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    Summary
    EudraCT Number:2019-002709-23
    Sponsor's Protocol Code Number:PLN-74809-IPF-202
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-08-06
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-002709-23
    A.3Full title of the trial
    A randomized, double-blind, dose-ranging, placebo-controlled Phase 2a evaluation of the safety, tolerability and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosis (IPF) (INTEGRIS-IPF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the efficacy, safety and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosis
    A.4.1Sponsor's protocol code numberPLN-74809-IPF-202
    A.5.4Other Identifiers
    Name:Clinical Trials.govNumber:NCT04396756
    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 SponsorPliant Therapeutics Inc.
    B.1.3.4CountryUnited States
    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 supportPliant Therapeutics Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPliant Therapeutics Inc.
    B.5.2Functional name of contact pointMonica Sandberg
    B.5.3 Address:
    B.5.3.1Street Address260 Littlefield Avenue
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1650481-6931
    B.5.5Fax number+1650481-6776
    B.5.6E-mailMsandberg@pliantrx.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 namePLN-74809
    D.3.2Product code PLN-74809
    D.3.4Pharmaceutical form 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 INNNot Available
    D.3.9.1CAS number 2376257-44-0
    D.3.9.2Current sponsor codePLN-74809
    D.3.9.3Other descriptive namePLN-74809-020
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 placeboTablet
    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
    Idiopathic pulmonary fibrosis (IPF)
    E.1.1.1Medical condition in easily understood language
    Idiopathic Pulmonary Fibrosis (IPF)
    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 PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assessment of the safety and tolerability of PLN-74809
    E.2.2Secondary objectives of the trial
    Assessment of pharmacokinetics (PK) of PLN-74809
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participants, aged 40 years or older.
    2.Diagnosis of IPF for up to 5 years prior to screening based on American Thoracic Society (ATS)/ European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/ Latin American Respiratory Society (ALAT) 2018 guidelines (Raghu et al, 2018).
    Note: If IPF diagnosis is within >3 to ≤5 years at screening, the participant must have evidence of progression within the last 24 months, as defined by decline in FVC percent predicted based on a relative decline of ≥ 5%
    3. FVC percent of predicted ≥45%; historical FVC for entry in the study is permitted if within 1 month of screening.
    4. Diffusing capacity for carbon monoxide (DLco) (hemoglobin-adjusted) ≥30%%; historical DLco for entry in the study is permitted if within 1 month of screening.
    5. Participants currently receiving treatment for IPF with nintedanib or pirfenidone are allowed, provided these drugs have been given at a stable dose for at least 3 months before the Screening Visit and are expected to remain unchanged during the study stable dose is defined as the highest dose tolerated by the participant during ≥ 3 months).
    6. Estimated glomerular filtration rate ≥ 50 mL/min, according to the Cockcroft-Gault equation.
    7. Female participants of non-childbearing potential must be surgically sterile or postmenopausal.
    8. Female participants of childbearing potential must use a contraceptive method with a failure rate of <1% per year or remain abstinent (refrain from heterosexual intercourse) during the treatment period and for 1 month after the last dose of study treatment. Male participants with female partners of childbearing potential must agree to use contraceptive measures or remain abstinent (refrain from heterosexual intercourse during the treatment period and for at least 3 months after the last dose of study treatment.
    9. Participants must agree to abstain from sperm or egg donation for the duration of the study, through to 3 months or 1 month, respectively, after administration of the last dose of study drug.
    10. Able to read and sign a written informed consent form (ICF).
    E.4Principal exclusion criteria
    1. Receiving any non-approved agent intended for treatment of fibrosis in IPF
    2. Forced expiratory volume during the first second (FEV1) over the forced vital capacity (FVC) ratio (FEV1/FVC ratio) <0.7 at Screening
    3. Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during Screening or at Randomization.
    4. Any other condition that prevents the correct assessment of spirometry performance (for example a broken rib or chest pain of other origin that prevents adequate forced breathing)
    5. Known acute IPF exacerbation or suspicion by the Investigator of such, within 6 months of Screening
    6. The extent of emphysema is greater than the extent of fibrotic changes on the most recent high-resolution computerized tomography (HRCT) scan (as determined by central reader); a) HRCT scan performed within 2 years of the screening date may be used
    7. Diagnosis of severe pulmonary hypertension
    8. Smoking of any kind (not limited to tobacco) within 3 months of Screening or unwilling to avoid smoking throughout the study
    9. Lower respiratory tract infection requiring antibiotics within 4 weeks prior to screening and/or during the screening period
    10. History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, resected noninvasive cutaneous squamous cell carcinoma, or treated cervical carcinoma in situ
    11. End-stage liver disease
