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    Summary
    EudraCT Number:2020-000697-22
    Sponsor's Protocol Code Number:FGCL-3019-095
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-01-21
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-000697-22
    A.3Full title of the trial
    Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF).
    Zephyrus II: Studio di fase 3, randomizzato, in doppio cieco, controllato con placebo sull’efficacia e sulla sicurezza di pamrevlumab in soggetti affetti da fibrosi polmonare idiopatica (IPF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis.
    Uno studio per confrontare l'uso di Pamrevlumab con Placebo in pazienti con fibrosi polmonare idiopatica.
    A.3.2Name or abbreviated title of the trial where available
    Zephyrus II
    Zephyrus II
    A.4.1Sponsor's protocol code numberFGCL-3019-095
    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
    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 Trials Information
    B.5.3 Address:
    B.5.3.1Street Address409 Illinois Street
    B.5.3.2Town/ citySan Francisco, California
    B.5.3.3Post code94158
    B.5.3.4CountryUnited States
    B.5.6E-mail3019-095study@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 namePamrevlumab
    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.3.9.4EV Substance CodeSUB198085
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Fibrosi polmonare idiopatica
    E.1.1.1Medical condition in easily understood language
    Idiopathic Pulmonary Fibrosis
    Fibrosi polmonare idiopatica
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    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
    The overall objective of this trial is to evaluate the efficacy and safety of 30 mg/kg IV infusions of pamrevlumab as compared to placebo in subjects with Idiopathic Pulmonary Fibrosis.
    L’obiettivo complessivo di questa sperimentazione clinica è quello di valutare l’efficacia e la sicurezza di infusioni EV di pamrevlumab 30mg/kg rispetto al placebo in soggetti affetti da fibrosi polmonare idiopatica.
    E.2.2Secondary objectives of the trial
    n/a
    n/a
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 40 to 85 years, inclusive, at screening initiation.
    2. Diagnosis of IPF as defined by ATS/ERS/JRS/ALAT guidelines (Raghu 2018).
    3. IPF diagnosis within the past 7 years, with onset defined as the date of the first recorded diagnosis of IPF by HRCT and/or surgical lung biopsy (SLB), or other appropriate tissue sample (e.g., cryobiopsy) in the medical history.
    4. Interstitial pulmonary fibrosis defined by HRCT scan at Screening, with evidence of =10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing, within the whole lung. NOTE: this requires confirmation by an Independent Radiology Imaging Review Group, prior to randomization. If a recent HRCT scan (within 3 months prior to screening) is available, it can be utilized for screening purposes, provided it is submitted and evaluated by the Independent Radiology Imaging Review Group, is adhering to the imaging parameters detailed in the Imaging Core Manual (ICM), and is using the same accredited scanner as the on-study HRCT scans.
    5. FVCpp value =50% and =80% at Screening and Day 1.
    6. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted and corrected by Hb value =30% and =90% at Screening (determined locally).
    7. Both FVC and DLCO testing must be representative of the IPF underlying disease (i.e. have been obtained in absence of an acute respiratory event [e.g. lung infection, cold] or other events that are known to affect PFT testing results [e.g., broken rib, chest pain, other]).
    8. Previously treated with an approved IPF therapy (i.e., pirfenidone or nintedanib) but discontinued at least 1 week prior to screening, unless neither treatment is available in the host country. NOTE: no subject should discontinue approved therapy for the purpose of enrolling in this study.
    9. Male subjects with partners of childbearing potential and female subjects of childbearing potential (including those <1 year postmenopausal) must use double barrier contraception methods during the conduct of the study, and for 3 months after the last dose of study drug. Women not of childbearing potential are defined as:
    a. Post-menopausal; women (defined as at least 12 months with no menses without an alternative medical cause); in women < 45 years of age, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. OR
    b. Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening; OR
    c. Have a congenital or acquired condition that prevents childbearing.
    10. Able to understand and sign a written informed consent form.
    1. Età compresa tra 40 e 85 anni inclusi all’inizio dello screening.
    2. Diagnosi di IPF definita in base alle linee guida ATS/ERS/JRS/ALAT (Raghu 2018).
    3. Diagnosi di IPF negli ultimi 7 anni, con insorgenza definita come la data della prima diagnosi registrata di IPF tramite HRCT e/o biopsia chirurgica (SLB) o altro appropriato campione tissutale (per es., criobiopsia) nell’anamnesi medica.
