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    Summary
    EudraCT Number:2011-002683-24
    Sponsor's Protocol Code Number:CP-NU100-01.00
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-12-23
    Trial 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 number2011-002683-24
    A.3Full title of the trial
    A phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the safety and efficacy of NU100 in patients with relapsing forms of multiple sclerosis
    Studio di Fase III, multicentrico, in doppio cieco, randomizzato, controllato con placebo, a gruppi paralleli, volto a valutare la sicurezza e l'efficacia di NU100 in pazienti con forme recidivanti di sclerosi multipla
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to test if NU100 is safe and can treat patient with relapsing types of multiple sclerosis
    Studio clinico che testa se NU100 e' sicuro ed efficace nel trattamento di pazienti con forme recidivanti di sclerosi multipla
    A.4.1Sponsor's protocol code numberCP-NU100-01.00
    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 SponsorNURON BIOTECH INC.
    B.1.3.4CountryUnited States
    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 supportNuron Biotech, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWorldwide Clinical Trials
    B.5.2Functional name of contact pointSheetal Haria
    B.5.3 Address:
    B.5.3.1Street Address2nd floor, 172 tottenham Court Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1T 7NS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 207 1216175
    B.5.5Fax number+44 207 1216160
    B.5.6E-mailsheetal.haria@wwctrials.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.3.2Product code NU100
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeNU100
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.25
    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 No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name Betaferon
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Schering Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 145155-23-3
    D.3.9.3Other descriptive nameINTERFERON BETA-1B
    D.3.9.4EV Substance CodeSUB12432MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.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) 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 placeboPowder and solvent for suspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    relapsing forms of multiple sclerosis
    forme recidivanti della sclerosi multipla
    E.1.1.1Medical condition in easily understood language
    multiple sclerosis
    sclerosi multipla
    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 SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    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 evaluate the safety and efficacy of NU100 in patients with relapsing remitting multiple sclerosis as compared to placebo and an active comparator. The primary clinical objective selected for this Phase 3 study, the cumulative number of new combined unique active lesions (CALs; defined as new gadolinium T1-weighted lesions and non enhancing new and newly enlarging T2-weighted lesions) on magnetic resonance imaging (MRI) scans over the course of 4 and 12 months of treatment to demonstrate the superiority of NU100 to placebo and the non-inferiority of NU100 to Betaferon, respectively.
    L'obiettivo primario di questo studio è: valutare la sicurezza e l'efficacia di NU100 nei pazienti con sclerosi multipla recidivante remittente (SMRR) rispetto a placebo e un farmaco attivo di confronto. L’obiettivo clinico primario ha selezionato per questo studio di fase 3 il numero cumulativo di nuove lesioni attive uniche combinate (LAC; definite come nuove lesioni pesate in T1 con gadolinio e lesioni nuove e di recente espansione pesate in T2 non captanti) su scansioni di risonanza magnetica (RM) nel corso di 4 e 12 mesi di trattamento per dimostrare, rispettivamente, la superiorità del NU100 sul placebo e la non inferiorità di NU100 su Betaferon.
    E.2.2Secondary objectives of the trial
    see protocol
    come da protocollo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will be eligible to participate in the study if all of the following criteria are met at both screening (V-1) and baseline (V0): 1.Female or male patients, aged between 18 and 60 years, inclusive 2.Signed and dated statement of informed consent 3.Diagnosis of RRMS according to McDonald's Criteria – revision 2010 4.Interferon (IFN) beta-1b naïve 5.Expanded Disability Status Scale (EDSS) score of < 5.5 6.At least 1 documented relapse in the past year (defined as the appearance of a new clinical sign/symptom [one that had been stable for at least 30 days] that persisted for a minimum of 24 hours in the absence of fever) ---or--- a subclinical sign/symptom (defined as a Gd enhancing lesion or a new T2 lesion demonstrated on MRI examination on a prior MRI that has been completed within 1 year of the screening MRI). The Screening (V1) MRI should not be used for this determination. 7.No relapse in the 4 weeks prior to the screening visit (V-1). 8.Must be in a clinically stable or improving neurological state 4 weeks preceding the screening visit (V-1)
    Criteri di inclusione I pazienti saranno ritenuti idonei a partecipare allo studio se sono soddisfatti tutti i seguenti criteri, allo screening (V-1) come al basale (V0): 1. Pazienti di sesso maschile o femminile, di età compresa tra i 18 e i 60 anni compresi 2. Dichiarazione firmata e datata del consenso informato 3. Diagnosi di SMRR secondo i criteri di McDonald - revisione 2010 (Polman et al., 2011) 4. Naïve all’interferone (IFN) beta-1b 5. Punteggio della Expanded Disability Status Scale (EDSS) &lt; 5,5 6. Almeno 1 recidiva documentata nell'ultimo anno (definita come la comparsa di un nuovo segno/sintomo clinico [che era stato stabile per almeno 30 giorni], persistente per almeno 24 ore in assenza di febbre) ---oppure--- un segno/sintomo subclinico (definito come una lesione captante gadolinio o una nuova lesione in T2 mostrata mediante esame RM su una precedente RM completata entro 1 anno dallo screening RM). La RM di screening (V-1) non deve essere utilizzata per questa determinazione 7. Nessuna ricaduta nelle 4 settimane precedenti la visita di screening (V-1). 8. Si deve trovare in uno stato neurologico clinicamente stabile o di miglioramento nelle 4 settimane precedenti la visita di screening (V-1).
