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    Summary
    EudraCT Number:2017-002667-17
    Sponsor's Protocol Code Number:CVAY736X2207
    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:2018-02-13
    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 number2017-002667-17
    A.3Full title of the trial
    A subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis
    Studio multicentrico, in cieco per il soggetto, lo sperimentatore e lo sponsor,
    randomizzato, controllato con placebo volto a valutare l’efficacia, la sicurezza e la tollerabilità di VAY736 in pazienti con fibrosi
    polmonare idiopatica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis
    Studio di farmacodinamica,
    farmacocinetica, sicurezza e tollerabilità di VAY736 in pazienti con fibrosi polmonare idiopatica
    A.3.2Name or abbreviated title of the trial where available
    Study of pharmacodynamics,pharmacokinetics, safety and tolerability of VAY736 in patients with idiop
    Studio di farmacodinamica, farmacocinetica, sicurezza e tollerabilità di VAY736 in pazienti con fibr
    A.4.1Sponsor's protocol code numberCVAY736X2207
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03287414
    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 SponsorNovartis Pharma AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Ireland Limited
    B.5.2Functional name of contact pointMedical Information Department
    B.5.3 Address:
    B.5.3.1Street AddressBeech House , Beech Hill Office Campus - Clonskeagh
    B.5.3.2Town/ cityClonskeagh
    B.5.3.3Post codeDublin 4
    B.5.3.4CountryIreland
    B.5.4Telephone number+353 12601255
    B.5.5Fax number+353 12601263
    B.5.6E-mailmedinfo.dublin@novartis.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.3.2Product code VAY736
    D.3.4Pharmaceutical form Powder for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot established
    D.3.9.3Other descriptive nameVAY736
    D.3.9.4EV Substance CodeSUB31641
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 injection/infusion
    D.8.4Route of administration of the placeboSubcutaneous 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
    Scar tissue in the lung that interferes with the ability to breathe
    Tessuto cicatriziale nel polmone che interferisce con la
    capacità di respirare
    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 20.0
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of VAY736 in patients with idiopathic pulmonary fibrosis
    Valutare l’efficacia di VAY736 in pazienti con FPI
    E.2.2Secondary objectives of the trial
    Impact of VAY736 on survival and disease progression.

    Other protocol-defined secondary objectives may apply
    Valutare l’impatto di VAY736 sulla sicurezza e la progressione della malattia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent must be obtained before any assessment is performed.
    2. Male and female subjects 40 to 80 years of age inclusive
    3. A diagnosis of definite or probable IPF within 5 years of the screening visit, as defined by the ATS/ERS/JRS/ALAT Diagnostic Guidelines (Raghu et al 2011)
    4. Seropositive at screening for at least one of the following auto-antibodies: RF, ANA, anti-dsDNA, anti-CCP, Scl-70, SSA (anti-Ro), SSB (anti-La), anti-RNP, anti-Smith, Jo-1, PL-7, PL-12, EJ, OJ, SRP, Ku, Mi-2, anti-PM/Scl;
    OR
    Presence of hilar/mediastinal adenopathy (>1cm in short-axis diameter), identified by screening HRCT scan of the chest
    5. FVC 50-90% predicted (inclusive)
    6. DLCO, corrected for hemoglobin, 30-79% predicted (inclusive)
    7. FEV1/FVC >70%
    8. Unlikely to die from cause other than IPF within the next 3 years, in the opinion of the investigator
    9. Unlikely to undergo lung transplantation during this trial
    10. Able to communicate well with the investigator, to understand and comply with the requirements of the study.

    Other protocol-defined inclusion/exclusion criteria may apply
    •Il consenso informato scritto deve essere ottenuto prima che sia eseguita qualsiasi valutazione.
