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    Summary
    EudraCT Number:2017-004919-39
    Sponsor's Protocol Code Number:ND-L02-s0201-005
    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:2018-07-16
    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 number2017-004919-39
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Biological Activity, and PK of ND-L02-s0201 in Subjects with Idiopathic Pulmonary Fibrosis (IPF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the safety, tolerability, biological activity, and pharmacokinetics of the drug ND-L02-s0201 compared with a placebo in patients with Idiopathic Pulmonary Fibrosis (IPF)
    A.4.1Sponsor's protocol code numberND-L02-s0201-005
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03538301
    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 SponsorNitto Denko Corporation
    B.1.3.4CountryJapan
    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 supportNitto Denko Corporation
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNitto Denko Corporation
    B.5.2Functional name of contact pointNitto Clinical Trial Help Desk
    B.5.3 Address:
    B.5.3.1Street Address1-1-2 Shimohozumi
    B.5.3.2Town/ cityIbaraki
    B.5.3.3Post code567-8680
    B.5.3.4CountryJapan
    B.5.4Telephone number+81-3-6632-2069
    B.5.6E-mailclinicaltrialinfo005@nitto.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 nameND-L02-s0201 for injection
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTBC
    D.3.9.2Current sponsor codeNDT-05-0038
    D.3.9.4EV Substance CodeSUB178466
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous 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
    Evaluate the safety and tolerability of ND-L02-s0201, administered at 2 dose levels, Q2W over 24 weeks, versus placebo, in conjunction with standard of care (SOC)
    E.2.2Secondary objectives of the trial
    • Evaluate the biological activity of ND-L02-s0201 as measured by spirometry over 24 weeks
    • Evaluate changes of interstitial lung abnormalities (ILA) as measured by high resolution computed tomography (HRCT)
    • Evaluate single-dose PK endpoints over 24 weeks in a subset of subjects
    • Evaluate trough levels for accumulation over time and identify when steady state conditions are achieved
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Forced vital capacity (FVC) ≥ 45% of predicted.
    •Diffusion capacity of the lung for carbon monoxide (DLco) corrected for hemoglobin ≥ 30% of predicted value
    •Ratio of forced expiratory volume in 1 second (FEV1) to FVC ≥ 0.70.

    Other protocol defined inclusion/exclusion criteria could apply
    E.4Principal exclusion criteria
    •Best, acceptable FVC from separate screening spirometry that differ by ≥ 200 mL.
    •Respiratory exacerbation(s) or hospitalization for IPF exacerbation within 3 months before screening.
    •Anticipated to receive a lung transplant during the subject's participation in the study.
    •Active smoker or smoking cessation within 12 weeks before screening.
    •Malignancy within the last 5 years, with the exception of curable cancer that has received adequate treatment.
    •Evidence of any unstable or untreated, clinically significant disease or condition that, in the opinion of the Investigator, might confound the interpretation of the study or place the subject at increased risk.
    •Treatment with high dose corticosteroids, cytotoxic agents, unapproved IPF targeted therapy, and cytokine modulating agents within 8 weeks or 5 half-lives (whichever is longer) before screening
    •Receiving an investigational treatment, whether or not approved for marketing, with the last dose of that study drug within 8 weeks or 5 half-lives (whichever is longer) before screening. Individuals allocated to receive no treatment beyond SOC in an investigational study are not excluded from this trial.
    •Pregnant or breastfeeding.
    •Known history of HIV infection, active chronic hepatitis B (eg hepatitis B surface antigen positive), and/or untreated hepatitis C antigen positive patients (with or without abnormal liver enzymes). If treated for hepatitis C viral eradication, then a viral load below the limits of quantitative detection for at least 12 weeks must be documented.
    •History of alcohol abuse and/or dependence within the last 2 years.
    •History within the last 2 years of significant mental illness, or dependence on any opioid or illicit drugs, as defined in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
    •Suspected or confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, defined as meeting one or more of the following criteria:
    a. The subject has known exposure to a person with signs or symptoms of SARS-CoV-2 infection or has tested positive for SARS-CoV-2 (suggesting current infection) within 21 days prior to the subject’s Visit 1a.
    b. The subject has current signs and symptoms suggestive of SARS-CoV-2 infection.
    c. The subject has SARS-CoV-2 virus or viral antigen detected at Visit 1a using a test approved for marketing if testing is available. (Detection of antibody to SARS-CoV-2 will not be exclusionary).

    Other protocol defined inclusion/exclusion criteria could apply
    E.5 End points
    E.5.1Primary end point(s)
    Safety
    • Incidence of treatment- emergent AEs (TEAEs) and treatment-emergent SAEs
    • Proportion of subjects discontinuing study treatment due to TEAEs
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    E.5.2Secondary end point(s)
    Biological Activity
    1. Rate of decline in FVC over 24 weeks (measured in mL and % of predicted over unit time)
    2. Absolute and relative change in FVC (mL and % of predicted) at Visit 14 (Day 169) as compared with baseline
    3. Proportion of subjects with an FVC response (mL and % of predicted) defined as either having improvement or a decline by 0% to ≤ 5%, > 5% to ≤ 10%, and by > 10% at Visit 14 (Day 169)
    4. Change in DLCO and DLCO corrected for hemoglobin
    5. Changes of ILA as measured by HRCT (ie, change in parenchymal feature [Baseline to Visit 14 (Day 169)]), as determined by qualitative assessment (central radiologist) and quantitative analysis (Quantitative Lung Fibrosis – QLF analysis)
    6. Time to first acute IPF exacerbation (ie, an unexplained worsening of dyspnea, evidence of hypoxemia as defined by worsened or severely impaired gas exchange, new radiographic alveolar infiltrates, and an absence of an alternative explanation such as infection, pulmonary embolism, pneumothorax, or heart failure
    [Raghu et al, 2011])
    7. Rate of hospitalization for respiratory ailments, rate of mortality due to all causes, and rate of deterioration of IPF resulting in lung transplantation (up to 12 weeks after the end of study treatment) or death
    Pharmacokinetics
    8. Serial PK sample collection for generation of single-dose PK parameters (noncompartmental analysis [NCA]) in a subset of subjects (N = 30)
    9. Trough samples will be collected during the study. PK subset subjects (N = 30) have 7 trough sample collections planned and the remainder of study subjects (approximately N = 90) have 2 trough sample collections planned during study conduct.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Biological Activity
    1. Day -42 to -7, Day 1, 29, 57, 85, 113, 141, 169, 197, 239
    2. Baseline and Day 169
    3. Day 169
    4. Day -42 to -7, Day 1, 29, 57, 85, 113, 141, 169, 197, 239
    5. Baseline to Day 169
    6. Ongoing basis
    7. Ongoing basis and up to 12 weeks after EOT
    Pharmacokinetics
    8. Day 1, 2, 3, 15, 43, 71, 99, 127, 155, 169
    9. Day 29, 57, 85, 113, 141, 169
    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 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) 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Germany
    Japan
    United Kingdom
    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 years2
    E.8.9.1In the Member State concerned months6
    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 months11
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8
    F.4.2.2In the whole clinical trial 120
    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)
    Standard of care, as per the approved local 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 Decision2018-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-08-24
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