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    Summary
    EudraCT Number:2020-004986-38
    Sponsor's Protocol Code Number:337HNAS20011
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-07-09
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-004986-38
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled, multicentre, Phase 3 study evaluating long-term efficacy and safety of lanifibranor in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to assess the long-term efficacy and safety of lanifibranor in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis
    A.3.2Name or abbreviated title of the trial where available
    NATIV3
    A.4.1Sponsor's protocol code number337HNAS20011
    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 SponsorInventiva S.A.
    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 supportInventiva SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInventiva S.A.
    B.5.2Functional name of contact pointMartine Baudin
    B.5.3 Address:
    B.5.3.1Street Address50 rue de Dijon
    B.5.3.2Town/ cityDaix
    B.5.3.3Post code21121
    B.5.3.4CountryFrance
    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 nameLanifibranor
    D.3.2Product code IVA337
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNlanifibranor
    D.3.9.1CAS number 927961-18-0
    D.3.9.2Current sponsor codeIVA337
    D.3.9.3Other descriptive name1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID
    D.3.9.4EV Substance CodeSUB176833
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 placeboFilm-coated tablet
    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
    Non-alcoholic Steatohepatitis (NASH)
    E.1.1.1Medical condition in easily understood language
    Non-alcoholic Steatohepatitis (NASH)
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level PT
    E.1.2Classification code 10053219
    E.1.2Term Non-alcoholic steatohepatitis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1
    To assess the effect of lanifibranor compared to placebo on NASH resolution and improvement of fibrosis assessed by liver histology.
    Part 2
    To assess the effect of lanifibranor compared to placebo on delaying NASH disease progression measured by a composite endpoint that includes progression to cirrhosis, liver-related clinical outcome events, or all-cause death.
    E.2.2Secondary objectives of the trial
    Key secondary objectives of Part 1
    • To assess the effect of lanifibranor compared to placebo on NASH resolution and no worsening of fibrosis
    • To assess the effect of lanifibranor compared to placebo on improvement of fibrosis with no worsening of NASH.
    Other secondary objectives of both Part 1 and Part 2:
    • To assess the effect of lanifibranor compared to placebo on other key histological features of NASH
    • To assess the effect of lanifibranor compared to placebo on NASH resolution and improvement of fibrosis in diabetic patients
    • To assess the effect of lanifibranor compared to placebo on liver function tests, glycaemic parameters, lipid parameters and liver stiffness
    • To assess the effect of lanifibranor compared to placebo on health-related quality of life
    • To assess the long-term safety of lanifibranor
    • To assess the population PK modeling of trough plasma levels of lanifibranor
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional Pharmacogenomic sub-study.
    E.3Principal inclusion criteria
    1. Able to understand the nature of the study, willing and able to comply with the study procedures and restrictions, and ableto provide signed, dated and written informed consent obtained before any study-related activities, sampling or analysis.
    2. The patient will be willing to continue on the study in case of moving or relocation during the first 72 weeks of the study.
    3. Male or female, aged ≥18 years at the time of signing informed consent
    4. If biopsy performed before Screening, histological diagnosis of NASH with liver fibrosis made no more than 6 months before Screening
    5. Upon central biopsy reading process: diagnosis of NASH according to the Steatosis-Activity-Fibrosis (SAF):
    a.Steatosis score ≥1
    b.Activity score: A3 or A4
    c.Fibrosis score: F2 or F3
    6. Model for End-Stage Liver Disease (MELD) score ≤12
    7. Stable dose for the specified period is required prior to the historical liver biopsy or before Screening visit (whichever is longer) until Baseline visit (Visit 0) for the drugs listed below:
    a.Antidiabetic treatment if glucagon-like peptide-1 receptor agonists (GLP1 receptor agonists) or sodium-glucose co-transporter-2 inhibitors (SGLT2 inhibitors): Stable dose for at least 3 months
    b.Vitamin E (if at a dose ≥400 IU/day): Stable dose for at least 6 months
    c.Statins: Stable dose for at least 3 months
    8. All chronically administered drugs not covered by criterion #7 (including but not limited to antidiabetic treatments other than GLP1 receptor agonists and SGLT2 inhibitors, antihypertensives, antidepressants, cardiovascular, antihyperlipidemic, etc) must be stable for at least 3 months prior to Screening
    9. History of at least 1 unsuccessful attempt to reduce body weight by diet and/or exercise within the past 6 years up to 6 months prior to Screening
    10. Weight stable for 6 months prior to Screening and between the qualifying liver biopsy and Baseline (no more than 5% change for both periods)
    11. No attempt to change lifestyle (diet and/or exercise) during the 3 months prior to Screening
    12. Patient agrees to follow recommendations with lifestyle modifications, which will be monitored throughout the whole study period.
