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    Summary
    EudraCT Number:2014-004132-20
    Sponsor's Protocol Code Number:D9423C00001
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-07-28
    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 number2014-004132-20
    A.3Full title of the trial
    A multicentre, double-blind, randomised, parallel-group, Phase III study to assess efficacy and safety of D9421-C 9 mg versus Mesalazine 3 g in patients with active Crohn’s Disease in Japan
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase III study to assess efficacy and safety of D9421-C 9 mg with active Crohn’s Disease in Japan
    A.4.1Sponsor's protocol code numberD9423C00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01514240
    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 SponsorAstraZeneca K.K.
    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 supportAstrazeneca KK
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca K.K.
    B.5.2Functional name of contact pointClinical Operations Division
    B.5.3 Address:
    B.5.3.1Street AddressGrand Front Osaka Tower B, 3-1
    B.5.3.2Town/ cityOfuka-cho, Kita-ku, Osaka
    B.5.3.3Post code530-0011
    B.5.3.4CountryJapan
    B.5.4Telephone number+81677114657
    B.5.5Fax number+81648023563
    B.5.6E-mailKazuhiko.Motono@astrazeneca.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 nameEntocort
    D.3.2Product code D9421-C
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbudesonide
    D.3.9.1CAS number 51333-22-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Pentasa
    D.2.1.1.2Name of the Marketing Authorisation holderKyorin Pharmaceutical CO. Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmesalazine
    D.3.9.1CAS number 0000089-57-6
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active Crohn’s Disease
    E.1.1.1Medical condition in easily understood language
    Symptomatic 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 19.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the clinical efficacy of D9421-C 9 mg once daily compared to Mesalazine 1 g three times a day to patients with mild to moderate active Crohn’s disease affecting ileum, ileocecal region and/or ascending colon as defined by a score of 180-400 on the Crohn’s Disease Activity Index (CDAI) by assessment of the remission after 8-week treatment defined by a CDAI score of ≤150.
    E.2.2Secondary objectives of the trial
    •To evaluate clinical efficacy of D9421-C compared to Mesalazine to patients with mild to moderate active Crohn’s disease affecting ileum, ileocecal region and/or ascending colon as defined by a score of 180-400 on the CDAIby assessment of the following variables:
    − Remission (ie, CDAI score of ≤150) rate after 2-week and 4-week treatment
    − Change in CDAI score
    − Time to the first remission
    − Clinical improvement defined by a remission (ie, CDAI score of ≤150) or a decrease in CDAI score of at least 100 from Visit 2 after 2-week, 4-week, and 8-week treatments

    •To evaluate the change in disease specific health-related quality of life (HRQL) of D9421-C compared to Mesalazine to patients with mild to moderate active Crohn’s disease

    •To evaluate the overall safety of D9421-C compared to Mesalazine to patients with mild to moderate active Crohn’s disease
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female or male ≥15 years of age
    2. Diagnosis of Crohn’s Disease, verified by X-ray, endoscopy or histology
    3. Main active disease of the ileal, ileocecal region, and/or ascending colon
    4. Signed informed consent has to be obtained from the patient, and patient’s legal representative additively if necessary, prior to conducting any study-related procedures.
    5. If patients treated with medication before entry, subjects should fulfil the following criteria:
    If treated with partial nutrition treatment (≤1200 kcal/day), the treatment has to be on constant calories from 14 days prior to randomisation until the study completion or discontinuation (including tapering period).
    If treated with azathioprine (≤2.0 mg/kg/day) or 6-mercaptopurine (≤1.2 mg/kg/day), the treatment has to be on constant dose from 12 weeks prior to randomisation until the study completion or discontinuation (including tapering period).
    6. Ability to read, write and to fill a diary card and HRQL questionnaire as instructed.

