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    Summary
    EudraCT Number:2015-000555-24
    Sponsor's Protocol Code Number:100752
    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:2021-06-18
    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 number2015-000555-24
    A.3Full title of the trial
    Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Efficacy and Safety of Vedolizumab in Prevention of Endoscopic Recurrence of Crohn's Disease in Patients with Ileo-colonic Surgical Resection and Ileocolonic Anastamosis : REPREVIO (recurrence prevention with Entyvio)
    Studio multicentrico, randomizzato, controllato verso placebo, in doppio cieco, per determinare l’efficacia e sicurezza di vedolizumab nella prevenzione della recidiva endoscopica di malattia di Crohn in pazienti sottoposti a resezione ileo-colica e anastomosi ileo-colica. REPREVIO (recurrence prevention with Entyvio)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Effectiveness and Safety of Vedolizumab in Prevention of Recurrence of Crohn's Disease of the mucosa in Patients with Surgical Removel of the area between the small and the large bowel.
    Studio multicentrico, randomizzato, controllato verso placebo, in doppio cieco, per determinare l’efficacia e sicurezza di vedolizumab nella prevenzione della recidiva endoscopica di malattia di Crohn in pazienti sottoposti a resezione ileo-colica e anastomosi ileo-colica.
    A.3.2Name or abbreviated title of the trial where available
    REPREVIO
    REPREVIO
    A.4.1Sponsor's protocol code number100752
    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 SponsorAMC MEDICAL RESEARCH B.V.
    B.1.3.4CountryNetherlands
    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 supportAcademic Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointAmsterdam UMC, location AMC A3-254
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205661125
    B.5.5Fax number0031205669285
    B.5.6E-maile.clasquin@amsterdamumc.nl
    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 AuthorisationNetherlands
    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 nameVedolizumab IV
    D.3.2Product code [MLN0002]
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNvedolizumab
    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/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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) Yes
    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
    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
    Crohn's disease
    Malattia di Crohn
    E.1.1.1Medical condition in easily understood language
    Crohn's disease
    Malattia di Crohn
    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 LLT
    E.1.2Classification code 10013099
    E.1.2Term Disease Crohns
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Prevent postoperative endoscopic recurrence of Crohn’s disease in the neoterminal ileum.
    Prevenzione della recidiva post-operativa endoscopica della Malattia di Crohn nell'ileo neoterminale.
    E.2.2Secondary objectives of the trial
    Prevention of clinical recurrence of Crohn’s disease
    Prevenzione della recidiva della Malattia di Crohn
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
    - The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. Consent must be documented.
    - Established Crohn’s disease as the indication for ileocolonic resection. Only patients treated with either conventional therapy or anti-TNF antagonist before surgery and with documented inadequate response, loss of response or intolerance to such treatments can be enrolled
    - Age > 18
    - Ileocolonic resection with ileocolonic anastomosis and removal of all tissue macroscopically affected by CD according to the surgeon
    - Presence of at least 1 risk factor for recurrence:
    o Active smoking > 10 cigarettes/day
    o 2nd, 3rd or later resection
    o Surgery for perforating complication (abscess, fistula)
    o Previous exposure to anti-TNF antibodies
    - Females of childbearing potential will be included if they are either sexually inactive (sexually abstinent for 14 days prior to the first study drug dose continuing through 6 months after the last study drug dose, or, in case of sexually active women, using one of the following highly effective contraceptive methods (i.e.results in < 1 % failure rate when used consistently and correctly) in this trial:
    a) intrauterine device(IUD)
    b) surgical sterilization of the partner (vasectomy for 6 months minimum)
    c) combined (estrogen or progestogen containing) hormonal contraception associated with the inhibition of ovulation (either oral, intravaginal, or transdermal);
    d) progestogen only hormonal contraception associated with the inhibition of ovulation (either oral, injectable, or implantable);
    e) intrauterine hormone releasing system (IUS)
    f) bilateral tubal occlusion
    - Females of childbearing potential agree to remain sexually inactive or to keep the same birth control method for at least 6 months following the last dose.
    - A female of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to the first study dose:
    a) hysteroscopic sterilization;
    b) bilateral tubal ligation or bilateral salpingectomy;
    c) hysterectomy;
    d) bilateral oophorectomy;
    or be postmenopausal with amenorrhea for at least 1-year prior to the first study drug dose and follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status i.e. FSH > 40 IU/L.
