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    Summary
    EudraCT Number:2019-001698-10
    Sponsor's Protocol Code Number:ION-682884-CS3
    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:2019-12-03
    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 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
    Studio di fase 3 globale, in aperto, randomizzato per valutare l'efficacia e la sicurezza di ION-682884 in pazienti con polineuropatia amiloide ereditaria mediata da 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
    Studio per valutare l'efficacia e la sicurezza di ION-682884 in pazienti con polineuropatia amiloide ereditaria mediata da transtiretina
    A.3.2Name or abbreviated title of the trial where available
    NEURO – TTRANSFORM
    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 nameinotersen
    D.3.2Product code ISIS 420915
    D.3.4Pharmaceutical form Solution for injection 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
    Polineuropatia amiloide ereditaria mediata da transtiretina
    E.1.1.1Medical condition in easily understood language
    An inherited condition that causes damage to peripheral nerves
    Condizione ereditaria che causa danni ai nervi periferici
    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.
    Per valutare l'efficacia di ION-682884, dopo somministrazione per 65 settimane, a confronto con il controllo storico del braccio del placebo (inotersen) nella sperimentazione NEURO-TTR, in base alla variazione rispetto al basale della concentrazione sierica di transtiretina (TTR), mNIS+7 e il Questionario sulla qualità della vita-Neuropatia diabetica Norfolk (QOL-DN Norfolk) nei pazienti con hATTR
    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)
    Valutare l'efficacia di ION-682884 rispetto alla coorte placebo nella sperimentazione NEURO-TTR, in base alla variazione rispetto al basale delle seguenti misure:
    Punteggi dei sintomi e variazioni della neuropatia (NCS)
    Punteggio del Riepilogo dei componenti fisici (PCS) del Modulo breve di indagine a 36 voci (SF-36)
    Punteggio della disabilità nella polineuropatia (PND)
    Indice di massa corporea modificato (mBMI)
    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) Avere un'età compresa tra 18 e 82 anni al momento del consenso informato
    2) Soggetto di sesso femminile: non deve essere incinta né in fase di allattamento, chirurgicamente sterile o in post-menopausa
    3) Soggetto di sesso maschile deve essere chirurgicamente sterile , o astinente o, se sessualmente attivo con una donna in età fertile , il paziente o la partner femminile non in gravidanza del paziente deve utilizzare un metodo contraccettivo altamente efficace.
    4) Diagnosi di polineuropatia amiloide ereditaria mediata da transtiretina come definito dal rispetto di tutti e 3 i seguenti criteri:
    Stadio 1 o Stadio 2 FAP
    Mutazione genetica documentata nel gene TTR
    Sintomi e segni coerenti con la polineuropatia, come misurata tramite NIS ≥ 10 e ≤ 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)
    -Anomalie clinicamente significative nella storia clinica, risultati di laboratorio dello screening, esame fisico che renderebbe un paziente non idoneo all'inclusione, incluso ma non limitato ad anormali valori di laboratorio sulla safety
    -Stato delle prestazioni secondo la scala di Karnofsky ≤ 50
    -Altre cause di neuropatia sensomotoria o autonomica (ovvero malattia autoimmune) incluso diabete non controllato
    -Precedente trapianto di fegato o trapianto di fegato anticipato entro 1 anno dallo screening
    -Classificazione funzionale della New York Heart Association (NYHA) ≥ 3
    -Sindrome coronarica acuta, chirurgia maggiore entro 3 mesi dallo screening
    -Altri tipi di amiloidosi
    -Presenza di altre condizioni che, a giudizio dello sperimentatore o dello Sponsor, renderebbero il paziente non idoneo all'inclusione o che potrebbero interferire con la partecipazione del paziente allo studio o con il completamento dello studio.
    -Trattamento attuale con qualsiasi farmaco approvato per l'amiloidosi da TTR ereditaria come Vyndaqel/Vyndamax (tafamidis), Tegsedi (inotersen), Onpattro (patisiran), uso off-label di diflunisal, doxiciclina o acido tauroursodesossicolico (TUDCA). In caso di trattamento precedente con Vyndaqel / Vyndamax, diflunisal o doxycycline, e TUDCA, il trattamento deve essere interrotto almeno 2 settimane prima del Giorno 1 dello studio.
    -Trattamento precedente con Tegsedi (inotersen) o Onpattro (patisiran) o altri oligonucleotidi o RNA terapeutici (incluso siRNA)
    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
    Analisi provvisoria degli endpoints co-primari di efficacia alla Settimana 35:
    -variazione rispetto al basale della concentrazione percentuale sierica di TTR
    -variazione rispetto al basale in mNIS+7;
    Analisi finale degli endpoints co primari di efficacia alla Settimana 66:
    -variazione rispetto al basale della concentrazione percentuale sierica di TTR
    -variazione rispetto al basale in mNIS+7;
    -variazione rispetto al basale in QOL-DN Norfolk
    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
    Analisi provvisoria degli endpoints co-primari di efficacia alla Settimana 35
    Analisi finale degli endpoints co primari di efficacia alla Settimana 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
    Analisi provvisoria alla Settimana 35 dell'endpoint chiave secondario di efficacia:
    -Variazione rispetto al basale in QOL-DN Norfolk
    Analisi finale endpoint secondario:
    -Variazione rispetto al basale del punteggio QOL-DN Norfolk
    -Variazione rispetto al basale del punteggio PCS di SF-36
    -Variazione rispetto al basale del punteggio PND
    -Variazione rispetto al basale di mBMI
    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
    Analisi provvisoria alla Settimana 35 dell'endpoint chiave secondario di efficacia:
    -Variazione rispetto al basale del punteggio in NSC alle settimane 35 e 66
    -Variazione rispetto al basale del punteggio PCS di SF-36 alla settimana 65
    -Variazione rispetto al basale del punteggio PND alla settimana 65
    -Variazione rispetto al basale di mBMI alla settimana 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 concerned4
    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.
    La fine dello studio è l'ultima visita dell'ultimo soggetto
    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 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.
    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 Decision2020-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-24
    P. End of Trial
    P.End of Trial StatusOngoing
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