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    Summary
    EudraCT Number:2011-005280-24
    Sponsor's Protocol Code Number:CFTY720I2201
    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:2012-09-13
    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 number2011-005280-24
    A.3Full title of the trial
    A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
    Studio in doppio cieco, randomizzato, multicentrico, controllato verso placebo, a gruppi paralleli, per valutare la efficacia e la sicurezza di fingolimod 0,5 mg somministrato una volta al giorno per via orale, rispetto al placebo, nel trattamento di pazienti con poliradiculoneuropatia demielinizzante infiammatoria cronica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluate efficacy and safety of fingolimod 0.5 mg orally once daily versus placebo in chronic inflammatory demyelinating polyradiculoneuropathy.
    Valutazione della efficacia e sicurezza di fingolimod assunto per via orale una volta al giorno rispetto a placebo nella polineuropatia infiammatoria cronica demielinizzante.
    A.4.1Sponsor's protocol code numberCFTY720I2201
    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 PHARMA 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 organisationPPD
    B.5.2Functional name of contact pointAD project management CNS
    B.5.3 Address:
    B.5.3.1Street Address45-47 Blvd Paul Vaillant Couturier
    B.5.3.2Town/ cityIvry-Sur-Seine Cedex
    B.5.3.3Post code94853
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 467402887
    B.5.5Fax number+44 1223899740
    B.5.6E-mailkim.dawe@ppdi.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/718
    D.3 Description of the IMP
    D.3.1Product nameFingolimod
    D.3.2Product code FTY720I
    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 codeFTY720I
    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
    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
    Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
    Poliradiculopatia cronica infiammatoria demielinizzante (CIDP).
    E.1.1.1Medical condition in easily understood language
    Chronic inflammatory demyelinating polyneuropathy (CIDP).
    polineuropatia demielinizzante infiammatoria cronica (CIDP).
    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 10057645
    E.1.2Term Chronic inflammatory demyelinating polyradiculoneuropathy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of fingolimod 0.5 mg daily compared with placebo on delaying disability progression, in patients with CIDP, measured by the time to the first confirmed worsening on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale. A confirmed worsening is defined as an increase by 1 point or more on the adjusted INCAT Disability Scale from the value at Baseline.
    L’obiettivo primario di questo studio è valutare l’effetto di fingolimod 0,5 mg somministrato giornalmente rispetto al placebo nel ritardare la progressione della disabilità nei pazienti affetti da poliradiculoneuropatia demielinizzante infiammatoria cronica, tramite misurazione del tempo trascorso al primo verificarsi di un peggioramento confermato sulla scala di disabilità INCAT (Inflammatory Neuropathy Cause and Treatment) corretta. Un peggioramento confermato viene definito come un incremento di 1 o più punti sulla scala di disabilità INCAT corretta, rispetto al valore registrato al baseline.
    E.2.2Secondary objectives of the trial
    • to assess the change in grip strength from Baseline to Month 6/End-of- Treatment (whichever occurs first) in CIDP patients on fingolimod as compared with those on placebo • to assess the change in Rasch-Built Linearly Weighted Overall Disability Scale (R-ODS) from Baseline to Month 6/End-of-Treatment (whichever occurs first) in CIDP patients on fingolimod as compared with those on placebo • to evaluate safety and tolerability of fingolimod compared with placebo in patients with CIDP
    • Valutare il cambiamento nella forza di prensione dal baseline al mese 6/fine del trattamento (a seconda dell’evento che si verifica per primo) nei pazienti con poliradiculoneuropatia demielinizzante infiammatoria cronica trattati con fingolimod rispetto a quelli che assumono placebo • Valutare il cambiamento nella scala di disabilità R-ODS (Rasch-Built Linearly Weighted Overall Disability Scale) dal baseline al mese 6/fine del trattamento (a seconda dell’evento che si verifica per primo) nei pazienti con poliradiculoneuropatia demielinizzante infiammatoria cronica trattati con fingolimod rispetto a quelli che assumono placebo • Valutare la sicurezza e la tollerabilità di fingolimod rispetto al placebo nei pazienti con poliradiculoneuropatia demielinizzante infiammatoria cronica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria 1. written informed consent must be obtained before any assessment is performed 2. Either confirmed diagnosis of typical CIDP as defined by the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) Task Force First Revision Or one of the following forms of atypical CIDP: • pure motor CIDP • MADSAM (Lewis-Sumner syndrome) • CIDP in association with MGUS IgG or IgA but not IgM MGUS 3. disability defined by an INCAT Disability Scale score of 1-9 or, if INCAT score is 0, a documented history of disability sufficient to require treatment within the past 2 years following reduction or interruption of CIDP treatment 4. receiving IVIg treatment (minimal dose equivalent to 0.4 g/kg every 4 weeks) or corticosteroids (minimal dose equivalent to prednisone 10 mg/day) treatment prior to the screening visit 5. history of relapsing or progressive clinical course upon interruption or reduction of therapies within 1 year prior to Screening 6. male or female, aged 18 years or older at Screening.
