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    Summary
    EudraCT Number:2016-002382-62
    Sponsor's Protocol Code Number:RNS60-ALS
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-22
    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 number2016-002382-62
    A.3Full title of the trial
    The effects of RNS60 on ALS biomarkers
    L'effetto del farmaco RNS60 sui biomarcatori della SLA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effects of RNS60 on ALS biomarkers
    L'effetto del farmaco RNS60 sui biomarcatori della SLA
    A.3.2Name or abbreviated title of the trial where available
    RNS60-ALS
    RNS60-ALS
    A.4.1Sponsor's protocol code numberRNS60-ALS
    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 SponsorIRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAssociazione ALSA
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportRevalesio Corporation
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportAssociazione "Get out" ONLUS
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Istituto di Ricerche Farmacologiche "Mario Negri", Milano
    B.5.2Functional name of contact pointLaboratorio di malattie neurologich
    B.5.3 Address:
    B.5.3.1Street AddressVia La Masa 19
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20156
    B.5.3.4CountryItaly
    B.5.4Telephone number0239014605
    B.5.5Fax number0239001916
    B.5.6E-mailrns60@marionegri.it
    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 nameRNS60
    D.3.2Product code RNS60
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 Yes
    D.3.11.13.1Other medicinal product typeSoluzione salina e ossigeno.
    D.IMP: 2
    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 nameRNS60
    D.3.2Product code RNS60
    D.3.4Pharmaceutical form Nebuliser solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 Yes
    D.3.11.13.1Other medicinal product typeSoluzione salina e ossigeno
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation vapour, solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Amyotrophic Lateral Sclerosis
    Sclerosi Laterale Amiotrofica
    E.1.1.1Medical condition in easily understood language
    Motor Neuron Disease
    Malattia del neurone motorio
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10002026
    E.1.2Term Amyotrophic lateral sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10052889
    E.1.2Term ALS
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10002026
    E.1.2Term Amyotrophic lateral sclerosis
    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 measure the effect of RNS60 treatment on selected pharmacodynamic biomarkers in ALS patients concurrently treated with riluzole. Candidate markers include:
    1. T-reg (measured via FOXP3 and CD25 mRNA);
    2. Cyp-A;
    3. 3-NT;
    4. Actin-NT;
    5. MCP-1;
    6. IL-17.
    Misurare l'effetto del farmaco RNS60 su biomarcatori selezionati nei pazienti SLA che stanno assumendo una terapia concomitante a base di riluzolo. I biomarcatori candidati per il presente studio sono:
    1. T-reg (misurato tramite FOXP3 e CD25 mRNA);
    2. Cyp-A;
    3. 3-NT;
    4. Actin-NT;
    5. MCP-1;
    6. IL-17.
    E.2.2Secondary objectives of the trial
    1. The preliminary efficacy of RNS60 on functional disability, as measured by the ALSFRS-R scale;
    2. The preliminary efficacy of RNS60 in prolonging survival (or time to tracheostomy, whichever comes first);
    3. The preliminary efficacy of RNS60 in slowing the decline of forced vital capacity (FVC) from baseline;
    4. The tolerability and safety of RNS60 through the identification of unexpected adverse events;
    5. The impact of RNS60 on quality of life as measured by ALSAQ-40 scale.
    1. Efficacia preliminare di RNS60 sulla disabilit¿ funzionale, misurato tramite la scala ALSFRS-R:
    2. Efficacia preliminare di RNS60 nel prolungare la sopravvivenza (o il momento in cui il paziente viene tracheostomizzato, il primo dei due eventi che si verifica);
    3. Efficacia preliminare di RNS60 nel rallentare il declino della capacit¿ respiratoria forzata (FVC) rispetto all'osservazione del basale;
    4. Tollerabilit¿ e sicurezza di RNS60 attraverso l'identificazione degli eventi avversi inattesi;
    5. L'impatto di RNS60 sulla qualit¿ di vita dei pazienti, misurata tramite la scala ALSAQ-40
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Age 18 through 70 years inclusive;
    2) Geographically accessible to the site and able to come to the site center once a week for 24
    weeks;
    3)Definite or probable ALS diagnosis according to the revised El Escorial criteria;
    4) Disease duration 6 to 24 months from symptom onset to study entry;
    5) Self sufficiency: Satisfactory bulbar and spinal function (score 3+ on the ALSFRS-R for swallowing, cutting food and handling utensils, and walking);
    6) Satisfactory respiratory function (FVC =80% of predicted);
    7) Documented progression of symptoms in the last three months as measured by the ALSFRS-R scale (decrease of at least one point);
    8) Ability to understand and comply with the study requirements;
    9) Ability to give written informed consent personally or, as an alternative, via a legally authorized representative;
    10) Treatment with riluzole 50 mg twice/day for at least 1 month prior to screening visit.
