Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36818   clinical trials with a EudraCT protocol, of which   6079   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2008-002784-14
    Sponsor's Protocol Code Number:C13008
    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:2009-03-17
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2008-002784-14
    A.3Full title of the trial
    A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberC13008
    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.1.1Name of SponsorMILLENNIUM PHARMACEUTICALS, 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 support
    B.4.2Country
    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.3.9.1CAS number 943609-66-3
    D.3.9.2Current sponsor codeMLN0002
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with Ulcerative Colitis (UC) and Crohn’s Disease (CD)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10045282
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10011401
    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 MLN0002 treatment
    E.2.2Secondary objectives of the trial
    To determine the effect of long-term MLN0002 treatment on time to major
    inflammatory bowel disease (IBD)-related events (hospitalizations, surgeries, and
    procedures)
    To examine the effect of long-term MLN0002 treatment on health-related quality
    of life (QOL) measurements
    Exploratory Objective
    To obtain data regarding the effect of long-term MLN0002 treatment on
    maintaining clinical response and remission
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Voluntarily able to give informed consent.
    2. Previous treatment in Study C13004, Study C13006 or Study C13007 that, in the
    opinion of the investigator, was well tolerated. Patients who withdrew early from
    C13006 or C13007 must have withdrawn due to one of the following:
    Sustained Nonresponse for patients with UC in C13006: Failure to achieve a
    clinical response (2 point and 25% improvement in partial Mayo score) by
    Week 14 and a minimum partial Mayo score of &amp;#8805;5 points
    Sustained Nonresponse for patients with CD in C13007: Failure to achieve a
    clinical response (70 point improvement in CDAI score) by Week 14 and a
    minimum CDAI score of 220 points
    Disease Worsening for patients with UC in C13006: An increase in partial
    Mayo score of &amp;#8805;3 points on 2 consecutive visits from the Week 6 value (or an
    increase to 9 points on 2 consecutive visits if the Week 6 value >6) and a
    minimum partial Mayo score of &amp;#8805;5 points
    Disease Worsening for patients with CD in C13007: A &amp;#8805;100 point increase
    in CDAI score on 2 consecutive visits from the Week 6 value at any study
    visit and a minimum CDAI score of 220 points
    Rescue medications for patients in C13006 and C13007: Any new medication
    or any increase in dose of a baseline medication required to treat new or
    unresolved UC or CD symptoms (other than antidiarrheals for control of
    chronic diarrhea)
    3. The first dose of MLN0002 in this study (ie, Week 0) must occur not more than
    5 weeks after the last dose of study drug in the previous MLN0002 study.
    4. Female patients who:
    &amp;#56256;&amp;#56451; are post-menopausal for at least 1 year before enrollment, OR
    &amp;#56256;&amp;#56451; are surgically sterile, OR
    &amp;#56256;&amp;#56451; 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 MLN0002 through 6 months after the last dose of MLN0002, OR agree to
    completely abstain from heterosexual intercourse.
    Male patients, even if surgically sterilized (ie, status post-vasectomy), who:
    &amp;#56256;&amp;#56451; agree to practice effective barrier contraception during the entire study
    treatment period and through 6 months after the last dose of MLN0002, OR
    &amp;#56256;&amp;#56451; agree to completely abstain from heterosexual intercourse.
    5. 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 enrollment.
    6. 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.
    7. May be receiving a therapeutic dose of the following drugs:
    a. Oral 5-ASA compounds
    b. Oral corticosteroid therapy (prednisone at a stable dose &amp;#8804;30 mg/day,
    budesonide at a stable dose &amp;#8804;9 mg/day, or equivalent steroid)
    c. Topical (rectal) treatment with 5-ASA or corticosteroid enemas/suppositories
    d. Probiotics (eg, Culturelle, Saccharomyces boulardii)
    e. Antidiarrheals (eg, loperamide, diphenoxylate with atropine) for control of chronic diarrhea
    f. Antibiotics used for the treatment of CD (ie, ciprofloxacin, metronidazole).
    E.4Principal exclusion criteria
    1. Female patients who are lactating or pregnant
    2. Required surgical intervention for IBD during or after participation in a prior MLN0002 study, currently requires surgical intervention for IBD, or is anticipated to require surgical intervention for IBD during this study.
    3. Any live vaccinations within 30 days prior to MLN0002 administration except for the influenza vaccine.
    4. Development of any new, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation,
    immunological, endocrine/metabolic, neurologic, oncologic, or other medical
    disorder during or after participation in a prior MLN0002 study that, in the opinion of the investigator, would confound the study results or compromise patient safety.
    5. Withdrawal from a previous MLN0002 study due to a study-drug related AE.
    6. Active psychiatric or substance abuse problems that, in the investigator’s opinion, may interfere with compliance with the study procedures.
    7. Unable to attend all the study visits or comply with study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    SAEs, AEs,segni vitali, risultati degli esami standard di laboratorio (chimica clinica, ematologia, coagulazione, esame delle urine, HAHA) e risultati degli elettrocardiogrammi.
    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 No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA219
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 219
    F.4.2.2In the whole clinical trial 1508
    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)
    Dopo il completamento dello studio, o in caso di interruzione anticipata i pazienti parteciperanno ad un periodo di di follow-up di 2 anni. Un questionario specifico sara` richiesto telefonicamente 6, 12, 18 e 24 mesi dopo l`ultimo dosaggio del farmaco. IL questionario raccolgiera` i dati relativi ad infezioni gravi o insolite, displasia colorettale o cancro, altre patologie, ospedalizzazioni e interventi chirurgici, disfunzione neurologica persistente progressiva, e sviluppo di PML.
    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 Opinion2008-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA