Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7259   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-004782-24
    Sponsor's Protocol Code Number:PRM-151-202
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-09-06
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-004782-24
    A.3Full title of the trial
    A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF)
    Sperimentazione di fase 2 per valutare l’efficacia di PRM-151 in soggetti affetti da fibrosi polmonare idiopatica (FPI).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test intravenous PRM-151 for safety and to see how PRM-151 acts in the body and blood of people with idiopathic pulmonary fibrosis (IPF) - a disorder where lung tissue becomes damaged and scarred making it difficult to breathe.
    Sperimentazione per valutare la sicurezza di PRM-151 endovena e vedere come agisce nel corpo e nel sangue di persone con fibrosi polmonare idiopatica (FPI) - un disordine dove il tessuto polmonare è danneggiato e cicatrizzato rendendo difficile la respirazione.
    A.3.2Name or abbreviated title of the trial where available
    PRM-151-202
    PRM-151-202
    A.4.1Sponsor's protocol code numberPRM-151-202
    A.5.4Other Identifiers
    Name:PRM-151-202Number:PRM-151-202
    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 SponsorPROMEDIOR, 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 supportPromedior Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGB Pharma Services & Consulting S.r.l.
    B.5.2Functional name of contact pointUnità Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia Ferreri, 11
    B.5.3.2Town/ cityPavia
    B.5.3.3Post code27100
    B.5.3.4CountryItaly
    B.5.4Telephone number00390382530676
    B.5.5Fax number00390382302619
    B.5.6E-mailinfo@gbpharmaservices.it
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/12/1020
    D.3 Description of the IMP
    D.3.2Product code PRM-151
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 (IPF)
    Fibrosi Polmonare Idiopatica
    E.1.1.1Medical condition in easily understood language
    Deadly lung disease with unknown cause in which the lung tissue that is needed to get oxygen into the blood becomes thick and stiff, which leads to difficulties with breathing
    Malattia polmonare mortale con cause non note nella quale il tessuto polmonare che è preposto alla distribuzione di ossigeno al sangue diviene spesso e rigido, portando ad una difficoltà nella respira
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    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
    Determine the effect size of PRM-151 relative to placebo in change from Baseline to Week 28 in mean FVC% predicted, pooling subjects on a stable dose of pirfenidone or nintedanib with subjects not on other treatment for IPF.
    • Determinare la dimensione dell’effetto di PRM-151 rispetto al placebo in termini di variazione dal basale alla Settimana 28 nella CVF (capacità vitale forzata) media in % del predetto, aggregando i soggetti in trattamento con una dose stabile di pirfenidone o nintedanib con i soggetti non in corso di altro trattamento per FPI.
    E.2.2Secondary objectives of the trial
    Determine the effect size of PRM-151 relative to placebo in change from Baseline to Week 28 in:
    -normal lung parenchyma as quantified on HRCT imaging analysis, pooling subjects on a stable dose of pirfenidone or nintedanib with subjects not on other treatment for IPF.
    -mean FVC% predicted, separately in subjects on a stable dose of pirfenidone or nintedanib and separately in subjects not on other treatments for IPF.
    -normal lung parenchyma as quantified on HRCT imaging analysis, separately in subjects on a stable dose of pirfenidone or nintedanib and in subjects not on other treatments for IPF.
    •Assess the tolerability and safety of PRM-151 in subjects with IPF
    through Week 28
    •Assess the ability of PRM-151 to reduce disease-related events associated with mortality.
    •Determine the effect size of PRM-151 relative to placebo on:
    -pulmonary function in addition to mean change in FVC% predicted.
    -6 minute walk distance.
    -DLCO.
    Determinare la dimensione dell’effetto di PRM-151 rispetto al placebo in termini di variazione dal basale alla Settimana 28:
    -nel parenchima polmonare normale quantificato all’analisi dell’imaging con esame TAC ad alta risoluzione, aggregando i soggetti in trattamento con una dose stabile di pirfenidone o nintedanib con i soggetti non in corso di altro trattamento per FPI.
    •nella CVF media in % del predetto, separatamente nei soggetti in trattamento con una dose stabile di pirfenidone o nintedanib e nei soggetti non in corso di altri trattamenti per FPI.
