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    Summary
    EudraCT Number:2005-002319-26
    Sponsor's Protocol Code Number:D8830C00002
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-10-28
    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
    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 ConcernedGermany - BfArM
    A.2EudraCT number2005-002319-26
    A.3Full title of the trial
    Efficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, four week, parallel-group, multicentre, phase II study
    A.4.1Sponsor's protocol code numberD8830C00002
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 Information not present in EudraCT
    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.3.2Product code AZD9056
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAZD9056
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) 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) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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
    Crohn's disease
    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
    The primary objective of this study is to study the efficacy of a daily dose of 200 mg
    AZD9056 in patients with active CD affecting ileum and/or colon by assessment of the
    change in CDAI from baseline after 28 days treatment.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    1. To study efficacy by assessment of
    a) proportion of patients in clinical remission after 28 days, where clinical remission is
    defined as CDAI ≤ 150
    b) proportion of patients with clinical response after 28 days, where clinical response is defined as reduction in CDAI of at least 70 points from baseline
    c) time to remission
    d) time in study
    e) patient reported outcomes
    2. To study safety by assessment of AEs, safety laboratory analyses, ECG, vital signs, fundoscopy and physical examination
    3. To study pharmacodynamics of AZD9056 in plasma
    For explorative purposes the following will be analyzed but the results will not be presented in the study report:
    - Cytokines with focus on IL1-related cytokines
    - Matrix metalloproteinase (MMP1, MMP3)
    - Proteomics
    - Calprotectin in faeces
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    For inclusion in the study s must fulfil all of the following criteria:
    1. Provision of written informed consent
    2. Female or male ≥18 years of age. Female patients should have cessation of regular
    menses for more than 12 months, be surgically sterile, or using two forms of
    contraceptives throughout the study period.
    3. Diagnosis of Crohn’s disease affecting ileum and/or colon verified by X-ray (small
    bowel follow-through), MRI and/or endoscopy
    4. Disease activity defined as CDAI ≥ 220 at Visit 2
    5. Normal stool culture
    6. Normal values of aspartate aminotransferase (ASAT), alanine aminotransferase
    (ALAT), alkaline phosphatase (ALP), and bilirubin
    7. If treated with oral sulphasalazine, olsalazine or 5-ASA at entry, the dose should
    have been kept constant during two weeks prior to visit 2
    8. If treated with azathioprine, methotrexate or 6-mercaptopurine at entry, the dose should have been kept constant for 3 months prior to Visit 2
    9. For inclusion in the genetic component of the study, see Appendix C. If a patient declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the patient.. The patient will not be excluded from other aspects of the study described in this Clinical Protocol, should they not consent to genetic sampling.
    E.4Principal exclusion criteria
    Any of the following is regarded as a criterion for exclusion from the study:
    1. Any significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal
    (other than Crohn’s disease), liver, renal, neurological, musculoskeletal,
    endocrine, metabolic, malignant, psychiatric, major physical impairment) which,
    in the opinion of the investigator, may either put the patient at risk because of
    participation in the study, or may influence the results of the study or patient´s
    ability to participate in the study
    2. Ileostomy, ileo-pouch-anal anastomosis, ileorectal anastomosis or proctocolectomy
    3. Active listeriosis or tuberculosis or positive screening for tuberculosis or a major episode of infection (e.g. pneumonia, pyelonephritis) requiring hospitalisation within 3 months prior to visit 2.
    4. Septic complication, abscess, perforation, obstruction and/or fistulae, except
    for inactive perianal fistulae
    5. Need for immediate surgery or unlikely to complete the trial due to poor general
    condition
    6. Histologically documented gastrointestinal malignancy or high-grade dysplasia
    within the last five years prior to visit 1
    7. History of carcinoma (excluding basal and squamous skin cell carcinoma) within
    the last five years prior to visit 1
    8. Uncontrolled diabetes
    9. Verified active gastric or duodenal ulcer
    10. Rheumatoid arthritis
    11. Sclerosing cholangitis
    12. Clinically significant abnormal values for White blood cells (WBC), neutrophils
    or platelet in the opinion of the investigator. The limits are given in Section 3.3.5.1
    13. Requirement for non-steroid anti-inflammatory drugs (NSAIDs) for chronic use
    except low dose aminosalicylic acid, ASA (<350 mg daily) for prophylaxis
    14. Currently treated with glucocorticosteroids or stopped treatment with glucocorticosteroids less than two weeks prior to Visit 2. However, nasal glucocorticosteroid sprays and/or low potent steroid ointment are allowed
    15. Received of infliximab or other biological treatments or cyclosporine within 12 weeks prior to Visit 2
    16. Reception of any kind of experimental treatment (e.g. cytokines, probiotics, or
    helminthics) within 12 weeks prior to visit 2
    17. Reception of immunization with live viruses (e.g. polio) or live bacteria (e.g.
    tubercle bacilli) within 12 weeks prior to visit 2
    18. Known HIV or high risk for HIV infection
    19. Clinically abnormal ECG, current treatment with antiarrhythmic drugs, history
    of clinically significant cardiac arrythmias, or resting QTc (according to Bazett’s
    correction method) greater than 460 ms on more than two baseline ECGs
    20. Evidence of retinopathy on fundoscopic examination
    21. Participation in any clinical study involving an investigational product within 90
    days prior to randomization
    22. Previous randomization in the present study
    23. Alcohol or drug abuse or any other conditions associated with poor compliance
    or other reason for not being appropriate for the study, in the opinion of the
    investigator
    24. History of known hypersensitivity to the excepients unse in the study
    investigational product.
    25. Involvement the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
    E.5 End points
    E.5.1Primary end point(s)
    Change of CDAI from baseline after 28 days treatment.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.3 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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-10-28. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    According to local practice
    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 Decision2005-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-05-25
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