    For randomisation in the study patients must fulfil all of the following criteria:
    7.Having mild to moderate active Crohn’s disease, defined as CDAI score of 180-400 based on the patient’s condition for 7 consecutive days prior to the Visit 2
    E.4Principal exclusion criteria
    1. Having ileostomy or pouch and/or colostomy.
    2. Having active Crohn’s disease in the rectum and/or anus
    3. Having limited active Crohn’s disease in upper gastrointestinal only.
    4. Having resection of ileum totalling more than 100 cm.
    5. Having previous total gastrectomy.
    6. Having a known or suspected systemic infection (eg, HBV, HCV, HIV infection).
    7. Other complications such as abscess, obstruction, stricture with proximal dilatation, and/or active fistula.
    8. Being candidates for immediate major surgery (including endoscopic treatment, but excluding tooth extraction and cataract surgery) or unlikely to complete the trial due to a poor general condition.
    9. Having histological documented gastrointestinal malignancy or high-grade dysplasia within five years prior to randomisation.
    10. Having a history of carcinoma (excluding basal and squamous skin cell carcinoma) within five years prior to randomisation.
    11. Having uncontrolled diabetes. Patient needs to have his/her diabetes controlled by diet, exercise, and medical treatment and without complications such as neuropathy, nephropaty or retinopathy.
    12. Having active peptic disease, such as a verified diagnose of esophagitis, gastric, duodenal ulcers and infectious diarrhea.
    13. Having rheumatoid arthritis.
    14. Having ankylosing spondylitis.
    15. Having parathyroid disease.
    16. Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis at Visit 1, which, in the opinion of the investigator(s), may put the patient at risk because of his/her participation in the study.
    17. Having a clinically relevant renal, hepatic, cardiovascular or psychiatric disease as judged by the investigator.
    18. Have received or requiring glucocorticosteroids for any reason, or antibiotics for treatment of Crohn’s Disease (eg, sulfasalazine, metronidazol, and ciprofloxacin), within two weeks prior to randomisation and during study period. Use of topical steroids (eg, nasal steroids, eye drops and steroid ointments) is eligible.
    19. Having been administered or requiring Mesalazine (≥2251 mg/day) from 14 days before randomisation until the day before the randomisation.
    20. Have received infliximab within 8 weeks or adalimumab within 2 weeks prior to randomisation
    21. Have received methotrexate, cyclosporine or tacrolimus hydrate within 12 weeks prior to randomisation
    22. Have received granulocytapheresis within 4 weeks prior to randomisation
    23. Have received immunisation with live viruses (eg, polio) or live bacteria (eg, tubercle bacilli) within 12 weeks prior to randomisation.
    24. Requiring concomitant medications listed in Section 5.6.3 during the study period.
    25. Being pregnant or breast-feeding. Female patients have to be postmenopausal, surgically sterile or using medically accepted contraceptive measures.
    26. Known hypersensitivity to budesonide, other glucocorticosteroids, any of the excipients of D9421-C capsule, salicylate esters such as Mesalazine, salicylates, or salazosulfapyridine.
    27. Scheduled to undergo any types of invasive treatment during the course of the study.
    28. Have participated in any clinical study involving an investigational product 4 weeks prior to randomisation.
    29. Have received any kind of experimental treatment within 12 weeks prior to randomisation eg, studies with new biologicals, surgical procedures in a clinical setting, leukocytapheresis and other experimental procedure.
    30. Having previously been randomised in this study
    31. Are alcohol or drug abusers, or any conditions associated with poor compliance.
    32. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
    33. Clinical judgment by the investigator that the subject should not participate in the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the remission defined as CDAI score of ≤150. The primary analysis will be based on the FAS and the analysis based on the PPS will also be done as a sensitivity analysis. The patients who dropped out without any remission will be considered as no remission after dropout in this analysis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 8-week treatment
    E.5.2Secondary end point(s)
    1. Remission rate after treatment
    2. CDAI scores at Visit 2 onwards and the changes from Visit 2
    3. Time to remission defined as the number of days from the randomisation
    4. Clinical improvement rate assesed by CDAI score
    -CDAI score of ≤150 or a decrease in CDAI score of at least 100 from Visit 2
    -CDAI score of ≤150 or a decrease in CDAI score of at least 70 from Visit 2.
    5. The canges of IBDQ scores
    6. Safety variables
    (a )Adverse events
    (b)Clinical Laboratory variables
    (c)Vital signs
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 2-week and 4-week after randomization
    2. at Visit 2 and the visits at post-dose
    3. the day when the first remission is obtained
    4. at Weeks 2, 4 and 8 after randomization
    5. at baseline, Weeks 2, 4, 8 and 10
    6. Safety variables
    (a) during study period.
    (b) at baseline, Weeks 2, 4, 8 and 10
    (c) at baseline, Weeks 2, 4, 8 and 10
    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 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 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) Yes
    E.8.2.2Placebo No
    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? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    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
    Request subject to come the investigational site for follow up visit even if out of the time window.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months31
    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: 1
    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: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 109
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 112
    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
    G.4 Investigator Network to be involved in the Trial: 1
    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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