    4. Fibrosi polmonare interstiziale definita dalla scansione HRCT allo screening, con evidenza di fibrosi parenchimale (reticolazione) compresa fra =10% e <50% e superficie a nido d’ape <25% in tutto il polmone. NOTA: questo richiede la conferma da un Gruppo di revisione indipendente della diagnostica per immagini radiologica, prima della randomizzazione. Se una scansione HRCT recente (nei 3 mesi precedenti lo screening) è disponibile, può essere utilizzata per gli scopi dello screening, a condizione che sia inoltrata e valutata dal Gruppo di revisione indipendente della diagnostica per immagini radiologica, rispetti i parametri di diagnostica per immagini dettagliati nel Manuale di diagnostica principale (Imaging Core Manual, ICM) e stia utilizzando lo stesso scanner accreditato delle scansioni HRCT durante lo studio.
    5. Valore di FVCpp compreso tra =50% e =80% allo screening e al Giorno 1.
    6. Percentuale della capacità di diffusione polmonare del monossido di carbonio (DLCO) prevista e corretta tramite un valore di emoglobina (Hb) compreso tra =30% e =90% allo screening (determinato a livello locale).
    7. Entrambe le analisi FVC e DLCO devono essere rappresentative della malattia IPF sottostante (per es. sono state ottenute in assenza di un evento respiratorio acuto [per es. infezione polmonare, raffreddore] o altri eventi che sono noti per influenzare i risultati del test PFT [per es., coste fratturate, dolore toracico, altro]).
    8. Pazienti precedentemente trattati con una terapia approvata per l’IPF (ovvero, pirfenidone o nintedanib) ma interrotta almeno 1 settimana prima dello screening, a meno che nessun trattamento sia disponibile nel Paese ospite. NOTA: nessun soggetto deve interrompere la terapia approvata al fine dell’arruolamento in questo studio.
    9. I soggetti di sesso maschile con partner potenzialmente fertili e i soggetti di sesso femminile in età fertile (compresi quelli in menopausa da <1 anno) devono utilizzare metodi contraccettivi a doppia barriera durante la conduzione dello studio e per 3 mesi dopo l’ultima dose del farmaco dello studio. Le donne non potenzialmente fertili sono definite come:
    a. donne in post-menopausa (definita da almeno 12 mesi senza mestruazioni senza una causa medica alternativa); nelle donne di età <45 anni, un alto livello di ormone follicolo-stimolante (FSH) nel range della post-menopausa può essere utilizzato per confermare uno stato post-menopausale nelle donne che non utilizzano la contraccezione ormonale o una terapia ormonale sostitutiva; OPPURE
    b. che hanno subito un’isterectomia e/o un’ooforectomia bilaterale, salpingectomia bilaterale o legatura/occlusione tubarica bilaterale, almeno 6 settimane prima dello screening; OPPURE
    c. che sono affette da una condizione congenita o acquisita che impedisce la fertilità.
    10. Capacità di comprendere e firmare un modulo di consenso informato scritto.
    E.4Principal exclusion criteria
    1. Previous exposure to pamrevlumab.
    2. Evidence of significant obstructive lung disease by any of the following criteria: (1) forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio <0.70, or (2) extent of emphysema greater
    than the extent of fibrosis on HRCT. NOTE: this requires confirmation by an Independent Radiology Imaging Review Group, prior to randomization.
    3. Female subjects who are pregnant or nursing.
    4. Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the study.
    5. Interstitial lung disease (ILD) other than IPF, including but not limited to any of the other types of idiopathic interstitial pneumonias; lung diseases related to exposure to fibrogenic agents or other environmental toxins or drugs; other types of occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases; systemic diseases, including vasculitis, infectious diseases (i.e. TB) and
    connective tissue diseases. In cases of uncertain diagnosis, serological testing and/or review by multi-disciplinary team should be performed to confirm diagnosis of IPF vs. other types of ILD.
    6. Sustained improvement in the severity of IPF during the 12 months prior to Screening, based on changes in FVC, DLCO, and/or HRCT scans of the chest.
    7. History of other types of respiratory diseases, including diseases or disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall that, in the opinion of the Investigator, would impact the primary protocol endpoint or otherwise preclude the subject's participation in the study.
    8. Medical conditions (e.g. MI/stroke within the past 6 month), or logistical challenges that in the opinion of the Investigator preclude the subject's adequate participation in the study.
    9. Poorly controlled chronic heart failure (NYHA Class 3 or above); clinical diagnosis of cor pulmonale requiring specific treatment; or severe pulmonary arterial hypertension requiring specific treatment that, in the opinion of the Investigator, would preclude the subject's participation in the study.
