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    Summary
    EudraCT Number:2007-002542-38
    Sponsor's Protocol Code Number:CAEB071A2210
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-11-08
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2007-002542-38
    A.3Full title of the trial
    A randomized, double blind, placebo controlled, parallel group design study to explore the efficacy, safety and tolerability of AEB071 in patients with active, moderate to severe ulcerative colitis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to explore the safe and effective use of the drug sotrastaurin in patients with ulcerative colitis
    A.3.2Name or abbreviated title of the trial where available
    A2210
    A.4.1Sponsor's protocol code numberCAEB071A2210
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Healthcare A/S
    B.5.2Functional name of contact pointKlinisk forskningsafdeling
    B.5.3 Address:
    B.5.3.1Street AddressLyngbyvej 172
    B.5.3.2Town/ cityKøbenhavn Ø
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4539168400
    B.5.5Fax number+4539168405
    B.5.6E-mailskriv.til@novartis.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 nameSotrastaurin
    D.3.2Product code AEB071
    D.3.4Pharmaceutical form Capsule, hard
    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.3.8INN - Proposed INNSotrastaurin (INN) acetate
    D.3.9.1CAS number 425637-18-9
    D.3.9.2Current sponsor codeAEB071
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100 to mg
    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 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.IMP: 2
    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.2.5The 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 nameVitamin B2
    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.3.8INN - Proposed INNRiboflavin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20 to mg
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Ulcerative colitis
    E.1.1.1Medical condition in easily understood language
    Autoimmune inflammatory disease of the small intestine
    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 14.0
    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
    Evaluate the efficacy of sotrastaurin (AEB071) in the treatment of active, moderate to severe ulcerative colitis in patients who have failed conventional therapy using mesalamine or steroids.
    E.2.2Secondary objectives of the trial
    Evaluate the safety, tolerability and pharmacokinetics of sotrastaurin (AEB071) given as an oral drug at 300 mg for two weeks twice a day followed by 200 mg for two weeks twice a day in ulcerative colitis patients.

    Explore the relationship between sotrastaurin (AEB071) pharmacokinetics, clinical efficacy outcomes, pharmacodynamic markers and potential biomarkers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females 18-75 years of age with an established diagnosis of ulcerative colitis are eligible for the study.

    2. Female patients of child-bearing potential must be concurrently using two acceptable methods of contraception, (e.g. intra-uterine device plus condom, spermicidal gel plus condom, diaphragma plus condom, etc.) from the time of screening and for the duration of the study, through study completion and for 1 month following study completion.

    3. Patients must have active, moderate to severe disease with a Partial Mayo Score between 5 and 10 (inclusive), with a score of at least 2 on either stool frequency or rectal bleeding and a Modified Baron Score of at least 2 upon endoscopic examination with the disease extending at least 25 cm from the anal verge.

    4. Patients must have responded poorly to conventional therapy. Poor response is considered to be any of the following:

    the continuous requirement for intermittent, oral steroid therapy of more than 20 mg methylprednisolone or equivalent per day for more than 3 months (including steroid dependence defined as relapse within 3 months after stopping).

    the requirement for ≥ 2 g mesalamine per day.

    the failure to remain symptom-free on maintenance medication of azathioprine or 6-
    mercaptopurin (an adequate course is considered to be at least 12 weeks of treatment).

    Patients that do not tolerate mesalamine or steroid therapy will also be included. Doses of steroids and mesalamine, where topical therapy is not allowed, will be frozen at the time of screening and may be continued unchanged. The maximum allowed daily steroid dose is 20 mg methylprednisolone (or equivalent steroid dose). Other maintenance medications like azathioprine or 6-mercaptopurin will be continued unchanged throughout the study period.

    5. Patients must be able to communicate well with the investigator, to understand and comply with the requirements of the study and to understand and sign written informed consent.
    E.4Principal exclusion criteria
    1. Previous treatment with biologics (e.g. anti TNF-α) within the last 3 months or use of any other investigational drug within the previous 1 month.

