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    Summary
    EudraCT Number:2020-003653-30
    Sponsor's Protocol Code Number:NS-065/NCNP-01-211
    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:2021-06-08
    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 number2020-003653-30
    A.3Full title of the trial
    A Phase 2 Open-label Study to Assess the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys with Duchenne Muscular Dystrophy (DMD) Compared to Natural History Controls
    Studio in aperto di fase 2 volto a valutare la sicurezza, la tollerabilità e l’efficacia di viltolarsen in ragazzi deambulanti e non deambulanti affetti da distrofia muscolare di Duchenne (DMD) rispetto a controlli passati con decorso naturale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is an Open-label Study to evaluate the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys with Duchenne Muscular Dystrophy (DMD)
    Questo è uno studio in aperto volto a valutare la sicurezza, la tollerabilità e l’efficacia di viltolarsen in ragazzi deambulanti e non deambulanti affetti da distrofia muscolare di Duchenne (DMD)
    A.3.2Name or abbreviated title of the trial where available
    Galactic-53
    Galactic-53
    A.4.1Sponsor's protocol code numberNS-065/NCNP-01-211
    A.5.4Other Identifiers
    Name:US INDNumber:127474
    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 SponsorNS Pharma, 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 supportNS Pharma, Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportNippon Shinyaku Co., Ltd
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace
    B.5.2Functional name of contact pointClinical Trial Management
    B.5.3 Address:
    B.5.3.1Street AddressMedpace Way
    B.5.3.2Town/ cityCincinnati
    B.5.3.3Post code5375
    B.5.3.4CountryUnited States
    B.5.4Telephone number+151357999111270
    B.5.6E-mailregsubmissions@medpace.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/3/20/2282
    D.3 Description of the IMP
    D.3.1Product nameViltolarsen
    D.3.2Product code [NS-065/NCNP-01]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Yes
    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 INNVILTOLARSEN
    D.3.9.1CAS number 2055732-84-6
    D.3.9.2Current sponsor codeNS-065/NCNP-01
    D.3.9.4EV Substance CodeSUB195543
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 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
    Duchenne Muscular Dystrophy (DMD)
    Distrofia Muscolare di Duchenne (DMD)
    E.1.1.1Medical condition in easily understood language
    Muscular Dystrophy
    Distrofia Muscolare
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10013801
    E.1.2Term Duchenne muscular dystrophy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic 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 safety and tolerability of viltolarsen administered intravenously (IV) at weekly doses of 80 mg/kg in ambulant and non ambulant boys >= 8 years of age with DMD
    Valutare la sicurezza e la tollerabilità di viltolarsen somministrato per via endovenosa (EV) in dosi settimanali di 80 mg/kg in ragazzi deambulanti e non deambulanti di età >= 8 anni affetti da DMD
    E.2.2Secondary objectives of the trial
    To compare the efficacy of viltolarsen administered IV at weekly doses of 80 mg/kg over a 48 week Treatment Period versus natural history controls in ambulant and non ambulant boys >= 8 years of age with DMD
    Confrontare l’efficacia di viltolarsen somministrato per via EV in dosi settimanali di 80 mg/kg nell’arco di un periodo di trattamento di 48 settimane rispetto ai controlli con decorso naturale in ragazzi deambulanti e non deambulanti di età >= 8 anni affetti da DMD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient (if age 18 years or older) or patient's parent(s) or legal guardian(s) has (have) provided written informed consent and Health Insurance Portability and Accountability Act authorization, where applicable, prior to any study-related procedures; patients younger than age 18 years will be asked to give written or verbal assent according to local requirements;
    2. Patient has a confirmed diagnosis of DMD defined as:
    a. Patient is male with clinical signs compatible with DMD; and
    b. Patient has a confirmed DMD mutation(s) in the dystrophin gene that is amenable to skipping of exon 53 to restore the dystrophin messenger ribonucleic acid reading frame including determination of unambiguously defined exon boundaries (using techniques such as multiplex ligation-dependent probe amplification, comparative genomic hybridization array, or other techniques with similar capability);
    3. Patient is >= 8 years of age at time of first infusion in the study;
    4. Patient has a Brooke scale rating of 3 or better OR an upright FVC 30% or greater at Screening;
    5. Patient, if sexually active, is willing to abstain from sexual intercourse or employ a barrier or medical method of contraception during and for 3 months following completion of IP administration;
    6. Patient and patient's parent(s)/guardian(s) (if patient is <18 years of age) and/or caregiver(s) are willing and able to comply with scheduled visits, IP administration plan, and study procedures;
    7. Patient must be either on a stable dose of glucocorticoid (GC) or not treated with GC for at least 3 months prior to the first dose of IP and is expected to remain on stable dose of GC treatment or off GC for the duration of the study.
    1. Il paziente (se di età pari o superiore a 18 anni) o un suo o entrambi i genitori o tutori legali ha/hanno fornito il consenso informato per iscritto e l’autorizzazione secondo la legge sulla portabilità e responsabilità delle polizze di assicurazione sanitaria (Health Insurance Portability and Accountability Act, HIPAA), ove applicabile, prima di iniziare qualsiasi procedura correlata allo studio; ai pazienti di età inferiore ai 18 anni sarà chiesto di fornire il proprio assenso per iscritto o verbalmente secondo i requisiti locali.
