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    Summary
    EudraCT Number:2013-005557-73
    Sponsor's Protocol Code Number:I10E-1302
    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:2014-08-27
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-005557-73
    A.3Full title of the trial
    An international, multicentre, efficacy and safety study of I10E in
    initial and maintenance treatment of patients with Chronic
    Inflammatory Demyelinating Polyradiculoneuropathy
    Studio internazionale multicentrico per valutare l’efficacia e la sicurezza di I10E nei trattamenti iniziale e di mantenimento dei pazienti affetti da poliradiculoneuropatia demielinizzante infiammatoria cronica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An international study on efficacy and safety of I10E in CIDP patients
    Uno studio internazionale sull’ l’efficacia e la sicurezza di I10E in pazienti affetti da poliradiculoneuropatia demielinizzante infiammatoria cronica (CIDP)
    A.3.2Name or abbreviated title of the trial where available
    PRISM
    A.4.1Sponsor's protocol code numberI10E-1302
    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 SponsorLFB BIOTECHNOLOGIES
    B.1.3.4CountryFrance
    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 supportLFB BIOTECHNOLOGIES
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLFB BIOTECHNOLOGIES
    B.5.2Functional name of contact pointClinical trial information desk
    B.5.3 Address:
    B.5.3.1Street Address3, avenue des Tropiques, BP 40305 – LES ULIS
    B.5.3.2Town/ cityCOURTABOEUF CEDEX
    B.5.3.3Post code91958
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 1 69 82 70 10
    B.5.5Fax number+33 1 69 82 72 72
    B.5.6E-mailneuharte@lfb.fr
    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 namehuman normal immunoglobulin for intravenous administration
    D.3.2Product code I10E
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN NORMAL IMMUNOGLOBULIN (IV)
    D.3.9.2Current sponsor codeI10E
    D.3.9.3Other descriptive nameHUMAN NORMAL IMMUNOGLOBULIN (IV)
    D.3.9.4EV Substance CodeSUB12041MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
    poliradiculoneuropatia demielinizzante infiammatoria cronica
    E.1.1.1Medical condition in easily understood language
    Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an acquired paralytic illness affecting peripheral nerves and caused by a demyelinating process.
    La poliradiculoneuropatia demielinizzante infiammatoria cronica è una condizione di paralisi acquisita dovuta a un processo di demielinizzazione dei nervi periferici
    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 17.0
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the efficacy of I10E in improving the disability of patients with CIDP.

    Valutare l’efficacia di I10E nel migliorare la disabilità dei pazienti affetti da CIDP.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the safety of I10E in patients with CIDP.
    Exploratory objectives:
    To assess a potential relationship between total serum IgG trough levels, biomarkers levels and clinical changes - as assessed by neurological scales - in patients with CIDP.
    To assess a potential relationship between ultrasonography (US) coupled to neurophysiology analysis of nerves and clinical changes - as assessed by neurological scales - in patients with CIDP (ancillary study in Italy).
    Valutare la sicurezza di I10E in pazienti affetti da CIDP.
    Obiettivi esplorativi:
    Valutare una potenziale correlazione tra i livelli sierici minimi delle IgG totali, i livelli dei biomarcatori e le alterazioni cliniche, come valutate dalle scale neurologiche, in pazienti affetti da CIDP.
    Valutare una potenziale correlazione tra l’ultrasonografia (US) insieme all’analisi neurofisiologica dei nervi e delle alterazioni cliniche, come valutate dalle scale neurologiche, in pazienti affetti CIDP (studio ausiliario in Italia).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Only in the Italian centre an ancillary study will be performed to evaluate:
    - Change from baseline to EOS visit in nerve conduction velocities, distal latencies, amplitude of the negative phase of compound muscle action potentials and F wave for the following peripheral nerves: median nerve, ulnar nerve and deep fibular nerve (F wave assessed on ulnar nerve only).
    - Change from baseline to EOS visit in nerve maximal/minimal cross section area (CSA), intra-nerve and inter-nerve variability and US immune-related classification (see section 1.4.4. Electrophysiology examination and peripheral nerve ultrasonography), in the following peripheral nerves: median nerve, ulnar nerve, fibular nerve and sural nerve.
    Solo nei centri Italiani sarà condotto uno studio ancillare atto a valutare:
    - la variazioni dal basale alla visita di EOS nelle velocità di conduzione nervosa, latenze distali, ampiezza della fase negativa del potenziale d’azione muscolare composto e onda F per i seguenti nervi periferici: nervo mediano, nervo ulnare e nervo fibulare profondo (onda F valutata solo sul nervo ulnare);
    - la variazioni dal basale alla visita di EOS nell’area della massima/minima sezione trasversale del nervo (Cross Section Area, CSA), variabilità intra-nervo e inter-nervo e classificazione US immunocorrelata (vedere sezione 1.4.4. Esame elettrofisiologico e ultrasonografia del nervo periferico), nei seguenti nervi periferici: nervo mediano, nervo ulnare, nervo fibulare e nervo surale.