    - A non-vasectomized male subject agrees to use a condom with spermicide during the study until 180 days beyond the last dose of study medication and the female partner agrees to comply with inclusion 7 or 9. For a vasectomized male who has had his vasectomy 6 months or more prior to study start, it is required that they use a condom during sexual intercourse. A male who has been vasectomized less than 6 months prior to study start must follow the same restrictions as a non-vasectomized male. If male, agrees not to donate sperm from the first study drug dose until 180 days after dosing.
    - Anti-TNF discontinued for at least 6 weeks prior to screening
    • Soggetti in grado, secondo lo sperimentatore, di comprendere e seguire le procedure previste dal protocollo
    • Ottenimento della firma del consenso informato e dell’autorizzazione al trattamento dei dati personali ai fini di ricerca antecedente all’avvio di qualsiasi procedura di studio. L’ottenimento del consenso deve essere documentato.
    • Diagnosi definita di Malattia di Crohn come indicazione per la resezione ileo-colica
    • Età >18 anni
    • Resezione ileo-colica con anastomosi ileo-colica e rimozione di tutti i tessuti macroscopicamente affetti da CD, secondo l’opinione del chirurgo
    • Presenza di almeno uno dei fattori di rischio di recidiva:
    o Fumo attivo (>10 sigarette al giorno)
    o Seconda, terza resezione o successiva
    o Chirurgia per complicanze correlate a perforazione (ascesso, fistola)
    o Precedente utilizzo di anticorpi anti-TNF
    • Soggetti di sesso maschile o donne non in gravidanza o allattamento. Soggetti di sesso femminile in età fertile dovranno avere test di gravidanza su siero negativo prima della randomizzazione e dovranno utilizzare metodi contraccettivi ormonali (orali, impiantabili o iniettabili) o di barriera per tutta la durata dello studio. Per le donne non potenzialmente fertili, dovrà essere documentata in cartella la causa di infertilità (legatura delle tube, isterectomia o stato post-menopausale, definito come minimo un anno dall’ultima mestruazione).
    • Sospensione degli anti-TNF almeno 6 mesi prima dello screening
    E.4Principal exclusion criteria
    - Patients that need to continue postoperative medication for their CD as per investigator's discretion, eg for fistulizing perianal CD.
    - Previous treatment with VDZ
    - Clinically significant CD elsewhere in the gastrointestinal tract not removed with surgery
    - Patients with clinically documented short bowel syndrome.
    - Patients with a history of cancer (other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer) with less than 2 disease-free documented years.
    - Patients with the following laboratory abnormalities:
    White blood count < 3 x 109/L
    Lymphocyte count < 0.5 x 109/L
    Hemoglobin < 8 g/dL
    Platelet count < 125 x 109/L or > 800 x 109/L
    ALT or AST > 3.0 times the upper limit of normal (ULN)
    Alkaline Phosphatase > 2.0 times the ULN
    Serum Creatinine > 2 times the ULN
    Prothrombin time (INR) > 1.5 times normal
    - Active participation in another trial.
    - Patients with abdominal abscess, active or latent tuberculosis or cancer.
    - A history of alcohol or illicit drug use that in the opinion of the principal investigator (PI) would interfere with study procedures.
    - Patients with psychiatric problems that in the opinion of the PI would interfere with study procedures.
    - Patients unable to attend all study visits.
    - Patients with a history of non-compliance with clinical study protocols.
    - Contraindication for endoscopy.
    - History of colonic dysplasia and /or colonic cancer
    - Received other biologics within the last 6 weeks of screening
    - Known HIV, hepatitis B or C infection
    - Evidence of or treatment for C. difficile infection or other intestinal pathogen within 4 weeks prior to enrollment or at screening
    - Active or latent tuberculosis
    - Received any investigational drug in the past 30 days or 5 half-lives, whichever is longer.
    - Positive PML subjective symptom checklist before enrollment
    - Patients exposed to a live vaccine in the previous 4 weeks before screening.
    - Patients with a history of hypersensitivity to the active substance or to any of it excipients
    -Patients with active or latent severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis and opportunistic infections.

    • Pazienti che debbano continuare i trattamenti per la malattia di Crohn, secondo giudizio dello sperimentatore, ad esempio pel malattia perianale fistolizzante.