    2. Il paziente presenta una diagnosi confermata di DMD definita come:
    a. Il paziente è di sesso maschile con segni clinici compatibili con la DMD; e
    b. Il paziente presenta una o più mutazioni della DMD confermate a livello del gene della distrofina, trattabili con skipping dell’esone 53 volto a ripristinare il frame di lettura dell’acido ribonucleico messaggero della distrofina, inclusa la determinazione dei confini dell’esone definiti in modo univoco (usando tecniche quali multiplex ligation-dependent probe amplification (MLPA), comparative genomic hybridization array (CGH) o altre tecniche con capacità simile);
    3. Il paziente ha un'età >= 8 anni al momento della prima infusione nello studio;
    4. Il paziente presenta una valutazione sulla scala di Brooke pari o superiore a 3 OPPURE una CVF in posizione eretta pari o superiore al 30% allo screening;
    5. Il paziente, se sessualmente attivo, è disposto ad astenersi dai rapporti sessuali o ad adottare un metodo contraccettivo di barriera o medico durante la somministrazione dell’IP e per i 3 mesi successivi al termine della stessa;
    6. Il paziente o un suo o entrambi i genitori o tutori legali (se il paziente ha età <18 anni) e/o caregiver sono disposti e in grado di attenersi alle visite programmate, al piano di somministrazione dell’IP e alle procedure dello studio;
    7. Il paziente deve assumere una dose stabile di glucocorticoide (GC) o non essere trattato con GC almeno per i 3 mesi precedenti alla prima dose di IP e deve continuare ad assumere una dose stabile di GC oppure non essere trattato con GC per tutta la durata dello studio.
    E.4Principal exclusion criteria
    1. Patient has had an acute illness within 4 weeks prior to the first dose of IP;
    2. Patient has evidence of symptomatic cardiomyopathy (New York Heart Association Class III or higher);
    3. Patient requires ventilation support while awake during the day;
    4. Patient has an allergy or hypersensitivity to IP or any of its constituents;
    5. Patient has severe behavioral or cognitive problems that preclude participation in the study, in the opinion of the investigator;
    6. Patient has a previous or ongoing medical condition, medical history, physical findings, or laboratory abnormalities that could affect patient safety, make it unlikely that treatment and follow-up will be correctly completed, or impair the assessment of study results, in the opinion of the investigator;
    7. Patient has had surgery within 3 months prior to the first anticipated administration of IP or has known plans to have surgery during the Treatment Period;
    8. Patient has positive test results for hepatitis B antigen, hepatitis C antibody, or human immunodeficiency virus antibody at Screening;
    9. Patient has been diagnosed with asthma that requires chronic treatment with a long-acting beta agonist;
    10. Patient has relevant history of or current drug or alcohol abuse or use of any tobacco/marijuana products by smoking or vaping within 3 months prior to treatment with IP;
    11. Patient is currently taking any other investigational drug or has taken any other investigational drug within 3 months prior to the first dose of IP or within 5 times the half life of a medication, whichever is longer;
    12. Patient has taken any gene therapy;
    13. Patient is currently taking any other exon skipping agent or has taken any other exon skipping agent within 3 months prior to the first dose of IP;
    14. Patient has hydronephrosis, hydroureter, renal or urinary tract calculi, or ureteral stenosis by renal ultrasound;
    15. Patient was previously enrolled in an interventional study of viltolarsen.
    1. Il paziente ha avuto una malattia acuta nelle 4 settimane precedenti alla prima dose di IP;
    2. Il paziente presenta evidenza di cardiomiopatia sintomatica (di Classe III o superiore secondo la New York Heart Association);
    3. Il paziente necessita di supporto ventilatorio da sveglio durante la giornata;
    4. Il paziente presenta allergia o ipersensibilità all’IP o a qualsiasi suo componente;
    5. Il paziente presenta problemi comportamentali o cognitivi seri che, a parere dello sperimentatore, precludono la partecipazione allo studio;
    6. Il paziente presenta una condizione medica precedente o attuale, un’anamnesi medica, risultati fisici o anomalie di laboratorio che potrebbero comprometterne la sicurezza, rendere improbabile che il trattamento e il follow-up siano completati correttamente o compromettere la valutazione dei risultati dello studio, a parere dello sperimentatore;
    7. Il paziente è stato sottoposto a intervento chirurgico nei 3 mesi precedenti alla prima somministrazione dell’IP prevista o ha in programma di sottoporsi a intervento chirurgico durante il periodo di trattamento;
    8. Il paziente presenta risultati positivi al test per gli antigeni dell’epatite B, degli anticorpi dell’epatite C o del virus dell’immunodeficienza umana allo screening;
    9. Il paziente ha ricevuto una diagnosi di asma che richiede un trattamento cronico con un beta-agonista a lunga durata d’azione;
    10. Il paziente presenta anamnesi rilevante o attuale di abuso di droghe o alcol o uso di qualsiasi prodotto a base di tabacco/marijuana da fumo o vaping nei 3 mesi precedenti al trattamento con l’IP;
    11. Il paziente sta attualmente assumendo un altro farmaco sperimentale o ne ha assunto uno nei 3 mesi precedenti alla prima dose di IP o in un periodo precedente pari a 5 volte l’emivita di un farmaco, a seconda di quale sia il periodo più lungo;
    12. Il paziente ha assunto una qualsiasi terapia genica;
    13. Il paziente sta attualmente assumendo un altro agente per lo skipping dell’esone o ne ha assunto uno nei 3 mesi precedenti alla prima dose di IP;
    14. Il paziente presenta idronefrosi, idrouretere, calcoli delle vie renali o urinarie o stenosi ureterale all’ecografia renale;
