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    Summary
    EudraCT Number:2020-003653-30
    Sponsor's Protocol Code Number:NS-065/NCNP-01-211
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-12-15
    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 ConcernedSpain - AEMPS
    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
    Estudio de fase II, abierto para evaluar la seguridad, la tolerabilidad y la eficacia de viltolarsén en niños con distrofia muscular de Duchenne (DMD), capaces e incapaces de caminar, en comparación con controles históricos no tratados.
    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)
    Estudio abierto para evaluar la seguridad, la tolerabilidad y la eficacia de viltolarsén en niños con distrofia muscular de Duchenne (DMD), capaces e incapaces de caminar.
    A.3.2Name or abbreviated title of the trial where available
    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 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
    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 muscular de Duchene (DMD)
    E.1.1.1Medical condition in easily understood language
    Muscular Dystrophy
    Distrofia muscular
    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
    Evaluar la seguridad y la tolerabilidad de viltolarsén administrado por vía intravenosa (i.v.) en dosis semanales de 80 mg/kg en niños ≥8 años con DMD capaces e incapaces de caminar.
    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
    Comparar la eficacia del viltolarsén administrado por vía i.v. en dosis semanales de 80 mg/kg durante un período de tratamiento de 48 semanas frente a controles históricos no tratados en niños ≥8 años con DMD capaces e incapaces de caminar.
    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.El paciente (si tiene 18 años o más) o sus padres o tutores han otorgado su consentimiento informado por escrito y la autorización HIPAA (Health Insurance Portability and Accountability Act), si procede, antes de realizar cualquiera de los procedimientos relacionados con el estudio; se pedirá a los pacientes menores de 18 años que den su asentimiento por escrito o verbal de conformidad con los requisitos locales.
    2.El paciente tiene un diagnóstico confirmado de DMD, que se define como:
    a.El paciente es un varón con signos clínicos compatibles con DMD y
    b.El paciente tiene una mutación de DMD confirmada en el gen de la distrofina que es susceptible de omisión del exón 53 para restablecer el
    marco de lectura del ácido ribonucleico mensajero de la distrofina, incluida una determinación de los límites del exón definidos de manera
    inequívoca (mediante técnicas tales como amplificación de sondas dependiente de ligandos múltiples, matriz de hibridación genómica comparativa u otras técnicas con capacidad similar).
    3.El paciente tiene ≥ 8 años de edad en el momento de recibir la primera infusión en el estudio.
    4.El paciente tiene una puntuación de 3 o mejor en la escala de Brooke O una FVC en posición erguida del 30 % o superior en la fase de selección.
    5.El paciente, si es sexualmente activo, está dispuesto a abstenerse de mantener relaciones sexuales o a utilizar un método anticonceptivo de
    barrera o médico durante la administración del PEI y en los 3 meses siguientes a su finalización.
    6.El paciente y sus padres o tutores (si el paciente tiene menos de 18 años) y/o sus cuidadores están dispuestos y son capaces de cumplir las
    visitas programadas, el plan de administración del PEI y los procedimientos del estudio.
    7.El paciente debe estar recibiendo una dosis estable de glucocorticoides (GC) o no haber sido tratado con GC durante al menos 3 meses antes de
    la primera dosis del PEI y se espera que permanezca con una dosis estable de GC o sin GC durante todo el estudio.
    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.El paciente ha tenido una enfermedad aguda en las 4 semanas previas a la primera dosis del PEI.
    2.El paciente presenta signos de miocardiopatía sintomática (clase III o superior de la New York Heart Association).
    3.El paciente necesita ventilación mecánica mientras está despierto durante el día.
    4.El paciente es alérgico o hipersensible al PEI o a alguno de sus componentes.
    5.El paciente tiene problemas conductuales o cognitivos graves que, en opinión del investigador, le impiden participar en el estudio.
