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    EudraCT Number:2016-002554-21
    Sponsor's Protocol Code Number:CN002-012
    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:2021-05-25
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-002554-21
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants with Progressive Supranuclear Palsy
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants with Progressive Supranuclear Palsy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the effectiveness and safety of test product BIIB092 compared to placebo in participants with progressive supranuclear palsy, a
    rare and progressive condition that can cause problems with balance, movement, vision, speech and swallowing
    Studio randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli per valutare l’efficacia e la sicurezza di BIIB092 somministrato per via endovenosa nel trattamento di pazienti affetti da paralisi sopranucleare progressiva
    A.3.2Name or abbreviated title of the trial where available
    A randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and s
    Studio randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli per valutare l’eff
    A.4.1Sponsor's protocol code numberCN002-012
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03068468
    A.5.4Other Identifiers
    Name:IND numberNumber:119,741
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/410/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.3.4CountryUnited Kingdom
    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 supportBiogen Idec Reserach Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House,70 Norden Road Maidenhead
    B.5.3.2Town/ cityBerkshire
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441628501000
    B.5.5Fax number00441628501010
    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/3/15/1522
    D.3 Description of the IMP
    D.3.1Product nameBIIB092
    D.3.2Product code [BIIB092]
    D.3.4Pharmaceutical form Solution for injection
    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 INNBIIB092
    D.3.9.2Current sponsor codeBIIB092
    D.3.9.4EV Substance CodeSUB186860
    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 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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 Yes
    D. medicinal product typeAnticorpo monoclonale umanizzato
    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
    Paralisi Sopranucleare Progressiva (PSP)
    E.1.1.1Medical condition in easily understood language
    A rare and progressive condition that can cause problems with balance,
    movement, vision, speech and swallowing
    Una rara e progressiva condizione che può causare problemi conl' equilibrio, con il movimento, con la visione, con la parola, con la deglutizione
    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 evaluate the efficacy of BIIB092, compared to placebo, as measured by a change from baseline in the PSP Rating Scale (PSPRS) at Week 52.
    To assess the safety and tolerability of BIIB092, relative to placebo, by measuring the frequency of deaths, SAEs, AEs leading to discontinuation, and Grade 3 & 4 laboratory abnormalities
    Valutare l'efficacia di BIIB092, rispetto al placebo, misurata da una variazione dal basale nella scala di valutazione della PSP (‘PSP Rating Scale’, PSPRS) alla Settimana 52.
    Valutare la sicurezza e la tollerabilità di BIIB092, rispetto al placebo, misurando la frequenza di decessi, EAG, EA che portano alla sospensione, ed anomalie di laboratorio di Grado 3 & 4.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of BIIB092, compared to placebo, as measured by:- a change in baseline in the MDS-UPDRS Part II at Week 52;- the CGI-C at Week 52; - a change in baseline in the RBANS at Week 52; - a change from baseline at Week 48 (Week 52 for CGI-S) on the following instruments:
    - SEADL Scale;- CGI-S; - Phonemic Fluency Test
    - Letter-Number Sequencing Test; - Color Trails Test
    - MoCA
    To assess the impact of BIIB092 on quality of life, relative to placebo, as measured by change from baseline on the PSP-QoL scale at Week 52.To assess the immunogenicity of BIIB092. To assess the efficacy of BIIB092, relative to placebo, as measured
    by absolute and percent change from baseline of brain volumes, as
    determined by MRI, at Week 52 in the following regions:
    - Ventricles
    - Whole brain
    - Midbrain
    - Superior cerebellar peduncle
    - Third ventricle
    - Frontal lobe
    Valutare l’efficacia di BIIB092, rispetto al placebo, misurata da: -una variazione nel basale nell’MDS-UPDRS (Parte II alla Sett.52); -il punteggio della scala CGI-C alla Sett.52;-una variazione al basale nella RBANS;-una variazione dal basale alla Sett48(sett.52 per CGI-C) sui seguenti strumenti:Scala SEADL,CGI-S,Test sulla Fluidità Fonemica,Test di Sequenziamento Lettera-Numero, Color Trials test, MoCA. Valutare l'impatto di BIIB092 sulla qualità della vita, rispetto al placebo, misurata dalla variazione dal basale sulla scala (PSP-QoL) alla sett.52. Valutare l'immunogenicità di BIIB092. Valutare l'efficacia di BIIB092, rispetto al placebo, misurata da una variazione assoluta e percentuale dal basale dei volumi cerebrali, determinata da RM, alla Settimana 52 nelle seguenti regioni:
    - Ventricoli
    - Cervello intero
    - Mesencefalo
    - Peduncolo cerebellare superiore
    - Terzo ventricolo
    - Lobo frontale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Participants with probable or possible PSP
    -Able to ambulate independently or with assistance
    -Able to tolerate MRI
    -Have reliable caregiver to accompany participant to all study visits
    -Score greater or equal to 20 on the Mini Mental State Exam (MMSE) at
    -Participant must reside outside a skilled nursing facility or dementia care facility at the time of screening and admission to such a facility must not be planned
    -Partecipanti con probabile o possibile PSP
    - In grado di deambulare indipendentemente o con assistenza
    - In grado di tollerare RM
    - Hanno un caregiver affidabile per accompagnare il/la partecipante a tutte le visite dello studio
