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    Summary
    EudraCT Number:2019-001698-10
    Sponsor's Protocol Code Number:ION-682884-CS3
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-12-02
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-001698-10
    A.3Full title of the trial
    A Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
    Estudio en fase III, global, abierto y aleatorizado para evaluar la eficacia y la seguridad de ION-682884 en pacientes con polineuropatía amiloidótica familiar por transtiretina
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
    Estudio para determinar la efectividad y seguridad de ION-682884 en pacientes con polineuropatía amiloidótica familiar por transtiretina
    A.3.2Name or abbreviated title of the trial where available
    NEURO – TTRANSFORM
    A.4.1Sponsor's protocol code numberION-682884-CS3
    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 SponsorIonis Pharmaceuticals, 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 supportIonis Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIonis Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointIonis Clinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address2855 Gazelle Court
    B.5.3.2Town/ cityCarlsbad
    B.5.3.3Post codeCA 92010
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1760931 9200
    B.5.5Fax number+1760603 2504
    B.5.6E-mailClinicalTrials@ionisph.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.3.1Product nameION-682884
    D.3.2Product code ION-682884
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNION-682884
    D.3.9.1CAS number 1637600-16-8
    D.3.9.2Current sponsor codeION-682884
    D.3.9.3Other descriptive nameION-682884
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Yes
    D.3.11.13.1Other medicinal product typeAntisense Oligonucleotide
    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 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/3/14/1250
    D.3 Description of the IMP
    D.3.1Product nameInoserten
    D.3.2Product code ISIS 420915
    D.3.4Pharmaceutical form Solution for infusion in pre-filled syringe
    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.3.8INN - Proposed INNINOTERSEN
    D.3.9.1CAS number 1432726-13-0
    D.3.9.2Current sponsor codeISIS 420915
    D.3.9.4EV Substance CodeSUB188590
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
    Polineuropatía amiloidótica familiar por transtiretina
    E.1.1.1Medical condition in easily understood language
    An inherited condition that causes damage to peripheral nerves
    Una condición hereditaria que causa daño a los nervios periféricos
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10057949
    E.1.2Term Familial amyloid polyneuropathy
    E.1.2System Organ Class 100000004850
    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 efficacy of ION-682884 after administration for 65 weeks, as compared to the historical control of the placebo cohort (inotersen) in the NEURO-TTR trial, based on the change from Baseline in serum TTR concentration, mNIS+7 and in the Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QOL-DN) in patients with hATTR.
    Evaluar la eficacia de ION-698884 tras administración durante 65 semanas, en comaración con el control histórico de la cohorte del placebo (inotersen), basándose en el cambio desde el inicio en la concentración sérica de TTR, mNIS+7 y el cuestionario sobre la calidad de vida con neuropatía diabética de Norfolk (Norfolk QOL-DN) en pacientes con PAF-TTR
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of ION-682884, as compared to the placebo cohort in the NEURO-TTR trial, based on the change from Baseline in the following measures:
    - Neuropathy Symptom and Change Score (NSC)
    - Physical component summary (PCS) score of 36-Item Short Form Survey (SF-36)
    - Polyneuropathy disability (PND) score
    - Modified body mass index (mBMI)
    Evaluar la eficacia de ION-682884, en comparación con la cohorte de placebo del ensayo NEURO-TTR, basándose en el cambio desde el inicio en lo siguiente:
    •Puntuación en el cuestionario de síntomas y cambios de la neuropatía (NSC)
    •Puntuación en el resumen del componente físico (PCS) del cuestionario breve de salud de 36 ítems (SF-36)
    •Puntuación de discapacidad por polineuropatía (PND)
    •Índice de masa corporal modificado (IMCm)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged 18 to 82 years at the time of informed consent
