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    Summary
    EudraCT Number:2012-000835-18
    Sponsor's Protocol Code Number:CFTY720D2306E1
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-12-19
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-000835-18
    A.3Full title of the trial
    Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis
    Studio di estensione, in aperto, con un solo gruppo di trattamento, dello studio multicentrico, randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli per confrontare l ™efficacia e la sicurezza di FTY720 0.5 mg somministrato per via orale una volta al giorno rispetto a placebo in pazienti con sclerosi multipla primaria progressiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS
    Uno studio per valutare la sicurezza e l efficacia di FTY720 0.5 mg in pazienti con sclerosi multipla primaria progressiva
    A.4.1Sponsor's protocol code numberCFTY720D2306E1
    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 SponsorNOVARTIS FARMA
    B.1.3.4CountryItaly
    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
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farma
    B.5.2Functional name of contact pointDrug Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni, 1
    B.5.3.2Town/ cityOriggio
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 02 96541
    B.5.5Fax number+39 02 9659066
    B.5.6E-mailinfo.studiclinici@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 nameFingolimod
    D.3.2Product code FTY720D
    D.3.4Pharmaceutical form Capsule, hard
    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 INNFINGOLIMOD HYDROCHLORIDE
    D.3.9.1CAS number 162359-56-0
    D.3.9.2Current sponsor codeFTY720D
    D.3.9.4EV Substance CodeSUB30967
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary progressive multiple sclerosis.
    Sclerosi multipla primaria progressiva
    E.1.1.1Medical condition in easily understood language
    a chronic autoimmune disease which attacks the central nervous system with a steady worsening of neurologic functioning, but without any distinct relapses or periods of remission
    una malattia autoimmune cronica che attacca il sistema nervoso centrale con un peggioramento costante del funzionamento neurologico, ma senza ricadute o periodi distinti di remissione
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10063401
    E.1.2Term Primary progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system 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 assess the long-term safety, tolerability, and efficacy (as measured by clinical and MRI parameters of disease activity) of fingolimod 0.5 mg/day in PPMS patients.
    valutare la sicurezza, la tollerabilità e l'efficacia a lungo termine (come misurato dai parametri di RMI e clinici di attività di malattia) di fingolimod 0,5 mg/giorno nei pazienti con Sclerosi multipla primaria progressiva
    E.2.2Secondary objectives of the trial
    none
    nessuno
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients eligible for inclusion in this study have to fulfill all of the following criteria: Patients who have provided written informed consent Patients initially randomized to fingolimod 1.25 mg or placebo as part of the first study cohort, who have completed at least 3 years on study drug treatment at the time of extension study initiation Patients initially randomized to fingolimod 0.5 mg or placebo as part of the second study cohort who have continued on study drug treatment until such time as the last ongoing patient enrolled in the study has reached 3 years in study.
    I pazienti eleggibili per l’inclusione in questo studio devono soddisfare tutti i seguenti criteri:
    Pazienti che hanno fornito il proprio consenso informato scritto.
    Pazienti inizialmente randomizzati a fingolimod 1.25 mg o placebo (prima coorte dello studio), che hanno completato almeno 3 anni di trattamento con il farmaco in studio al momento dell’inizio dello studio di estensione.
    Pazienti inizialmente randomizzati a fingolimod 0.5 mg o placebo (seconda coorte dello studio), che hanno continuato il trattamento con il farmaco in studio fino al momento in cui l’ultimo paziente partecipante arruolato nello studio ha raggiunto i 3 anni in studio.
    E.4Principal exclusion criteria
    Patients who meet any of the following exclusion criteria at the baseline visit will not be eligible for enrollment in the extension study: 1. active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjogren's syndrome, Crohn's disease, ulcerative colitis) or with a known immunodeficiency syndrome (HIV-antibody positive, AIDS, hereditary immune deficiency, drug-induced immune deficiency) 2. active systemic bacterial, viral or fungal infections 3. uncontrolled diabetes mellitus (HbA1c>7%) 4. positive screening for serological markers for hepatitis A, B, C, and E indicating acute or chronic infection: • anti-hepatitis A virus IgM, • hepatitis B surface antigen and/or anti-hepatitis B core antigen IgM, • anti-hepatitis C virus IgG or IgM, • anti-hepatitis E virus IgM (positive IgG: do hepatitis E virus-RNA polymerase chain reaction; if negative, patient can be included) Note: The following patients, assuming they have normal aminotransferase activities, can be included in the trial: • those testing positive for hepatitis B surface antibody, indicating hepatitis B immunization -OR- • those testing positive for anti-hepatitis B core antigen IgG, indicating a cured hepatitis B -OR- • those testing positive for anti-hepatitis A virus IgG, indicating a cured hepatitis A 5. macular edema at baseline 6. treatment with Class Ia or III antiarrhythmic drugs (e.g. amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide) 7. any of the following cardiovascular conditions: • myocardial infarction within the past 6 months prior to enrollment or current unstable ischemic heart disease • cardiac failure at time of Screening (Class III, according to NYHA Classification; Appendix 2) or any severe cardiac disease as determined by the investigator • second degree AV block Mobitz type II or a third degree AV block on screening ECG • an increased QTc (Fridericia and Bazett) interval >500 ms on Screening ECG • hypertension, uncontrolled by medication 8. any of the following pulmonary conditions: • severe respiratory disease or pulmonary fibrosis • active tuberculosis • reduction of FEV1, FVC and/or DLCO below 60% of core study baseline values or if FEV1, FVC and/or DLCO at extension study baseline is the second of two consecutive pulmonary function tests with values <80% of core study baseline 9. any of the following hepatic conditions: • total or conjugated bilirubin greater than the upper limit of the normal range, unless in context of Gilbert's syndrome • two consecutive alkaline phosphatase (AP) values greater than 3 times the upper limit of the normal range • two consecutive AST (SGOT), ALT (SGPT) values greater than 3 times the upper limit of the normal range • two consecutive gamma-glutamyl-transferase (GGT) values greater than 3 times the upper limit of the normal range 10. any medically unstable condition, as assessed by the primary treating physician PLS SEE PROTOCOL
    Malattia cronica attiva (o stabile ma trattata con terapia immunitaria) del sistema immunitario diversa dalla sclerosi multipla (ad es. artrite reumatoide, scleroderma, sindrome di Sjogren, malattia di Crohn, colite ulcerosa) o con sindrome da immunodeficienza nota (positività agli anticorpi per HIV, AIDS, immunodeficienza ereditaria, immunodeficienza indotta da farmaci).
