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    Summary
    EudraCT Number:2005-000365-19
    Sponsor's Protocol Code Number:CFTY720D2301
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-03-27
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2005-000365-19
    A.3Full title of the trial
    A 24A 24-month, double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis
    A.4.1Sponsor's protocol code numberCFTY720D2301
    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 SponsorNovartisPharma 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 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 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 nameFTY720
    D.3.2Product code FTY720
    D.3.4Pharmaceutical form Capsule*
    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 codeFTY720
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1,25
    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 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 nameFTY720
    D.3.2Product code FTY720
    D.3.4Pharmaceutical form Capsule*
    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 codeFTY720
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,5
    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*
    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
    Relapsing-remitting multiple sclerosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare FTY720 1.25 mg and 0.5 mg with placebo and to demonstrate that at least the 1.25 mg FTY720 dose is superior to placebo as assessed by the annual relapse rate in patients with RRMS treated up to 24 months.
    E.2.2Secondary objectives of the trial
    Key secondary objectives:
    To evaluate: the effect of FTY720 relative to placebo on disability progression in patients treated for up to 24 months; safety and tolerability of FTY720 compared to placebo in patients with RRMS during the 24-month treatment phase.
    To demonstrate that FTY720 is effective in reducing the frequency of relapses compared to placebo in patients treated for up to 12 months.
    To evaluate: the effect of FTY720 relative to placebo on the proportion of relapse-free patients treated for up to 12 months and up to 24 months; the effect of FTY720 relative to placebo on time to the first relapse in patients treated for up to 24 months; the effect of FTY720 relative to placebo on burden of disease in patients treated for up to 24 months.

    To study the pharmacokinetics of FTY720 in patients with RRMS.
    To study the pharmacokinetic/pharmacodynamic relationship for main efficacy and safety outcomes in patients with RRMS.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Exploratory Biomarker sub-study for Protocol No. CFTY720D2301
    04-May-05
    Exploratory pharmacogenetic assessments are planned as a part of this Study with the objectives of examining whether individual genetic variation in genes relating to drug metabolism, multiple sclerosis, and the drug target pathway confer differential response to FTY720.
    Exploratory genomic, proteomic and metabonomic studies are planned as a part of this Study to identify gene expression patterns, proteins, and metabolites of blood and/or cerebrospinal fluid that are associated with treatment response to FTY720, or that possibly correlate with the severity or progression of multiple sclerosis.
    This exploratory biomarker substudy is optional. These assessments will only be
    performed on patients who agree to participate in this biomarker component by signing the separate exploratory biomarker informed consent form.
    E.3Principal inclusion criteria
    1. Male and female patients aged 18-55 with clinically definite diagnosis of Multiple Sclerosis (McDonald criteria) see Appendix 3.
    2. Patients with a relapsing-remitting course with at least 1 documented relapse during the last year or 2 documented relapses in the past 2 years, preceding their enrollment to the study (signing of the study consent form).
    3. Patients with Expanded Disability Status Scale (EDSS) score of 0-5.5 at Screening.
    4. Patients who explicitly decline initiation or continuation of treatment with available disease modifying drugs for whatever reason after having been informed about their respective benefits and possible adverse events.
    5. Neurologically stable patients with no evidence of relapse for at least 30 days prior to the Screening visit.
    6. Females of childbearing potential must have a negative pregnancy test at Baseline prior to entry into the Treatment period, or be either post-menopausal for 12 months prior to Screening or surgically sterile, or use adequate contraception during the treatment and 3 months after discontinuation of the study medication
    7. All patients must give written consent for participation in the study at Screening.
    E.4Principal exclusion criteria
    1. Patients with a manifestation of MS other than RRMS.
    2. Patients with a history of chronic disease of the immune system other than MS or with a known immunodeficiency syndrome.
    3. Patients with a history or presence of malignancy (except of successfully treated basal or squamous cell carcinoma of skin).
    4. Patients with history of uncontrolled diabetes mellitus, macular edema or other retinal vascular diseases known to be associated with macular edema, e.g. retinal vein occlusion.
