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    Summary
    EudraCT Number:2009-016488-12
    Sponsor's Protocol Code Number:C13011
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-18
    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 ConcernedAustria - BASG
    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.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease
    A.4.1Sponsor's protocol code numberC13011
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01224171
    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 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 supportMillennium Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMillennium Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointDrug Information Call Center
    B.5.3 Address:
    B.5.3.1Street Addressn/a
    B.5.3.2Town/ cityn/a
    B.5.3.3Post coden/a
    B.5.3.4CountryUnited States
    B.5.4Telephone number +1 510 740 2412
    B.5.5Fax number +1 800 881 6092
    B.5.6E-mailmedical@mlnm.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 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 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.3.10 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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution 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 Crohn's Disease
    E.1.1.1Medical condition in easily understood language
    Crohn’s Disease
    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 14.0
    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 tumour necrosis factor alpha (TNF alpha) antagonist therapy (TNF alpha 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 alpha 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 TNF alpha
    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 alpha subpopulation
    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.
    3. Female patients who:
    • Are postmenopausal 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.
    Male patients, even if surgically sterilized, 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.
    5. Moderately to severely active CD as determined by a CDAI score of 220 to 400 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, OR
    c. Fecal calprotectin >250 micro 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.
    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.
    9. 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.
    • TNF alpha 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 at least 2 weeks apart,
    OR
    o Recurrence of symptoms during scheduled maintenance dosing
    following prior clinical benefit, OR
    o History of intolerance of at least 1 TNF alpha antagonist.
    • Corticosteroids
    o Signs and symptoms of persistently active disease despite a history
    of at least one 4-week induction regimen that included a dose
    equivalent to prednisone 30 mg daily orally for 2 weeks or
    intravenously for 1 week, OR
    o Two failed attempts to taper corticosteroids to below a dose
    equivalent to prednisone 10 mg daily orally on 2 separate occasions,
    OR
    o History of intolerance of corticosteroids (including, but not limited
    to, Cushing’s syndrome, osteopenia/osteoporosis, hyperglycemia,
    insomnia, and infection).10. May be receiving a therapeutic dose of the following drugs:
    a. Oral 5-ASA compounds provided that the dose has been stable for the
    2 weeks immediately before enrollment
    b. Oral corticosteroid therapy (prednisone at a stable dose <=30 mg/day,
    budesonide at a stable dose <=9 mg/day, or equivalent steroid) provided that
    the dose has been stable for the 4 weeks immediately before enrollment if
    corticosteroids have just been initiated, or for the 2 weeks immediately before
    enrollment if corticosteroids are being tapered
    c. Probiotics (eg, Culturelle, Saccharomyces boulardii) provided that the dose
    has been stable for the 2 weeks immediately before enrollment
    d. Antidiarrheals (eg, loperamide, diphenoxylate with atropine) for control of
    chronic diarrhea
    e. Azathioprine or 6-MP provided that the dose has been stable for the 8 weeks
    immediately before enrollment
    f. Methotrexate provided that the dose has been stable for the 8 weeks
    immediately before enrollment
    g. Antibiotics used for the treatment of CD (ie, ciprofloxacin, metronidazole)
    provided that the dose has been stable for the 2 weeks immediately before
    enrollment
    E.4Principal exclusion criteria
    Gastrointestinal 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 syndrome
    4. 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
    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 during the study.
    12. History or evidence of adenomatous colonic polyps that have not been removed
    13. History or evidence of colonic mucosal dysplasia
    14. Diagnosis of ulcerative colitis or indeterminate colitis
    Infectious Disease Exclusion Criteria
    1. Chronic hepatitis B or C infection
    2. Active or latent tuberculosis, regardless of treatment history, as evidenced by any
    of the following:
    a. History of tuberculosis
    b. A positive diagnostic TB test defined as:
    i. A positive QuantiFERON test or 2 successive indeterminate
    QuantiFERON tests within 1 month before enrollment, OR
    ii. A tuberculin skin test reaction => 10 mm ( => 5 mm in patients receiving
    the equivalent of > 15 mg/day prednisone) within 3 months before
    enrollment
    c. Chest X-ray within 3 months before enrollment in which active or latent
    pulmonary TB cannot be excluded
    3. Any identified congenital or acquired immunodeficiency
    4. Any live vaccinations within 30 days before enrollment except for the influenza
    vaccine
    5. Clinically significant extra-intestinal infection within 30 days before screening or during screening
    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 before
    enrollment.
    3. Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, GI,
    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 before enrollment or is planning to undergo major surgery during the study period.
    5. Any history of malignancy, except for the following: (a) adequately treated
    nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has been
    adequately treated and that has not recurred for at least 1 year before enrollment;
    and (c) history of cervical carcinoma in situ that has been adequately treated and
    that has not recurred for at least 3 years before enrollment.
    6. History of any major neurological disorders including, but not limited to, stroke,
    multiple sclerosis, brain tumor, or neurodegenerative disease.
    7. Positive PML subjective symptom checklist before enrollment.
    8. Any of the following laboratory abnormalities during the Screening period:
    a. Hemoglobin level <8 g/dL (80 g/L)
    b. White blood cell (WBC) count <3 x10^3/microL (3x10^9/L)
    c. Lymphocyte count <0.5x10^3/microL (0.5x10^9/L)
    d. Platelet count <100x10^3/microL (100x10^9/L) or >1200x10^3/microL (1200x10^9/L)
    e. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x the upper limit of normal (ULN)
    f. Alkaline phosphatase >3x ULN
    g. Serum creatinine >2x ULN
    h. Albumin <2.0 g/dL (<20 g/L)
    9. Current or recent history (within 1 year before enrollment) of alcohol dependence
    or illicit drug use.
    10. Active psychiatric problems that, in the investigator’s opinion, may interfere with
    compliance with the study procedures.
    11. Unable to attend all the study visits or comply with study procedures.
    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.5.1.1Timepoint(s) of evaluation of this end point
    Week 6
    E.5.2Secondary end point(s)
    •Proportion of patients in clinical remission
    •Proportion of patients with sustained clinical remission
    •Proportion of patients with enhanced clinical response
    •Safety profile - Adverse events, serious adverse events, results of standard laboratory tests and results of 12-lead electrocardiograms (ECGs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 6, 10 or 22
    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.8.2.4Number 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 concerned2
    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 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
    Austria
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Italy
    Korea, Republic of
    Malaysia
    Netherlands
    New Zealand
    Norway
    Poland
    Slovakia
    South Africa
    Turkey
    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
    After the Screening period, enrolled patients will complete the 6 week induction treatment and a follow-up observation visit at Week 10, at which time they may be eligible to receive vedolizumab treatment by enrolling in Study C13008 (long-term safety). Patients who do not enroll in Study C13008 will complete the Final Safety visit for a maximum time on study of 22 weeks. Patients who do not enroll in Study C13008 will participate in a 2 year follow-up survey.
    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.1.1Number of subjects for this age range: 0
    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
    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)
    Enrolled patients who complete theinduction treatment and a follow-up observation visit, may be eligible to receive active vedolizumab treatment by enrolling in Study C13008 (long-term safety). Patients who do not enroll in Study C13008 will complete the Final Safety visit (16 weeks after the last dose of study drug) for a maximum time on study of 22 weeks. After the end of the study, patients who do not enroll in Study C13008 will participate in a 2-year follow-up survey.
    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 Decision2011-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-30
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