    - Punteggio maggiore o uguale a 20 del Mini Mental State Exam (MMSE) allo screening
    - Il/la partecipante deve risiedere al di fuori di una struttura di assistenza infermieristica qualificata o di struttura per la cura della demenza, al momento dello screening, e non deve essere programmata l’ammissione a tale struttura

    E.4Principal exclusion criteria
    -Presence of other significant neurological or psychiatric disorders
    -Diagnosis of amyotrophic lateral sclerosis (ALS) or other motor neauron disease
    -History of early, prominent rapid eye movement (REM) sleep behaviour disorder
    -History of or screening brain MRI scan indicative of significant abnormality
    -Known history of serum or plasma progranulin level less than one standard deviation below the normal patient mean for the laboratory performing the assay
    -Presenza di altri disturbi neurologici e psichiatrici significativi
    -Diagnosi di sclerosi laterale amiotrofica (SLA) o altra malattia del motoneurone
    -Anamnesi di precoci e prominenti disturbi del comportamento durante il sonno causati da movimenti oculari rapidi (REM)
    -Anamnesi di anormalità significativa o scansione RM del cervello di screening indicativa della stessa
    -Nota anamnesi del livello di progranulina serica o del plasma inferiore ad una deviazione standard al di sotto della normale media del/la paziente per il laboratorio che esegue l’analisi
    E.5 End points
    E.5.1Primary end point(s)
    1. Change in PSP (Progressive Supranuclear Palsy) Rating Scale
    2. Frequency of Adverse Events
    1. Cambiamento nella Scala di Valutazione della PSP (Paralisi Sopranucleare Progressiva)
    2. Frequenza di Eventi Avversi
    E.5.1.1Timepoint(s) of evaluation of this end point
    up to 52 week
    fino a 52 settimane
    E.5.2Secondary end point(s)
    1. Change in Movement Disorder Society
    (MDS)-sponsored revision of
    the Unified Parkinson's Disease Rating Scale (MDSUPDRS) Part II.
    2. Impact of on the Clinical Global Impression of Change (CGI-C) scale
    score .
    3. Impact on the Repeatable Battery for the Assessment of
    Neuropsychological Disease Severity (RBANS) scale.
    4. Impact on the Progressive Supranuclear Palsy Quality of Life scale
    (PSP-QoL) scale.
    5. Impact on the following instruments:
    - Schwab and England Activities of Daily Living (SEADL) Scale
    - Clinical Global Impression of Severity (CGI-S)
    - Phonemic Fluency Test
    - Letter-Number Sequencing Test
    - Color Trails Test
    - Montreal Cognitive Assessment (MoCA).
    6. Immunogenicity by assessment of the presence or absence of specific
    drug antibodies (anti-BIIB092) in serum.
    1.Cambiamento nella revisione sponsorizzata dalla Movement Disorder Society (MDS, Società sui
    Disturbi Motori) della Scala Unificata
    per la Valutazione del Morbo di Parkinson (MDSUPDRS) Parte II.2.Impatto di sul punteggio della scala sull'Impressione Clinica Globale di Cambiamento (‘Clinical Global Impression of Change’,
    3.Impatto sulla scala della Batteria Ripetibile per la Valutazione della Gravità della Malattia Neuropsicologica (‘Repeatable Battery
    for the Assessment of Neuropsychological Disease Severity’, RBANS).
    4.Impatto sulla scala della Qualità della Vita per la Paralisi Sopranucleare Progressiva (‘Progressive Supranuclear Palsy Quality of
    Life’, PSP-QoL).
    5.Impatto sui seguenti strumenti:
    -Scala di Schwab ed England delle Attività della Vita Quotidiana (‘Schwab and England Activities of Daily Living’, SEADL)
    -Impressione Clinica Globale della Gravità (‘Clinical Global Impression of Severity’, CGI-S)
    -Test sulla Fluidità Fonemica
    -Test di Sequenziamento Lettera-Numero
    -Color-Trails Test
    -Valutazione Cognitiva di Montreal (‘Montreal Cognitive Assessment’, MoCA).
    6.Immunogenicità mediante la valutazione di presenza o assenza di specifici anticorpi al farmaco (anti-BIIB092) nel siero.7.Impatto sui volumi cerebrali, determinato da RM.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All: - screening and Week 52.
    - Scale, Phonemic Fluency Test, Letter-Number Sequencing Test, Color
    Trails Test and MoCA - screening and Week 48.
    - Immunogenicity - Day 1, Weeks 4, 8, 12, 24, 36 and 48 then at 24 week intervals during the open-label period.
    Tutti: - screening e Settimana 52.Ad eccezione di:
    -Scala, Test sulla Fluidità Fonemica, Test di Sequenziamento Lettera-Numero, Color Trails Test e MoCA che verranno effettuate
    allo screening e Settimana 48.
    -Immunogenicità: - Giorno 1, Settimane 4, 8, 12, 24, 36 e 48 quindi ad intervalli di 24 settimane durante la fase in aperto.
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, biomarker analysis
    Immunogenicità, analisi biomarker
    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. 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    Fase di trattamento in doppio cieco seguita da una fase di estensione in aperto
    Double-blind treatment period followed by an open-label extension
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Korea, Republic of
    Russian Federation
    United States
    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 date that the last participant completes the last study visit or
    scheduled procedure, will be defined as the end of the study
    La data in cui l'ultimo/a partecipante completa l'ultima visita dello studio o una procedura programmata, verrà definita come fine dello studio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    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: 138
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 321
    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 Yes
    F. of other specific vulnerable populations
    Subjects requiring support of a caregiver
    soggetti che richiedono il supporto di un caregiver
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 278
    F.4.2.2In the whole clinical trial 459
    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)
    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 Decision2018-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
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