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    Summary
    EudraCT Number:2014-003942-28
    Sponsor's Protocol Code Number:MLN0002-3023
    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:2021-01-19
    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 number2014-003942-28
    A.3Full title of the trial
    Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Vedolizumab IV for the
    Treatment of Primary Sclerosing Cholangitis, With Underlying Inflammatory Bowel Disease
    Studio randomizzato, globale, in doppio cieco, controllato con placebo, a gruppi paralleli, volto a valutare l¿efficacia e la sicurezza di vedolizumab per infusione endovenosa EV per il trattamento della colangite sclerosante primitiva con malattia infiammatoria intestinale sottostante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Vedolizumab IV in the treatment of Primary Sclerosing Cholangitis in patients with Inflammatory Bowel Disease
    Efficacia e Sicurezza di vedolizumab EV per il trattamento della colangite sclerosante primitiva con malattia infiammatoria intestinale
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and Safety of Vedolizumab IV in the treatment of Primary Sclerosing Cholangitis in patients
    Efficacia e Sicurezza di vedolizumab EV per il trattamento della colangite sclerosante primitiva con
    A.4.1Sponsor's protocol code numberMLN0002-3023
    A.5.4Other Identifiers
    Name:NANumber:NA
    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 SponsorTAKEDA DEVELOPMENT CENTRE EUROPE LTD
    B.1.3.4CountryUnited Kingdom
    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 supportTakeda Development Centre Europe Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Development Centre Europe Ltd
    B.5.2Functional name of contact pointStudy Manager
    B.5.3 Address:
    B.5.3.1Street Address61 Aldwych
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC2B 4AE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442031168000
    B.5.5Fax number+442031168199
    B.5.6E-mailclinicaloperations@tgrd.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 Yes
    D.2.1.1.1Trade name Entyvio
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 943609-66-3
    D.3.9.2Current sponsor codeMLN0002
    D.3.9.4EV Substance CodeSUB30452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 injection
    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
    Primary Sclerosing Cholangitis (PSC)
    Inflammatory Bowel Disease (IBD)
    Colangite sclerosante primitiva (CSP)
    Malattia infiammatoria intestinale (IBD)
    E.1.1.1Medical condition in easily understood language
    Liver disease
    Inflammatory bowel disease
    Malattia del fegato
    Malattia infiammatoria intestinale
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10036732
    E.1.2Term Primary sclerosing cholangitis
    E.1.2System Organ Class 100000004871
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10021973
    E.1.2Term Inflammatory bowel disease NOS
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10021972
    E.1.2Term Inflammatory bowel disease
    E.1.2System Organ Class 10017947 - Gastrointestinal 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 evaluate the efficacy and safety of vedolizumab IV in non¿end-stage PSC subjects with underlying IBD.
    Valutare l¿efficacia e la sicurezza di vedolizumab EV in soggetti affetti da CSP in stadio non terminale con IBD sottostante.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of vedolizumab IV on inflammation and alkaline phosphatase (ALP) in non¿end-stage PSC subjects with underlying IBD.
    Valutare l¿effetto di vedolizumab EV sull¿infiammazione e sui livelli di fosfatasi alcalina (ALP) in soggetti affetti da CSP in stadio non terminale con IBD sottostante.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: An Magnetic Resonance Elastography (MRE) sub-study will be conducted at selected qualified sites, in a maximum of approximately 50% of subjects. Only subjects from the preselected sites will be included in this study; these subjects will undergo an MRE assessment at Screening,
    Week 54, and Week 106 or early termination (ET) visit, unless they have contraindications to the procedure.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Un sottostudio di elastografia a risonanza magnetica (MRE) sar¿ condotto in siti qualificati selezionati, in un massimo di circa il 50% dei soggetti. Solo i soggetti dai siti pre selezionati saranno inclusi in questo studio; questi soggetti saranno sottoposti ad una valutazione MRE allo screening,
    Settimana 54, e la Settimana 106 o visita di risoluzione anticipata (ET), a meno che non abbiano
    controindicazioni alla procedura.
