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    EudraCT Number:2016-002554-21
    Sponsor's Protocol Code Number:CN002-012
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-04-24
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    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 BMS-986168 in Participants with Progressive Supranuclear Palsy
    Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos para evaluar la eficacia y la seguridad de BMS-986168 administrado por vía intravenosa en participantes con parálisis supranuclear progresiva
    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 BMS-986168 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
    Estudio para evaluar la eficacia y la seguridad del medicamento en investigación BMS-986168 en comparación con el placebo en participantes con parálisis supranuclear progresiva, una enfermedad rara y progresiva que causa problemas de equilibrio, movilidad, visión, habla y deglución
    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/041/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBristol-Myers Squibb International Corporation
    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 supportBristol-Myers Squibb International Corporation
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointGCT-SU
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.4Telephone number003491586 83 39
    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.3.2Product code BMS-986168
    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 INNBMS986168
    D.3.9.2Current sponsor codeBMS986168
    D.3.9.3Other descriptive nameBMS986168
    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 No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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. medicinal product typeHumanized 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
    Parálisis supranuclear progresiva
    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
    Enfermedad rara y progresiva que causa problemas de equilibrio, movilidad, visión, habla y deglución
    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 19.1
    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 BMS-986168, 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 BMS-986168, relative to placebo, by measuring the frequency of deaths, SAEs, AEs leading to discontinuation, and Grade 3 & 4 laboratory abnormalities.
    Evaluar la eficacia de BMS-986168 en comparación con un placebo midiendo el cambio con respecto al inicio en la escala de valoración de la PSP (PSPRS) en la semana 52.

    Evaluar la seguridad y la tolerabilidad de BMS-986168 en comparación con el placebo midiendo la frecuencia de muertes, AAGs, AAs que conlleven la interrupción del tratamiento y anomalías en las pruebas de laboratorio de grado 3 y 4.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of BMS-986168, 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
    - SEADL Scale
    - CGI-S
    - Phonemic Fluency Test
    - Letter-Number Sequencing Test
    - Color Trails Test
    - MoCA

    To assess the impact of BMS-986168 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 BMS-986168.

    To assess the efficacy of BMS-986168, 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
    Evaluar eficacia BMS-986168 respecto placebo midiendo :
    -cambio respecto inicio en parte II de revisión escala valoración unificada enfermedad Parkinson (UPDRS) promovida por Sociedad trastornos movimiento (MDS-UPDRS) en sem 52
    -impresión clínica global cambio (CGI-C) en sem 52
    -cambio respecto inicio en RBANS sem 52
    -cambio respecto inicio en sem 48 (sem 52 para CGI-S) en:
    - Escala actividades vida diaria Schwab y England-SEADL
    - CGI-S
    - Prueba fluidez fonémica, secuenciación letras-números, rastros de color
    - Evaluación cognitiva Montreal (MoCA)
    -Evaluar efecto BMS-986168 en calidad vida respecto placebo midiendo cambio respecto inicio en PSP-QoL en sem 52
    -Evaluar inmunogenia BMS-986168
    -Evaluar eficacia BMS-986168 en respecto placebo midiendo cambio absoluto y porcentual respecto inicio en sem 52 según determinado por RM en los volúmenes cerebrales siguientes : Ventrículos, todo el cerebro, mesencéfalo, pedúnculo cerebeloso superior, tercer ventrículo, lóbulo frontal
    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 screening
    • 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
    -Participante con PSP probable o posible.
    -Capaz de deambular con independencia o con ayuda.
    -Capaz de tolerar una RM.
    -Que cuenta con un cuidador fiable que lo acompaña a todas las visitas del estudio.
    -Con una puntuación igual o superior a 20 en el Miniexamen del Estado Mental (MMSE) en la selección.
    -El participante debe residir fuera de un centro especializado de enfermería o de un centro de atención a personas con demencia en el momento de la selección y no debe estar previsto su ingreso en un centro de ese tipo.
    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
    -Presencia de otros trastornos psiquiátricos o neurológicos importantes.
    -Diagnóstico de esclerosis lateral amiotrófica (ELA) u otras enfermedades de la motoneurona.
    -Antecedentes de trastorno del comportamiento del sueño de movimientos oculares rápidos (REM) precoz e importante.
    -Antecedentes o RM cerebral en la selección indicativos de anomalías significativas.
    -Antecedentes conocidos de concentración plasmática o sérica de progranulina menor que una desviación estándar inferior a la media del valor de paciente normal para el laboratorio que realiza el análisis.
    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. Cambio en la escala de valoración de la PSP (PSPRS)
    2.Frecuencia de Acontecimientos Adversos
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 52 weeks
    Hasta 52 semanas
    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-BMS-986168) in serum.
    7. Impact on brain volumes, as determined by MRI.
    1. Cambio en la parte II de la revisión de la escala de valoración unificada de la enfermedad de Parkinson (UPDRS) promovida por la Sociedad de trastornos del movimiento (MDS-UPDRS)
    2. Efecto en la puntuación de la escala de impresión clínica global de cambio (CGI-C)
    3. Efecto en la escala de la batería repetible para la evaluación de la gravedad de la enfermedad neuropsicológica (RBANS)
    4. El efecto en la escala de calidad de vida de la parálisis supranuclear progresiva (PSP-QoL)
    5. El efecto en los instrumentos siguientes:
    - Escala de actividades de la vida diaria de Schwab y England (SEADL).
    - Impresión clínica global de la gravedad (CGI-S).
    - Prueba de fluidez fonémica.
    - Prueba de secuenciación de letras y números.
    - Prueba de rastros de color.
    - Evaluación cognitiva de Montreal (MoCA).
    6. La inmunogenia se evaluará midiendo la presencia o ausencia de anticuerpos específicos contra el fármaco (anti-BMS-986168) en el suero.
    7. El efecto según lo determinado por la RM en los volúmenes cerebrales
    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.
    Todos: selección y Semana 52.
    - Escala, Prueba de Fluidez Fonética, Prueba de Secuenciación de Letras y Números, Prueba de Rastros de Color y Evaluación Cognitiva de Montreal (MoCA): selección y Semana 48.

    - Inmunogenia: Día 1, Semanas 4, 8, 12, 24, 36 y 48 y después a intervalos de 24 semanas durante el periodo en abierto.
    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
    Inmunogenia y análisis de biomarcadores
    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
    Periodo de tratamiento en doble ciego seguido de una fase de extensión de tratamiento abierta.
    Double-blind treatment period followed by an open-label extension period
    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 concerned7
    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 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
    Korea, Republic of
    Russian Federation
    United Kingdom
    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 date that the last participant completes the last study visit or scheduled procedure, will be defined as the end of the study.
    Se definirá como fin del estudio la fecha en que el último participante complete la última visita del estudio o el último procedimiento programado.
    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 years3
    E.8.9.2In all countries concerned by the trial months1
    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: 198
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 198
    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
    Sujetos que precisan del apoyo de un cuidador
    F.4 Planned number of subjects to be included
    F.4.1In the member state29
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 146
    F.4.2.2In the whole clinical trial 396
    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 Decision2017-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-02-07
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