    10. Clinically important abnormal laboratory tests (including serum creatinine =1.5 x upper limit of normal [ULN], hemoglobin (Hb) <10 g/dL, white blood cells <3,000/mm3, platelets less than 100,000/mm3,
    serum total bilirubin >1.5 x ULN, serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =2 x ULN, or serum alkaline phosphatase =2 x ULN.
    11. Ongoing acute IPF exacerbation, or suspicion of such process by the Investigator, during Screening or Randomization.
    12. High likelihood of lung transplantation (in the opinion of the Investigator) within 6 months after Day 1.
    13. Use of any investigational drugs or unapproved therapies, or participation in any clinical trial with an investigational new drug within 30 days prior to screening.
    14. Daily use of PDE-5 inhibitor drugs (e.g. sildenafil, tadalafil), except for treatment of severe pulmonary artery hypertension.
    15. Any current malignancy (this does not include localized cancer such as basal or squamous cell carcinoma of skin). Any history of malignancy likely to result in mortality, or requiring significant medical or surgical intervention within the next year.
    16. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies.
    17. Any condition (other than IPF) that is likely to result in the death of the patient within the next year.
    18. The Investigator judges that the subject will be unable to fully participate in the study and complete it for any reason, including inability to comply with study procedures and treatment, addiction, or any other relevant medical or psychiatric conditions.
    1. Precedente esposizione a pamrevlumab.
    2. Evidenza di malattia polmonare ostruttiva significativa secondo uno dei seguenti criteri: (1) rapporto volume espiratorio forzato in 1 secondo/capacità vitale forzata (FEV1/FVC) <0,70 o (2) entità dell’enfisema maggiore dell’entità della fibrosi alla HRCT. NOTA: questo richiede la conferma da un Gruppo di revisione indipendente della diagnostica per immagini radiologica, prima della randomizzazione.
    3. Soggetti di sesso femminile in gravidanza o che stanno allattando.
    4. Fumatori nei 3 mesi precedenti lo screening e/o non disposti a evitare di fumare per tutta la durata dello studio.
    5. Malattia polmonare interstiziale (Interstitial lung disease, ILD) diversa dall’IPF, compresa, a titolo esemplificativo ma non limitativo, qualsiasi altro tipo di polmonite interstiziale idiopatica, malattie polmonari correlate all’esposizione ad agenti fibrogenici o altre tossine ambientali o farmaci, altri tipi di malattie polmonari professionali, malattie polmonari granulomatose, malattie polmonari vascolari, malattie sistemiche, compresa la vasculite, malattie infettive (ovvero TBC) e malattie del tessuto connettivo. Nei casi di diagnosi incerta, devono essere effettuati test sierologici e/o una revisione da parte del team multi-disciplinare per confermare la diagnosi di IPF rispetto ad altri tipi di ILD.
    6. Miglioramento duraturo nella gravità dell’IPF nei 12 mesi precedenti lo screening, sulla base delle variazioni in FVC, DLCO e/o nelle scansioni HRCT del torace.
    7. Anamnesi di altri tipi di malattie respiratorie, tra cui malattie o disturbi delle vie respiratorie, parenchima polmonare, spazio pleurico, mediastino, diaframma o parete toracica che, a giudizio dello sperimentatore, avrebbero un impatto sull’endpoint primario del protocollo o precluderebbero altrimenti la partecipazione del soggetto allo studio.
    8. Condizioni mediche (per es., IM/ictus negli ultimi 6 mesi) o problemi logistici che, a giudizio dello sperimentatore, precludano un’adeguata partecipazione del soggetto allo studio.
    9. Insufficienza cardiaca cronica scarsamente controllata (classe 3 o superiore del NYHA), diagnosi clinica di cuore polmonare che richieda un trattamento specifico o grave ipertensione arteriosa polmonare che richieda un trattamento specifico che, a giudizio dello sperimentatore, precluderebbe la partecipazione del soggetto allo studio.
    10. Anomalie clinicamente importanti ai test di laboratorio (compresi creatinina sierica =1,5 volte il limite superiore alla norma [ULN], emoglobina (Hb) <10 g/dl, globuli bianchi <3.000/mm3, piastrine inferiori a 100.000/mm3, bilirubina sierica totale >1,5 volte l’ULN, alanina aminotransferasi sierica (ALT) o aspartato aminotransferasi (AST) =2 volte l’ULN, o fosfatasi alcalina sierica =2 volte l’ULN.