    E.3Principal inclusion criteria
    1. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
    2. The subject or, when applicable, the subject's legally acceptable representative signs and dates a written, informed consent form and any
    required privacy authorization prior to the initiation of any study procedures.
    3. The subject has chronic cholestatic liver disease, of at least 6 months duration, with a subsequent diagnosis of PSC, based on cholangiographic
    findings of intrahepatic and/or extrahepatic bile duct irregularities consistent with PSC.
    4. The subject has a diagnosis of IBD (either UC, CD, or IBDU), established at least 3 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report.
    5. The subject is male or female and aged 18 years and older, inclusive.
    6. A male subject who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of the informed consent throughout the duration of the
    study and for 18 weeks after last dose.
    7. A female subject of childbearing potential* who is sexually active with a non-sterilized male partner agrees to routinely use adequate contraception from signing of the informed consent throughout the
    duration of the study and for 18 weeks after the last dose.
    8. The subject has had a colorectal cancer screen within 12 months of the Screening Visit with no signs of malignancy, dysplasia, or neoplasia.
    1.Secondo il parere dello sperimentatore, il soggetto è in grado di comprendere e rispettare i requisiti del protocollo.
    2.Il soggetto o, se applicabile, il rappresentante legalmente riconosciuto del soggetto firma e data il modulo di consenso informato e la autorizzazione relativa alla privacy necessari prima dell'inizio di eventuali procedure di studio.
    3. Il soggetto presenta un’epatopatia colestatica cronica, di durata pari almeno a 6 mesi, con una diagnosi successiva di CSP basata sul riscontro colangiografico di irregolarità dei dotti biliari intraepatici e/o extraepatici coerente con un quadro di CSP.
    4. Il soggetto ha una diagnosi di IBD (colite ulcerosa [CU], malattia di Crohn [CD] o IBD non classificata [IBDU]), formulata almeno 3 mesi prima dell’arruolamento in base all’evidenza clinica ed endoscopica e confermata da un referto istopatologico.
    5.Il soggetto è maschio o femmina e di età compresa tra 18 anni e più, compreso.
    6. Un soggetto di sesso maschile che non è sterilizzato e sessualmente attive con un partner di sesso femminile in età fertile si impegna ad utilizzare un adeguato metodo contraccettivo dalla firma del consenso informato per tutta la durata dello studio e per 18 settimane dopo l'ultima dose.
    7. Un soggetto femminile di età fertile * che è sessualmente attivo con un partner maschio non sterilizzato si impegna ad utilizzare regolarmente un adeguato metodo contraccettivo dalla firma del consenso informato per tutta la durata dello studio e per 18 settimane dopo l'ultima dose.
    8. Il soggetto ha avuto uno screening cancro colorettale entro 12 mesi dalla visita di screening senza segni di malignità, displasia o neoplasia.
    E.4Principal exclusion criteria
    1. The subject has had previous exposure to vedolizumab
    2. The subject has a history of hypersensitivity or allergies to vedolizumab
    3. The subject has had previous exposure to natalizumab, efalizumab, rituximab or any other integrin antagonist
    4. The subject has received any investigational or approved biologic or biosimilar agent
    5. The subject has received any of the following for the treatment of underlying disease within 30 days of screening:
    • Nonbiologic therapies other than those specifically listed in the protocol Section 7.3.1 Permitted Medications for the Treatment of IBD
    • An approved nonbiologic therapy in an investigational protocol
    6. The subject has, in the judgment of the investigator, clinically significant abnormal hematological parameters of hemoglobin,
    hematocrit, or erythrocytes
    7. The subject has any history of malignancy, except for (a) adequately treated nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has not recurred for at least 1 year prior to randomization;
    and (c) history of cervical carcinoma in situ that has not recurred for at least 3 years prior to randomization
    8. The subject has a history of any major neurological disorders,including stroke, multiple sclerosis, brain tumor, demylelinating or neurodegenerative disease
    9. The subject has a positive response on the PML subjective symptom checklist prior to the administration of study drug
    1.Il soggetto ha ricevuto vedolizumab in uno studio clinico precedente.
