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    Summary
    EudraCT Number:2009-016488-12
    Sponsor's Protocol Code Number:C13011
    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:2011-05-18
    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 number2009-016488-12
    A.3Full title of the trial
    A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberC13011
    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.3.8INN - Proposed INNMonoclonal antibodies
    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
    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
    moderate to Severe Crhon`s Disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10013099
    E.1.2Term Disease Crohns
    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 effect of vedolizumab induction treatment on clinical remission at Week 6 in the subgroup of patients defined as having failed tumor necrosis factor alpha (TNFα) antagonist therapy (TNFα subpopulation)
    E.2.2Secondary objectives of the trial
    To determine the effect of vedolizumab induction treatment on clinical remission at Week 6 in the entire study population To determine the effect of vedolizumab induction treatment on clinical remission at Week 10 in the TNF subpopulation and in the entire study population To determine the effect of vedolizumab induction treatment on sustained clinical remission (ie, clinical remission at both Week 6 and Week 10) in the TNFα subpopulation and in the entire study population To determine the effect of vedolizumab induction treatment on enhanced clinical response at Week 6 in the TNF αsubpopulation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 to 80. 2. Male or female patient who is voluntarily able to give informed consent.Female patients who:  Are postmenopausal for at least 1 year before screening, OR  Are surgically sterile, OR  If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form (ICF) 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 postvasectomy), 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 CD established at least 3 months before enrollment by clinical and endoscopic evidence and corroborated by a histopathology report. Cases of CD established at least 6 months before enrollment for which a histopathology report is not available will be considered based on the weight of the evidence supporting the diagnosis and excluding other potential diagnoses, and must be discussed with the sponsor’s (or designee’s) medical monitor on a case-by-case basis before enrollment. 5. Moderately to severely active CD as determined by a CDAI score of 220 to 400(see Section 15.1) within 7 days before enrollment and 1 of the following: a. CRP level > 2.87 mg/L during the Screening period, OR b. Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomotic ulcerations (each > 0.5 cm in diameter) or 10 aphthous ulcerations (involving a minimum of 10 contiguous cm of intestine) consistent with CD, within 4 months before enrollment, ORFecal calprotectin ≥ 250 g/g stool during the Screening period in conjunction with computed tomography (CT) enterography, magnetic resonance (MR) enterography, contrast-enhanced small bowel radiography, or wireless capsule endoscopy revealing Crohn’s ulcerations (aphthae not sufficient), within 4 months before screening. (Patients with evidence of fixed stenosis or small bowel stenosis with prestenotic dilation should not be included.) 6. CD involvement of the ileum and/or colon, at a minimum. 7. Patients with extensive colitis or pancolitis of > 8 years duration or limited colitis of > 12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months before enrollment (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-todate on colorectal cancer surveillance (may be performed during screening).Demonstrated, over the previous 5-year period, an inadequate response to, loss of response to, or intolerance of at least 1of the following agents as defined below:  Immunomodulators o Signs and symptoms of persistently active disease despite a history of at least one 8-week regimen of oral azathioprine (≥ 1.5 mg/kg) or 6-MP (≥ 0.75 mg/kg), OR o Signs and symptoms of persistently active disease despite a history of at least one 8-week regimen of methotrexate (≥ 12.5 mg/week), OR o History of intolerance of at least 1 immunomodulator (including, but not limited to, nausea/vomiting, abdominal pain, pancreatitis, liver function test abnormalities, lymphopenia, TPMT genetic mutation, infection).TNF antagonists o Signs and symptoms of persistently active disease despite a history of at least one 4-week induction regimen of 1 of the following agents:  Infliximab: 5 mg/kg IV, 2 doses at least 2 weeks apart  Adalimumab: one 80-mg subcutaneous (SC) dose, followed by one 40-mg dose, at least 2 weeks apart  Certolizumab pegol: 400 mg SC, 2 doses atleast(vd protocollov116/09/2010)
    E.4Principal exclusion criteria
    1. Evidence of abdominal abscess during screening 2. Extensive colonic resection or subtotal or total colectomy 3. History of > 3 small bowel resections or diagnosis of short bowel syndrome4. Have received tube feeding, defined formula diets, or parenteral alimentation within 21 days before enrollment 5. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine 6. Within 30 days before enrollment, have received any of the following for the treatment of underlying disease: a. Nonbiologic therapies (eg, cyclosporine, thalidomide) other than those specifically listed in Section 6.2.1 b. A nonbiologic investigational therapy c. An approved nonbiologic therapy in an investigational protocol d. Adalimumab 7. Within 60 days before enrollment, have received any of the following: a. Infliximab b. Certolizumab pegol c. Any other investigational or approved biological agent, other than local administration for non-IBD conditions (eg, intra-ocular injections) 8. Any prior exposure to natalizumab, efalizumab, or rituximab 9. Use of topical (rectal) treatment with 5-ASA or corticosteroid enemas/suppositories within 2 weeks before enrollment 10. Evidence of or treatment for C. difficile infection or other intestinal pathogen within 28 days before enrollment 11. Currently require or are anticipated to require major surgical intervention for CD (eg, bowel resection) during the study. (Minor surgical procedures to treat complications of CD [eg, fistulotomy] are acceptable.) 12. History or evidence of adenomatous colonic polyps that have not been removed 13. History or evidence of colonic mucosal dysplasia (vd protocollo v 1 16/09/2010)
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients in clinical remission at Week 6 in the TNF alpha subpopulation
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA56
    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 years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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 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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 137
    F.4.2.2In the whole clinical trial 396
    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 Decision2011-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-30
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