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    Summary
    EudraCT Number:2015-000852-12
    Sponsor's Protocol Code Number:Vedolizumab-4003
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-20
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-000852-12
    A.3Full title of the trial
    TITLE
    A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn?s Disease

    SUMMARY
    The drug being tested in this study is called vedolizumab IV [intravenous(ly)]). Vedolizumab IV is being tested to treat people who have fistulizing Crohn's disease (CD). This study will look at fistula healing in people who take vedolizumab IV.
    The study will enroll approximately 126 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups?which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
    *Group 1: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 14 and 22, and a placebo infusion at Week 10 (dummy inactive infusion - this is a solution that looks like the study drug but has no active ingredient).
    *Group 2: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 10, 14 and 22.
    This multi-center trial will be conducted worldwide. The overall time to participate in this study from screening to 18 weeks after the last dose is 43 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 6 months after last dose of study drug for a follow-up assessment.
    TITULO
    Estudio de fase IV, aleatorizado, con doble enmascaramiento, para evaluar la seguridad y la proporción de sujetos con curación de una o más fístulas en dos regímenes de dosis de Entyvio (vedolizumab i.v.) en el tratamiento de la enfermedad de Crohn fistulizante

    RESUMEN
    El medicamento a investigar en este estudio es Vedolizumab IV (intravenoso). Vedolizumab IV está siendo evaluado para tratar pacientes con Enfermedad de Crohn (EC) fistulizante. Este estudio observará la curación de una o más fístulas en pacientes que toman Vedolizumab IV.
    El estudio reclutará aproximadamente 126 pacientes. Los participantes serán asignados aleatoriamente (a suertes, como tirar una moneda al aire) a uno de los dos grupos de tratamiento, que no será revelado al paciente ni al doctor del estudio (a no ser que exista una urgencia médica):
    *Grupo 1: Vedolizumab IV, dosis de 300 mg en la semana 0, 2, 6, 14 y 22, y una infusión de placebo en la semana 10 (infusión intravenosa inactiva - esta es una solución que se parece al medicamento del estudio pero que no tiene principio activo).
    *Grupo 2: Vedolizumab IV, dosis de 300 mg en las semanas 0, 2, 6, 10, 14 y 22.
    Este es un ensayo multicéntrico que se lleva a cabo a nivel mundial. El tiempo total de participación en el estudio des de la selección del paciente hasta 18 semanas después de la última dosis es 43 semanas. Los participantes se visitarán varias veces en el hospital y serán contactados por teléfono 6 meses después de la última dosis del medicamento del estudio para una valoración de seguimiento.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NCT02630966
    Estudio de fase IV (post-comercialización), aleatorizado (el grupo de dosis administrada al paciente es determinado como tirando una moneda al aire), con doble enmascaramiento (el grupo de dosis que le ha tocado será desconocido por el paciente y el doctor del ensayo), para evaluar la seguridad y la proporción de sujetos con curación de una o más fístulas en dos regímenes de dosis de Entyvio (nombre comercial de Vedolizumab intravenoso) en el tratamiento de la enfermedad de Crohn fistulizante
    A.3.2Name or abbreviated title of the trial where available
    ENTERPRISE
    ENTERPRISE
    A.4.1Sponsor's protocol code numberVedolizumab-4003
    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+44203116 8000
    B.5.5Fax number+44203116 8199
    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 concentrate 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.3.8INN - 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 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 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 placeboInfusion
    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
    Fistulizing Crohn?s Disease (CD)
    Enfermedad de Crohn (EC) fistulizante
    E.1.1.1Medical condition in easily understood language
    Crohn?s disease is an inflammatory disease of the gastrointestinal tract.
    La Enfermedad de Crohn es una enfermedad inflamatoria del tracto gastrointestinal
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10075465
    E.1.2Term Fistulizing Crohn's disease
    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
    The primary objective is to evaluate the proportion of subjects with fistula healing at Week 30 in 2 different dose regimens of vedolizumab IV 300mg in subjects with fistulizing CD.
    El objetivo primario es evaluar la proporcion de sujetos con curacion de una o mas fistulas en la semana 30 con dos regímenes diferentes de dosis de vedolizumab i.v. 300 mg en sujetos con Enfermedad de Crohn.
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate fistula healing over a 30-week evaluation period.