    •Soggetti di sesso maschile e femminile di età compresa tra 40 e 80 anni compresi
    •Diagnosi di FPI definita o probabile entro 5 anni dalla visita di screening, secondo quanto stabilito dalle linee guida diagnostiche
    ATS/ERS/JRS/ALAT
    •Sieropositività allo screening per almeno uno dei seguenti autoanticorpi: RF, ANA, anti-dsDNA, anti-CCP, Scl-70, SSA (anti-Ro),
    SSB (anti-La), anti-RNP, anti-Smith, Jo-1, PL-7, PL-12, EJ, OJ, SRP, Ku, Mi-2, anti-PM/Scl; OPPURE Presenza di adenopatia
    ilare/mediastinica (>1 cm nel diametro dell’asse minore), identificata mediante scansione HRCT del torace eseguita allo screening
    •CVF 50-90% del valore previsto (compreso)
    •Diffusione alveolo-capillare del monossido di carbonio (DLCO), corretta per l’emoglobina, al 30-79% del valore previsto
    (compreso)
    •Volume espiratorio massimo in 1 secondo (VES1)/(CVF) >70%
    •Bassa probabilità di morire per una causa diversa da FPI nei 3 anni successivi, secondo il parere dello sperimentatore
    •Bassa probabilità di doversi sottoporre a un trapianto di polmone durante questa sperimentazione
    • In grado di comunicare bene con l'investigatore, per capire e rispettare i requisiti dello studio.
    Possono essere applicati altri criteri di inclusione / esclusione definiti dal protocollo
    E.4Principal exclusion criteria
    1. Emphysema > fibrosis on screening HRCT (must be confirmed by central reader)
    2. Active viral, bacterial or other infections requiring systemic treatment at the time of screening or enrollment, or history of recurrent clinically significant infection or of bacterial infections with encapsulated organisms
    3. History of major organ, hematopoietic stem cell or bone marrow transplant
    4. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (e.g., mAb of IgG1 class) or to any of the constituents of the study drug (sucrose, L-Arginine hydrochloride, L-histidine, polysorbate 80, hydrochloric acid)
    5. Receipt of live/attenuated vaccine within a 2 month period before baseline
    6. History of primary or secondary immunodeficiency, including a positive Human Immunodeficiency Virus (HIV) (Enzyme-linked Immunosorbent Assay (ELISA) and Western blot) test result
    7. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin, in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
    8. Any one of the following screening values of complete blood count laboratory values: Hemoglobin levels below 8.0 g/dL; Total leukocyte count less than 2,000/μL; Platelets <100.0 x 109/L; Absolute neutrophil count (ANC) <1.5 x 109/L
    9. Any surgical, medical (e.g., uncontrolled hypertension, heart failure or diabetes), psychiatric or additional physical condition that the Investigator feels may jeopardize the patient in case of participation in this study
    10. Positive hepatitis B surface antigen (HBsAg) with concurrent negative hepatitis B surface antibody (anti-HBs); or positive total hepatitis B core antibody (anti-HBc) with concurrent negative anti-HBs; or positive hepatitis C antibody (anti-HCV); i.e., any acute or chronic infection with hepatitis B or hepatitis C
    11. Evidence of active or latent tuberculosis (TB) infection, as determined by Quantiferon test (after anti-TB treatment, patients with history of or latent TB may become eligible according to national guidelines)

    Other protocol-defined inclusion/exclusion criteria may apply
    •Enfisema > fibrosi alla scansione HRCT eseguita allo screening (deve essere confermata mediante lettura centrale)
    •Infezioni virali attive, batteriche o di altro tipo che richiedono un trattamento sistemico al momento dello screening o
    dell'arruolamento o anamnesi di recidiva di infezione clinicamente significativa o di infezioni batteriche con organismi incapsulati
    •Anamnesi di trapianto di uno dei principali organi, cellule staminali ematopoietiche o midollo osseo
    •Anamnesi di ipersensibilità a uno qualsiasi dei farmaci in studio o ai farmaci di classi chimiche simili (ad esempio, mAb di classe
    IgG1) o a uno qualsiasi dei componenti del farmaco in studio (saccarosio, L-Arginina cloridrato, L-istidina, polisorbato 80, acido
    cloridrico)
    •Ha ricevuto un vaccino vivo / attenuato entro un periodo di 2 mesi prima del basale
    •Anamnesi di immunodeficienza primaria o secondaria, incluso un risultato del test positivo del virus dell'immunodeficienza umana
