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    Summary
    EudraCT Number:2021-000630-34
    Sponsor's Protocol Code Number:MLN0002-3029
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-10-28
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-000630-34
    A.3Full title of the trial
    A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease
    Estudio de extensión de fase 3b para evaluar la seguridad a largo plazo de vedolizumab intravenoso en pacientes pediátricos con colitis ulcerosa o enfermedad de Crohn
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the long term safety of Vedolizumab in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease
    Estudio para evaluar la seguridad a largo plazo de vedolizumab en pacientes pediátricos con colitis ulcerosa o enfermedad de Crohn
    A.4.1Sponsor's protocol code numberMLN0002-3029
    A.5.4Other Identifiers
    Name:INDNumber:009125
    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 Center Americas, Inc.
    B.1.3.4CountryUnited States
    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 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 Center Americas, Inc.
    B.5.2Functional name of contact pointDirector, Clinical Operations
    B.5.3 Address:
    B.5.3.1Street Address40 Landsdowne Street
    B.5.3.2Town/ cityCambridge, Massachusetts
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34900834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 AuthorisationEuropean Union
    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
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Yes
    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 nameMLN0002
    D.3.9.4EV Substance CodeSUB30452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 300
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active Ulcerative Colitis (UC) or Crohn's disease (CD)
    Colitis ulcerosa (CU) o enfermedad de Crohn (EC) activa
    E.1.1.1Medical condition in easily understood language
    Active UC or CD. UC is a long-term condition that results in inflammation and ulcers of the colon and rectum. CD is a disease that causes inflammation of the digestive system.
    CU o EC activa. La CU es una enfermedad crónica que produce inflamación y úlceras en el colon y el recto. La EC es una enfermedad que causa inflamación del sistema digestivo.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    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 of this study is to evaluate the safety profile of long-term vedolizumab IV treatment in pediatric subjects with UC or CD.
    El objetivo principal de este estudio consiste en evaluar el perfil de seguridad del tratamiento a largo plazo con vedolizumab IV en sujetos pediátricos con CU o EC.
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of long-term vedolizumab IV treatment on time to major inflammatory bowel disease (IBD)-related events (eg, hospitalizations, surgeries, and procedures) in pediatric subjects with UC or CD.
    • To evaluate quality of life in subjects aged 9 to 17 years who were treated with vedolizumab IV using the IMPACT-III questionnaire.
    • Evaluar el efecto del tratamiento a largo plazo con vedolizumab IV sobre el tiempo transcurrido hasta la aparición de episodios importantes relacionados con la enfermedad inflamatoria intestinal (EII) (por ejemplo, hospitalizaciones, intervenciones quirúrgicas y procedimientos) en sujetos pediátricos con CU o EC.
    • Evaluar la calidad de vida de sujetos de entre 9 y 17 años tratados con vedolizumab IV mediante el cuestionario IMPACT-III.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. In the opinion of the investigator, the subject, parent, or legal guardian is capable of understanding and complying with protocol requirements.
    2. The subject, parent, or legal guardian signs and dates a written, informed consent form and any required privacy authorization before the initiation of any study procedures.
    3. The subject is male or female with UC or CD and aged <18 years. (Note: Subjects who reach adult age [18 years of age in most jurisdictions/regions] during the study should be considered to transition to commercial drug if available in their country, especially if transition to an adult care setting is required by local regulation.).
    4. The subject has completed Study MLN0002-3024 or Study MLN0002-3025 and has achieved corticosteroid-free clinical response at Week 54 (and has tapered off of steroids, as applicable, at least 12 weeks before Week 54) as defined by a reduction of partial Mayo score of ≥2 points and ≥25% from baseline for subjects with UC; or a reduction of PCDAI of ≥15 points for subjects with CD from baseline of the parent study.
    5. A male subject who is sexually active with a female partner of childbearing potential agrees to use barrier method of contraception (eg, condom with or without spermicide) from signing of informed consent throughout the duration of the study and for 18 weeks after last dose. The female partner of a male subject should also be advised to use a highly effective method of contraception.
    6. A female subject of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of informed consent throughout the duration of the study and 18 weeks after the last dose.
    1. En opinión del investigador, el sujeto, progenitor o tutor legal es capaz de entender y cumplir los requisitos del protocolo.
    2. El sujeto, progenitor o tutor legal firma y fecha un documento de consentimiento informado por escrito y cualquier autorización necesaria en materia de privacidad antes del inicio de cualquiera de los procedimientos del estudio.
    3. El sujeto es un varón o mujer con CU o EC y tiene una edad menor de 18 años. (Nota: En los sujetos que alcancen la edad adulta [18 años en la mayoría de las jurisdicciones o regiones] durante el estudio deberá contemplarse la transición al fármaco comercial, si está disponible en su país, especialmente si la normativa local exige la transición a un entorno asistencial para adultos).