    2. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal
    3. Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential, the subject or the subject's non-pregnant female partner must be using a highly effective contraceptive method
    4. Diagnosis of hereditary transthyretin-mediated polyneuropathy as defined by meeting all 3 of the following:
    • Stage 1 or Stage 2 FAP
    • Documented genetic mutation in the TTR gene
    • Symptoms and signs consistent with polyneuropathy as measured by NIS score ≥ 10 and ≤ 130
    1. Edad de entre 18 y 82 años en el momento del consentimiento informado
    2. Las mujeres deberan no estar embarazadas ni en periodo de lactacia y con esterilización quirúrgica o posmenopáusicas
    3. Los varones deberan ser estériles quirúrgicamente o, abstenentes o, si mantienen relaciones sexuales con mujeres con posibilidad de embarazo, el paciente o su pareja no embarazada deben utilizar un método anticonceptivo muy eficaz
    4. Diagnostico de Polineuropatía amiloidótica familiar por transtiretina según se define mediante los 3 criterios siguientes;
    - Estado 1 o 2 PAF
    - Mutación genética documentada en el gen TTR
    - Signos y síntomas indicativos de neuropatía asociada con ploneuropatía includa una putuación >_10 y <_130
    E.4Principal exclusion criteria
    1. Clinically-significant (CS) abnormalities in medical history, screening laboratory results, physical or physical examination that would render a subject unsuitable for inclusion, including but not limited to abnormal safety labs
    2. Karnofsky performance status ≤ 50
    3. Other causes of sensorimotor or autonomic neuropathy (e.g., autoimmune disease), including uncontrolled diabetes
    4. Prior liver transplant or anticipated liver transplant within 1-yr of Screening
    5. New York Heart Association (NYHA) functional classification of ≥ 3
    6. Acute coronary syndrome or major surgery within 3 months of Screening
    7. Other types of amyloidosis
    8. Have any other conditions, which, in the opinion of the Investigator or Sponsor would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the Study
    9. Current treatment with any approved drug for hereditary TTR amyloidosis such as Vyndaqel® / Vyndamax™ (tafamidis), Tegsedi™ (inotersen), Onpattro™ (patisiran),off-label use of diflunisal or doxycycline, and tauroursodeoxycholic acid (TUDCA).If previously treated with Vyndaqel® / Vyndamax™, diflunisal or doxycycline, and TUDCA, must have discontinued treatment for 2 weeks prior to Study Day 1
    10. Previous treatment with TegsediTM (Inotersen) or OnpattroTM (patisiran), or other oligonucleotide or RNA therapeutic (including siRNA)
    1. Anomalías de importancia clínica en el historial médico, en los resultados de laboratorio de la selección, o en el examen físico que haría que un sujeto no sea apto para la inclusión, incluído pero no limitado alos de seguridad de laboratorio
    2. Estado funcional de Karnofsky <_50
    3. Otras causas de neuropatía autónoma o sensitivomotora (p. ej., enfermedad autoinmunitaria), incluída diabetes no controlada
    4. Trasplante de hígado previo o previsto en el plazo de 1 año de la selección
    5. Clasificación funcional de la Asociación de Cardiología de Nueva York (New York Heart Association, NYHA) >_3
    6. Síndrome coronario agudo o cirugía mayor dentro de los 3 meses posteriores a la detección.
    7. Otros tipos de amiloidosis
    8. Otros trastornos que, en opinión del investigador, hagan que el paciente no sea apto para la inclusión o que puedan interferir en su participación o su capacidad de completar el estudio.
    9. Tratamiento en curso con algún fármaco autorizado para la amiloidosis hereditaria por TTR, como Vyndaqel®/Vyndamax™ (tafamidis), Tegsedi™ (inotersén), Onpattro™ (patisirán) o uso para una indicación no recogida en la ficha técnica de diflunisal, doxiciclina o ácido tauroursodeoxicólico (tauroursodeoxycholic acid, TUDCA). En caso de tratamiento previo con Vyndaqel®/Vyndamax™, diflunisal o doxiciclina y TUDCA, este debe haberse interrumpido al menos 2 semanas antes del día 1 del estudio
    10. Tratamiento previo con Tegsedi™ (inotersén) u Onpattro™ (patisirán) u otros oligonucleótidos o ARN terapéuticos (incluido el ARNip)
    E.5 End points
    E.5.1Primary end point(s)
    Interim Analysis Co-Primary Efficacy Endpoints at Week 35
    - Percent change from Baseline in serum TTR concentration
    - Change from Baseline in mNIS+7