    E.3Principal inclusion criteria
    1. Male or female patient aged 18 years or more.
    2. - Definite or probable CIDP according to the European Federation of Neurological Societies (EFNS)/Peripheral Nerve Society (PNS) guidelines 2010 clinical and neurophysiological criteria.
    - Pure motor CIDP, provided that a diagnosis of multifocal motor neuropathy has been ruled out.
    - CIDP associated with monoclonal gammopathy of undetermined significance (MGUS), provided that anti-MAG antibodies titer is lower than the used technique's negativity threshold (1000 BTU for Bühlmann ELISA technique).
    - Lewis-Sumner syndrome.
    3. Score of at least 2 on the adjusted INCAT disability scale.
    4. Patient who either :
    a) has never been previously treated with Ig (Ig-naive patient)
    Or
    b) was previously treated with Ig but is in clinical relapse following treatment withdrawal. In the latter case, the last Ig course shall have been administered no less than 3 months prior to screening.
    5. Covered by national healthcare insurance system as required by local regulations.
    6. Written informed consent obtained prior to any study-related procedures.
    1. Pazienti di sesso maschile o femminile di età uguale o superiore a 18 anni.
    2.
     CIDP definita o probabile secondo la Federazione Europea delle Società di Neurologia (European Federation of Neurological Societies, EFNS)/le linee guida 2010 della Peripheral Nerve Society (PNS) e i criteri neurofisiologici.
     CIDP puramente motoria, a condizione che sia stata esclusa una diagnosi di neuropatia motoria multifocale.
     CIDP associata a gammopatia monoclonale di significatività indeterminata (Monoclonal Gammopathy of Undetermined Significance, MGUS), a condizione che il titolo degli anticorpi anti-MAG sia inferiore alla soglia di negatività della tecnica utilizzata (1000 BTU per la tecnica ELISA di Bühlmann).
     Sindrome di Lewis-Sumner.
    3. Punteggio di almeno 2 nella scala di disabilità rettificata Cause e trattamento delle neuropatie infiammatorie (Inflammatory Neuropathy Cause and Treatment, INCAT).
    4. Paziente che:
    a) o non è mai stato precedentemente trattato con Ig (paziente naïve alle Ig)
    oppure
    b) è stato precedentemente trattato con Ig, ma è in fase di recidiva clinica dopo il ritiro dal trattamento. Nel secondo caso, l’ultimo corso di somministrazione di Ig deve essere stato somministrato non meno di 3 mesi prima dello screening.
    5. Coperto dal sistema di assicurazione sanitaria nazionale, come richiesto dai regolamenti locali.
    6. Consenso informato scritto ottenuto prima di effettuare qualsiasi procedura correlata allo studio.
    E.4Principal exclusion criteria
    1. History of severe allergic reaction or serious adverse reaction to any immunoglobulin (Ig).
    2. Clinically documented lack of response to previous Ig treatment.
    3. History of IgA deficiency, unless the absence of anti-IgA antibodies has been documented.
    4. Known hypersensitivity to human Ig or to any of the excipients of I10E (glycine and polysorbate 80).
    5. History of cardiac insufficiency (New York Heart Association [NYHA] III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled
    hypertension.
    6. History of venous thrombo-embolic disease, myocardial infarction or, cerebrovascular accident.
    7. Risk factor for blood hyperviscosity such as cryoglobulinemia or haematologic malignancy with monoclonal gammopathy.
    8. History of personal or familial congenital thrombophilia or acquired thrombophilia.
    9. Factors contributing to venous stasis such as long-term bed confinement.
    10. Body mass Index (BMI) ≥40 kg/m².
    11. Protein-losing enteropathy characterised by serum protein levels <60 g/L and serum albumin levels <30 g/L or nephrotic syndrome characterised by proteinuria ≥3.5 g/24hours, serum protein levels <60 g/L and serum albumin levels <30 g/L.
    12. Glomerular filtration rate <80 mL/min/1.73m² measured according to the Modified Diet in Renal Disease (MDRD) calculation.
    13. Serum levels of alanine aminotransferase (AST) or aspartate aminotransferase (ALT), >2 times upper limit of normal range.
    Anamnesi di grave reazione allergica o reazione avversa grave a qualsiasi immunoglobulina (Ig).
    2. Assenza di risposta al precedente trattamento con Ig clinicamente documentata.
    3. Anamnesi di deficit di IgA, a meno che non sia stata documentata l’assenza di anticorpi anti-IgA.
    4. Ipersensibilità nota alle Ig umane o a uno qualsiasi degli eccipienti di I10E (glicina e polisorbato 80).
    Anamnesi di insufficienza cardiaca (New York Heart Association [NYHA] III/IV), aritmia cardiaca non controllata, cardiopatia ischemica instabile o ipertensione non controllata.
