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    Summary
    EudraCT Number:2015-003270-32
    Sponsor's Protocol Code Number:IISR-2014-100922
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-03-20
    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 number2015-003270-32
    A.3Full title of the trial
    Identification of circulating and tissutal T cell subsets to predict clinical and endoscopical response to Entyvio® (vedolizumab) in patients with Ulcerative Colitis (UC) and Crohn’s disease (CD)
    Identificazione di subset di cellule T circolanti e tissutali nella predizione della risposta clinica ed endoscopica a Entyvio® (vedolizumab) in pazienti con colite ulcerosa (UC) e malattia di Crohn (CD) in fase attiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Identification of cells predicting response to Entyvio® (vedolizumab) in patients with Ulcerative Colitis and Crohn’s disease
    Identificazione di cellule in grado di prevedere la risposta al farmaco Entyvio® (vedolizumab) in pazienti con rettocolite ulcerosa e malattia di Crohn
    A.3.2Name or abbreviated title of the trial where available
    Immunological predictors of therapeutic response to vedolizumab
    Predittori immunologici di risposta terapeutica a vedolizumab
    A.4.1Sponsor's protocol code numberIISR-2014-100922
    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 SponsorFONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTakeda Pharma A/S
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
    B.5.2Functional name of contact pointUOC Gastroenterologia ed Endoscopia
    B.5.3 Address:
    B.5.3.1Street Addressvia Commenda 19
    B.5.3.2Town/ citymilano
    B.5.3.3Post code20122
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 0255033368
    B.5.5Fax number+39 0255032140
    B.5.6E-mailflavio.caprioli@unimi.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 Yes
    D.2.1.1.1Trade name ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderTAKEDA PHARMA A/S
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameentyvio
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVEDOLIZUMAB
    D.3.9.1CAS number 943609-66-3
    D.3.9.2Current sponsor code-
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative colitis (UC) and Crohn disease (CD)
    Colite ulcerosa (UC) e malattia di Crohn (CD)
    E.1.1.1Medical condition in easily understood language
    Inflammatory bowel diseases
    Malattie infiammatorie intestinali
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    E.1.2System Organ Class 10017947 - Gastrointestinal 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 evaluate the expression of α4β7 heterodimer in circulating T lymphocytes (CD4 and CD8) from active IBD patients and healthy controls, in combination with chemokine receptors known to define specific inflammatory and regulatory T cell subsets (Th1,Th17,Th1-17,Tc1,Tc17,Tregs)
    Valutare l'espressione dell’eterodimero α4β7 su linfociti T (CD4 e CD8) circolanti in pazienti con IBD attiva ed in controlli sani, in combinazione con molecole di superficie utili a definire subset specifici di cellule T infiammatorie e regolatorie (Th1, Th17, Th1-17, Tc17, Treg)
    E.2.2Secondary objectives of the trial
    To evaluate the expression of α4β7 in gut-infiltrating T lymphocytes (CD4 and CD8 subsets) of active IBD patients and controls and to correlate the relative frequencies of circulating and gut-infiltrating α4β7-expressing T cell subsets at baseline with the short-term (14 week) clinical and endoscopical response to Vedolizumab
    Valutare l'espressione dell’eterodimero α4β7 in linfociti T intestinali (CD4 e CD8) in pazienti con IBD attiva e controlli e correlare la frequenza relativa di subset T linfocitari α4β7-positivi prima della terapia con la risposta clinica ed endoscopica a breve termine (12 settimane) alla terapia con Vedolizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria (IBD patients):
    Patients with Crohn´s disease and ulcerative colitis qualified for vedolizumab therapy can be included.

    Key Inclusion Criteria (healthy controls):
    Healthy subject between 18 and 80 years old doing colonoscopy either for colorectal cancer screening or gastrointestinal symptoms
    Criteri di inclusione – pazienti IBD
    Pazienti adulti (18-80 anni)
    Diagnosi confermata di malattia di Crohn o colite ulcerosa da almeno 6 mesi
    HBI > 7 al basale o Mayo score > 6 e < 12
    SES-CD > 2 al basale
    Punteggio Mayo parziale endoscopico > 1
    Assunzione di tiopurine, se in dose stabile negli ultimi 4 mesi

    Criteri di inclusione – soggetti sani
    Soggetti adulti (18-80 anni) sottoposti ad ileocolonscopia a fini di screening del cancro colorettale o per sintomi gastrointestinali

    E.4Principal exclusion criteria
    Key Exclusion Criteria (IBD patients):
    1. Subjects <18 years or > 80 years
    2. History of malignancy in the previous 5 years
    3. Serious infections within 4 weeks prior to baseline or active chronic infections
    4. Pregnancy or lactation
    5. Any medical condition that could negatively impact on the participation to the study
    6. Therapy with any investigational or approved biologics within the last 60 days

    Key Exclusion Criteria (healthy controls):
    1. Subjects <18 years or > 80 years
    2. Serious infections within 4 weeks prior to baseline or active chronic infections
    3. Pregnancy or lactation
    4. Any medical condition that could negatively impact on the participation to the study, in particular previous diagnosis of cancer or IBD.
    5. Endoscopic signs of intestinal inflammation at baseline endoscopy, or detection of adenoma or colorectal cancer at screening endoscopy.
    Criteri di esclusione - pazienti IBD
    Soggetti > 80 anni o < 18 anni
    Storia di neoplasia maligna nei 5 anni precedenti
    Gravi infezioni entro 4 settimane prima dello screening o infezioni croniche attive
    Gravidanza o allattamento
    Qualsiasi condizione medica che potrebbe incidere negativamente sulla partecipazione allo studio
    Terapia con antiTNF negli ultimi 60 giorni

    Criteri di esclusione – soggetti sani
    Soggetti > 80 anni o < 18 anni
    Gravi infezioni entro 4 settimane prima dello screening o infezioni croniche attive
    Gravidanza o allattamento
    Qualsiasi condizione medica che potrebbe incidere negativamente sulla partecipazione allo studio, in particolare precedente diagnosi di tumore o IBD.
    Segni endoscopici di infiammazione intestinale all'endoscopia basale o rilevazione di adenoma o cancro colorettale all'endoscopia di screening.

    E.5 End points
    E.5.1Primary end point(s)
    to correlate the relative frequencies of circulating and gut-infiltrating α4β7-expressing T cell subsets at baseline with the short-term (14 week) clinical and endoscopical response to Vedolizumab
    correlare la frequenza relativa di subset T linfocitari α4β7-positivi circolanti e intestinali prima della terapia con la risposta clinica ed endoscopica a breve termine (14 settimane) alla terapia con Vedolizumab
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 weeks
    14 settimane
    E.5.2Secondary end point(s)
    to evaluate the expression of α4β7 in gut-infiltrating T lymphocytes (CD4 and CD8 subsets) of active IBD patients and controls;
    valutare l'espressione dell’eterodimero α4β7 in linfociti T intestinali (CD4 e CD8) in pazienti con IBD attiva e controlli;
    E.5.2.1Timepoint(s) of evaluation of this end point
    14 weeks
    14 settimane
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    to evaluate predictive factors for the efficacy of the therapy
    valutazione fattori prognostici di risposta
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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 years2
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months24
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    Clinical follow up
    Follow up clinico e strumentale
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-13
    P. End of Trial
    P.End of Trial StatusOngoing
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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
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