    • Precedente trattamento con VDZ
    • Presenza di malattia di Crohn clinicamente significativa e non rimossa chirurgicamente in altre zone del tratto gastrointestinale
    • Pazienti con sindrome dell’intestino corto documentata clinicamente
    • Pazienti con anamnesi positiva per neoplasie maligne (ad eccezione di carcinoma cutaneo basocellulare o cellule squamose o, in caso di pazienti femmine, carcinoma della cervice in situ, escisso chirurgicamente) con intervallo libero da malattia inferiore ai due anni
    • Pazienti con le seguenti anomalie di laboratorio:
    o Leucociti < 3 x 109/L
    o Linfociti < 0.5 x 109/L
    o Emoglobina < 8 g/dL
    o Piastrine < 125 x 109/L o > 800 x 109/L
    o ALT o AST >3.0 volte il limite superiore della norma
    o Fosfatasi alcalina >3.0 volte il limite superiore della norma
    o Creatininemia >3.0 volte il limite superiore della norma
    o Tempo di protrombina (INR) >1.5 volte la norma
    • Partecipazione ad altro studio clinico
    • Pazienti con ascesso addominale, tubercolosi attiva o latente, cancro
    • Anamnesi positiva per abuso di alcol o altre sostanze da abuso che, secondo l’opinione dello sperimentatore, possa interferire con la partecipazione allo studio
    • Pazienti con problemi psichiatrici che, secondo lo sperimentatore, possano interferire con la partecipazione allo studio
    • Pazienti che non siano in grado di effettuare tutte le visite di studio
    • Pazienti che abbiano già mostrato scarsa compliance a procedure previste da protocolli di studio
    • Controindicazioni all’esecuzione di esami endoscopici
    • Anamnesi positiva per displasia o carcinoma del colon
    • Trattamenti con farmaci biologici nelle 6 settimane che precedono lo screening
    • Infezione da HIV, epatite B o C
    • Presenza di infezione, anche trattata farmacologicamente, da C.difficile o altro patogeno intestinale nelle 4 settimane che precedono il baseline o durante lo screening
    • Tubercolosi attiva o latente
    • Trattamento con farmaci sperimentali nei 30 giorni o 5 emivite precedenti, considerando il periodo più lungo tra i due
    • Checklist dei sintomi soggettivi per PML positiva prima dell’arruolamento
    • Pazienti esposti a un vaccino vivo nelle 4 settimane precedenti allo screening
    • Pazienti con una storia di ipersensibilità alla sostanza attiva o a uno qualsiasi degli eccipienti
    • Pazienti con infezioni gravi attive o latenti come la tubercolosi, la sepsi, l'infezione da citomegalovirus, la listeriosi e le infezioni opportunistiche.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with severe endoscopic postoperative recurrence of CD (Rutgeerts i2b, i3 or i4) after approximately 6 months (Week 26).
    Percentuale di pazienti che mostra recidiva endoscopica severa di CD (Rutgeerts i2b, i3 o i4) 6 mesi dopo la resezione ileocolica con anastomosi (pazienti stomizzati esclusi).
    Lo score endoscopico di Rutgeerts rappresenta un endpoint surrogato validato per valutare il decorso clinic successive della malattia (si veda l’appendice per il sistema di attribuzione del punteggio). Tutte le endoscopie saranno registrate per una successiva revisione e ri-lettura centralizzata.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 26
    Settimana 26
    E.5.2Secondary end point(s)
    The proportion of patients with any endoscopic recurrence of CD (Modified Rutgeerts Grade > i0) after 6 months; Changes in the CDAI (Crohn's disease activity index) and HBI (Harvey Bradshaw index) between week 0 and 26. ; Quality of life measure with a disease-specific instrument (IBDQ) and a generic QoL instrument (SF-36). ; Serum concentrations of vedolizumab and antibodies to vedolizumab before every infusion
    La proporzione di pazienti con recidiva endoscopica di CD (Modified Rutgeerts Grade> I0) dopo 6 mesi.; Andamento del CDAI (indice di attività della Malattia di Crohn) e HBI (indice Harvey Bradshaw) tra settimana 0 e 26; Qualità di misura la vita con uno strumento specifico per la malattia (IBDQ) e uno strumento QoL generici (SF-36). ; Le concentrazioni sieriche di Vedolizumab e anticorpi anti Vedolizumab prima di ogni infusione
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 26; at week 26 ; at week 26 ; at every visit
    A settimana 26; a settimana 26 ; a settimana 26 ; a tutte le visite
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) 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 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 EEA13
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    No specific programs. Best medical standard care
    Nessun programma specifico. La migliore cura standard.
    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 Decision2017-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-17
    P. End of Trial
    P.End of Trial StatusOngoing
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