    •nel parenchima polmonare normale quantificato all’analisi dell’imaging con HRCT, separatamente nei soggetti in trattamento con una dose stabile di pirfenidone o nintedanib e nei soggetti non in corso di altri trattamenti
    -nella CVF%, 6MWDT, and DLCO;
    •Valutare la tollerabilità e la sicurezza di PRM-151 in soggetti con FPI fino alla Settimana 28.
    •Valutare la capacità di PRM-151 di ridurre gli eventi associati a mortalità.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subject is aged 40-80 years.
    2.Subject has IPF satisfying the ATS/ERS/JRS/ALAT diagnostic criteria
    (Raghu, Collard et al. 2011).
    In the absence of a surgical lung biopsy, HRCT must be "consistent with UIP" defined as meeting either criteria A, B, and C, or criteria A and C, or criteria B and C below:
    A.Definite honeycomb lung destruction with basal and peripheral predominance.
    B.Presence of reticular abnormality AND traction bronchiectasis
    consistent with fibrosis, with basal and peripheral predominance.
    C.Atypical features are absent, specifically nodules and consolidation.
    Ground glass opacity, if present, is less extensive than reticular opacity pattern.
    3.If on pirfenidone or nintedanib, subject must have been on a stable dose of pirfenidone or nintedanib for at least 3 months without increase in FVC% predicted on two consecutive PFTs, including screening PFTs.
    Subjects may not be on both pirfenidone and nintedanib.
    4.If not currently receiving pirfenidone or nintedanib, subject must have been off pirfenidone or nintedanib for = 4 weeks before baseline.
    5.Subject has a FVC = 50% and = 90% of predicted.
    6.Subject has a DLCO = 25% and = 90% of predicted.
    7.Minimum distance on 6MWT of 150 meters.
    8.Subject has a forced expiratory volume in 1 second (FEV1)/FVC ratio > 0.70.
    9.Women of child bearing potential (WCBP), defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if = 55 years or 12 months if > 55 years, must have a negative serum pregnancy test within four weeks prior to the first dose of study drug and must agree to use adequate methods of birth control throughout the study. Adequate methods of contraception include use of oral contraceptives or Depo-Provera, with an additional barrier method (diaphragm with spermicidal gel or condoms with spermicide), double-barrier methods (diaphragm with spermicidal gel and condoms with spermicide), partner vasectomy, and total abstinence.
    10.Subject has a life expectancy of at least 9 months
    11.Subject, according to the investigator's best judgment, can comply with the requirements of the protocol.
    12.Subject has provided written informed consent to participate in the study.
    1.Il soggetto ha un’età compresa tra 40 e 80 anni.
    2.Il soggetto presenta una FPI che soddisfa i criteri diagnostici della Società toracica americana (American Thoracic Society, ATS)/Società europea per le malattie respiratorie (European Respiratory Society, ERS)/Società giapponese per le malattie respiratorie (Japanese Respiratory Society, JRS)/Società toracica dell’America Latina (Asociación Latinoamericana de Tórax, ALAT) (Raghu, Collard et al. 2011).
    In assenza di una biopsia polmonare chirurgica, l’esame HRCT deve essere “coerente con un quadro di polmonite interstiziale usuale (Usual Interstitial Pneumonia, UIP)”, definita dal soddisfacimento dei criteri A, B e C o dei criteri A e C o dei criteri B e C di cui sotto:
    A. chiara distruzione a nido d’ape del polmone con predominanza basale e periferica;
    B. presenza di anomalie reticolari E di bronchiettasie da trazione coerenti con un quadro di fibrosi, con predominanza basale e periferica;
    C. assenza di caratteristiche atipiche, in particolare noduli e consolidamento. Pattern con opacità a vetro smerigliato, se presente, meno esteso del pattern con opacità reticolari
    3. Se in trattamento con pirfenidone o nintedanib, il soggetto deve assumere una dose stabile di pirfenidone o nintedanib da almeno 3 mesi, senza aumento nella CVF in % del predetto a due PFT consecutivi, inclusi i PFT di screening. I soggetti non possono essere in trattamento sia con pirfenidone che con nintedanib.
    4. Se al momento non sta ricevendo pirfenidone o nintedanib, il soggetto deve avere smesso pirfenidone o nintedanib da =4 settimane prima del basale.