    12. Renal impairment or end-stage kidney disease requiring dialysis
    13. History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the 6 months prior to Screening, including but not limited to the following:
    a. Unstable angina pectoris or myocardial infarction
    b. Congestive heart failure requiring hospitalization during the 6 months prior to
    Screening
    c. Uncontrolled clinically significant arrhythmias (e.g., potentially resulting in health care utilization or hospitalization)
    d. Any clinically relevant electrocardiogram (ECG) abnormalities, including but not limited to, QT interval corrected for heart rate using Fridericia's formula (QTcF) > 450 msec for males or > 460 msec for females at the Screening visit (including Day -1) or prior to administration of the initial dose of study drug.
    14. Any of the following liver function test criteria above specified limits: total bilirubin >1.5× the upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3× ULN; alkaline phosphatase >2.5× ULN.
    Note: participants currently receiving nintedanib or pirfenidone as IPF SoC treatment, who have previously presented any liver function test elevations associated with nintedanib or pirfenidone treatment greater than that described above or resulting in dose reduction, treatment interruption, or discontinuation are not eligible.
    15. Any of the following at Screening: hemoglobin <10.0 g/dL, or neutrophils <1500 /mm3, or platelets <100.000 /mL
    16. Pregnant or lactating females
    17. Daily use of phosphodiesterase-5 (PDE-5) inhibitor drugs (e.g., sildenafil, tadalafil, other) (Note: Intermittent use for erectile dysfunction is allowed.)
    18. A medical or surgical condition known to affect drug absorption (e.g., major gastric surgery)
    19. Surgical procedures planned to occur during the study period
    20. Uncontrolled systemic arterial hypertension
    21. Has participated in a clinical study with an investigational agent in the 30 days prior to screening or 5 half-lives of the investigational drug, whichever is longer
    22. Likely to have lung transplantation during the study (being on transplantation list is acceptable)
    23. Any medical condition that, in the opinion of the Investigator, may make candidates not suitable for the study, including, but not limited to, suspected infection with COVID-19
    24. Hypersensitivity to PLN-74809 or to any of the excipients, or placebo
    25. Currently receiving and expected to remain on treatment during the study with: potent (i.e., strong) inhibitors or inducers of cytochrome P450 (CYP) 3A4 and Pglycoprotein (P-gp) (e.g., itraconazole), breast cancer resistance protein (BCRP) or organic anion transporting polypeptide (OATP) 1B1/1B3 transporters
    E.5 End points
    E.5.1Primary end point(s)
    Primary Safety Endpoint
    Nature and proportion of AEs between PLN-74809 and placebo groups (descriptive)
    Safety data from all participants who received at least one dose of study drug will be incorporated into the final safety analysis. Further details of the safety analyses will be provided in the SAP. AEs will be collected from the time the participant signs the ICF until the last study visit. Treatment-emergent adverse events (TEAEs) are defined as AEs that emerged or worsened in severity after the first administration of study drug.
    E.5.1.1Timepoint(s) of evaluation of this end point
    AEs will be collected from the time the participant signs the ICF until the last study visit.
    E.5.2Secondary end point(s)
    a. Secondary Pharmacokinetic Endpoints
    Plasma PLN-74809 concentrations (total and unbound concentrations) at each sampling time point will be presented in listings and descriptive summary statistics by dose and visit. The data will also be presented graphically.

    Further details of the analyses will be provided in the SAP to be prepared and agreed prior to final ‘database lock’ at the end of the study. The PK analysis plan and report may be prepared separately from the SAP as appropriate.

    b. Secondary Pharmacodynamic Endpoints
    Urine, plasma and serum samples will be analyzed for biomarkers (presence or actual concentration). These samples will be used to determine the levels of these markers in participants and the relationship between these markers. Results will be presented by listings, descriptive summary statistics and in graphical form by treatment and dose and expressed as the relative change (and or absolute) for each participant.

    In addition, relationships between PK and PD may be evaluated in an exploratory fashion and presented in graphical manner.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, Week 4, Week 12 and Week 14
    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 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 No
    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 trial5
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Belgium
    Canada
    Germany
    Italy
    Korea, Republic of
    Netherlands
    New Zealand
    United Kingdom
    United States
    France
    E.8.7Trial has a data monitoring committee No
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days23
    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: 112
    F.1.3Elderly (>=65 years) No
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 112
    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)
    Subsequent treatments of the study subject will be at the discretion of the investigator in accordance to standard 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 Decision2020-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-15
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