    13. Negative serum pregnancy test at study Screening for females of childbearing potential confirmed by central laboratory.. Females of childbearing potential must practice a consistent and proper use of highly effective method of contraception throughout the study and for 1 month after treatment discontinuation. Highly effective contraceptive methods are defined as follows: combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, and sexual abstinence.
    E.4Principal exclusion criteria
    Liver-related:
    1. Documented causes of chronic liver disease other than NASH including, but not restricted to:
    a.Viral hepatitis, unless eradicated at least 3 years prior to Screening
    b.Drug-induced liver disease
    c.Alcoholic liver disease
    d.Autoimmune hepatitis
    e.Wilson’s disease
    f.Haemochromatosis
    g.Primary biliary cholangitis
    h.Primary sclerosing cholangitis
    i.Alpha-1-antitrypsin deficiency
    2. Histologically documented liver cirrhosis (fibrosis stage F4), either at Screening or in a historical biopsy or diagnosis of cirrhosis based on clinic biochemical and imaging criteria
    3. History or current diagnosis of hepatocellular carcinoma HCC
    4. History of or planned liver transplant
    5. Inability or unwillingness to undergo a liver biopsy at Screening (if a suitable historical biopsy is unavailable for central review), at Week 72, and after the non-invasive algorithm suggests high risk of progression to F4 OR at the End of Study)
    6. Positive human immunodeficiency virus (HIV) serology
    7. ALT or AST >5 × ULN
    8. Abnormal synthetic liver function as defined by Screening central laboratory evaluation of any of the following:
    a.Albumin below the lower limit of the normal range
    b.International normalised ratio (INR) ≥1.3 (unless patient is on anticoagulants)
    c.Total bilirubin level ≥1.3 mg/dL (22.2 µmol/L) (patients with a documented history of Gilbert’s syndrome can be enrolled if the direct bilirubin is within normal reference range)
    9. Haemoglobin <110 g/L (11 g/dL) for females and <120 g/L (12 g/dL) for males
    10. White blood cell (WBC) count <5.0 × 10^9/L (<5.0 × 10^3/µL)
    11. Platelet count <150,000/µL
    12. Alkaline phosphatase (ALP) >2 × ULN
    13. Patient currently receiving any approved treatment for NASH or obesity
    14. Current or recent history (<5 years) of significant alcohol consumption, which is typically defined as higher than 30 g pure alcohol per day for men and as higher than 20 g pure alcohol per day for women
    15. Treatment with drugs that may cause non-alcoholic fatty liver disease (NAFLD) administered for at least 2 weeks within 12 months prior to qualifying liver biopsy Glycaemia related:
    16. HbA1c >9% at Screening
    17. Diabetes mellitus other than type 2
    18. Current treatment with insulin
    19. Previous or current treatment with PPAR-gamma agonists
    20. Obesity related:
    21. Bariatric surgery: Restrictive procedures (e.g. lap banding, intragastric balloon, sleeve gastrectomy) are allowed, if performed >6 months prior to the qualifying liver biopsy; malabsorptive procedures (e.g. biliopancreatic diversion) and procedures combining both restrictive and malabsorptive methods (e.g. Roux-en-Y gastric bypass, duodenal switch surgery) are not allowed within 5 years of the qualifying liver biopsy. Liposuction and/or abdominoplasty are allowed if performed >6 months before qualifying liver biopsy. Planned bariatric surgery is not allowed
    22. Participation in an organised weight-loss programme within 3 months of the study, or planned participation through Week 72
    23. Cardiovascular related:
    24. History of heart failure with reduced left ventricular ejection fraction (LVEF) defined as any past measurement of LVEF ≤ 40%
    25. N-terminal-prohormone B-type natriuretic peptide (NT-proBNP) >900 pg/mL
    26. Atrial fibrillation requiring anticoagulation
    27. Unstable heart failure with preserved ejection fraction
    28. Any other clinical significant cardiovascular event requiring hospitalisation within 6 months before Screening
    29. Uncontrolled hypertension at Screening (values >160/100 mm Hg)
    30. Corrected QT interval by Fridericia (QTcF) >480 ms
    General safety:
    31. Based on the investigator’s evaluation, evidence of any other unstable or untreated clinically significant hepatic, pulmonary, immunological, endocrine, haematological, gastrointestinal, neurological, neoplastic, psychiatric disease, or any medical condition that may diminish life expectancy to less than 2 years