    5. Il soggetto presenta una CVF =50% e =90% del predetto.
    6. Il soggetto presenta una DLCO =25% e =90% del predetto.
    7. Il soggetto deve avere percorso una distanza minima al 6MWT di 150 metri.
    8. Il soggetto presenta un rapporto volume espiratorio forzato in 1 secondo (Forced Expiratory Volume in 1 second, FEV1)/CVF >0,70.
    9. Le donne in età fertile vale a dire donne sessualmente mature non sterilizzate chirurgicamente né in stato post-menopausale per almeno 24 mesi consecutivi se =55 anni o 12 mesi se >55 anni, devono avere un test di gravidanza eseguito sul siero negativo entro le quattro settimane precedenti la prima dose di farmaco dello studio e devono accettare di utilizzare metodi di contraccezione adeguati per l’intera durata dello studio. Metodi di contraccezione adeguati includono l’uso di contraccettivi orali o di Depo-Provera, con un metodo barriera supplementare (diaframma con gel spermicida oppure preservativi con spermicida), metodi di doppia barriera (diaframma con gel spermicida e preservativi con spermicida), vasectomia del partner e astinenza totale.
    10. Il soggetto ha un’aspettativa di vita di almeno 9 mesi.
    11. Il soggetto, in base al miglior giudizio dello sperimentatore, è in grado di attenersi ai requisiti del protocollo.
    12. Il soggetto ha fornito consenso informato scritto alla partecipazione allo studio.
    E.4Principal exclusion criteria
    1.Subject has emphysema = 50% on HRCT or the extent of emphysema is greater than the extent of fibrosis according to reported results from the most recent HRCT.
    2.Subject has a history of cigarette smoking within the previous 3 months.
    3.Subject has received investigational therapy for IPF within 4 weeks before baseline.
    4.Subject is receiving systemic corticosteroids equivalent to prednisone > 10 mg/day or equivalent within 2 weeks of baseline.
    5.Subject received azathioprine, cyclophosphamide, or cyclosporine A within 4 weeks of baseline.
    6.Subject has a history of a malignancy within the previous 5 years, with the exception of basal cell skin neoplasms. In addition, a malignant diagnosis or condition first occurring prior to 5 years must be considered cured, inactive, and not under current treatment.
    7.Subject has any concurrent condition other than IPF that, in the Investigator's opinion, is unstable and/or would impact the likelihood ofsurvival for the study duration or the subject's ability to complete the
    study as designed, or may influence any of the safety or efficacy assessments included in the study.
    8.Subject has baseline resting oxygen saturation of < 89% on room air or supplemental oxygen.
    9.Subjects that are unable to refrain from use of the following:
    a)Short acting bronchodilators on the day of and within 12 hours of pulmonary function, DLCO, and 6 minute walk assessments.
    b)Long acting bronchodilators on the day of and within 24 hours of these assessments.
    10.Subject has a known post bronchodilator (short acting beta agonist [SABA] – albuterol or salbutamol) increase in FEV1 of >10% and in FVC of >7.5%.
    1. Il soggetto presenta un enfisema con estensione =50% all’esame HRCT oppure l’estensione dell’enfisema è maggiore dell’estensione della fibrosi in base ai risultati riferiti dell’esame HRCT più recente.
    2. Il soggetto presenta una storia di fumo di sigaretta nei 3 mesi precedenti.
    3. Il soggetto ha ricevuto una terapia sperimentale per la FPI nelle 4 settimane precedenti il basale.
    4. Il soggetto sta ricevendo corticosteroidi per via sistemica a una dose pari a prednisone >10 mg/die o equivalente entro 2 settimane prima del basale.
    5. Il soggetto ha ricevuto azatioprina, ciclofosfamide o ciclosporina A nelle 4 settimane precedenti il basale.
    6. Il soggetto ha un’anamnesi di neoplasia maligna negli ultimi 5 anni, con l’eccezione delle neoplasie cutanee basocellulari. Inoltre, una diagnosi o patologia maligna che risale a prima di 5 anni deve essere considerata curata, inattiva e non essere attualmente in trattamento.
