of contraception include hormonal intrauterine devices, hormonal contraceptives (oral birth control pills, depo, patch, or injectable) together with supplementary double barrier methods such as condoms or diaphragms with spermicidal gel or foam.
    Note: The following categories define women who are NOT considered to be of childbearing potential:
    • Premenopausal women with 1 of the following:
    o Documented hysterectomy
    o Documented bilateral salpingectomy
    o Documented bilateral oophorectomy
    OR
    • Postmenopausal women, defined as having amenorrhea for at least 12 months without an alternative medical cause.
    5. Women of childbearing potential must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test result at the Inclusion Visit (Visit 2, Day 1).
    E.4Principal exclusion criteria
    1. Known or suspected secondary HTN (eg, hyperaldosteronism, renovascular HTN, pheochromocytoma, Cushing's disease).
    2. Automated office SBP >170 mmHg or DBP >110 mmHg at the Screening or Inclusion Visit (Visit 2, Day 1) and confirmed by a second measurement within 30 minutes to 1 hour.
    3. Known hypertensive retinopathy (Keith-Wagener Grade 3 or Grade 4) and/or hypertensive encephalopathy.
    4. Upper arm circumference that is outside the limits of the study provided BP cuff associated with either the ABPM and/or AOBP measurement device.
    5. History of spontaneous or drug-induced angioedema.
    6. History of drug-related allergy or hypersensitivity to any components of the IP (firibastat [QGC001] or placebo).
    7. Known severe aortic stenosis (symptomatic or asymptomatic with valvular indexed surface <0.5 cm²/m²).
    8. Subjects with severe symptomatic HF (NYHA Class III or Class IV).
    9. History of acute coronary syndrome (non-ST elevation MI, ST elevation MI, and unstable angina pectoris), stroke, or transient ischemic attack within 6 months prior to Screening.
    10. Known history of malabsorption syndrome, or has undergone gastrointestinal surgery, including bariatric procedures, that induce chronic malabsorption, within 2 years of Screening.
    11. Treatment with antiobesity drugs or procedures 3 months prior to Screening (ie, surgery, aggressive diet regimen, etc.), leading to unstable body weight.
    12. Female who is breastfeeding, pregnant, or planning to become pregnant during the study period.
    13. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 3 years.
    14. Shift workers who routinely sleep during the daytime and/or whose work hours include midnight.
    15. Subjects with moderate to severe hepatic impairment (Child-Pugh B or C); alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >3×upper limit of normal (ULN), or a total bilirubin ≥1.5×ULN (unless secondary to Gilbert's syndrome), or direct bilirubin >ULN in subjects with Gilbert's syndrome at Screening.
    16. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)41 formula at Screening.
    17. History of any blood disorder, other than sickle cell trait, causing hemolysis or unstable red blood cells (eg, malaria, babesiosis, hemolytic
    18. Subjects with documented DI.
    19. Subjects with Type 1 diabetes mellitus.
    20. Subjects with Type 2 diabetes mellitus who:
    • Are poorly controlled, defined as glycosylated hemoglobin A1c (HbA1c) >9% at Screening; OR
    • Are taking short-acting insulin or sodium-glucose co-transporter 2 (SGLT2) inhibitors. Use of a stable dose(≥12 weeks prior to Screening) of medications listed in Section 7.7.1 is permitted.
    21. Routine or anticipated treatment with any systemic corticosteroid. Use of topical, inhaled, intra-articular, or nasal corticosteroids is permitted.
    22. 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×lower limit of normal or >1.5×ULN at Screening.
    23. History of alcohol or drug abuse (including opioid overuse/misuse) within the 3 months prior to Screening that would interfere with study participation or lead to decreased compliance to study procedures or IP
    intake in the investigator's opinion.
    24. Participation in another clinical study involving an investigational drug within 30 days prior to Screening or plans to participate in another clinical study within 30 days of discontinuation of IP.
    25. Any other condition that precludes adequate understanding, cooperation, and compliance with study procedures or any condition that could pose a risk to the subject's safety, as per the investigator's
    judgment.
    26. Subjects with a life expectancy of less than 1 year per investigator's

    discretion.
    27. Legal incapacity or limited legal capacity.
    28. Previous participation in this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change in systolic AOBP.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Week 12 (Visit 5, Day 84).
    E.5.2Secondary end point(s)
    • Change in diastolic AOBP from baseline to Week 12 (Visit 5, Day 84)
    • Change in systolic and diastolic AOBP from baseline to Week 4 (Visit 3, Day 28) and Week 8 (Visit 4, Day 56)
    • Change in mean 24-hour ambulatory SBP and DBP from baseline to Week 12 (Visit 5, Day 84)
    • Percentage of controlled subjects (defined as subjects with normalized AOBP, ie, <140/90 mmHg at Week 12 [Visit 5, Day 84]) (as per European Society of Cardiology [ESC]/European Society of Hypertension [ESH] guidelines)
    • Percentage of controlled subjects (defined as subjects with normalized AOBP, ie, <130/80 mmHg at Week 12 [Visit 5, Day 84]) (as per 2017 American College of Cardiology [ACC]/American Heart Association [AHA] guidelines)
    • Predictive factors for controlled subjects at Week 12 (Visit 5, Day 84)
    • Biomarkers NT-ProBNP
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to Week 12 (Visit 5, 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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    Brazil
    Canada
    Czech Republic
    France
    Germany
    Mexico
    Poland
    Spain
    United States
    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 years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days15
    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: 402
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 320
    F.4.2.2In the whole clinical trial 502
    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 Decision2020-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-09-20
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