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    Summary
    EudraCT Number:2008-002782-32
    Sponsor's Protocol Code Number:C13006
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-24
    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 ConcernedEstonia - SAM
    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 Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis
    A.4.1Sponsor's protocol code numberC13006
    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 solution 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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300mg
    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 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 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 10045365
    E.1.2Term Ulcerative colitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective for the Induction Phase

    • To determine the effect of MLN0002 induction treatment on clinical response at 6 weeks

    Primary Objective 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
    Secondary Objectives 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 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 must:
    • be post-menopausal for at least 1 year before the screening visit, OR
    • be 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 through 6 months after the last dose of study drug, OR
    • agree to completely abstain from heterosexual contact.
    Male patients, even if surgically sterilized (ie, status post-vasectomy), must:
    • 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 contact.

    4. Diagnosis of ulcerative colitis established at least 6 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report.

    5. Moderate to severe ulcerative colitis as determined by a Mayo score of 6 to 12 with an endoscopic subscore ≥2 during the screening period

    6. Evidence of ulcerative colitis extending proximal to the rectum (≥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 of a surveillance colonoscopy 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)

    9. Demonstrated, over the previous 5 year period, an inadequate response to, loss of reponse to, or intolerance of at least one of the following agents as defined below:
    • Corticosteroids

    i) 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
    ii) Recurrence of clinical symptoms upon tapering below a dose equivalent to prednisone 10 mg daily orally on two separate occasions OR
    iii) History of intolerance of corticosteroids (including, but not limited to Cushing’s syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, infection)
    • Immunomodulators
    i) 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-mercaptopurine mg/kg (≥0.75 mg/kg) OR
    ii) History of intolerance of at least one immunomodulator (including, but not limited to nausea/vomiting, abdominal pain, pancreatitis, LFT abnormalities, lymphopenia, TPMT genetic mutation, infection)
    • TNF antagonists
    i) Signs and symptoms of persistently active disease despite a history of at
    least one 4 week induction regimen of infliximab 5 mg/kg IV, 2 doses at
    least 2 weeks apart OR
    ii) Recurrence of symptoms during maintenance dosing following prior
    clinical benefit (discontinuation despite clinical benefit does not qualify)
    OR
    iii) History of intolerance of infliximab (including, but not limited to infusionrelated
    reaction, demyelination, congestive heart failure, infection)

    10. May be receiving a therapeutic dose of the following drugs:
    • Oral 5-ASA compounds provided that the dose has been stable for the 2 weeks immediately prior to enrollment
    • Oral corticosteroid therapy (prednisone at a stable dose ≤30 mg/day, or equivalent steroid) provided that the dose has been stable for the 4 weeks immediately prior to enrollment if corticosteroids have just been initiated, or 2 weeks immediately prior to enrollment if corticosteroids were in the process of being tapered
    • Probiotics (eg, Culturelle, Saccharomyces boulardii) provided that the dose has been stable for the 2 weeks immediately prior to enrollment
    • Antidiarrheals (eg, loperamide, diphenoxylate with atropine) for control of chronic diarrhea
    • Azathioprine or 6-mercaptopurine provided that the dose has been stable for the 8 weeks immediately prior to enrollment
    E.4Principal exclusion criteria
    The exclusion criteria are divided into 3 categories: gastrointestinal exclusion criteria, infectious disease exclusion criteria, and general exclusion criteria. Patients meeting any of the following exclusion criteria are not to be enrolled in the study.

    Gastrointestinal Exclusion Criteria

    1. Evidence of abdominal abscess or toxic megacolon at the initial screening visit
    2. Extensive colonic resection, subtotal or total colectomy
    3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
    4. Within 30 days prior to enrollment, have received any of the following for the treatment of underlying disease:
    • Non-biologic therapies (eg, cyclosporine, thalidomide) other than those
    permitted in Section 6.2
    • A non-biologic investigational therapy
    • An approved non-biologic therapy in an investigational protocol
    5. Within 60 days prior to enrollment, have received any of the following:
    • Infliximab
    • Other investigational or approved biological agent
    6. Any prior exposure to natalizumab, efalizumab or rituximab
    7. Use of topical (rectal) treatment with 5-ASA or corticosteroid enemas/suppositories within 2 weeks of the administration of the first dose of study drug
    8. Evidence of or treatment for C. difficile infection within 60 days or other intestinal pathogen within 30 days prior to enrollment
    9. Currently require or are anticipated to require surgical intervention for UC during the study
    10. History or evidence of adenomatous colonic polyps that have not been removed
    11. History or evidence of colonic mucosal dysplasia
    12. Diagnosis of Crohn’s colitis or indeterminate colitis

    Infectious Disease Exclusion Criteria

    1. Any chronic hepatitis B or C infection
    2. Active or latent tuberculosis, regardless of treatment history, as evidenced by any of the following:
    • History of tuberculosis
    • A positive diagnostic tuberculosis (TB) test within one month of enrollment defined as:
    i) a positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests OR
    ii) a tuberculin skin test reaction ≥10 mm ( ≥5 mm in patients receiving the equivalent of > 15 mg/day prednisone).
    • Chest x-ray within 3 months of enrollment in which active or latent pulmonary tuberculosis cannot be excluded
    3. Any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation)
    4. Any live vaccinations within 30 days prior to study drug administration except for the influenza vaccine
    5. Clinically significant extra-intestinal infection (eg, pneumonia, pyelonephritis) within 30 days prior to enrollment

    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 surgery during the study period
    5. Any history of malignancy, except for the following:
    • adequately-treated non-metastatic basal cell skin cancer;
    • Squamous cell skin cancer that has been adequately treated and has not recurred for at least 1 year prior to enrollment; and
    • history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to enrolment. Patients with remote history of malignancy (eg, >10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received and must be discussed with the sponsor on a case-by-case basis 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:
    • Hemoglobin level <8 g/dL
    • WBC count <3 × 10exp9/L
    • Lymphocyte count <0.5 × 10exp9/L
    • Platelet count <100 × 10exp9/L or >1200 × 10exp9/L
    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × the upper limit of normal (ULN)
    • Alkaline phosphatase >3 × ULN
    • Serum creatinine >2 × ULN
    9. Current or recent history (within one year prior to 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)
    Primary Endpoint for the Induction Phase:

    • Proportion of patients with clinical response at Week 6


    Primary Endpoint 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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    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 EEA104
    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
    End of Study

    • Week 52 or Early Termination (ET) Visit (safety and efficacy assessments)

    • Week 66 Visit (safety assessments)
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state10
    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)
    Patients may be eligible to receive active MLN0002 treatment by enrolling in Study C13008 (Long-term Safety). Patients who do not enroll in Study C13008 will complete the Week 66/Final Safety Visit (16 weeks after the last dose of study drug) for a maximum time on study of 66 weeks. At 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 Decision2009-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-12
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