    7. Il soggetto presenta qualsiasi patologia concomitante diversa dalla FPI che, a giudizio dello sperimentatore, è instabile e/o avrebbe un impatto sulla probabilità di sopravvivenza per la durata dello studio o sulla capacità del soggetto di completare lo studio secondo il disegno dello stesso oppure potrebbe influenzare una qualsiasi delle valutazioni di sicurezza o di efficacia previste dallo studio.
    8. Il soggetto presenta al basale una saturazione di ossigeno a riposo <89% in aria ambiente o dopo somministrazione di ossigeno supplementare.
    9. Soggetti non in grado di astenersi dall’uso dei seguenti dispositivi:
    a) broncodilatatori ad azione rapida nel giorno e nelle 12 ore precedenti le valutazioni della funzione polmonare e della DLCO e il test del cammino dei 6 minuti;
    b) broncodilatatori ad azione prolungata nel giorno e nelle 24 ore precedenti queste valutazioni.
    10. Il soggetto presenta dopo somministrazione di broncodilatatore (beta-agonista ad azione rapida [Short-Acting Beta Agonist, SABA] - albuterolo o salbutamolo) un aumento noto del FEV1 >10% e della CVF >7,5%.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the mean change in FVC % predicted from Baseline to Week 28.
    L’endpoint primario è la variazione media nella CVF in % del predetto dal basale alla Settimana 28.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 28.
    Alla settimana 28.
    E.5.2Secondary end point(s)
    Structural Imaging:
    Mean change from Baseline to Week 28 in volume of parenchymal features on HRCT (in ml and % of total lung volume) representative of normal lung (non-ILA), including normal and low attenuation areas, using quantitative imaging software.; Structural Imaging:
    - Correlation between mean change from Baseline to Week 28 in FVC %predicted and mean change from Baseline to Week 28 in total lung volume and volume of parenchymal features on HRCT (in ml and % of total lung volume) representative of interstitial lung abnormalities (ILA), including ground glass density, reticular changes, and honeycombing by quantitative imaging software.; 2) Safety: Tolerability/safety will be assessed over the 28 week study period by the
    following parameters:
    • Incidence of AEs.
    • Incidence of serious adverse events (SAEs).
    • Incidence of respiratory AEs and SAEs.
    • Proportion of subjects discontinuing study drug due to AEs.
    • Change from Baseline in hematology and serum chemistries.
    • All-cause mortality.
    • Mortality due to respiratory deterioration.; 3) Disease related events associated with mortality: The number of “respiratory
    decline” events over the 28 week study period as defined below:
    • Unscheduled visits to a healthcare professional for respiratory status
    deterioration.
    • Urgent care visit for respiratory status deterioration.
    • Hospitalization due to a worsening or exacerbation of respiratory symptoms.
    All “respiratory decline” events will be further characterized according to the
    definitions of IPF-related acute exacerbation, as proposed by an expert committee
    sponsored by the IPF Clinical Research Network and the National Heart Lung and
    Blood Institute (NHLBI) (Collard, Moore et al. 2007) and applied by (Collard, Yow et
    al. 2013)
    • Acute onset of symptoms (< 30 days in duration)
    • New radiographic abnormalities (bilateral ground glass or consolidation on
    HRCT with no pneumothorax or pleural effusion)
    • The absence of an identified infectious etiology by routine clinical practice
    • Exclusion of alternative causes by routine clinical practice, including:
    a.Left heart failure
    b.Pulmonary embolism
    c.Identifiable cause of acute lung injury; 4) Pulmonary Function Tests
    • Proportion (%) of subjects with a decline in FVC% predicted of = 5% and =
    10% from Baseline to Week 28.
    • Proportion (%) of subjects with a decline in FVC in ml of = 100 ml and = 200
    ml from Baseline to Week 28.
    • Proportion of subjects with an increase in FVC % predicted of = 5% and = 10%
    from Baseline to Week 28.
    • Proportion of subjects with an increase in FVC in ml of =100 ml and = 200 ml
    from Baseline to Week 28.
    • Proportion of subjects with stable disease by FVC %, defined as a change in
    FVC % predicted of <5% from Baseline to Week 28.
    • Proportion of subjects with stable disease by FVC in ml, defined as a change in
    FVC of < 100ml from Baseline to Week 28.