    11. Esacerbazione acuta dell’IPF in corso o sospetto di tale processo da parte dello sperimentatore, durante lo screening o la randomizzazione.
    12. Elevata probabilità di trapianto del polmone (a giudizio dello sperimentatore) entro 6 mesi dopo il Giorno 1.
    13. Utilizzo di qualsiasi farmaco sperimentale o terapie non approvate, o partecipazione a qualsiasi sperimentazione clinica con un nuovo farmaco sperimentale nei 30 giorni precedenti lo screening.
    14. L’utilizzo quotidiano di farmaci inibitori della PDE-5 (per es. sildenafil, tadalafil) eccezion fatta per il trattamento dell’ipertensione arteriosa polmonare grave.
    15. Qualsiasi neoplasia attuale (ciò non comprende carcinomi localizzati come carcinoma cutaneo basocellulare o a cellule squamose). Qualsiasi anamnesi di neoplasia che potrebbe portare a mortalità o con necessità di un significativo intervento medico o chirurgico nell’anno successivo.
    16. Anamnesi di reazione allergica o anafilattica agli anticorpi umani, umanizzati, chimerici o monoclonali murini.
    17. Qualsiasi condizione (diversa dalla IPF) che potrebbe portare al decesso del paziente nell’anno successivo.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects with Disease Progression, defined as absolute FVC percent predicted (FVCpp) decline of =10% or death, whichever occurs first
    Percentuale di soggetti con progressione della malattia, definita come declino percentuale del valore predetto della capacità vitale forzata (forced vital capacity, FVC) (FVCpp) =10% o decesso, a seconda di quale evento si verifichi prima
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks (or end of trial)
    52 settimane (o fine dello studio)
    E.5.2Secondary end point(s)
    • Change in FVC (L) from baseline at Week 52
    • Change in absolute FVCpp from baseline at Week 52
    • Change in relative FVCpp from baseline at Week 52
    • Composite of clinical outcomes: respiratory hospitalization or death or absolute FVCpp decline =10%, whichever occurs first
    • Respiratory hospitalizations during study
    • Change in Quantitative Lung Fibrosis (QLF) volume from baseline at Week 52
    • Change in St. George's Respiratory Questionnaire (SGRQ) score from baseline at Week 48
    • Change in University of California San Diego – Shortness of Breath Questionnaire (UCSD-SOBQ) score from baseline at Week 48
    • Change in Leicester Cough Questionnaire (LCQ) from baseline at Week 48
    • All-cause mortality during study
    • Acute IPF exacerbations during study
    •Variazione della capacità vitale forzata (forced vital capacity, FVC) (L) rispetto al basale alla Settimana 52
    •Variazione della FVCpp assoluta rispetto al basale alla Settimana 52
    • Variazione della FVCpp relativa rispetto al basale alla Settimana 52
    • Composito degli esiti clinici: Ricovero per problemi respiratori o decesso o declino della FVCpp assoluta =10%, a seconda di quale evento si verifichi prima
    • Ricoveri per problemi respiratori durante lo studio
    • Variazione nel volume quantitativo di fibrosi polmonare (QLF) dal basale alla Settimana 52
    • Variazione del punteggio del questionario respiratorio di St. George (SGRQ) dal basale alla Settimana 48
    • Variazione del punteggio del questionario sul respiro affannoso della University of California San Diego - (UCSD-SOBQ) dal basale alla Settimana 48
    • Variazione del questionario della tosse di Leicester Cough Questionnaire (LCQ) dal basale alla Settimana 48
    • Mortalità per qualsiasi causa durante lo studio
    • Riacutizzazioni acute dell’IPF durante lo studio
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks (or end of trial)
    52 settimane (o fine dello studio)
    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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA74
    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 Information not present in EudraCT
    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
    Colombia
    Dominican Republic
    Georgia
    India
    Lebanon
    Mexico
    Peru
    Serbia
    Ukraine
    Belgium
    Bulgaria
    Czechia
    Denmark
    France
    Germany
    Hungary
    Ireland
    Italy
    Netherlands
    Norway
    Poland
    Spain
    United Kingdom
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 170
    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 state29
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 260
    F.4.2.2In the whole clinical trial 340
    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)
    Subjects who complete the study (regardless of the number of study drug infusions received) will be eligible for rollover into an open-label, extension (OLE), offering extended treatment with Pamrevlumab.
    I soggetti che completano lo studio (indipendentemente dal numero di infusioni di farmaco in studio ricevute) saranno idonei ad un’estensione in aperto con pamrevlumab.
    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 Decision2020-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-06-26
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