    6.El paciente ha tenido previamente o tiene una enfermedad, antecedentes médicos, hallazgos físicos o anomalías analíticas que, en opinión del investigador, podrían afectar a la seguridad del paciente, reducir las probabilidades de que se completen correctamente el tratamiento y seguimiento o alterar la evaluación de los resultados del estudio.
    7.El paciente se ha sometido a una intervención quirúrgica en los 3 meses previos a la primera administración prevista del PEI o tiene previsto operarse durante el período de tratamiento.
    8.El paciente tiene resultados positivos en las determinaciones de antígeno del virus de la hepatitis B, anticuerpos contra el virus de la hepatitis C o anticuerpos contra el virus de la inmunodeficiencia humana realizadas en la fase de selección.
    9.El paciente ha sido diagnosticado de asma con necesidad de tratamiento crónico con un agonista beta de acción prolongada.
    10.El paciente tiene antecedentes de interés o presenta actualmente abuso de drogas o alcohol o consume (fuma o vapea) de productos de tabaco/marihuana en los 3 meses previos al tratamiento con el PEI.
    11.El paciente está recibiendo otro fármaco experimental o ha recibido otro fármaco experimental en los tres meses previos a la primera dosis
    del PEI o durante el tiempo equivalente a cinco veces la semivida del fármaco, lo que suponga más tiempo.
    12.El paciente ha recibido cualquier tipo de terapia génica.
    13.El paciente está recibiendo otro fármaco que causa omisión de exones o ha recibido cualquier otro fármaco que causa omisión de exones en los
    tres meses previos a la primera dosis del fármaco del estudio.
    14.El paciente presenta hidronefrosis, hidrouréter, cálculos renales o urinarios o estenosis ureteral en la ecografía renal.
    15.El paciente ha sido incluido previamente en un estudio intervencionista de viltolarsén.
    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)
    •Constantes vitales
    •Exploración física
    •Ecografía renal
    •Ecocardiograma
    •Análisis clínicos: Hematología y bioquímica clínica, Análisis de orina,
    Citología de orina
    •Electrocardiograma (ECG) de 12 derivaciones
    •Anticuerpos contra el viltolarsén
    •Anticuerpos contra la distrofina
    •Acontecimientos adversos aparecidos durante el tratamiento (AAAT) y
    acontecimientos adversos graves (AAG)
    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
    •Constantes vitales y (AAAT´s)/(SAE´s): cada visita del estudio
    •Exploración física: Día 1 y semanas 5, 9, 13, 17, 21, 25, 37, 49
    •Ecografía renal y Ecocardiograma: Semanas 25 y 49
    •Análisis clínicos:
    - Hematología y bioquímica clínica: Dia 1 y semanas 3, 5, 9, 13, 17, 21, 25, 37, 49
    - Análisis de orina: Semanas 3, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49
    - Citología de orina: Semanas 13, 25, 27, 49
    • Electrocardiograma (ECG) de 12 derivaciones: Semanas 13, 25, 37, 49
    • Anticuerpos contra el viltolarsén y anticuerpos contra la distrofina: Semanas 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)
    •Flujo espiratorio máximo (PEF)
    •Capacidad vital forzada (FVC)
    •Volumen espiratorio máximo en el primer segundo (FEV1)
    -Rendimiento de las extremidades superiores (PUL)
    -Escala de Brooke
    -Escala de Vignos
    -Dinamómetro manual
    -Evaluación de la capacidad de caminar de 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, FVC, FEV1: Día 1 y Semanas 13, 25, 37, 49
    • Pruebas de funcionamiento y resistencia: Semanas 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 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 No
    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.8.5The 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 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
    Turkey
    China
    Italy
    Russian Federation
    Spain
    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
    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 fecha de finalización del estudio se define como la fecha en que el último paciente es evaluado o recibe una intervención para su evaluación en el estudio (es decir, la última visita del paciente).
    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 days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 20
    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
    El consentimiento sólo debe facilitarse, si procede, debido a la edad del paciente
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    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
    Ninguno
    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 Decision2021-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-07-18
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