    2. Il soggetto ha una storia di ipersensibilità o allergie al Vedolizumab
    3.Il soggetto è stato precedentemente esposto a natalizumab, efalizumab, rituximab o a qualsiasi altro antagonista delle integrine.
    4.Il soggetto ha ricevuto qualsiasi agente biologico o biosimilare sperimentale approvato
    5. Il soggetto ha ricevuto una delle seguenti per il trattamento della malattia sottostante entro 30 giorni dallo screening:
    • terapie non biologiche diversi da quelle specificamente elencati nella protocollo Sezione 7.3.1 Farmaci consentiti per il trattamento del IBD
    • Una terapia biologica non autorizzata in un protocollo di sperimentazione
    6. Il soggetto ha, a giudizio del ricercatore, clinicamente significativi parametri ematologici anomali di emoglobina, ematocrito, o eritrociti
    7. Il soggetto ha una storia di neoplasia, ad eccezione di (a) carcinoma non metastatico a cellule basali della pelle trattati in modo adeguato; (b) cancro della pelle a cellule squamose cancro che non si è ripetuto per almeno 1 anno prima della randomizzazione;
    e (c) storia del carcinoma cervicale in situ, che non si è ripetuto da almeno 3 anni prima della randomizzazione
    8. Il soggetto ha una storia di grossi disturbi neurologici, tra cui ictus, sclerosi multipla, tumore al cervello, demielinizzante o malattie neurodegenerative
    9. Il soggetto ha una risposta positiva sulla lista di controllo del sintomo soggettivo di PML lista di controllo prima della somministrazione del farmaco
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects with no worsening in Ishak fibrosis staging score, from Baseline to the Week 106 visit
    L’endpoint primario per questo studio è la proporzione di soggetti senza alcun peggioramento del punteggio di Ishak per la stadiazione della fibrosi dal basale alla visita della Settimana 106.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 106
    Settimana 106
    E.5.2Secondary end point(s)
    ¿ Proportion of subjects with a =35% reduction in serum ALP from Baseline to the Week 106 visit.
    ¿ Change in Ishak necroinflammatory grading score from the Baseline visit to the Week 106 visit.
    Gli endpoint secondari per questo studio sono:
    ¿Proporzione di soggetti con una riduzione =35% nei livelli sierici di ALP dalla visita basale alla visita della Settimana 106.
    ¿Variazione nel punteggio di Ishak per il grado di necroinfiammazione dalla visita basale alla visita della Settimana 106.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 106
    Settimana 106
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA57
    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
    Canada
    Israel
    Japan
    Russian Federation
    United States
    Austria
    Belgium
    Bulgaria
    Czechia
    Denmark
    Finland
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Spain
    Sweden
    Switzerland
    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
    For subjects who successfully complete the study they may be eligible of enrolling in an extension study.
    For subjects who do not enrol in the extension study, the study medication will not be available upon completion of the subject's participation in the study. The subject should be returned to the care of a physician and standard therapies as required.
    Per i soggetti che completano con successo lo studio potrebbero avere diritto di iscriversi in uno studio di estensione.
    Per i soggetti che non si iscrivono nello studio di estensione, il farmaco in studio non sar¿ disponibile al completamento della partecipazione del soggetto allo studio. Il soggetto deve essere restituito alle cure di un medico e terapie standard come richiesto.
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months7
    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: 246
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 151
    F.4.2.2In the whole clinical trial 258
    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)
    For subjects who successfully complete the study they may be eligible of enrolling in an extension study.
    For subjects who do not enrol in the extension study, the study medication will not be available upon completion of the subject's participation in the study. The subject should be returned to the care of a physician and standard therapies as required.
    Per i soggetti che completano con successo lo studio potrebbero avere diritto di iscriversi in uno studio di estensione.
    Per i soggetti che non si iscrivono nello studio di estensione, il farmaco in studio non sar¿ disponibile al completamento della partecipazione del soggetto allo studio. Il soggetto deve ritornare alle cure di un medico e alle terapie standard richieste.
    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 Decision2016-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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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