    15. Il paziente è stato precedentemente arruolato in uno studio interventistico di viltolarsen.
    E.5 End points
    E.5.1Primary end point(s)
    • Vital signs
    • Physical examination
    • Renal ultrasound
    • Echocardiogram
    • Clinical laboratory tests : Hematology and clinical chemistry, Urinalysis, Urine cytology
    • 12-lead electrocardiogram (ECG)
    • Anti-viltolarsen antibodies
    • Anti-dystrophin antibodies
    • Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
    • Segni vitali
    • Esame obiettivo
    • Ecografia renale
    • Ecocardiogramma
    • Esami clinici di laboratorio: Ematologia e chimica clinica, Esame delle urine, Citologia urinaria
    • Elettrocardiogramma (ECG) a 12 derivazioni
    • Anticorpi anti-viltolarsen
    • Anticorpi anti-distrofina
    • Eventi avversi emergenti dal trattamento (TEAE) ed eventi avversi seri (SAE)
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Vital signs & TEAE's/SAE's: every study visit
    • Physical examination: Day 1 and Weeks 5, 9, 13, 17, 21, 25, 37, 49
    • Renal Ultrasound & Echocardiogram: Weeks 25 and 49
    • Clinical Laboratory:
    - Hematology & Chemistry: Day 1 and Weeks 3, 5, 9, 13, 17, 21, 25, 37, 49
    - Urinalysis: Weeks 3, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49
    - Urine Cytology: Weeks 13, 25, 27, 49
    • 12-Lead ECG: Weeks 13, 25, 37, 49
    • Anti-viltolarsen and anti-dystrophin antibodies: Weeks 13, 25, 37, 48
    • Segni vitali & TEAE/SAE: ogni visita dello studio
    • Esame obiettivo: Giorno 1 e Settimane 5, 9, 13, 17, 21, 25, 37, 49
    • Ecografia renale & Elettrocardiogramma: Settimane 25 and 49
    • Esami clinici di laboratorio:
    - Ematologia & Chimica: Giorno 1 e Settimane 3, 5, 9, 13, 17, 21, 25, 37, 49
    - Esame delle urine: Settimane 3, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49
    - Citologia urinaria: Settimane 13, 25, 27, 49
    • ECG 12-derivazioni: Settimane 13, 25, 37, 49
    • Anticorpi anti-viltolarsen e anti-distrofina antibodies: Settimane 13, 25, 37, 48
    E.5.2Secondary end point(s)
    • Peak Expiratory Flow (PEF)
    • Forced Vital Capacity (FVC)
    • Forced expiratory volume in 1 second (FEV1)
    • Function and Strength tests:
    - Performance of Upper Limb (PUL) test
    - Brooke scale
    - Vignos scale
    - Hand-held dynamometer
    - North Star Ambulatory Assessment (NSAA)
    • Picco di flusso espiratorio (PEF)
    • Capacità vitale forzata (CVF)
    • Volume espiratorio forzato in 1 secondo (FEV1)
    • Test funzionali e della forza:
    - Performance degli arti superiori (PUL)
    - Scala di Brooke
    - Scala di Vignos
    - Dinamometro manuale
    - Valutazione della mobilità North Star (NSAA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    • PEF, FVC, FEV1: Day 1 and Weeks 13, 25, 37, 49
    • Function and Strength tests: Weeks 13, 25, 37, 49
    • PEF, CVF, FEV1: Giorno 1 e Settimane 13, 25, 37, 49
    • Test funzionali e della forza: Settimane 13, 25, 37, 49
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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
    in aperto
    open trial
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    China
    Russian Federation
    Turkey
    United States
    Italy
    Spain
    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
    The end of study date is defined as date when the last patient is assessed or receives an intervention for evaluation in the study (i.e., last patient last visit).
    La data di fine studio è definita come la data in cui l'ultimo paziente è valutato o riceve una procedura di valutazione per lo studio (cioè, ultima visita dell'ultimo paziente)
    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 months1
    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 months1
    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 Yes
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 9
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Assent only to be provided, where appropriate, due to patient age
    Dove appropriato, a causa dell'età del paziente sarà richiesto il solo assenso
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 7
    F.4.2.2In the whole clinical trial 20
    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)
    None
    Nessuno
    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 Decision2021-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-22
    P. End of Trial
    P.End of Trial StatusCompleted
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