    Criteri di inclusione 1. Consenso informato scritto, da ottenere prima dell’esecuzione di qualsiasi valutazione dello studio 2. O diagnosi confermata di poliradiculoneuropatia demielinizzante infiammatoria cronica tipica secondo la definizione della prima revisione della task force della European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) O una delle seguenti forme di poliradiculoneuropatia demielinizzante infiammatoria cronica atipica: • poliradiculoneuropatia demielinizzante infiammatoria cronica motoria pura • MADSAM (sindrome di Lewis-Sumner) • poliradiculoneuropatia demielinizzante infiammatoria cronica associata a gammopatia monoclonale di significato incerto (MGUS) IgG o IgA ma non IgM 3. Disabilità definita da un punteggio della scala di disabilità INCAT compreso tra 1 e 9; se il punteggio INCAT è 0, una storia documentata di disabilità tale da richiedere un trattamento nei 2 anni precedenti in seguito a riduzione o interruzione del trattamento della poliradiculoneuropatia demielinizzante infiammatoria cronica 4. Somministrazione del trattamento IVIg (dose minima equivalente a 0,4 g/kg ogni 4 settimane) o trattamento con corticosteroidi (dose minima equivalente al prednisone da 10 mg/giorno) prima della visita di screening 5. Storia di decorso clinico con recidive o progressione dopo l’interruzione o la riduzione delle terapie entro 1 anno dallo screening 6. Uomini e donne di età pari o superiore a 18 anni allo screening
    E.4Principal exclusion criteria
    Exclusion Criteria 1. other chronic demyelinating neuropathies, including: • Distal Acquired Demyelinating Symmetric Neuropathy (DADS) • Multifocal Motor Neuropathy with conduction block (MMN) • pure sensory CIDP • hematopoietic malignancy except for MGUS IgG or IgA 2. conditions in which the pathogenesis of the neuropathy may be different from CIDP such as: Lyme disease, POEMS syndrome, osteosclerotic myeloma, Castleman's disease 3. treatment with: • plasma exchange within 2 months of randomization • immunosuppressive/chemotherapeutic medications: • azathioprine, cyclophosphamide, cyclosporine, mycophenolate, etanercept, methotrexate within 6 months of randomization • Rituximab in the 2 years prior to randomization • other immunosuppressive medications (including mitoxantrone, alemtuzumab, cladribine) at any time • hematopoietic stem cell transplantation at any time 4. a CIDP relapse or significant worsening of symptoms within 2 months of randomization.