    6. Anamnesi di malattia tromboembolica venosa, infarto del miocardio o incidente cerebrovascolare.
    7. Fattore di rischio per iperviscosità ematica, quale la crioglobulinemia o le malignità ematologiche con gammopatia monoclonale.
    8. Anamnesi personale o familiare di trombofilia congenita o trombofilia acquisita.
    9. Fattori che contribuiscono alla stasi venosa, quali il confinamento a letto a lungo termine.
    10. Indice di massa corporea (IMC) 40 kg/m².
    11. Enteropatia proteino-disperdente caratterizzata da livelli sierici di proteine < 60 g/l e livelli sierici di albumina < 30 g/l o sindrome nefrosica caratterizzata da proteinuria 3,5 g/24h, livelli sierici di proteine < 60 g/l e livelli sierici di albumina < 30 g/l.
    12. Velocità di filtrazione glomerulare < 80 ml/min/1,73m², misurata secondo il calcolo della Dieta modificata per la malattia renale (Modified Diet in Renal Disease, MDRD).
    13. Livelli sierici di alanina aminotransferasi (ALT) o aspartato aminotransferasi (AST) > 2 volte il limite superiore della norma.
    E.5 End points
    E.5.1Primary end point(s)
    Responder rate at EOS visit.
    Responders are defined as patients with a decrease ≥1 point in the
    adjusted INCAT score between baseline and the EOS visit.
    Tasso di rispondenti alla visita di EOS.
    I rispondenti sono definiti come pazienti con una diminuzione di ≥1 punto nel punteggio INCAT rettificato tra la visita al basale e quella di EOS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at baseline and the End Of Study visit.
    al basale e alla visita di fine studio
    E.5.2Secondary end point(s)
    - Responder rate at 12 weeks.
    - Time to response.
    - Percentage of patients at 12 weeks and EOS visit with no change in
    CIDP treatment.
    - Changes from baseline to 12 weeks and EOS visit in the following
    scores:
    • Adjusted INCAT score;
    • Grip strength with the Martin vigorimeter in both hands;
    • Rasch-built Overall Disability Scale (R-ODS);
    • Patient and Investigator Clinical Global Impression (CGI);
    • Medical Research Council (MRC) 12 muscles sum score (0 to 5) and Rasch-modified MRC (0 to 3).
    Tasso di rispondenti a 12 settimane.
    - Tempo alla risposta.
    - Percentuale di pazienti con nessuna modifica nel trattamento della CIDP a 12 settimane e alla visita di EOS.
    - Variazioni dal basale a 12 settimane e alla visita di EOS nei seguenti punteggi:
    Punteggio INCAT rettificato;
    Forza della presa in entrambe le mani con il vigorimetro di Martin;
    Scala di disabilità R-ODS (Rasch-Built Overall Disability Scale);
    Impressione clinica globale (Clinical Global Impression, CGI) del paziente e dello sperimentatore;
    Somma del punteggio di 12 muscoli secondo la scala MRC (Medical Research Council) (da 0 a 5) e la scala MRC modificata Rasch (da 0 a 3).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, at 12 weeks and End of study visit
    al basale, a 12 settimane e alla visita di fine 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 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
    Other exploratory objectives are to assess:
    - To assess a potential relationship between total serum IgG trough levels, biomarkers levels and clinical changes – as assessed by neurological scales – in patients with CIDP.
    - To assess a potential relationship between US coupled to neurophysiology analysis of nerves and clinical changes – as assessed by neurological scales – in patients with CIDP (ancillary study in
    Italy).
    Altri obiettivi esplorativi sono:
    • Valutare una potenziale correlazione tra i livelli sierici minimi delle IgG totali, i livelli dei biomarcatori e le alterazioni cliniche, come valutate dalle scale neurologiche, in pazienti affetti da CIDP.
    • Valutare una potenziale correlazione tra l’ultrasonografia (US) insieme all’analisi neurofisiologica dei nervi e delle alterazioni cliniche, come valutate dalle scale neurologiche, in pazienti affetti CIDP (studio ausiliario in Italia).
    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 Yes
    E.8.1.7.1Other trial design description
    singolo braccio
    Single arm
    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 concerned8
    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 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
    France
    Italy
    Mexico
    Morocco
    Spain
    Tunisia
    Turkey
    United Kingdom
    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
    LVLS
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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.1.2.1Number of subjects for this age range: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 26
    F.4.2.2In the whole clinical trial 42
    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)
    At the last visit patients will be switched to the normal standard of care for the condition.
    dopo l’ultima visita dello studio i pazienti saranno seguiti secondo le normali procedure standard di cura per la loro condizione.
    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 Decision2014-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-16
    P. End of Trial
    P.End of Trial StatusCompleted
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