    1. Età compresa tra 18 e 70 anni inclusi;
    2. Pazienti che abitano in un'area geografica adiacente al centro sperimentale, tale da permettere al paziente di raggiungere il centro sperimentale una volta alla settimana per 24 settimane consecutive;
    3. Diagnosi di SLA definita o probabile secondo i criteri El Escorial rivisti;
    4. Durata di malattia compresa tra 6 e 24 mesi (tra l'insorgenza dei sintomi e l'inclusione del paziente nello studio)
    5. Pazienti autosufficienti: funzioni bulbari e spinali soddisfacenti (punteggio di 3+ nella scala ALSFRS-R per gli item di deglutizione, tagliare il cibo e maneggiare utensili, camminare);
    6. Valore FVC=80% rispetto al valore predetto per il paziente;
    7. Documentata progressione dei sintomi negli ultimi tre mesi misurata tramite la scala ALSFRS-R (diminuzione di almeno un punto sul totale);
    8. Capacità di comprendere e rispettare le procedure previsteste dallo studio;
    9. Capacità di fornire un consenso informato scritto personalmente, o tramite legale rappresentante;
    10. Trattamento con riluzolo 50 mg due volte al giorno da almeno 1 mese prima della visita di screening
    E.4Principal exclusion criteria
    1) History of HIV, clinically significant chronic hepatitis, antecedent polio infection, or other active infection;
    2) Motor neuron disease (MND) other than ALS;
    3) Involvement of other systems possibly determining a functional impairment (as measured by the end-points) for the entire duration of the study;
    4) Other severe clinical conditions (e.g., cardiovascular disorders, neoplasms) with impact on survival or functional disability in the next 12 months;
    5) Renal insufficiency as defined by a serum creatinine > 1.5 times the upper limit of normal
    6) Poor compliance with previous treatments;
    7) Other experimental treatments in the preceding 3 months;
    8) Women who are lactating or able to become pregnant and men unable to practice contraception for the duration of the treatment and 3 months after its completion;
    9) Unwillingness or inability to take riluzole;
    10) Poor compliance with an inhalation device;
    11) Abnormal liver function defined as AST and/or ALT > 3 times the upper limit of the normal.
    1. Storia di HIV, epatite cronica clinicamente significativa, antecedente infezione di polio o altre infezioni attive;
    2. Altra malattia del motoneurone oltre alla SLA;
    3. Malattie che colpiscono altri organi e che potrebbero comportare menomazioni (misurate dagli end point) per l'intera durata dello studio;
    4. Altre malattie gravi (esempio patologie cardiovascolari, neoplasie) che abbiano un impatto sulla sopravvivenza o sulla disabilità funzionale nei 12 mesi successivi;
    5. Insufficienza renale definita da valori di creatinina serica > 1.5 volte il valore superiore limite normale;
    6. Scarsa compliance con precedenti terapie;
    7. Altre terapie sperimentali nei tre mesi precedenti all'inclusione del paziente nello studio;
    8. Donne che stanno allattando o che potrebbero diventare gravide durante il trial e uomini non disposti ad utilizzare un metodo contraccettivo per l'intera durata dello studio e per i tre mesi successivi al completamento della terapia sperimentale;
    9. Pazienti che si rifiutano o che non possono assumere riluzolo
    10. Poca abilità nell'utilizzo di un dispositivo inalatore;
    11. Valori epatici anomali, definiti da AST e/o ALT 3 volte maggiore rispetto al limite superiore normale
    E.5 End points
    E.5.1Primary end point(s)
    The mean change over time in the proportion of T-reg (measured via FOXP3 and CD25 mRNA); the mean change over time in the plasma concentrations of Cyp-A, 3-NT, Actin-NT, MCP-1, IL-17 in the two treatment arms, during the entire treatment period (from baseline to 24 weeks).