    Infezioni attive sistemiche batteriche, virali o fungine.
    Diabete mellito non controllato (HbA1c&gt;7%).
    Screening positivo per gli indicatori sierologici dell’epatite A, B, C ed E che indicano un’infezione acuta o cronica:
    - IgM contro il virus dell’epatite A
    - IgM anti antigene di superficie per epatite B e/o ntigene core dell’epatite B
    - IgG o IgM contro il virus dell’epatite C
    - IgM contro il virus dell’epatite E (se IgG positive: effettuare la reazione a catena della RNA polimerasi del virus dell’epatite E: se negativa, il paziente può essere arruolato)
    Nota: i seguenti pazienti possono essere arruolati a patto che abbiano attività aminitrasferasica normale:
     pazienti positivi per gli anticorpi per l’antigene di superficie dell’epatite B, indicativo di un’immunizzazione per l’epatite B
     pazienti positivi per le IgG per l’antigene core dell’epatite B, indicativo di una epatite B pregressa
     pazienti positivi per le IgG per il virus dell’epatite A, indicativo di una epatite A pregressa
    Edema maculare al basale.
    Trattamento con farmaci antiaritmici di classe Ia o III (ad es. amiodarone, bretilio, sotalolo, ibulitide, azimilide, dofelitide).
    Una qualsiasi delle seguenti condizioni cardiovascolari:
    - Infarto miocardico nei 6 mesi precedenti l’arruolamento o attuale malattia cardiaca ischemica instabile
    - Insufficienza cardiaca al momento dello screening (Classe III, secondo la classificazione NYHA) o qualsiasi malattia cardiaca severa come determinata dallo sperimentatore
    - Blocco AV di secondo grado tipo Mobitz II o blocco AV di terzo grado all’ECG di screening
    - Intervallo QTc aumentato (Fridericia e Bazett) &gt;500 ms all’ECG di screening
    - Ipertensione non controllata da farmaci.
    Una qualsiasi delle seguenti condizioni polmonari:
    - Malattia respiratoria grave o fibrosi polmonare
    - Tubercolosi attiva
    - Riduzione di FEV1, FVC e/o DLCO al di sotto del 60% dei valori basali dello studio principale o se FEV1, FVC e/o DLCO al basale dello studio di estensione costituiscono il secondo di due test consecutivi di funzionalità polmonare con valori &lt; 80% del basale dello studio principale.
    Una qualsiasi delle seguenti condizioni epatiche:
    - Bilirubina totale o coniugata superiore ai limiti superiori della normalità, se non nel contesto della sindrome di Gilbert
    - Due valori consecutivi di fosfatasi alcalina superiori a 3 volte il limite superiore di normalità
    - Due valori consecutivi di AST (SGOT), ALT (SGPT) ..Per FAVORE VEDERE SINOSSI IN ITALIANO
    E.5 End points
    E.5.1Primary end point(s)
    long-term safety, tolerability, and efficacy
    sicurezza, tollerabilità ed efficacia a lungo termine
    E.5.1.1Timepoint(s) of evaluation of this end point
    Physical examination,Vital signs, Blood pressure, laboratory evaluations - All visits: Electrocardiogram, baseline, monthly through month 3, every 6 months afterwards); Dermatological and Ophthalmic examinations and Pulmonary Function Tests, yearly; EDSS, 9HPT and 25TWT every 6 months; MRI parameters, yearly.
    esame fisico,segni Vitali, pressione del sangue, esami di laboratorio evaluations - Tutte le visite: Elettrocardiogramma, basale, mensile fino al 3^ mese, eogni 6 mesi in seguito; Esami Dermatologici, Oftalmici e funzionalità polmonare Tests, annualmente; EDSS, 9HPT e 25TWT ogni 6 mesi; parametri MRI, annualmente.
    E.5.2Secondary end point(s)
    none
    nessuno
    E.5.2.1Timepoint(s) of evaluation of this end point
    N.A.
    N.A.
    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 Yes
    E.6.13.1Other scope of the trial description
    Health-related quality of life, Patient reported outcomes PRIMUS and MSWS12
    Qualità della vita correlata con la salute, Risultati riferiti dal Pazienti PRIMUS e MSWS12
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Switzerland
    Turkey
    United States
    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
    LVLP : 20/MARCH/2017
    LVLP : 20/03/2017
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months49
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months51
    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.1.1Number of subjects for this age range: 0
    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.1.2.1Number of subjects for this age range: 750
    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 Yes
    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 state73
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 522
    F.4.2.2In the whole clinical trial 750
    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 study on study drug, may be offered access to fingolimod, under a separate protocol, until the drug is available on the market for the treatment of PPMS or the development is discontinued
    I pazienti che terminano lo studio con il farmaco in studio, possono essere offerti l'accesso a fingolimod, nell'ambito di un protocollo separato, finché il farmaco non sia disponibile sul mercato per il trattamento della PPMS
    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 Decision2013-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-05-13
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