    E.4Principal exclusion criteria
    Patients meeting any of the following exclusion criteria at screening (V- 1) and baseline (V0) will not be enrolled in the study: 1.Relapse at the baseline visit (V0) or occurring within 4 weeks prior to the screening visit (V-1) 2.Intake of glatiramer acetate within 3 months prior to the screening (V- 1) visit 3.Intake of previous immunotherapy or immunosuppressant treatment, within 4 months prior to the screening (V-1) visit 4.Intake of or previously received therapy with cladribine or alemtuzumab 5.An active viral, bacterial, or systemic fungal infection within 1 week of baseline (V0) 6.Use of systemic steroids within 3 weeks prior to the screening (V-1) MRI 7.Progressive disease
    Criteri di esclusione I pazienti che soddisfano uno qualsiasi dei seguenti criteri di esclusione al momento dello screening (V-1) e al basale (V0) non saranno arruolati nello studio: 1. Ricaduta alla visita al basale (V0) o che si verifica nelle 4 settimane precedenti la visita di screening (V-1) 2. Assunzione di glatiramer acetato nei 3 mesi precedenti la visita di screening (V-1) 3. Immunoterapia o trattamento immunosoppressivo nei 4 mesi precedenti la visita di screening (V-1) 4. Attuale o precedente terapia con cladribina o alemtuzumab 5. Infezione sistemica virale, batterica o fungina attiva entro 1 settimana dal basale (V0) 6. Uso di steroidi sistemici nelle 3 settimane precedenti la RM di screening (V-1) 7. Malattia progressiva
    E.5 End points
    E.5.1Primary end point(s)
    •Cohort 1: new CALs after 4 months of treatment based on the MRI outcomes obtained at Months 2, 3, and 4 •Cohort 2: new CALs over 12 months of treatment based on the MRI outcomes obtained at Months 3, 6, 9, and 12
    • Coorte 1: nuovi LAC dopo 4 mesi di trattamento sulla base degli esiti della risonanza magnetica ottenuti ai mesi 2, 3 e 4 • Coorte 2: nuovi LAC dopo 12 mesi di trattamento sulla base degli esiti della risonanza magnetica ottenuti ai mesi 3, 6, 9 e 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    as per protocol
    come da protocollo
    E.5.2Secondary end point(s)
    •Incidence of annualized relapse rates •Proportion of relapse-free patients at 12 months •Incidence and severity of all drug related flu-like symptoms (FLS) during the first 4 months of study participation in all patients. •Incidence of antibody (neutralizing antibodies [NABs]/binding antibodies [BABs]) formation against IFN beta-1b •Changes from baseline in the EDSS score after 3, 4, 6, 9, and 12 months of treatment •Sustained change in EDSS measured for at least 3 months •Changes from baseline in the Hamilton Depression Scale (HDS) score after 4, 6, 9, and 12 months of treatment •Changes from baseline in the Multiple Sclerosis Impact Scale-29 (MSIS- 29) score after 4, 6, 9, and 12 months of treatment
    • Incidenza del tasso annualizzato di recidive • Percentuale di pazienti liberi da recidive a 12 mesi • Incidenza e gravità di tutti i sintomi simil-influenzali (FLS) correlati ai farmaci durante i primi 4 mesi di partecipazione allo studio in tutti i pazienti. • Incidenza della formazione di anticorpi (anticorpi neutralizzanti [NAB]/anticorpi leganti [BAB]) anti-IFN beta-1b • Variazioni rispetto al basale nel punteggio della scala EDSS dopo 3, 4, 6, 9 e 12 mesi di trattamento • Cambiamento sostenuto nella scala EDSS, misurato per almeno 3 mesi • Variazioni rispetto al basale nel punteggio della Hamilton Depression Scale (HDS) dopo 4, 6, 9 e 12 mesi di trattamento • Variazioni rispetto al basale nel punteggio della Multiple Sclerosis Impact Scale-29 (MSIS-29) dopo 4, 6, 9 e 12 mesi di trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    as per protocol
    come da protocollo
    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 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 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 EEA150
    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
    Belarus
    Russian Federation
    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
    The study will be considered completed when the last patient completes the final visit (V7).
    Lo studio si considerera' completato quando l'ultimo paziente avra' completato la visita finale (V7)
    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 months12
    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 months21
    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: 500
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 350
    F.4.2.2In the whole clinical trial 500
    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)
    as per protocol
    come da protocollo
    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 Decision2012-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-06-10
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