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    Summary
    EudraCT Number:2015-000482-31
    Sponsor's Protocol Code Number:MLN0002SC-3030
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-03-14
    Trial 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-000482-31
    A.3Full title of the trial
    A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease
    A.3.2Name or abbreviated title of the trial where available
    Vedolizumab SC Long-Term Open-Label Extension Study
    A.4.1Sponsor's protocol code numberMLN0002SC-3030
    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 SponsorTakeda Development Centre Europe, Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportTakeda Development Center Americas, 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., wholly owned subsidiary of Takeda Pharmaceuticals Company Limited
    B.5.2Functional name of contact pointDirector, Clinical Operations
    B.5.3 Address:
    B.5.3.1Street Address40 Landsdowne Street
    B.5.3.2Town/ cityCambridge, Massachusetts
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number16174441281
    B.5.6E-mailmark.patti@takeda.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 SC
    D.3.2Product code MLN0002 SC
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVedolizumab SC
    D.3.9.1CAS number 943609-66-3
    D.3.9.2Current sponsor codeMLN0002 SC
    D.3.9.4EV Substance CodeSUB30452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number108
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative Colitis
    Crohn’s Disease
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    Crohn’s Disease
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    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 obtain data on long term safety and tolerability on vedolizumab SC in subjects with Ulcerative Colitis (UC) and Crohn’s Disease (CD).
    E.2.2Secondary objectives of the trial
    • To obtain data on adverse events of special interest (AESIs; serious infections including opportunistic infection such as PML, liver injury, malignancies, injection site reactions or systemic reactions and hypersensitivity) in UC and CD subjects receiving long-term vedolizumab SC treatment.
    • To obtain data on maintaining clinical response and clinical remission in UC and CD subjects receiving long-term vedolizumab SC treatment.
    • To obtain data on PROs, including quality of life and work productivity and activity, in UC and CD subjects receiving long-term vedolizumab SC treatment.
    • To obtain data on time to major UC and CD-related events (hospitalizations, bowel surgeries,
    and procedures) in UC and CD subjects receiving long-term vedolizumab SC treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject has previously participated in Study MLN0002SC-3027 or MLN0002SC-3031, and, in the opinion of the investigator, tolerated the study drug well. Subjects who withdraw early from Study MLN0002SC-3027 or MLN0002SC-3031 must have withdrawn due to treatment failure (ie, as determined by disease worsening or need for rescue medications from Week 14) during the Maintenance Period.
    2. Subjects 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.
    3. Subjects 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 the initial Screening Visit of MLN0002SC-3027 or MLN0002SC-3031.
    4. May be receiving a therapeutic dose of the following drugs provided that the dose has been stable throughout the qualifying double-blind study:
    ● Oral 5-ASA compounds.
    ● Oral corticosteroid therapy (prednisone or equivalent steroid at a dose ≤30 mg/day, budesonide at a dose ≤9 mg/day).
    ● Probiotics (eg, Culturelle, Saccharomyces boulardii).
    ● Antidiarrheals (eg, loperamide, diphenoxylate with atropine) for control of chronic diarrhea.
    ● Antibiotics used for treatment of IBD (eg, ciprofloxacin, metronidazole).
    ● Azathioprine or 6-mercaptopurine, provided the subject was receiving this medication during prior participation in Study MLN002SC-3027 or MLN002SC-3031.
    ● Methotrexate, provided the subject was receiving this medication during prior participation in Study MLN002SC-3031.
    5. The subject has previously participated in Study MLN0002SC-3027 or MLN0002SC-3031, and, in the opinion of the investigator, tolerated the study drug well. Subjects who did not achieve a clinical response at Week 6 and were not randomized into the Maintenance Phase, and achieved a clinical response at Week 14 after receiving a third open-label vedolizumab IV infusion are eligible to participate.
    E.4Principal exclusion criteria
    1. The subject required surgical intervention for UC or CD during or after participation in Study MLN0002SC-3027 or MLN0002SC-3031, currently requires surgical intervention for UC or CD, or is anticipated to require surgical intervention for IBD during this study.
    2. The subject has had previous exposure to approved or investigational anti-integrins (eg, natalizumab, efalizumab, etrolizumab, AMG 181) or anti-MAdCAM1 antibodies or rituximab.
    3. The subject has had hypersensitivity to any of the vedolizumab excipients.
    4. Any live vaccinations within 30 days prior to vedolizumab SC administration.
    5. The subject has developed a chronic or severe infection, or, 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 vedolizumab study that, in the opinion of the investigator, would confound the study results or compromise subject safety.
    6. The subject has withdrawn from Study MLN0002SC-3027 or MLN0002SC-3031due to a study-drug related AE.
    7. The subject is unwilling or unable to self-inject, or does not have a caregiver (defined as a legal adult) to inject the study medication.
    8. The subject has 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 prior to enrollment; and (c) history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to enrollment. Subjects 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.
    9. The subject has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or demyelinating neurodegenerative disease.
    10. The subject has a positive PML subjective symptom checklist prior to the administration of study drug.
    E.5 End points
    E.5.1Primary end point(s)
    • Subject-year-adjusted treatment emergent AEs and SAEs during long-term vedolizumab SC treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Collection of AEs will commence from the time that the subject is first administered study medication (Week 0). Routine collection of AEs will continue until 18 weeks post last dose of medication.

