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    Summary
    EudraCT Number:2017-002182-21
    Sponsor's Protocol Code Number:Vedolizumab-2005
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-12-15
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-002182-21
    A.3Full title of the trial
    A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.
    (Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or
    Crohn’s Disease)
    Étude d’extension de phase 2b visant à déterminer la sécurité d’emploi à long terme du védolizumab en IV chez des enfants atteints de rectocolite hémorragique ou de la maladie de Crohn.
    (Sécurité d'emploi à long-terme du védolizumab en IV chez des enfants atteints de rectocolite hémorragique ou de la maladie de Crohn)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease
    Etude d'extension visant à évaluer la sécurité d'emploi chez des enfants atteints de rectocolite hémorragique ou de la maladie de Crohn
    A.3.2Name or abbreviated title of the trial where available
    Hubble Zoom
    A.4.1Sponsor's protocol code numberVedolizumab-2005
    A.5.4Other Identifiers
    Name:IND numberNumber:009125
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/146/2017
    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
    B.5.2Functional name of contact pointTakeda Study Registration Call Cent
    B.5.3 Address:
    B.5.3.1Street AddressUknown
    B.5.3.2Town/ cityUknown
    B.5.3.3Post codeUknown
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1877825-3327
    B.5.6E-mailmedicalinformation@tpna.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.3.2Product code MLN0002
    D.3.4Pharmaceutical form Powder 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.3.9.3Other 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) Yes
    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 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.3.2Product code MLN0002
    D.3.4Pharmaceutical form Powder 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.3.9.3Other 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 number150
    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) Yes
    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: 3
    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.3.2Product code MLN0002
    D.3.4Pharmaceutical form Powder 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.3.9.3Other 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 number200
    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) Yes
    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: 4
    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.3.2Product code MLN0002
    D.3.4Pharmaceutical form Powder 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.3.9.3Other 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 number100
    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) Yes
    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
    Ulcerative Colitis or Crohn’s Disease
    Rectocolite hémorragique ou maladie de Crohn
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis (UC) is an inflammatory disease of the large bowel.
    Crohn's disease (CD) is an inflammatory disease of the gastrointestinal tract.
    La rectocolite hémorragique (RCH) est une maladie inflammatoire de l'intestin grêle.
    La maladie de Crohn (MC° est une maladie inflammatoire du tractus gastro-intestinal.
    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 PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    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 determine the safety profile of long-term vedolizumab IV treatment in pediatric subjects with UC or CD.
    Déterminer le profil de sécurité d’emploi à long terme du traitement par védolizumab par voie IV chez des enfants atteints de RCH ou de MC.
    E.2.2Secondary objectives of the trial
    -To determine the effect of long-term vedolizumab IV treatment on time to major inflammatory bowel disease (IBD)-related events (hospitalizations, surgeries, and procedures) in pediatric subjects with UC or CD.
    -To examine the effect of long-term vedolizumab IV treatment on health-related quality-of- life measurements in pediatric subjects with UC or CD.
    -To determine the effect of long-term vedolizumab IV treatment on patterns of growth and development in pediatric subjects with UC or CD.
    •Déterminer l’effet à long terme du traitement par védolizumab par voie IV sur le délai d’apparition d’événements majeurs liés à une maladie inflammatoire de l’intestin (MII) (hospitalisations, interventions chirurgicales et procédures) chez des enfants atteints de RCH ou de MC.
    •Examiner l’effet du traitement à long terme par védolizumab par voie IV sur les mesures de qualité de vie liée à la santé chez des enfants atteints de RCH ou de MC.
    •Déterminer l’effet du traitement à long terme par védolizumab par voie IV sur les schémas de croissance et de développement chez des enfants atteints de RCH ou de MC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -The subject is male or female with UC or CD and was between 2 to 17 years, inclusive, at the time of their first dose of study drug in Study MLN0002-2003. (Note: A subject remains eligible to participate in this study after they reach 18 years of age if they continue to meet the inclusion criteria and do not meet any exclusion criteria.)
    -The subject completed Study MLN0002-2003 and in the opinion of the investigator is expected to benefit from continued vedolizumab treatment.
    -Subjects with a family history of colorectal cancer, personal history of increased colorectal cancer risk, or other known risk factor must be up-to-date on colorectal cancer surveillance.
    -The subject may be receiving a therapeutic dose of the following drugs:
    – Oral 5-aminosalicylic (5-ASA) compounds.
    – Oral corticosteroid therapy (prednisone or equivalent steroid at a dose ≤50 mg/day, budesonide at a dos ≤9 mg/day).
    – Topical (rectal) treatment with 5-ASA or corticosteroid enemas/suppositories.
    – Probiotics (eg, Saccharomyces boulardii).
    – Antidiarrheals (eg, loperamide, diphenoxylate with atropine) for control of chronic diarrhea.
    – Antibiotics used for treatment of CD (eg, ciprofloxacin, metronidazole).
    – Azathioprine, 6-mercaptopurine, or methotrexate provided the subject was receiving this medication during prior participation in Study MLN0002-2003.
    •Le patient est de sexe masculin ou féminin, est atteint de RCH ou de MC, et était âgé de 2 à 17 ans inclus au moment de l’administration de sa première dose de médicament de l’étude dans l’étude MLN0002-2003. (Remarque : le patient reste éligible à participer à cette étude après avoir atteint la majorité (18 ans) s’il continue de satisfaire les critères d’inclusion et ne remplit aucun critère d’exclusion.)
    •Le patient a terminé l’étude MLN0002-2003 et l’investigateur estime que le patient tirera un bénéfice de la poursuite du traitement par védolizumab.
    •Les patients ayant des antécédents familiaux de cancer colorectal, des antécédents personnels de risque accru de cancer colorectal ou d’autres facteurs de risque connus doivent être à jour sur la surveillance du cancer colorectal.
    •Le patient peut recevoir une dose thérapeutique des médicaments suivants :
    – Composés oraux d’acide 5-aminosalicylique (5-ASA).
    – Traitement oral par corticoïdes (prednisone ou stéroïde équivalent à une dose ≤ 50 mg/jour, budésonide à une dose ≤ 9 mg/jour).
    – Traitement topique (rectal) par 5-ASA ou lavements/suppositoires à base de corticoïdes.
    – Probiotiques (par ex., saccharomyces boulardii).
    – Antidiarrhéiques (par ex., lopéramide, diphénoxylate avec atropine) pour contrôler des diarrhées chroniques.
    – Antibiotiques utilisés dans le traitement de la MC (par ex., ciprofloxacine, métronidazole).
    – Azathioprine, 6-mercaptopurine ou méthotrexate, à condition que le patient ait reçu ce médicament pendant sa participation antérieure à l’étude MLN0002-2003.
    E.4Principal exclusion criteria
    -The subject is female and is lactating or pregnant.
    -The subject has hypersensitivity or allergies to vedolizumab or any of its excipients.
    -The subject has withdrawn from Study MLN0002-2003.
    -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.
    -The subject has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.
    -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.
    -The subject has other serious comorbidities that will limit their ability to complete the study.
    •Le patient est une femme allaitante ou enceinte.
    •Le patient présente une hypersensibilité ou des allergies au védolizumab ou à l’un de ses excipients.
    •Le patient a quitté l’étude MLN0002-2003.
    •Le patient a développé une nouvelle affection cardiovasculaire instable ou non contrôlée, une insuffisance cardiaque modérée à sévère (New York Class Association III ou IV), une affection pulmonaire, hépatique, rénale, gastro-intestinale, génito-urinaire, hématologique, de coagulation, immunologique, endocrinienne/métabolique, neurologique ou autre affection médicale qui, de l’avis de l’investigateur, biaiserait les résultats de l’étude ou compromettrait la sécurité du patient.
    •Le patient répond positivement à une liste de contrôle des symptômes subjectifs de leucoencéphalopathie multifocale progressive (LEMP) avant l’administration de la première dose de médicament de l’étude.
    •Le patient a actuellement besoin d’une intervention chirurgicale lourde pour sa RCH ou MC (par ex. résection de l’intestin) ou devrait en avoir besoin pendant l’étude.
    •Le patient présente d’autres co-morbidités graves qui limiteront sa capacité à mener à bien l’étude.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is percentage of subjects with treatment-emergent adverse events (TEAEs).

    Le critère d'évaluation principal pour cette étude est le pourcentage de patients présentant des effets indésirables émergents.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monitored throughout the study
    Evalués tout au long de l'étude
    E.5.2Secondary end point(s)
    The secondary endpoints for this study are:
    - Time to major IBD-related events (hospitalizations, surgeries, or procedures).
    - Changes from Baseline in IMPACT-III (where translations are available) total and subscale scores at Week 24 and every 24 weeks, thereafter.
    - Height velocity at Week 48 and every 48 weeks, thereafter.
    - Change from Baseline in height, weight, and body mass index (BMI) at Week 24 and every 24 weeks, thereafter.
    - Percentage of subjects achieving Tanner stage V at or before age 16 years (females) or 17 years (males).
    Les critères d’évaluation secondaires de cette étude sont :
    •Délai d’apparition d’événements majeurs liés à une MII (hospitalisations, interventions chirurgicales ou procédures).
    •Variations, par rapport à la visite de référence, du score total et des sous-scores de l’IMPACT-III (dans la mesure des traductions disponibles) à la semaine 24 et toutes les 24 semaines par la suite.
    •Poussée de croissance à la semaine 48 et toutes les 48 semaines par la suite.
    •Variations par rapport à la visite de référence de la taille, du poids et de l’indice de masse corporelle (IMC) à la semaine 24 et toutes les 24 semaines par la suite.
    •Pourcentage de patients atteignant le stade V de Tanner à l’âge ou avant l’âge de 16 ans (filles) ou 17 ans (garçons).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Monitored throughout the study
    Evalués tout au long de l'étude
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Vedolizumab to be tested at doses of 300mg, 200mg, 150 mg and 100mg
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Germany
    Hungary
    Israel
    Netherlands
    Poland
    Ukraine
    United Kingdom
    United States
    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
    Final Safety Visit 18 weeks after last dose of study drug and participate in a long-term follow-up safety survey by telephone 6 months after the last dose of study drug.
    La fin de l'étude sera la visite de sécurité finale 18 semaines après la dernière dose de médicament de l'étude et la participation à un suivi téléphonique sur la sécurité à long terme, 6 mois après la dernière dose de médicament d'étude.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months7
    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: 80
    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: 35
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 45
    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 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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 31
    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)
    None
    Aucun
    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 Decision2017-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-18
    P. End of Trial
    P.End of Trial StatusOngoing
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