    Principali criteri di esclusione 1. Altre neuropatie demielinizzanti croniche, tra cui: • Neuropatia distale demielinizzante simmetrica acquisita (DADS) • Neuropatia motoria multifocale (MMN) con blocco della conduzione • poliradiculoneuropatia demielinizzante infiammatoria cronica sensoriale pura • Tumore ematopoietico maligno, tranne MGUS 2. Condizioni nelle quali la patogenesi della neuropatia può essere diversa dalla poliradiculoneuropatia demielinizzante infiammatoria cronica, quali: malattia di Lyme, sindrome POEMS, mieloma osteosclerotico, malattia di Castleman 3. Trattamento con: • Plasmaferesi entro 2 mesi dalla randomizzazione • Farmaci immunosoppressivi/chemioterapici • Azatioprina, ciclofosfamide, ciclosporina, micofenolato, etanercept, metotrexato entro 6 mesi dalla randomizzazione • Rituximab nei 2 anni precedenti la randomizzazione • Altri farmaci immunosoppressivi (tra cui mitoxantrone, alemtuzumab, cladribina) in qualsiasi momento • Trapianto di cellule staminali emopoietiche in qualsiasi momento 4. Una poliradiculoneuropatia demielinizzante infiammatoria cronica recidiva oppure un peggioramento significativo dei sintomi entro 2 mesi dalla randomizzazione.
    E.5 End points
    E.5.1Primary end point(s)
    Delay of disease progression, measured by time to first confirmed worsening on the adjusted INCAT disability scale by 1 point or more from the value at baseline, in patients who were being treated with IVIG and/or corticosteroids prior to study start.
    La misura d’efficacia primaria sarà il tempo trascorso al primo verificarsi di un peggioramento confermato di 1 o più punti sulla scala di disabilità INCAT corretta rispetto al valore registrato al baseline, in pazienti che erano in corso di trattamento con IVIg e/o corticosteroidi prima dell'inizio dello studio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time to event.
    Tempo del evento.
    E.5.2Secondary end point(s)
    1) The change in grip strength from baseline in CIDP patients on fingolimod as compared with those on placebo. Grip strength measurements will be done using a vigorimeter 2) The change from baseline for Rasch-Built Linearly Weighted Overall Disability Scale (R-ODS). This questionnaire was constructed using the patients perception of their ability to perform daily and social activities 3) Safety and tolerability of fingolimod compared with placebo in patients with CIDP. Measured by AE/SAE, hematology and biochemistry lab tests, vital signs, ECG, and pulmonary function test.
    1) Cambiamento nella forza di prensione dal baseline nei pazienti con poliradiculoneuropatia demielinizzante infiammatoria cronica trattati con fingolimod rispetto a quelli che assumono placebo. Il test è effettuato mediante l'uso di un vigorimetro. 2) cambiamento nella scala di disabilità R-ODS (Rasch-Built Linearly Weighted Overall Disability Scale) dal baseline nei pazienti con poliradiculoneuropatia demielinizzante infiammatoria cronica trattati con fingolimod rispetto a quelli che assumono placebo. Il questionario misura la percezione dei pazienti nella abilità a svolgere le attività giornaliere e sociali. 3)La sicurezza e la tollerabilità di fingolimod rispetto al placebo nei pazienti con poliradiculoneuropatia demielinizzante infiammatoria cronica, misurate in base agli eventi avversi (AE) ed agli eventi avversi gravi (SAE), alle analisi ematologiche e biochimiche di laboratorio, ai segni vitali, all’elettrocardiogramma (ECG) ed ai test di funzionalità polmonare.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Month 6/ End of treatment. 2) Month 6/ End of treatment. 3) End of study.
    1) Mese 6/fine del trattamento. 2) Mese 6/fine del trattamento. 3) Fine dello studio.
    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 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 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.8.2.4Number of treatment arms in the trial2
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Israel
    Japan
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 78
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 78
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 83
    F.4.2.2In the whole clinical trial 156
    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)
    For safety reasons, patients will have a follow-up visit approximately 3 months after study drug discontinuation, regardless of when in the trial they discontinued from study drug. Patients who complete the study will have an option to enter in an extension study.
    Per ragioni di sicurezza, i pazienti saranno sottoposti ad una visita di follow up circa 3 mesi dopo l'interruzione del farmaco, indipendentemente da quando hanno interrotto l'assunzione. I pazienti che hanno terminato lo studio avranno l'opportunitàdi entrare in uno studio di estensione.
    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 Decision2012-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-12
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