    • Mean change from Baseline to Week 28 in % predicted diffusion capacity of
    carbon monoxide (DLCO).
    • Change in 6-minute walk distance, in meters, from Baseline to Week 28.; Structural Imaging:
    •Mean change from Baseline to Week 28 in total lung volume and volume of parenchymal features on HRCT (in ml and % of total lung volume) representative of interstitial lung abnormalities (ILA) including ground glass density, reticular changes, and honeycombing, usingquantitative imaging software.; Exploratory:
    Other Weeks
    •Examine the change from Baseline at Weeks 4, 8, 12, 16, 20, and 24 for the FVC % predicted, FVC in ml, and 6MWT distance
    Structural Imaging
    •Transitions from Baseline to Week 28 between all categories of lung features (normal, ground glass density, reticular changes, honeycombing, and mild, moderate, and severe low attenuation areas) by quantitative imaging software.
    •Correlation of transitions between categories of lung features by quantitative imaging and changes in FVC% predicted.
    •Correlation of transitions between categories of lung features by quantitative imaging and changes in DLCO.
    •Impact of inspiratory effort on results of HRCT quantitative imaging.
    Patient Reported Outcomes
    •Change in Patient Reported Outcomes as measured by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) and Leicester Cough Questionnaire (LCQ) from Baseline to Week 28.
    Biomarkers
    •Changes in serum and cellular biomarkers and response according to
    baseline genetic characteristics: including but not limited to TLR3, L412F polymorphism, and MUC5B promoter polymorphism.
    Imaging strutturale:
    •Variazione media dal basale alla Settimana 28 nel volume degli elementi del parenchima all’HRCT (in ml e in % del volume polmonare totale) rappresentativi di un polmone normale (senza ILA), tra cui aree di normale e ridotta attenuazione, valutata utilizzando software di imaging quantitativo. ; Imaging strutturale:
    •Correlazione tra la variazione media dal basale alla Settimana 28 nella CVF in % del predetto e la variazione media dal basale alla Settimana 28 nel volume polmonare totale e nel volume degli elementi del parenchima all’HRCT (in ml e in % del volume polmonare totale) rappresentativi di anomalie polmonari interstiziali (ILA), tra cui densità a vetro smerigliato, alterazioni reticolari e aree a nido d’ape, valutata mediante software di imaging quantitativo. ; 2) Sicurezza: la tollerabilità/sicurezza sarà valutata nell’arco del periodo dello studio di 28 settimane in base ai seguenti parametri:
    • incidenza degli eventi avversi (Adverse Event, AE);
    • incidenza degli eventi avversi seri (Serious Adverse Event, SAE);
    • incidenza degli AE e SAE respiratori;
    • percentuale di soggetti che interrompono il farmaco dello studio a causa di AE;
    • variazione rispetto al basale nei parametri ematologici e di chimica sierica;
    • mortalità da tutte le cause;
    • mortalità dovuta a deterioramento respiratorio. ; 3) Eventi correlati alla malattia associati a mortalità: numero di eventi di “declino respiratorio” nell’arco del periodo dello studio di 28 settimane, in base alla definizione di cui sotto:
    • visite non programmate presso un operatore sanitario per deterioramento delle condizioni respiratorie;
    • visita urgente per deterioramento delle condizioni respiratorie;
    • ricovero dovuto a peggioramento o esacerbazione dei sintomi respiratori.
    Tutti gli eventi di “declino respiratorio” saranno ulteriormente caratterizzati in base alle definizioni dell’esacerbazione acuta correlata a FPI, come proposte da una commissione di esperti sponsorizzata dal Gruppo di Ricerca IPF (IPF Clinical Research Network) edal National Heart Lung and Blood Institute, NHLBI) e (Collard, Moore et al. 2007) e applicate da (Collard, Yow et al. 2013).
    • insorgenza acuta di sintomi (durata <30 giorni);
    • nuove anomalie radiografiche (vetro smerigliato bilaterale o consolidamento all’HRCT in assenza di pneumotorace o versamento pleurico);
    • assenza di un’eziologia infettiva identificata in base alla pratica clinica di routine;
    • esclusione di cause alternative in base alla pratica clinica di routine, incluse:
    a. insufficienza cardiaca sinistra;
    b. embolia polmonare;
    c. causa identificabile di lesione polmonare acuta.
