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    Summary
    EudraCT Number:2008-002784-14
    Sponsor's Protocol Code Number:C13008
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-11-06
    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 ConcernedPortugal - INFARMED
    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.4.1Sponsor's protocol code numberC13008
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative Colitis and Crohn’s Disease
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10013099
    E.1.2Term Disease Crohns
    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

    • To determine the safety profile of long-term MLN0002 treatment



    E.2.2Secondary objectives of the trial
    Resource Utilization and Patient Reported Outcome Objectives

    • To determine the effect of long-term MLN0002 treatment on time to major IBD-related events (hospitalizations, surgeries, and IBD-related procedures)

    • To determine 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 ≥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 ≥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 ≥5 points

    • Disease Worsening for patients with CD in C13007: A ≥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 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 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 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.

    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 ≤30 mg/day, budesonide at a stable dose ≤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 require surgical intervention for IBD, or are 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)
    Primary Endpoints

    • SAEs, AEs, vital signs, standard laboratory tests (clinical chemistry, hematology, coagulation, urinalysis, and HAHA), and electrocardiograms (ECGs)



    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 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 Yes
    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 concerned3
    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 days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 592
    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)
    Upon completion of, or early termination from this study, patients will participate in a 2-year follow-up. A specific questionnaire will be administered via telephone at 6, 12, 18, and 24 months after the final on-study dose of MLN0002. The questionnaire will collect data on the occurrence of severe or unusual infections, colorectal dysplasia or cancer, other malignancies, hospitalizations and surgeries, and persistent progressive neurological dysfunction and the development of 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 Decision2009-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-10-31
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