    32. Cancer: Presence or history of malignant neoplasm within 5 years prior to Screening.
    33. Major surgery scheduled for the first 72 weeks of study
    34. Any condition which, in the investigator’s opinion, might jeopardise a patient’s safety or compliance with the protocol, or warrants exclusion from the study
    35. Women currently breastfeeding
    36. Known or suspected hypersensitivity to any of the excipients (including sodium benzoate E211) of lanifibranor/placebo or PPAR agonists
    37. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
    38. Previous exposure to lanifibranor
    39. Participation in any clinical trial of an approved or non approved investigational medicinal product/device within 3 months from Screening or 5 half-lives from Screening, whichever is longer
    40. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value <60 mL/min/1.73 m2.
    41. Screening triglycerides >500 mg/dL (0.45-1.81 mmol/L)
    E.5 End points
    E.5.1Primary end point(s)
    Part 1
    Resolution of NASH and improvement of fibrosis at Week 72, defined by NASH CRN scores for ballooning of 0 and inflammation of 0 to 1, and fibrosis score ≥1 stage decrease compared to Baseline.
    Part 2
    Time to first clinical outcome event; defined as a composite endpoint of any of the following:
    • Histological progression to cirrhosis (defined as histological confirmation of fibrosis score CRN F4)
    • All-cause mortality
    • Liver transplant
    • MELD score ≥15
    • New onset ascites requiring treatment
    • Overnight hospitalisation due to hepatic decompensation event(s) including:
    oHepatic encephalopathy Grade ≥2 (as assessed by West Haven scale)
    oVariceal bleeding
    oSpontaneous bacterial peritonitis (assessed by positive culture or cell count)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1: from date of randomisation until the date of biopsy at Week 72.
    Part 2: from date of randomisation until the End of Study date.
    E.5.2Secondary end point(s)
    Resolution of NASH and no worsening of fibrosis at Week 70, defined by NASH CRN scores for ballooning of 0, inflammation of 0 to 1, and no fibrosis score increased compared to Baseline.
    Improvement of fibrosis and no worsening of NASH, defined by a decrease in NASH CRN fibrosis score ≥1 stage from Baseline and no increase in scores for ballooning, inflammation, or steatosis.
    Resolution of NASH and improvement of fibrosis at Week 72 and End of Study (EoS).
    Resolution of NASH and no worsening of fibrosis at Week 72 and EoS.
    Improvement of fibrosis and no worsening of NASH at Week 72 and EoS.
    Improvement of NASH CRN fibrosis stage by at least 2 points and no worsening of NASH (no increase in scores for steatosis, ballooning, or lobular inflammation) at Week 72 and EoS.
    Resolution of fibrosis, defined as NASH CRN fibrosis stage 0, at Week 72 and EoS.
    Improvement in NAFLD Activity Score (NAS) by at least 2 points (at least a 1-point reduction in either lobular inflammation or hepatocellular ballooning) and no worsening of fibrosis at Week 72 and EoS.
    Improvement of each histological feature of NASH by at least 1 point (steatosis, lobular inflammation, hepatocellular ballooning) and no worsening of fibrosis at Week 72 and EoS.
    NASH resolution and improvement of fibrosis at Week 72 and EoS, in the subgroup of diabetics.
    Change from Baseline in liver function tests (AST, ALT, GGT, ALP, direct and total bilirubin).
    Change from Baseline in liver stiffness by elastography (only at sites with suitable equipment).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part 1 : Date of randomisation until the date of biopsy at Week 72 visit.
    Part 2: Date of randomisation until the EoS date.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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
    Australia
    Brazil
    Canada
    Israel
    Mexico
    South Africa
    Ukraine
    United States
    Austria
    Belgium
    Bulgaria
    Denmark
    Finland
    France
    Germany
    Italy
    Netherlands
    Norway
    Poland
    Portugal
    Romania
    Sweden
    United Kingdom
    Czechia
    Argentina
    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
    A patient is considered to have completed the study if he or she has completed all parts of the study.
    The End of Study will occur at the time when a total of 281 pre-specified clinical outcome events have been observed, or 7 years after first patient is enrolled, whichever is shorter.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    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: 1800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state109
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 2000
    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 Part 1, patients will continue in Part 2 of the study, a long term safety assessment. After the end of Part 2, the investigator/hepatologists/general prationer will decide, according to each patient, the need to use the lifestyle changes recommendations whenever appropriate and treatment of comorbidities which may play a role in NASH such as, for example, diabetes and hyperlipidaemia.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Synexus Clinical Research GmbH - Affiliate AES
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-04
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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