    (HIV) (saggio di immunoassorbimento enzimatico collegato (ELISA) e Western blot)
    •Anamnesi di malignità di qualsiasi sistema di organi (diverso dal carcinoma a cellule basali localizzate della cute, carcinoma
    cervicale in situ), trattati o non trattati, negli ultimi 5 anni, indipendentemente dal fatto che vi sia evidenza di recidiva locale o
    metastasi
    •Uno qualsiasi dei seguenti valori di screening dei valori di laboratorio con emocromo completo: livelli di emoglobina inferiori a 8,0
    g / dl; Conta leucocitaria totale inferiore a 2.000 / μL; Piastrine <100,0 x 109 / L; Conteggio assoluto dei neutrofili (ANC) <1,5 x 109
    / L
    •Qualsiasi intervento chirurgico, medico (per esempio ipertensione non controllata, insufficienza cardiaca o diabete), psichiatrico o
    condizione fisica aggiuntiva che l'Investigatore ritiene possa mettere a repentaglio il paziente in caso di partecipazione a questo
    studio
    •HBsAg positivo con anti-HBs negativo; o anti-HBc positivo con anti-HBs concomitante negativo; o anticorpo anti-epatite C positivo
    (anti-HCV); cioè qualsiasi infezione acuta o cronica con epatite B o epatite C
    •Evidenza di tubercolosi (TB) attiva o latente, determinata dal test Quantiferon (dopo il trattamento anti-TB, i pazienti con storia di
    tubercolosi latente o latente possono diventare idonei secondo le linee guida nazionali)
    Possono essere applicati altri criteri di inclusione / esclusione definiti dal protocollo
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to end of treatment epoch (48 weeks of treatment) in Forced Vital Capacity (FVC).
    variazione dal basale a fine trattamento (48 settimane di trattamento) nella capacità vitale forzata (CVF)
    E.5.1.1Timepoint(s) of evaluation of this end point
    end of treatment epoch (48 weeks of treatment)
    fine trattamento (48 settimane di trattamento)
    E.5.2Secondary end point(s)
    All-Cause mortality; Progression-free survival (PFS); Disease progression; Composite Endpoint; Change from baseline to end of treatment epoch (Week 48) in Diffusing Capacity of the Lungs (DLCO); Change from baseline to the end of treatment epoch (Week 48) in 6-minute walk test and in distance-saturation product; Change from baseline to the end of treatment epoch (Week 48) in resting oxygen saturation (on room air); Immunogenicity of VAY736; To assess the pharmacokinetics Cmin,ss of VAY736 after multiple s.c. doses; Idiopathic Pulmonary Fibrosis (IPF) -related Mortality; Change from baseline to end of treatment epoch (Week 48) in Total Lung Capacity (TLC)
    Other protocol defined endpoints may apply
    Mortalità per tutte le cause; Sopravvivenza libera da progressione (PFS); progressione della
    Malattia; Endpoint composito; Cambiamento dal basale alla fine del trattamento (Settimana 48) nella Capacità di diffusione dei
    polmoni (DLCO);
    cambiamento dal basale alla fine del trattamento (settimana 48) nel test della camminata di 6 minuti e nel prodotto di saturazione
    della distanza; Cambiamento dal basele alla fine del trattamento (settimana 48) nella saturazione dell'ossigeno a riposo (sull'aria
    della stanza); Immunogenicità di VAY736; Per valutare la farmacocinetica Cmin, ss di VAY736 dopo dosi multiple s.c.;
    Mortalità da Fibrosi Polmonare Idiopatica (IPF); Cambiamento dal basale alla fine del trattamento (settimana 48) nella capacità polmonare totale (TLC)
    Possono essere applicati altri endpoint definiti dal protocollo
    E.5.2.1Timepoint(s) of evaluation of this end point
    across the 48 weeks of treatment and at the end of study
    nelle 48 settimane di trattamento e alla 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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Canada
    France
    Germany
    Ireland
    Italy
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    E.8.9.2In all countries concerned by the trial months6
    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: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 42
    F.4.2.2In the whole clinical trial 84
    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)
    None
    Nessuno
    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 Decision2018-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-02-13
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