    2. Hypersensitivity to AEB071 compound.

    3. Weight of less than 50 kg or more than 150 kg.

    4. Ongoing treatment with antibiotics, cyclosporine, methotrexate, tacrolimus or rectally administered corticosteroid or 5-aminosalicylate containing medication. Eligible patients must have stopped cyclosporine, methotrexate and tacrolimus at least 8 weeks and antibiotics and rectal topical therapy at least 2 weeks prior to study entry.

    5. Patients with active or history of clinically significant cardiac abnormalities, for example:

    Patients requiring drugs with QT-prolonging properties (e.g. antiarrhythmic drugs, such as amiodarone, sotalol, dofetilide, quinidine, procainamide, disopyramide).

    Patients with sustained heart rate <50 bpm or >90 bpm after resting in supine position for 5 minutes.

    Patients with hypokalemia, QTc >470msec, long QT-syndrome (own or with a family history) or with a family history of sudden unexplained death. •Patients with implanted cardiac pacemaker or defibrillator.

    Patients with left branch bundle block (LBBB), and patients with known history of congestive heart failure (NYHA class II to IV) or known left-ventricular dysfunction (LVEF < 45%).

    History of tachyarrhythmia e.g., supraventricular tachycardia, atrial flutter, atrial fibrillation, ventricular tachycardia, ventricular flutter, ventricular fibrillation.

    History of myocardial infarction within the previous 12 months; uncontrolled or unstable angina pectoris.

    History of syncope.

    6. Patients who are requiring the administration of strongly interacting drugs of the CYP450 3A4/5 system (See Appendix 6).

    7. Positive results for the detection of enteropathogens (including Salmonella, Yersinia, Shigella, Camplylobacter, EHEC and C. difficile).

    8. Laboratory findings showing:

    Aspartate aminotransferase, alanine aminotransferase and bilirubin higher than 3 times the upper limit of normal,

    Alkaline phosphatase higher than 2 times the upper limit of normal,

    Absolute neutrophil count of <1,500/mm3, an absolute leukocyte count <2,500/mm3 or platelets <75,000/mm3.

    9. Patients who have been diagnosed with primary sclerosing cholangitis are excluded from the study.

    10. History of renal trauma, glomerulonephritis or patients with one kidney. Presence of clinically significant proteinuria, active sediments, casts or WBCs in urine.

    11. Clinical signs and symptoms of toxic megacolon.

    12. Presence or history of major chronic inflammatory autoimmune diseases, e.g. SLE.

    13. History of alcohol or drug abuse.

    14. Pregnant or breastfeeding women are excluded.

    15. Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.

    16. Administration of live vaccines within 6 months prior to dosing.

    17. A positive HIV (ELISA and Western blot) test result, Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

    18. Significant illness within the two weeks prior to dosing or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study.

    19. History of malignancy (other than basal cell carcinoma or adequately treated carcinoma-in-situ of the cervix).

    20. Presence or history of underlying metabolic, endocrine, hematologic, pulmonary, cardiac, blood, renal, hepatic, infectious, psychiatric or gastrointestinal conditions which, in the opinion of the investigator, immunocompromise the patient and/or place the patient at unacceptable risk for participation in a study of an immunomodulatory therapy.

    21. Positive purified protein derivative (PPD) tuberculin skin test reaction (PPD 5 TU [tuberculin units] or as according to local standard practice) of ≥ 5 mm induration at baseline (Day -4 to Day -1), according to national guidelines. PPD tuberculin test results that were obtained within 2 months prior to screening can be used. Patients who have a positive PPD skin test with a documentation of Bacillus Calmette-Guérin (BCG) vaccination or those who are at low environmental risk for tuberculosis (TB) infection and/or reactivation (in the opinion of the Investigator) and have a negative chest X-ray can be included.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is clinical remission 4 weeks after treatment initiation, defined as a Modified Baron Score of 0 or 1 and a Partial Mayo Score of 0 or 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Clinical remission 4 weeks after treatment initiation
    E.5.2Secondary end point(s)
    Change from baseline in partial Mayo score 4 weeks after treatment initiation
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 4
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) 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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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 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
    Provided in the protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 47
    F.4.2.2In the whole clinical trial 60
    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)
    Normal treatment for the condition will be re-started following the end of the study. Possible continued provision of study treatment detailed in the protocol.
    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 Decision2007-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-01-02
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