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    Summary
    EudraCT Number:2016-002554-21
    Sponsor's Protocol Code Number:CN002-012
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2018-06-15
    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 ConcernedFrance - ANSM
    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
    Étude randomisée, en double aveugle contrôlée contre placebo et en groupes parallèles évaluant l’efficacité et l’innocuité du BMS-986168 administré en intraveineuse à des participants atteints de paralysie supranucléaire progressive
    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
    Etude évaluant l'efficacité et l'innocuité du produit à l'étude BMS-986168 comparé au placebo chez des participants atteints de paralysie supranucléaire progressive, une affection rare et progressive qui peut causer des problèmes d’équilibre, de mouvement, de vision, de parole et pour avaler
    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.1.3.4CountryBelgium
    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.4.2CountryBelgium
    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.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.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/3/15/1522
    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.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 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
    paralysie supranucléaire progressive
    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
    une affection rare et progressive qui peut causer des problèmes d’équilibre, de mouvement, de vision, de parole et pour avaler
    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 20.0
    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.
    Évaluer contre placebo l’efficacité du BMS-986168, mesurée par la variation à la semaine 52 du score obtenu à la visite de référence sur l’échelle PSPRS d’évaluation de la PSP

    Évaluer contre placebo l’innocuité et la tolérance du BMS-986168, en mesurant la fréquence de décès, les EIG, les EI conduisant à l’arrêt, et les anomalies de laboratoire de Grades 3 et 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
    instruments:
    - 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
    Évaluer contre placebo l’efficacité du BMS-986168, mesurée par:
    - la variation à la semaine 52 du score obtenu à la visite de référence sur l’échelle MDS-UPDRS Partie II
    - l'échelle CGI-C à la semaine 52
    - la variation à la semaine 52 du score obtenu à la visite de référence sur l’échelle RBANS
    - la variation dans les instruments suivants entre la visite de référence et la semaine 48 (semaine 52 pour le CGI-S):
    - Echelle SEADL
    - CGI-S
    - Test de fluence phonémique
    - Test Séquences lettres-chiffres (LNS)
    - Test CTT (Color Trails Test)
    - Évaluation MoCA

    Évaluer contre placebo l’impact du BMS-986168 sur la qualité de vie, mesuré par la variation à la semaine 52 du score obtenu à la visite de référence sur l’échelle PSP-QoL

    Evaluer l'immunogénicité du BMS-986168

    Evaluer vs placebo l'efficacité du BMS-986168 sur les volumes cérébraux déterminés par IRM, mesurée par la variation absolue et en pourcentage de la visite de référence à la semaine 52
    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
    - Participants avec une PSP probable ou possible
    - Capacité à se déplacer de manière autonome ou avec assistance
    - Tolérance à l’IRM
    - Présence d’un soignant pour accompagner le participant à toutes les visites de l’étude
    - Score supérieur ou égal à 20 au mini-examen de l’état mental (Mini Mental State Exam ou MMSE) à la sélection
    - Au moment de la sélection, le participant doit résider hors d’un établissement de soins ou d’un centre de prise en charge des patients atteints de démence, et l’admission dans ces types d’établissements ne doit pas être envisagée
    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
    - Présence d’autres troubles neurologiques ou psychiatriques significatifs
    - Diagnostic de sclérose latérale amyotrophique (SLA) ou autre maladie du motoneurone.
    - Antécédents de troubles importants et précoces du sommeil paradoxal avec mouvements oculaires rapides
    - Réalisation antérieure ou à la sélection d’une IRM du cerveau indiquant une anomalie significative
    - Antécédents connus de taux de progranuline sérique ou plasmatique inférieur de moins d’un écart-type à la moyenne normale du patient pour le laboratoire qui réalise le test
    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. Changement dans les échelle d'évaluation de la PSP (PSPRS)
    2. Fréquence des Evènements Indésirables
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 52 weeks
    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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All - screening and Week 52.
    Except:
    - 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.
    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
    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 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.8.1.7.1Other trial design description
    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
    Australia
    Austria
    Canada
    France
    Germany
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Russian Federation
    Spain
    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.
    La date à laquelle le dernier participant termine la dernière visite d’étude ou de la procédure prévue, sera définie comme la fin de l’étude.
    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 years2
    E.8.9.2In all countries concerned by the trial months9
    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.3.3.7.1Details of other specific vulnerable populations
    Subjects requiring support of a caregiver
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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)
    None
    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 Decision2017-06-01
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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