    El objetivo secundario es evaluar la curación de las fístulas a lo largo de un periodo de 30 semanas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Adult subjects, aged 18 to 80 years, inclusive, with moderately to severely active CD and 1 to 3 draining perianal fistula(e) of at least 2 weeks duration.
    -Subjects who have historically had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-alfa antagonist for their underlying CD (does not require treatment failure for currently active draining fistula).
    -Noncutting seton placement as part of standard of care within 1 to 4 weeks prior to randomization.
    -Sujetos adultos, de entre 18 y 80 años de edad, ambos inclusive, con EC con actividad de moderada a muy grave y con entre 1 y 3 fístulas perianales drenantes de al menos dos semanas de duración.
    -Sujetos que han presentado en el pasado una respuesta inadecuada, una pérdida de respuesta o una intolerancia al tratamiento convencional o a un antagonista del FNT-alfa administrado para tratar su EC subyacente (no requiere fracaso del tratamiento para la fístula drenante activa actual).
    -Colocación de un setón sin realizar corte, como parte de la atención de rutina, entre 1 y 4 semanas antes de la aleatorización.
    E.4Principal exclusion criteria
    -Subjects who have perianal abscesses greater than 2 cm or an abscess that the investigator feels requires drainage based on either clinical assessment or MRI.
    -Subjects who have a CDAI score greater than 400.
    -Subjects who have ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
    -Subjects who have significant anal or rectal stenosis.
    -Subjects who have any evidence of an active infection (eg, sepsis, cytomegalovirus, or listeriosis) during Screening, other than related to the fistula(e).
    -Subjects who have a positive progressive multifocal leukoencephalopathy (PML) subjective checklist.
    -Subjects who have received any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of randomization (whichever is longer).
    -Subjects who have had prior exposure to vedolizumab, natalizumab, efalizumab, or rituximab.
    -Sujetos con abscesos perianales de más de 2 cm o un absceso que el investigador considera que requiere drenaje en base a la evaluación clínica o a la RM.
    -Sujetos con una puntuación CDAI superior a 400.
    -Sujetos con una ileostomía, colostomía o con una estenosis intestinal sintomática conocida.
    -Sujetos con una estenosis anal o rectal significativa.
    -Sujetos que presenten evidencia de infección activa (p. ej., septicemia, citomegalovirus o listeriosis) durante la Selección, aparte de la infección asociada a la fístula o fístulas.
    -Sujetos con resultado positivo en una lista de verificación subjetiva para leucoencefalopatía multifocal progresiva (LMP).
    -Sujetos que han recibido cualquier fármaco biológico o biosimilar aprobado o en investigación en los 60 días o 5 semividas (lo que sea más largo) posteriores a la aleatorización.
    -Sujetos que han recibido previamente vedolizumab, natalizumab, efalizumab o rituximab.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is the proportion of subjects with a reduction of at least 50% from Day 1 in the number of draining fistulae at Week 30 (where closed fistulae are no longer draining despite gentle finger compression).
    La principal valoración de este estudio es la proporción de sujetos con una reducción de al menos el 50 porciento en el número de fístulas drenantes en la semana 30 en comparación con el día 1 (donde las fístulas cerradas no drenan aunque se ejerza una leve presión con el dedo).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 30
    En la semana 30
    E.5.2Secondary end point(s)
    -The proportion of subjects with 100% fistulae closure at Week 30 (where all fistulae are no longer draining despite gentle finger compression).
    -Time to first fistula closure.
    -Time to last (100%) fistulae closure.
    -Duration of fistula response (number of days with drainage)
    -La proporción de sujetos con cierre del 100 porcien de las fístulas en la semana 30 (donde no drena ninguna fístula aunque se ejerza una leve presión con el dedo).
    -Tiempo hasta el cierre de la primera fístula.
    -Tiempo hasta el cierre de la última (100 %) fístula.
    -Duración de la respuesta fistular (p.ej., número de días con drenaje).
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 week period
    Periodo de 30 semanas
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 EEA15
    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
    Belgium
    Canada
    France
    Italy
    Netherlands
    Spain
    United Kingdom
    United States
    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
    The end of trial will be the date of the last visit of the last subject at the Week 40 Follow-up Visit
    El fin del ensayo será la fecha de la última visita del último paciente en la semana 40, Visita de Seguimiento.
    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 months6
    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 months6
    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: 107
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 19
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 126
    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 a patient has completed/terminated their study participation, long term care for the participant will remain the responsibility of their primary treating physicians
    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 Decision2016-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-14
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