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    Summary
    EudraCT Number:2017-001590-16
    Sponsor's Protocol Code Number:M15-563
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-11-04
    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 number2017-001590-16
    A.3Full title of the trial
    An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)
    Sperimentazione di estensione su ABBV-8E12 nella paralisi sopranucleare progressiva (PSP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)
    Sperimentazione di estensione su ABBV-8E12 nella paralisi sopranucleare progressiva (PSP)
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberM15-563
    A.5.4Other Identifiers
    Name:naNumber:na
    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 SponsorABBVIE DEUTSCHLAND GMBH & CO. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441628561090
    B.5.5Fax number441628461153
    B.5.6E-maileu-clinical-trials@abbvie.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/3/16/1649
    D.3 Description of the IMP
    D.3.1Product namena
    D.3.2Product code ABBV-8E12
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNABBV-8E12
    D.3.9.2Current sponsor codeABBV-8E12
    D.3.9.4EV Substance CodeSUB183488
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) Yes
    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 Yes
    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 typeHumanized IgG4 anti-tau monoclonal antibody
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Progressive Supranuclear Palsy (PSP)
    Paralisi sopranucleare progressiva (PSP)
    E.1.1.1Medical condition in easily understood language
    Progressive Supranuclear Palsy (PSP)
    Paralisi sopranucleare progressiva (PSP)
    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 10036813
    E.1.2Term Progressive supranuclear palsy
    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 assess the long-term safety and tolerability of ABBV-8E12 in subjects with PSP.
    ¿ To assess the long-term efficacy of ABBV-8E12 in slowing disease progression.
    - Valutare la sicurezza a lungo termine e la tollerabilit¿ di ABBV-8E12 in soggetti con PSP.
    - Valutare l'efficacia a lungo termine di ABBV-8E12 nel rallentare la progressione della malattia.
    E.2.2Secondary objectives of the trial
    ¿ To assess the long-term efficacy of ABBV-8E12 in slowing disease progression and functional impairment.
    ¿ To assess the pharmacokinetics of ABBV-8E12.
    ¿ To assess the long-term efficacy of ABBV-8E12 in slowing regional and/or whole brain atrophy.
    - Valutare l¿efficacia a lungo termine di ABBV-8E12 nel rallentare la progressione della malattia e la compromissione funzionale.
    - Valutare la farmacocinetica di ABBV-8E12.
    - Valutare l'efficacia a lungo termine di ABBV-8E12 nel rallentare l¿atrofia cerebrale regionale e/o totale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject completed the 52-week treatment period of Study M15-562.
    2. In the opinion of the Investigator, subject was compliant during participation in Study M15-562.
    3. Subject has an identified, reliable study partner (e.g., caregiver, family member, social worker, or friend).
    1. Il soggetto ha completato il periodo di trattamento di 52 settimane della sperimentazione M15-562.
    2. Secondo lo sperimentatore, il soggetto è stato conforme durante la partecipazione alla sperimentazione M15-562.
    3. Il soggetto ha un partner della sperimentazione identificato e affidabile (es. caregiver, familiare, assistente sociale o amico).
    E.4Principal exclusion criteria
    1. Subject weighs less than 44 kg (97 lbs.) at time of study entry.
    2. Subject has any contraindication or inability to tolerate brain MRI.
    3. Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results.
    4. More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-562.
    5. Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.
    1. Il soggetto pesa meno di 44 kg (97 lbs.) al momento dell’entrata nella sperimentazione.
    2. Il soggetto presenta una qualsiasi controindicazione o non è in grado di tollerare la RM cerebrale.
    3. Il soggetto presenta un qualsiasi cambiamento significativo delle sue condizioni mediche che potrebbe interferire con la sua partecipazione allo sperimentazione, potrebbe esporlo a un rischio aumentato o potrebbe alterare l’interpretazione dei risultati della sperimentazione.
    4. Sono trascorse più di 8 settimane dall’ultima dose del farmaco dello sperimentazione M15-562.
    5. Il soggetto viene considerato dallo sperimentatore, per una qualsiasi ragione, un candidato non valido a ricevere ABBV-8E12 o il soggetto viene considerato dallo sperimentatore non in grado o difficilmente in grado di rispettare lo schema di dosaggio o le valutazioni dello sperimentazione.
    E.5 End points
    E.5.1Primary end point(s)
    Change in Progressive Supranuclear Palsy Rating Scale (PSPRS).
    Variazione nella scala di valutazione della paralisi sopranucleare progressiva (PSPRS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline up to 5 years
    Dal Baseline fino a 5 anni
    E.5.2Secondary end point(s)
    Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)
    Variazioni nella Scala di valutazione unificata della malattia di Parkinson (UPDRS) Parte II (Activities of Daily Living)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 5 years
    Fino a 5 anni
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 concerned6
    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 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
    Australia
    Canada
    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
    LSLV
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 105
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects lacking full cognitive capacity aren't eligible. However during the study, if disease progresses to limit subject's ability to provide consent independently, study allows for Legally Authorized Representative to sign on subject's behalf.
    I soggetti privi di piena capacit¿ cognitiva non sono eleggibili. Tuttavia, durante lo studio, se la malattia progredisce per limitare la capacit¿ del soggetto di fornire il consenso in modo indipendente, lo studio consente al rappresentante legalmen
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 180
    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)
    Subjects in study M15-563 will continue receiving ABBV-8E12 for a period of up to 5 years or until premature discontinuation of the subject or the study. After completing Study M15-563, the investigator will discuss the appropriate subsequent treatment with the subject.
    I soggetti dello studio M15-563 continueranno a ricevere ABBV-8E12 per un periodo fino a 5 anni o fino all'interruzione anticipata del soggetto alla sperimentazione. Dopo aver completato la sperimentazione M15-563, l'investigatore
    discuter¿ il trattamento successivo appropriato con il soggetto.
    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 Decision2018-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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