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    Summary
    EudraCT Number:2006-000704-17
    Sponsor's Protocol Code Number:CFTY720D2302
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-07-27
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2006-000704-17
    A.3Full title of the trial
    A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon β-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis
    A.3.2Name or abbreviated title of the trial where available
    D2302
    A.4.1Sponsor's protocol code numberCFTY720D2302
    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 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 nameFingolimod
    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.3.8INN - Proposed INNFingolimod
    D.3.9.1CAS number 162359-56-0
    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
    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 (RRMS)
    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 is to compare fingolimod 1.25 mg and 0.5 mg with interferon β-1a and to demonstrate that at least 1.25 mg fingolimod is superior to interferon β-1a in terms of annualized relapse rate for patients with RRMS treated for up to 12 months.
    E.2.2Secondary objectives of the trial
    To demonstrate superiority of two doses of fingolimod (1.25 mg and 0.5 mg per day) over interferon β-1a (30 µg/week i.m.) in patients with RRMS treated for up to 12 months in the proportion of relapse-free patients.

    To assess the efficacy of fingolimod 1.25 mg/day vs. fingolimod 0.5 mg/day in the annualized relapse rate and proportion of relapse free patients.
    To evaluate the safety and tolerability of fingolimod compared to interferon β-1a.
    To test for difference in efficacy of fingolimod (1.25 mg and 0.5 mg per day) vs. interferon β-1a on: other relapse-related parameters; disability progression; and burden of disease and inflammatory disease activity as measured by MRI
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General
    1. male or female;
    • females of childbearing potential must: have negative pregnancy tests prior to entry into the Double-Blind Treatment Phase, or be either post-menopausal for 12 months prior to Randomization or surgically sterile, or use adequate contraception during the treatment and 3 months after discontinuation of the study medication
    2. 18 through 55 years of age inclusive
    3. signed written informed consent prior to participating in the study.

    Multiple sclerosis
    4. diagnosis of multiple sclerosis as defined by 2005 revised McDonald criteria
    5. a relapsing-remitting course with at least 1 documented relapse during the previous year or 2 documented relapses during the previous 2 years; prior to randomization
    6. an Expanded Disability Status Scale (EDSS) score of 0-5.5 inclusive
    7. neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to randomization
    E.4Principal exclusion criteria
    Patients who meet any of the following exclusion criteria during the Pre-Randomization Phase will not be eligible for enrollment in the study:
    1. a manifestation of MS other than RRMS
    2. a history of chronic disease of the immune system other than MS or a known
    immunodeficiency syndrome
    3. a history of epileptic seizures within 3 months of randomization
    4. a history or presence of malignancy (except for successfully treated basal or squamous cell carcinoma of skin)
    5. a known or ‘new’ diagnosis of diabetes mellitus
    6. a diagnosis of macular edema during Pre-randomization Phase (patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at the ophthalmic screening visit).
    7. active systemic bacterial, viral or fungal infections, or diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively
    8. have received total lymphoid irradiation or bone marrow transplantation
    9. have been treated with:
    • corticosteroids or adrenocorticotropic hormones (ACTH) within 1 month prior to randomization
    • immunosuppressive medications such as azathioprine or methotrexate within 6 months prior to randomization
    • immunoglobulins and/or monoclonal antibodies (including natalizumab) within 6 months prior to randomization
    • cladribine, cyclophosphamide or mitoxantrone at any time
    10. any medically unstable condition, as assessed by the primary treating physician
    11. any of the following cardiovascular conditions:
    • myocardial infarction within the past 6 months prior to enrollment or current unstable ischemic heart disease
    • history of angina pectoris due to coronary spasm or history of Raynaud’s phenomenon
    • cardiac failure at time of Screening (Class III, according to NYHA Classification; or any severe cardiac disease as determined by the investigator
    • history of cardiac arrest
    • history of symptomatic bradycardia
    • resting pulse rate <55 bpm prior to randomization
    • history of sick sinus syndrome or sino-atrial heart block
    • 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)
    • history of a positive tilt test from workup for vasovagal syncope
    • hypertension, uncontrolled by medication
    12. 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 skin reaction
    • abnormal chest High Resolution Computer Tomography (HRCT) [or chest x-ray in case HRCT is not permitted by local regulations] suggestive of active pulmonary
    disease
    • abnormal Pulmonary Function Tests: FEV1;, FVC values lower than 70% of predicted value, DLCO values lower than 60% of predicted value
    • patients receiving daily therapies for asthma
    13. any of the following hepatic conditions:
    • known history of alcohol abuse, chronic liver or biliary disease, with the exception of Gilbert’s syndrome
    • total or conjugated bilirubin greater than the upper limit of the normal range
    • alkaline phosphatase (AP) greater than 1.5 times the upper limit of the normal range
    • AST (SGOT), ALT (SGPT) greater than 2 times the upper limit of the normal range
    • gamma-glutamyl-transferase (GGT) greater than 3 times the upper limit of the normal range
    14. any of the following abnormal laboratory values:
    • serum creatinine greater than 1.7 mg/dL (150 µmol/L)
    • white blood cell (WBC) count <3,500/mm3 (<3.5 X 109 / L)
    • lymphocyte count <800/mm3 (<0.8 X 109 / L)
    15. any of the following neurologic/psychiatric disorders:
    • episode of severe depression within three months of randomization
    • 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.
    16. unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA
    17. history of hypersensitivity to natural or recombinant interferon beta, human albumin, or any other component of the formulation
    18. participation in any clinical research study evaluating another investigational drug or therapy within 6 months prior to randomization
    19. history of fingolimod therapy.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the annualized relapse rate (ARR), which is defined as the number of relapses in a year.

    The key secondary endpoint will be the proportion of relapse-free patients.

    Other secondary endpoints include:
    • time to first relapse
    • time to second relapse
    • number of hospitalizations due to relapses
    • frequency of corticosteroid use to treat relapses
    • time to confirmed disability progression
    • proportion of patients with confirmed disability progression
    • change from Baseline to the end of study on the MSFC z-score
    • Burden of disease as measured by MRI:
    • % change from baseline in volume of T2 lesions at 12 months
    • % change from baseline in volume of T1 hypointense lesions at 12 months
    • Inflammatory disease activity as measured by MRI:
    • proportion of scans showing Gd-enhanced T1 lesions
    • proportion of scans showing new/ newly enlarged T2 lesions
    • number of new/ newly enlarged T2 lesions
    • number of Gd-enhanced T1 lesions
    • volume of Gd-enhanced T1 lesions
    • proportion of scans free of new inflammatory activity (Gd-enhanced lesions or
    new/ newly enlarged T2 lesions)
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Double dummy design
    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.8.3 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 concerned5
    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 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 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
    The core study will be considered complete for an individual patient, when he/she completes the Double-blind Treatment Phase. The study as a whole will be considered completed when all randomized patients remaining in the core study have completed the Double-blind Treatment Phase.
    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 days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 1275
    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 12-month double blind treatment phase while being treated with study drug, may enter the Extension Phase - which will be applied for in a separate application to the Hungarian Health Authorities - and which is expected to last until fingolimod is commercially available or development is stopped.
    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 Decision2007-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-26
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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