    AE/SAE assessments:
    QW: Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 16 then every 8 weeks, plus unscheduled and final safety/early termination visit.
    Q2W: Weeks 0, 2, 4, 6, 8, 16 then every 8 weeks, plus unscheduled and final safety/early termination visit.
    E.5.2Secondary end point(s)
    • Subject-year-adjusted AESIs during long-term vedolizumab SC treatment.
    • Proportion of subjects with clinical response during long-term vedolizumab SC treatment using partial Mayo scores defined as a reduction in partial Mayo score of ≥2 points and ≥25% from Baseline with an accompanying decrease in rectal bleeding score of ≥1 or absolute rectal bleeding subscore of ≤1) in UC subjects and Harvey- Bradshaw Index (HBI) scores (defined as a ≥3-point decreased in HBI score from baseline) in CD subjects (randomized early terminator CD subjects only [defined as randomized CD subjects withdrawn from the parent study between Week 6 and Week 52]).
    • Proportion of subjects with clinical remission during long-term vedolizumab SC treatment using partial Mayo scores (defined as a partial Mayo score of ≤2 and no individual subscore >1 point) in UC subjects and HBI scores (defined as a HBI score of ≤4 points) in CD subjects.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Collection of AEs will commence from the time that the subject is first administered study medication (Week 0). Routine collection of AEs will continue until 18 weeks post last dose of medication.

    AE/SAE assessments:
    QW: Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 16 then every 8 weeks, plus unscheduled and final safety/early termination visit.
    Q2W: Weeks 0, 2, 4, 6, 8, 16 then every 8 weeks, plus unscheduled and final safety/early termination visit.

    Disease activity (Mayo/HBI):
    QW and Q2W: Weeks 0, 4, 8, 16 then every 8 weeks, plus unscheduled and final safety/early termination visit.
    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 Yes
    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 No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA165
    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
    Argentina
    Australia
    Bosnia and Herzegovina
    Brazil
    Canada
    Colombia
    Israel
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    Serbia
    South Africa
    Turkey
    Ukraine
    United States
    Belgium
    Bulgaria
    Croatia
    Denmark
    Estonia
    Germany
    Hungary
    Italy
    Lithuania
    Netherlands
    Poland
    Romania
    Slovakia
    Spain
    Sweden
    United Kingdom
    Czechia
    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
    Subjects enrolled onto the study will be eligible to continue receiving vedolizumab SC until the vedolizumab SC formulation becomes commercially available in their country of residence, the subject withdraws from the study, or the sponsor decides to close the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months3
    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.1.2.1Number of subjects for this age range: 659
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 259
    F.4.2.2In the whole clinical trial 692
    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)
    The study medication will not be available upon completion of the subject's participation in the study. The subject should be returned to the care of a physician and standard therapies as required.
    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 Decision2016-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-30
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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