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    Summary
    EudraCT Number:2014-005658-20
    Sponsor's Protocol Code Number:FGCL-3019-067
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-18
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2014-005658-20
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients with Idiopathic Pulmonary Fibrosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    FG-3019 treatment in Idiopathic Pulmonary Fibrosis (IPF) patients.
    A.4.1Sponsor's protocol code numberFGCL-3019-067
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01890265
    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 SponsorFibroGen, 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 supportFibroGen, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFibroGen, Inc.
    B.5.2Functional name of contact pointClinical Trial Information Desk.
    B.5.3 Address:
    B.5.3.1Street Address409 Illinois Street
    B.5.3.2Town/ citySan Francisco
    B.5.3.3Post code94158California
    B.5.3.4CountryUnited States
    B.5.6E-mail067study@fibrogen.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 nameFG-3019 10mg/mL in 10 mL vials
    D.3.2Product code FG-3019
    D.3.4Pharmaceutical form 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 INNPamrevlumab
    D.3.9.1CAS number 946415-13-0
    D.3.9.2Current sponsor codeFG-3019
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    E.1.1.1Medical condition in easily understood language
    Pulmonary Fibrosis
    Scarring in the lungs
    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 19.1
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level SOC
    E.1.2Classification code 10038738
    E.1.2Term Respiratory, thoracic and mediastinal disorders
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level HLT
    E.1.2Classification code 10033979
    E.1.2Term Parenchymal lung disorders NEC
    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
    To determine the safety and tolerability of FG-3019 administered at a dose of 30 mg/kg by IV infusion every 3 weeks.
    To determine the effect of FG-3019 on FVC (percent of predicted value) when administered at a dose of 30 mg/kg by IV infusion every 3 weeks for 45 weeks in the target population.
    E.2.2Secondary objectives of the trial
    Efficacy:
    1. To evaluate the effect of FG-3019 on the extent of pulmonary fibrosis as measured by HRCT ( high resolution computer tomography) scans of the chest.
    2. To evaluate the relationship between changes in quantified scores of pulmonary fibrosis and clinical outcomes.
    3. To evaluate the effect of FG-3019 on progression of IPF and the frequency of respiratory-related hospitalizations and respiratory-related mortality.
    4. To evaluate the effect of FG-3019 on health-related quality of life (HRQoL).
    Exploratory Efficacy Objectives:
    1. To evaluate the effect of FG-3019 on FVC (liters).
    2. To evaluate the effect of FG-3019 on a panel of serum and plasma biomarkers.
    3. To evaluate the relationship between known chromosomal loci associated with IPF and the response to FG-3019.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Age 40 to 80 years, inclusive.
    2.Clinical diagnosis of IPF by high resolution computed tomography (HRCT) scan (and in some cases by surgical lung biopsy) and reduced lung function (forced vital capacity).
    3.History of IPF of 5 years duration or less.
    4.Forced Vital Capacity (FVC) equal or greater than 55% predicted value at screening.
    5.Women of childbearing potential (including those <1 year postmenopausal) and men with women partners of childbearing potential must use double barrier contraception methods during the conduct of the study, and for 3 months after the last dose of study drug.
    6.All subjects enrolled to FG-3019 whose FVC percent predicted value (mean of Week 36 and Week 48 values) is greater than the original pre-treatment baseline (mean of Screening Visit 1 and Day 1 values) and all subjects assigned to Placebo in the Randomized Treatment Phase will be offered participation in an Extended Treatment Phase.
    E.4Principal exclusion criteria
    1.Women who are pregnant or nursing.
    2.History of any other types of lung or heart disease and any other medical conditions that, in the opinion of the investigator, would impact the endpoints in the protocol or otherwise preclude the subject's participation in the study.
    3.Clinically important abnormal laboratory tests.
    4.Upper or lower respiratory tract infection of any type within 4 weeks of screening.
    5.Acute exacerbation of IPF within 3 months of screening.
    6.Use of medications to treat IPF within 5 half-lives of Day 1 dosing. If monoclonal antibodies were used, the last dose of the antibody must be at least 4 weeks before Day 1 dosing.
    7. Use of investigational drugs, including any investigational drugs for IPF, within 4 weeks prior to Day 1 dosing.
    8.History of cancer of any type in the 3 years preceding the first screening visit, excluding non-melanomatous skin cancer, localized bladder cancer, or in situ cancer.
    9.Diffusing capacity (DLCO) less than 30% of predicted value.
    10.History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies.
    11.Previous treatment with FG-3019.
    12.Body weight greater than 130 kilograms.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoint:
    • Change from baseline in FVC (percent of predicted value) at Week 48.
    E.5.1.1Timepoint(s) of evaluation of this end point
    FVC: At Baseline and Week 48 of Randomised Treatment Phase.
    E.5.2Secondary end point(s)
    Efficacy Endpoints:
    • Change in pulmonary fibrosis score by quantitative HRCT (high resolution computed tomography).
    • Change from baseline in HRQoL (health-related quality of life).
    • Progression of IPF, defined as time from Day 1 to any one of the following:
    o Death from any cause
    o Absolute decline in FVC % of predicted value of ≥10% not due to intercurrent illness confirmed by repeat spirometry
    o Clinical diagnosis of IPF progression
    • Proportion of subjects with at least one respiratory-related hospitalization.
    • Proportion of subjects with respiratory-related death.
    • Categorical assessment of absolute change from baseline in FVC percent of predicted value at week 48.

    Safety Endpoints:
    • AEs and SAEs.
    • Laboratory test abnormalities (graded by NCI Common Terminology Criteria for Adverse Events [NCI CTCAE, v4.0]).
    • 12-lead electrocardiograms (ECGs).
    • Physical examinations.
    • Human anti-human antibody (HAHA).

    Exploratory Efficacy:
    • Change from baseline in FVC (liters).
    • Change in a panel of serum and plasma biomarkers that will be determined by FibroGen.
    • Relationship between known chromosomal loci associated with IPF and the response to FG-3019.
    E.5.2.1Timepoint(s) of evaluation of this end point
    HRCT: Baseline, Week 24, Week 48 and every 24 weeks beyond 48 weeks.
    HRQoL: Day 1 and every 12 weeks.
    IPF Progression:Measured at several occasions.
    FVC: Baseline, Week 24, Week 48.
    Hospitalisation: Throughout study.
    Respiratory Death: Censored at Week 52.
    AEs and SAEs: From baseline and at each study visit.
    Serum Chemistry: Screening, Day 1 and every 12 weeks.
    ECGs: From baseline and every 24 weeks.
    Physical Examinations: Screening, baseline and every 6 weeks.
    HAHA: Day 1 and 10 weeks after last dose at End of Study visit
    Biomarkers: Baseline and Week 48.
    Chromosomal Loci: Sample taken on Day 1 before dosing or at subsequent visits for subjects already enrolled in the study who agree to DNA analysis .
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Exploratory Biomarker Analysis
    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 Yes
    E.8.1.7.1Other trial design description
    Randomised Treatment Phase is double blind and Extended Treatment Phase Open Label
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Bulgaria
    Canada
    India
    New Zealand
    South Africa
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 68
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 68
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 14
    F.4.2.2In the whole clinical trial 136
    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)
    Once the subject end participation in the trial they may no longer receive FG-3019 and will discuss with their doctor other treatment options for IPF.
    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 Decision2016-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-16
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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