    Variazione media nel tempo nel rapporto di T-reg (misurato tramite FOXP3 e CD25 mRNA); variazione media nel tempo nella concentrazione plasmatica di Cyp-A, 3-NT, Actin-NT, MCP-1, IL-17 nei due bracci di trattamento, durante l'intero periodo di studio (dal basale alla settimana 24)
    E.5.1.1Timepoint(s) of evaluation of this end point
    from baseline to 24 weeks
    dal basale alla settimana 24
    E.5.2Secondary end point(s)
    The mean change in the proportion of T-reg (measured via FOXP3 and CD25 mRNA); the mean change over time in the plasma concentrations of Cyp-A, 3-NT, Actin-NT, MCP-1, IL-17 during the follow up period ; The cumulative proportion of subjects becoming no longer self-sufficient at 4, 12, 24, 36 and 48 weeks in the two treatment arms (defined as those scoring 2 or lower on at least one of the ALSFRS-R items for swallowing, cutting food and handling utensils, or walking); The mean change of ALSFRS-R total score in the two treatment arms ; The cumulative proportion of deaths or tracheostomies in the two treatment arms ; The mean change of FVC score in the two treatment arms ; The total number of subjects in the two treatment arms experiencing at least one AE leading to treatment discontinuation ; The mean number of AEs per treatment arm ; The mean change of ALSAQ-40 score measuring quality of life
    Variazione media nel tempo nel rapporto di T-reg (misurato tramite FOXP3 e CD25 mRNA); variazione media nel tempo nella concentrazione plasmatica di Cyp-A, 3-NT, Actin-NT, MCP-1, IL-17 nei due bracci di trattamento, durante il follow up ; La percentuale cumulativa di soggetti che non sono pi¿ autosufficienti a 4, 12, 24, 36 e 48 settimane nei due bracci di trattamento (definito con un punteggio pari a 2 o inferiore su almeno uno degli elementi ALSFRS-R per la deglutizione, tagliare il cibo e la gestione di utensili, o camminare); La variazione media del punteggio totale della scala ALSFRS-R nei due bracci di trattamento ; La percentuale cumulativa di pazienti deceduti o che hanno ricorso alla tracheostomia nei due bracci di trattamento; La variazione media del punteggio FVC nei due bracci di trattamento ; Il numero totale di soggetti nei due bracci di trattamento con almeno un evento avverso che porta alla sospensione del trattamento ; Il numero medio di eventi avversi per braccio di trattamento ; La variazione media del punteggio della scala ALSAQ-40 che misura la qualit¿ della vita
    E.5.2.1Timepoint(s) of evaluation of this end point
    from 24 to 48 weeks; weeks 4, 12, 24, 36 and 48; during the treatment and follow up period; during the entire study including follow-up; during the treatment and follow up period; Weeks N 4, 12 and 24; Weeks N 4,12 e 48 ; at the completion of the treatment and follow up period
    dalla settimana 24 alla 48; settimana N 4, 12, 24, 36 e 48 ; durante il periodo di trattamento e di follow-up; durante l'intero studio compreso il follow-up; durante il periodo di trattamento e di follow-up; Settimane 4, 12 e 24; Settimane N 4, 12, 24 e 48 ; al completamento del trattamento e durante il periodo di follow-up
    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 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
    The effect of RNS60 on selected biomarkers
    Effetto di RNS60 su biomarcatori selezionati
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned20
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA20
    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
    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.1.1.1In 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: 112
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Amyotrophic Lateral Sclerosis (ALS) is a rare and incurable diseases
    La sclerosi laterale amiotrofica (SLA) ¿ una malattia rara ed incurabile
    F.4 Planned number of subjects to be included
    F.4.1In the member state136
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 136
    F.4.2.2In the whole clinical trial 142
    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 will take the best pharmacological treatment for Clinical Practice chosen by the Neurologist
    Al termine dello studio ogni paziente assumer¿ la terapia farmacologica che il clinico riterr¿ pi¿ opportuna per la sua condizione clinica.
    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 Decision2016-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-13
    P. End of Trial
    P.End of Trial StatusOngoing
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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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