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    Summary
    EudraCT Number:2015-000939-33
    Sponsor's Protocol Code Number:MLN0002-3026
    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:2015-11-05
    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 number2015-000939-33
    A.3Full title of the trial
    A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis
    Estudio multicéntrico, aleatorizado, doble ciego, de doble simulación, controlado con principio activo para evaluar la eficacia y la seguridad del vedolizumab IV en comparación con el adalimumab SC en sujetos con colitis ulcerosa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC
    Eficacia y seguridad del vedolizumab IV en comparación con el adalimumab SC en sujetos con colitis ulcerosa
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis
    Eficacia y seguridad del vedolizumab IV en comparación con el adalimumab SC en sujetos con colitis u
    A.4.1Sponsor's protocol code numberMLN0002-3026
    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.4.1Name of organisation providing supportTakeda Development Center Americas, Inc
    B.4.2CountryUnited States
    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 number44203116 8000
    B.5.5Fax number44203116 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.3.1Product nameVedolizumab IV
    D.3.2Product code MLN0002
    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.3.9.3Other descriptive nameVEDOLIZUMAB
    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.IMP: 2
    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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Ltd.
    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 Solution for injection in pre-filled syringe
    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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    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
    Ulcerative Colitis
    Colitis Ulcerosa
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    Colitis Ulcerosa
    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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    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
    To determine the effect of vedolizumab IV compared to adalimumab SC on clinical remission at Week 52.
    Determinar el efecto del vedolizumab IV en comparación con el adalimumab SC sobre la remisión clínica en la semana 52
    E.2.2Secondary objectives of the trial
    ? To evaluate the effect of vedolizumab IV compared to adalimumab SC on mucosal healing at Week 52.
    ? To evaluate the effect of vedolizumab IV compared to adalimumab SC on corticosteroid-free remission at Week 52.
    Evaluar el efecto del vedolizumab IV en comparación con el adalimumab SC sobre la curación de la mucosa en la semana 52.
    Evaluar el efecto del vedolizumab IV en comparación con el adalimumab SC sobre la remisión sin corticosteroides en la semana 52.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Has a diagnosis of ulcerative colitis established at least 6 months prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.
    2.Has moderately to severely active ulcerative colitis as determined by a Mayo score of 6 to 12 with an endoscopic subscore greater than or equal to >=2 within 14 days prior to the randomization.
    3.Has evidence of ulcerative colitis proximal to the rectum (>=15 centimeter [cm] of involved colon).
    4.With extensive colitis (up to the hepatic flexure) or pancolitis of >8 years duration or left-sided colitis of >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit (may be performed during the Screening Period).
    5.Has had previous treatment with tumor necrosis factor- alpha (TNF-alpha) antagonists without documented clinical response to treatment or is naïve to TNF-alpha antagonist therapy but is failing current treatment.
    El sujeto presenta un diagnóstico de CU establecido al menos 6 meses antes de la inscripción en el estudio por medio de evidencia clínica y endoscópica y corroborado por un informe histopatológico.
    El sujeto presenta CU de moderada a gravemente activa según se determina mediante una puntuación Mayo completa de 6 a 12 con una subpuntuación endoscópica ? 2 en los 14 días previos a la aleatorización.
    El sujeto presenta indicios de CU que se extiende en sentido proximal al recto (? 15 cm de colon afectados).
    El sujeto ha sido tratado previamente con antagonistas del factor de necrosis tumoral alfa (TNF-?) sin respuesta clínica documentada al tratamiento o el sujeto no ha sido tratado anteriormente con antagonistas de TNF-? pero está fallando el tratamiento convencional actual.
    E.4Principal exclusion criteria
    1.Clinical evidence of abdominal abscess or toxic megacolon at Screening.
    2.The subject has had an extensive colonic resection, subtotal or total colectomy.
    3.The subject has had ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
    4.The subject has a diagnosis of Crohn's colitis or indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
    5.The subject has received any of the following within 30 days of screening:
    a.Non-biologic therapies other than those specifically listed in Section Permitted Medications For Treatment of UC.
    b.An approved non-biologic therapy in an investigational protocol.
    6.The subject has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half lives prior to the screening (whichever is longer).
    7.The subject has previously received natalizumab, efalizumab, adalimumab, or rituximab.
    8.The subject has history or evidence of adenomatous colonic polyps that have not been removed, or colonic mucosal dysplasia.
    9.Evidence of an active infection during Screening.
    10.Evidence of, or treatment for, C. difficile or other intestinal pathogen within 28 days prior to the 1st dose of study drug.
    11.The subject has chronic HBV or HCV infection.
    12.The subject has active or latent TB, regardless of treatment history.
    13.The subject has used a topical (rectal) treatment with (5-ASA) or corticosteroid enemas/suppositories within 2 weeks of the administration of the 1st dose of study drug.
    14.The subject has a history of hypersensitivity or allergies to vedolizumab or adalimumab.
    15.The subject has a positive PML subjective symptom checklist prior to the administration of the first dose of study drug.
    El sujeto se ha sometido a una resección colónica extensa o a colectomía subtotal o total.
    El sujeto presenta cualquier indicio de infección activa durante la selección.
    El sujeto presenta una lista de verificación subjetiva de la leucoencefalopatía multifocal progresiva (LMP) positiva antes de la administración del fármaco del estudio.
    El sujeto ha recibido cualquier agente biológico o biosimilar en investigación o aprobado en los 60 días o 5 semividas previos a la selección (lo que sea más largo).
    El sujeto se ha visto expuesto previamente al vedolizumab, natalizumab, efalizumab, adalimumab o rituximab.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects achieving clinical remission (defined as a complete Mayo score of ?2 points and no individual subscore >1 point) at Week 52.
    El criterio de valoración principal para el estudio es la proporción de sujetos que alcanzan la remisión clínica (definida como una puntuación Mayo completa ? 2 puntos y sin subpuntuaciones individuales > 1 punto) en la semana 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    Semana 52
    E.5.2Secondary end point(s)
    ? Proportion of subjects achieving mucosal healing (defined as Mayo endoscopic subscore ?1 point) at Week 52.
    ? Proportion of subjects using oral corticosteroids at Baseline who have discontinued corticosteroids and are in clinical remission at Week 52.
    ?Proporción de sujetos que alcanzan la cicatrización de la mucosa (definida con una subpuntuación endoscópica Mayo ? 1 punto) en la semana 52.
    ?Proporción de sujetos en tratamiento con corticosteroides orales al inicio del estudio que han dejado de tomarlos y están en remisión clínica en la semana 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 52
    Semana 52
    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 No
    E.6.7Pharmacodynamic No
    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) Yes
    E.8.2.2Placebo No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA140
    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
    Australia
    Belgium
    Bosnia and Herzegovina
    Bulgaria
    Canada
    Chile
    Colombia
    Croatia
    Czech Republic
    Denmark
    Estonia
    France
    Germany
    Hong Kong
    Hungary
    Israel
    Italy
    Korea, Republic of
    Latvia
    Lithuania
    Mexico
    Netherlands
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Slovakia
    Spain
    Taiwan
    Turkey
    Ukraine
    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
    End of trial will be the date of the last visit of the last subject at the Week 68 Follow-up visit
    Fin del ensayo será la fecha de la última visita del último sujeto tras visita de seguimiento de la Semana 68
    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 months4
    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 months4
    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: 638
    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 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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 246
    F.4.2.2In the whole clinical trial 658
    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)
    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.
    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 Decision2016-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-11
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