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    Summary
    EudraCT Number:2019-001199-12
    Sponsor's Protocol Code Number:MLN0002/CCT-001
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-05-28
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2019-001199-12
    A.3Full title of the trial
    Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Examine the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Induction and Maintenance Therapy in Japanese Patients With Moderately or Severely Active Crohn's Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease.
    A.4.1Sponsor's protocol code numberMLN0002/CCT-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02038920
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1150-2688
    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
    B.1.3.4CountryJapan
    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
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda
    B.5.2Functional name of contact pointMedical Director
    B.5.3 Address:
    B.5.3.1Street Address1-1, Doshomachi 4-chome
    B.5.3.2Town/ cityChuo-ku, Osaka-shi
    B.5.3.3Post code540-8645
    B.5.3.4CountryJapan
    B.5.4Telephone number18778253327
    B.5.5Fax number18778253327
    B.5.6E-mailtrialdisclosures@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 Yes
    D.2.1.1.1Trade name Entyvio
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameEntyvio
    D.3.2Product code PRD1598541
    D.3.4Pharmaceutical form Powder for concentrate 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.3.9.2Current 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 No
    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 concentrate for solution 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
    This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of intravenous Vedolizumab (300 mg) infusion in induction and maintenance therapy in Japanese patients with moderately or severely active Crohn's disease.
    E.1.1.1Medical condition in easily understood language
    Moderately or severely active Crohn's disease.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate efficacy of MLN0002 in induction and maintenance therapy in Japanese subjects with moderately or severely active Crohn's disease.
    E.2.2Secondary objectives of the trial
    To evaluate safety of MLN0002 in induction and maintenance therapy in Japanese subjects with moderately or severely active Crohn's disease.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients aged 15 to 80 years (inclusive) at the time of consent
    2. Patients with a diagnosis of small-intestinal, large-intestinal,or small-/large-intestinal Crohn's disease established based on the Revised Diagnostic Criteria for Crohn’s disease issued by Research Group for Intractable Inflammatory Bowel Disease Designated as Specified Disease by the Ministry of Health, Labor and Welfare of Japan (2012) at least 3 months before the start of administration of study drug
    3. Patients with baseline Crohn's Disease Activity Index (CDAI) score of 220 to 450(inclusive) and meeting at least one of the followings:

    ・C-reactive protein (CRP) at screening test is above 0.30 mg/dL
    ・Patients with irregular or semicircular ulcers or multiple aphthae (10 or more) observed over an extensive area of the small or large intestine on
    endoscopy or imaging test within the 4 months before the start of administration of study drugs
    ・Patients with longitudinal ulcers or a cobblestone appearance observed in the small or large intestine on endoscopy or imaging test within 4 months before the start of administration of study drugs
    4. In case of the patients who meet any of the following criteria; patients with ≥ 8-year history of extensive or limited colitis, patients aged ≥ 50 years, or patients with a first-degree family history of colon cancer, those whom the complication of colon cancer or dysplasia was ruled out by total colonoscopy at the start of study drug administration (Or the results from total colonoscopy performed within 1 year before giving consent are available)
    5. Patients meeting the criteria for treatment failure below with at least one of the following agents received within previous 5 year period before giving consent
    ・Corticosteroids
    ・ Resistance
    ・ Dependence
    ・ Intolerance
    ・Immunomodulators (azathioprine, 6-mercaptopurine or methotrexate)
    ・ Refractory
    ・ Intolerance
    ・Anti-TNFα antibodies
    ・ Inadequate response
    ・Loss of response
    ・Intolerance
    E.4Principal exclusion criteria
    1. Patients with an evidence of or suspected abdominal abscess
    2. Patients with a history of subtotal or total colectomy
    3. Patients who have had a resection of the small intestine in at least 3 locations or have a diagnosis of short bowel syndrome
    4. Patients with ileostomy,colostomy,or internal fistula, or severe intestinal stenosis
    5. Patients who started 5-aminosalicylic acid oral drug or probiotics treatment, antimicrobials to treat Crohn’s disease, or 30 mg/day or less of oral corticosteroids within 13 days before initiation of study drug administration. If these drugs were used within 14 days before initiation of study drug administration, the dosage must have been changed or their use discontinued within 13 days before the initiation of study drug administration
    6. Patients who have received 5-aminosalicylic acid or corticosteroid enemas/suppositories, intravenous corticosteroid injections, or more than 30 mg/day of oral corticosteroids, medications for diarrhea-predominant irritable bowel syndrome, or Chinese herbal medicine for the treatment of Crohn’s disease (e.g., Daikenchuto) within 13 days before initiation of study drug administration
    7. Patients who have received azathioprine, 6-mercaptopurine, or methotrexate within 27 days before initiation of study drug administration. However, this shall not apply to patients who have received these drugs for 83 or more days before initiation of the study drug administration and continued the steady dose administration of the drugs for 27 or more days before initiation of the study drug administration
    8. Patients who have received cyclosporin, tacrolimus, tofacitinib or any study drugs for treatment of ulcerative colitis within 27 days before initiation of the study drug administration
    9. Patients who have received adalimumab within 27 days before initiation of study drug administration or any biological drugs other than adalimumab within 55 days before initiation of study drug administration.Topical administration (such as intraocular implantation for treatment of age-related maculopacy) is allowed
    10. Patients who have received any live vaccinations within 27 days before initiation of study drug administration
    11. Patients who have undergone intestinal resection within 27 days before initiation of study drug administration or those anticipated to require intestinal resection during the study
    12. Patients who have received leukocytapheresis or granulocyte apheresis within 27 days before initiation of the study drug administration
    13. Patients who have received intravenous hyperalimentation or total enteral nutrition within the 20 days before initiation of the study drug administration. Or patients who are fasted
    14. Patients who have received enteral nutrition at > 900 kcal/day or started enteral nutrition at <= 900 kcal/day within the 20 days before initiation of the study drug administration. Patients receiving 900 kcal/day or less of enteral nutrition for at least 21 days before initiation of the study drug administration whom these dosage was changed or the medications were discontinued within 20 days before initiation of the study drug administration
    15. Patients with evidence of adenomatous colonic polyps that need to be removed at the start of study drug administration
    16. Patients with a history or an an complication of dysplasia of the small or large intestine
    E.5 End points
    E.5.1Primary end point(s)
    - Induction phase: Crohn's Disease Activity Index (CDAI)-100
    response at Week 10
    - Maintenance Phase: Clinical remission at Week 60
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Induction phase: 10 weeks
    - Maintenance phase: 60 weeks
    E.5.2Secondary end point(s)
    - Induction phase: Clinical remission at Week 10
    - Induction phase: Changes in C-reactive protein (CRP) values
    - Maintenance Phase: Crohn's Disease Activity Index (CDAI)-100
    response at Week 60
    - Maintenance Phase: Durable clinical remission
    - Maintenance Phase: Corticosteroid-free clinical remission at Week 60
    E.5.2.1Timepoint(s) of evaluation of this end point
    Induction phase respectively:
    - Week 10
    - From baseline to Week 10

    Maintenance phase respectively:
    - Week 60
    - From Week 14 to Week 60
    - From baseline to 16 weeks after the last dose of study drug
    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 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 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 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Japan
    E.8.7Trial has a data monitoring committee No
    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
    The end-of-study examination performed at 16 weeks after the last dose in all subjects who received the study drug. In addition, the follow-up survey performed every 6 months from the last dose of the study drug up to 2 years or until the date of marketing approval of the study drug, whichever comes earlier.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 3
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 3
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 152
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 157
    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)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Japan
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