    4. El sujeto ha completado el estudio MLN0002-3024 o el estudio MLN0002-3025 y ha logrado una respuesta clínica sin corticosteroides en la semana 54 (y ha reducido progresivamente los corticosteroides, según proceda, al menos 12 semanas antes de la semana 54), definida como una reducción de la puntuación parcial de Mayo ≥2 puntos y ≥25% con respecto al momento basal en los sujetos con CU o una reducción de la puntuación PCDAI ≥15 puntos en los sujetos con EC con respecto al momento basal del estudio original.
    5. Los varones que mantengan relaciones sexuales con una pareja con capacidad reproductiva deben comprometerse a utilizar un método anticonceptivo de barrera (por ejemplo, preservativo con o sin espermicida) a partir de la firma del consentimiento informado, durante la totalidad del estudio y hasta 18 semanas después de la última dosis. También debe aconsejarse a las parejas de los varones participantes que utilicen un método anticonceptivo altamente eficaz.
    6. Las mujeres con capacidad reproductiva que mantengan relaciones sexuales con una pareja masculina no esterilizada deben comprometerse a utilizar un método anticonceptivo altamente eficaz a partir de la firma del consentimiento informado, durante la totalidad del estudio y hasta 18 semanas después de la última dosis.
    E.4Principal exclusion criteria
    1. The subject is female and is lactating or pregnant.
    2. The subject has hypersensitivity or allergies to any of the vedolizumab excipients.
    3. The subject currently requires major surgical intervention for UC or CD (eg, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
    4. The subject has developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise subject safety.
    5. The subject has other serious comorbidities that will limit their ability to complete the study.
    6. The subject is unable to comply with all study assessments.
    1. El sujeto es una mujer en período de lactancia o embarazada.
    2. El sujeto tiene hipersensibilidad o alergia a cualquiera de los excipientes de vedolizumab.
    3. El sujeto requiere actualmente una intervención de cirugía mayor para la CU o EC (por ejemplo, resección intestinal) o se prevé que la necesitará durante el estudio.
    4. El sujeto ha presentado insuficiencia cardíaca moderada o grave (clase III o IV de la New York Class Association) o cualquier trastorno cardiovascular, pulmonar, hepático, renal, digestivo, genitourinario, hematológico, de coagulación, inmunológico, endocrino/metabólico, neurológico o de otro tipo inestable o no controlado nuevo que, en opinión del investigador, podría confundir los resultados del estudio o comprometer la seguridad del sujeto.
    5. El sujeto presenta otras enfermedades concomitantes graves que limitarán su capacidad para completar el estudio.
    6. El sujeto no puede cumplir todas las evaluaciones del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is adverse events (AEs).
    El criterio de valoración principal de este estudio son los acontecimientos adversos (AA).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Once every 16 weeks until Week 48, thereafter once every 24 weeks.
    Cada 16 semanas hasta la semana 48 y cada 24 semanas a partir de entonces.
    E.5.2Secondary end point(s)
    • Time to major IBD-related events (eg, hospitalizations, surgeries, or procedures).
    • Changes from baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III total and subscale scores for subjects aged 9 to 17 years as measured every 24 weeks.
    • Tiempo transcurrido hasta episodios importantes relacionados con la EII (por ejemplo, hospitalizaciones, intervenciones quirúrgicas o procedimientos).
    • Variaciones con respecto al momento basal del estudio MLN0002-3024 (CU) o MLN0002-3025 (EC) de las puntuaciones total y de subescalas del cuestionario IMPACT-III en los sujetos de entre 9 y 17 años, medidas cada 24 semanas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time to major IBD-related events - through-out duration of the study.
    Changes from baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III total and subscale scores for subjects aged 9 to 17 years as measured - every 24 weeks.
    Tiempo transcurrido hasta episodios importantes relacionados con la EII a lo largo del estudio.
    Variaciones con respecto al momento basal del estudio MLN0002-3024 (CU) o MLN0002-3025 (EC) de las puntuaciones total y de subescalas del cuestionario IMPACT-III en los sujetos de entre 9 y 17 años, medidas cada 24 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 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 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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Diferentes dosis de medicamento en investigación en los brazos de tratamiento
    Different doses of IMP are used in treatment arms
    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 EEA41
    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
    Canada
    China
    Israel
    Japan
    Korea, Republic of
    United States
    Lithuania
    Poland
    Spain
    Czechia
    Greece
    Italy
    Belgium
    Croatia
    Hungary
    Russian Federation
    Slovakia
    Ukraine
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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 Yes
    F.1.1Number of subjects for this age range: 93
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 46
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 47
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2022-10-28. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children & adolescents (2-17)
    Niños y adolescentes (2-17)
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Pediatric patients
    Pacientes pediátricos
    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 43
    F.4.2.2In the whole clinical trial 93
    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 final safety visit will be performed 18 weeks after the last dose of study drug
    La visita final de seguridad se realizará 18 semanas después de la última dosis del medicamento en investigación
    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 Decision2023-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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