    5. Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
    6. Patients who have received total lymphoid irradiation or bone marrow transplantation.
    7. Patients who have been treated with corticosteroids or adrenocorticotropic hormones (ACTH) in the past 30 days prior to the Screening visit.
    8. Patients who have been previously treated with cladribine, cyclophosphamide or mitoxantrone.
    9. Patients who have been treated with immunosuppressive medications such as azathioprine or methotrexate in the past 6 months prior to the Screening visit.
    10. Patients who have been treated with IFN-β or glatiramer acetate in the past 3 months prior to the Screening visit.
    11. Patients who have been treated with immunoglobulins and/or monoclonal antibodies (including natalizumab) in the past 6 months prior to the Screening visit.
    12. Patients with any medically unstable condition, as assessed by the primary treating physician at each site.
    13. Patients with any of the following cardiovascular conditions: history of cardiac arrest; myocardial infarction within the past 6 months prior to enrollment or with current unstable ischemic heart disease; cardiac failure at time of Screening (Class III, according to New York Heart Association Classification or any severe cardiac disease as determined by the investigator; past or current history of recurrent symptomatic bradycardia (e.g. syncope); history or presence of a second degree AV block or a third degree AV block or an increased QTc interval >440 ms on screening ECG; arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide). resting pulse rate <55 bpm at Screening or at Baseline; proven history of sino-atrial heart block;
    history of vagal syncope with a positive tilt test; hypertension, not controlled by prescribed medications.
    14. Patients with any of the following pulmonary conditions: severe respiratory disease or pulmonary fibrosis; tuberculosis, except for history of successfully treated tuberculosis or history of prophylactic treatment after positive PPD; abnormal chest x-ray suggestive of active pulmonary disease; abnormal Pulmonary Function Tests values lower than 70% of predicted at Screening.
    15. Patients with any of the following hepatic conditions: known history of alcohol abuse, chronic liver or biliary disease, with the exception of Gilbert’s syndrome; AST (SGOT), ALT (SGPT) greater than 2 times the upper limit of the normal range at
    Screening; alkaline phosphatase (AP) greater than 1.5 times the upper limit of the normal range at Screening; gamma-glytamyl-transferase (GGT) greater than 3 times the upper limit of the normal range at Screening; total or conjugated bilirubin greater than the upper normal limits at Screening.
    16. Patients with any of the abnormal laboratory values: serum creatinine greater than 1.7 mg/dL (150 µmol/L) at Screening. white blood cell (WBC) count <3,500/mm3 or lymphocyte count <800/mm3 at Screening or Baseline.
    17. Patients with any of the following neurologic/psychiatric disorders: relevant history of suicide attempt or who, in the opinion of the investigator, are at risk of
    suicide attempt; history of substance abuse (drug or alcohol) or any other factor (i.e., serious psychiatric condition) that may interfere with the subject’s ability to cooperate and comply with the study procedures; progressive neurological disorder, other than MS, which may affect participation in the study or require the use of medications not allowed by the protocol.
    18. Patients unable to undergo MRI scans, including history of severe hypersensitivity to gadolinium-DTPA.
    19. Participation in any clinical research study evaluating another investigational drug or therapy within 6 months prior to Baseline.
    20. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml)
    21. History of FTY720 therapy.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the annualized relapse rate at 24 months and will be analyzed using Poisson regression model adjusted for treatment, country, baseline relapse rate (in previous 2 years), baseline number of Gd-enhanced T1 lesions, baseline EDSS and age. Log (time on study) will be used as the offset variable in the Poisson model. Confirmed relapses only will be considered for the primary analysis.
    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 No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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 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.1.3Elderly (>=65 years) No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 850
    F.4.2.2In the whole clinical trial 1250
    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)
    Patients who complete the Double-blind Treatment Phase, will be eligible to either continue or initiate treatment (patients in placebo arm during the Double-blind Treatment Phase) with FTY720 in the long-term extension study that will be provided in a separate protocol.
    The investigator also must provide follow-up medical care for all patients who are
    prematurely withdrawn from the study, or must refer them for appropriate ongoing care.
    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 Decision2007-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-30
    P. End of Trial
    P.End of Trial StatusCompleted
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