    Final Analysis Co-Primary Efficacy Endpoints at Week 66
    - Percent change from Baseline in serum TTR concentration
    - Change from Baseline in mNIS+7
    - Change from Baseline in Norfolk QOL-DN
    Análisis intermedio de los criterios de valoración principales en la semana 35:
    - Porcentaje de cambio desde el inicio en la concentración sérica de TTR
    - Cambio desde el inicio en mNIS+37

    Análisis final de los criterios de valoración principales en la semana 66:
    - Porcentaje de cambio desde el inicio en la concentración sérica de TTR
    - Cambio desde el inicio en mNIS+37
    E.5.1.1Timepoint(s) of evaluation of this end point
    Interim Analysis Co-Primary Efficacy Endpoints at Week 35
    Final Analysis Co-Primary Efficacy Endpoints at Week 66
    Análisis intermedio de los criterios de valoración principales en la semana 35
    Análisis final de los criterios de valoración principales en la semana 66
    E.5.2Secondary end point(s)
    Interim Analysis Key Secondary Efficacy Endpoint at Week 35
    - Change from Baseline in Norfolk QOL-DN

    Final Analysis Secondary Endpoint
    - Change from Baseline in Norfolk QOL-DN
    - Change from Baseline in the PCS score of SF-36
    - Change from Baseline in PND score
    - Change from Baseline in mBMI
    Análisis intermedio de los criterios de valoración secundarios en la semana 35
    - Cambios desde el inicio en Norfolk QOL-DN

    Analisis final de los criterios de valoración secundarios:
    - Cambios desde el inicio en Norfolk QOL-DN
    - Cambios desde el inicio en la puntuación PCS y en el cuestionario SF-36
    - Cambios desde el inicio en la puntuación PND
    E.5.2.1Timepoint(s) of evaluation of this end point
    Interim Analysis Key Secondary Efficacy Endpoint at Week 35

    Change from Baseline in NSC at Weeks 35 and 66
    Change from Baseline in the PCS score of SF-36 at Week 65
    Change from Baseline in PND score at Week 65
    Change from Baseline in mBMI at Week 65
    Análisis intermedio de los criterios de valoración secundarios claves en la semana 35:
    - Cambio desde el inicio en la puntuación del NSC en las semanas 35 y 66
    - Cambio desde el inicio en la puntuación del PCS del cuestionario SF-36 en la semana 65
    - Cambio desde el inicio en la puntuación de PND en la semana 65
    - Cambio desde el inicio en el IMCm en la semana 65
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Chile
    China
    Colombia
    Cyprus
    Estonia
    France
    Germany
    Greece
    Ireland
    Israel
    Italy
    Japan
    Korea, Democratic People's Republic of
    Latvia
    Malaysia
    Mexico
    Netherlands
    New Zealand
    Portugal
    Spain
    Switzerland
    Taiwan
    Turkey
    United Kingdom
    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 is last subject, last visit.
    El fin de Estudio es la última visita del último 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 months4
    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 months8
    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: 86
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 46
    F.4.2.2In the whole clinical trial 140
    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)
    Eligible patients (including patients that initially received inotersen) may elect to enroll in an open-label extension study where they will receive ION-682884 once every 4 weeks, pending study approval by the IRB/IEC and appropriate regulatory authority. In this case, patients will not participate in the Post-Treatment Evaluation Period.
    Los pacientes elegibles (incluidos los pacientes que inicialmente hayan recibido inotersen) puede ser elegidos para participar en un estudio de extensión abierto donde recibirán ION-682884 una vez cada 4 semans, a la espera de la aprobación del estudio por parte del IRB/IEC y de las autoridades regulatorias que correspondan. En este caso, los pacientes no participarán en el periodo de evaluación post-tratamiento
    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 Decision2020-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-14
    P. End of Trial
    P.End of Trial StatusOngoing
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