    ; 4) Test di funzionalità polmonare
    • percentuale (%) di soggetti con un declino nella CVF in % del predetto =5% e =10% dal basale alla Settimana 28;
    • percentuale (%) di soggetti con un declino nella CVF in ml =100 ml e =200 ml dal basale alla Settimana 28;
    • percentuale (%) di soggetti con un aumento nella CVF in % del predetto =5% e =10% dal basale alla Settimana 28;
    • percentuale (%) di soggetti con un aumento nella CVF in ml =100 ml e =200 ml dal basale alla Settimana 28;
    • percentuale di soggetti con malattia stabile in base alla CVF in %, definita come una variazione nella CVF in % del predetto <5% dal basale alla Settimana 28;
    • percentuale di soggetti con malattia stabile in base alla CVF in ml, definita come una variazione nella CVF <100 ml dal basale alla Settimana 28;
    • variazione media dal basale alla Settimana 28 nella capacità di diffusione polmonare del monossido di carbonio (DLCO) in % del predetto;
    • variazione nella distanza percorsa al test del cammino dei 6 minuti, in metri, dal basale alla Settimana 28.
    ; • Imaging strutturale:
    • Variazione media dal basale alla Settimana 28 nel volume polmonare totale e nel volume degli elementi del parenchima all’HRCT (in ml e in % del volume polmonare totale) rappresentativi di anomalie polmonari interstiziali (Interstitial Lung Abnormalities, ILA), tra cui densità a vetro smerigliato, alterazioni reticolari e aree a nido d’ape, valutata utilizzando software di imaging quantitativo. ; Esplorativi: (Altre settimane)
    • valutazione della variazione dal basale alle Settimane 4, 8, 12, 16, 20 e 24 nella CVF in % del predetto, nella CVF in ml e nella distanza percorsa al test del cammino dei 6 minuti (6-Minute Walk Test, 6MWT).
    Imaging strutturale
    • transizioni dal basale alla Settimana 28 tra tutte le categorie di caratteristiche del polmone (normale, densità a vetro smerigliato, alterazioni reticolari, nido d’ape e aree di attenuazione lieve, moderata e grave) valutate mediante software di imaging quantitativo;
    • correlazione delle transizioni tra le categorie di caratteristiche del polmone valutate mediante imaging quantitativo e le variazioni nella CVF in % del predetto;
    • correlazione delle transizioni tra le categorie di caratteristiche del polmone valutate mediante imaging quantitativo e le variazioni nella DLCO;
    • impa
    E.5.2.1Timepoint(s) of evaluation of this end point
    With every visit after randomization and at week 28.; With every visit after randomization and at week 28.; With every visit after randomization and at week 28.; With every visit after randomization and at week 28.; With every visit after randomization and at week 28.; With every visit after randomization and at week 28.; With every visit after randomization and at week 28.
    Ciascuna visita dopo la randomizzazione e alla settimana 28.; Ciascuna visita dopo la randomizzazione e a 28 settimane.; Ciascuna visita dopo la randomizzazione e alla settimana 28.; Ciascuna visita dopo la randomizzazione e alla settimana 28.; Ciascuna visita dopo la randomizzazione e alla settimana 28.; Ciascuna visita dopo la randomizzazione e alla settimana 28.; Ciascuna visita dopo la randomizzazione e alla settimana 28.
    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 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 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 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 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
    United States
    Belgium
    France
    Germany
    Italy
    Netherlands
    Spain
    United Kingdom
    Czechia
    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 months3
    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 months3
    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: 58
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 59
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 117
    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 completion of study treatment through Week 24, all subjects may receive PRM-151 10 mg/kg IV infusion over 60 minutes days 1,3, and 5, and then one infusion every 4 weeks for up to an additional 96 weeks in an open label study extension.
    Dopo il completamento del trattamento in studio alla settimana 24, tutti i soggetti potranno ricevere PRM-151 10 mg/kg in infusione endovenosa di un'ora al giorno 1,3 e 5 e poi un'infusione ogni 4 settimane fino ad un massimo 96 settimane in una fase di estensione dello studio in aperto.
    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 Decision2015-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-03
    For support, Contact us.
    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.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA