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    The EU Clinical Trials Register currently displays   40051   clinical trials with a EudraCT protocol, of which   6562   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2008-002782-32
    Sponsor's Protocol Code Number:C13006
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-01-22
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2008-002782-32
    A.3Full title of the trial
    A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberC13006
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    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 support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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 infusion*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboPowder for infusion*
    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
    Patients with Moderate to Severe Ulcerative Colitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10009900
    E.1.2Term Colitis ulcerative
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    For the Induction Phase: To determine the effect of MLN0002 induction treatment on clinical response at 6 weeks.
    For the Maintenance Phase:
    To determine the effect of MLN0002 maintenance treatment on clinical remission at 52 weeks.
    E.2.2Secondary objectives of the trial
    for the Induction Phase
    To determine the effect of MLN0002 induction treatment on clinical remission at 6 weeks
    To determine the effect of MLN0002 induction treatment on mucosal healing at 6 weeks.
    Secondary Objectives for the Maintenance Phase
    To determine the effect of MLN0002 maintenance treatment on durability of clinical response
    To determine the effect of MLN0002 maintenance treatment on mucosal healing at 52 weeks
    To determine the effect of MLN0002 maintenance treatment on durability of clinical remission
    To determine the effect of MLN0002 maintenance treatment on corticosteroid-free remission at 52 weeks
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ALTRI SOTTOSTUDI: Sottostudio opzionale di farmacogenomica

    E.3Principal inclusion criteria
    1. Age 18 to 80
    2. Male or female patient who is voluntarily able to give informed consent
    3. Female patients who:
    Are post-menopausal for at least 1 year before the screening visit, OR
    Are surgically sterile, OR
    If they are of childbearing potential, agree to practice 2 effective methods of
    contraception, at the same time, from four weeks before the first dose of
    study drug through 6 months after the last dose of study drug, OR agree to
    completely abstain from heterosexual intercourse.
    Male patients, even if surgically sterilized (ie, status post-vasectomy), who:
    Agree to practice effective barrier contraception during the entire study
    treatment period and through 6 months after the last dose of study drug, OR
    Agree to completely abstain from heterosexual intercourse.
    4. Diagnosis of ulcerative colitis established at least 6 months prior to enrollment
    by clinical and endoscopic evidence and corroborated by a histopathology
    5. Moderately to severely active ulcerative colitis as determined by a Mayo score
    of 6 to 12 with an endoscopic subscore &amp;#8805;2 within 7 days prior to the first dose
    of study drug (see Section 15.1)
    6. Evidence of ulcerative colitis extending proximal to the rectum (&amp;#8805;15 cm of
    involved colon)
    7. Patients with extensive colitis 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 screening).
    8. Patients with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance (may be performed during screening).See protocol pp.39-41)
    E.4Principal exclusion criteria
    General Exclusion Criteria
    1. Previous exposure to MLN0002
    2. Female patients who are lactating or have a positive serum pregnancy test
    during the screening period or a positive urine pregnancy test on Day 1 prior to
    study drug administration.
    3. Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal,
    gastrointestinal, genitourinary, hematological, coagulation, immunological,
    endocrine/metabolic, or other medical disorder that, in the opinion of the
    investigator, would confound the study results or compromise patient safety
    4. Had any surgical procedure requiring general anesthesia within 30 days prior
    to enrollment or is planning to undergo major surgery during the study period
    5. Any history of malignancy, except for the following: (a) adequately-treated
    non-metastatic basal cell skin cancer; (b) any other type of non-melanoma skin
    cancer that has been adequately treated and has not recurred for at least 1 year
    prior to enrollment; and (c) adequately treated in situ cervical cancer that has
    not recurred for at least 1 year prior to enrollment
    6. History of any major neurological disorders, including stroke, multiple
    sclerosis, brain tumor, or neurodegenerative disease
    7. Positive PML subjective symptom checklist prior to the administration of the
    first dose of study drug
    8. Any of the following laboratory abnormalities during the screening period:
    a. Hemoglobin level <8 g/dL
    b. WBC count <3 × 109/L
    c. Lymphocyte count <0.5 × 109/L
    d. Platelet count <100 × 109/L or >1200 × 109/L. (See protocol pp. 41-44)
    E.5 End points
    E.5.1Primary end point(s)
    For the Induction Phase: Proportion of patients with clinical response at Week 6.
    For the Maintenance Phase: proportion of patients in clinical remission at Week 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 Yes
    E.6.7Pharmacodynamic Yes
    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. 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 Yes
    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 Yes
    E.8.2.3Other No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA116
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Settimana 52 o Early Termination Visit valutazioni di sicurezza ed efficacia)
    Visita della Settimana 66 (valutazioni di sicurezza)
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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.1.3Elderly (>=65 years) Yes
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 277
    F.4.2.2In the whole clinical trial 826
    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)
    I pazienti potrebbero essere idonei per la partecipazione ad uno studio clinico in aperto di long-term safety: C13008. I pazienti che non parteciperanno a questa sperimentazione saranno monitorati con una visita di follow-up telefonico 12 settimane dopo aver ricevuto l`ultima dose di farmaco in studio. In aggiunta i pazienti che non saranno arruolati nello studio C13008 parteciperanno ad un follow-uo di 2 anni.
    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 Decision2009-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-12
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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