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    Summary
    EudraCT Number:2016-002554-21
    Sponsor's Protocol Code Number:251PP301
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-04-19
    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 ConcernedGermany - PEI
    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 BIIB0092 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 of BIIB092 in participants with Progressive Supranuclear Palsy
    A.4.1Sponsor's protocol code number251PP301
    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 SponsorBiogen Idec Research Limited
    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 Research 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 pointN/A
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailclinicaltrials@biogen.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 BIIB092
    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 INNBIIB092
    D.3.9.2Current sponsor codeBIIB092
    D.3.9.3Other descriptive nameBIIB092
    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
    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
    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 Progressive Supranuclear Palsy 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.
    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 Movement Disorder Society (MDS)-sponsored revision of the Unified Parkinson's Disease Rating Scale
    (MDS-UPDRS) Part II at Week 52.
    - the Clinical Global Impression of Change (CGI-C) at Week 52.
    - a change in baseline in the Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) at Week 52.
    To assess the impact of BIIB092 on quality of life, relative to placebo, as measured by change from baseline on the Progressive Supranuclear Palsy Quality of Life (PSP-QoL) scale at Week 52.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    This study includes an optional substudy to measure quantitative movement assessments (QMAs ) using wearable sensors. The QMAs will measure gait, postural instability, motor function, and falls in a subset of study participants participating in the long-term extension period.
    E.3Principal inclusion criteria
    • Participants with probable or possible Progressive Supranuclear Palsy (PSP)
    • Able to ambulate independently or with assistance
    • Able to tolerate Magnetic Resonance Imaging (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
    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

    NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
    E.5 End points
    E.5.1Primary end point(s)
    1. Change From Baseline in PSP (Progressive Supranuclear Palsy) Rating Scale (PSPRS) at Week 52
    2. Percentage of Participants with Death, Serious Adverse Events
    (SAEs), Adverse Events Leading to Discontinuation, and Grade 3 and 4 Laboratory Abnormalities
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Baseline, Week 52
    2) Up to 52 weeks
    E.5.2Secondary end point(s)
    1) Change From Baseline in Movement Disorder Society (MDS)-
    sponsored Revision of the Unified Parkinson'Disease Rating Scale (MDSUPDRS)
    Part II at Week 52
    2) Clinical Global Impression of Change (CGI-C) Scale Score
    3) Change From Baseline in Repeatable Battery for the Assessment of
    Neuropsychological Disease Severity (RBANS) Scale at Week 52
    4) Change From Baseline in Progressive Supranuclear Palsy Quality of
    Life Scale (PSP-QoL) Score
    5) Change From Baseline in Schwab and England Activities of Daily
    Living (SEADL) Scale Score at Week 48
    6) Change From Baseline in Clinical Global Impression of Severity (CGIS)
    Score at Week 52
    7) Change From Baseline in Phonemic Fluency Test Score at Week 48
    8) Change From Baseline in Letter Number Sequencing Test at Week 48
    9) Change From Baseline in Color Trails Test at Week 48
    10) Change From Baseline in Montreal Cognitive Assessment (MoCA)
    Score at Week 48
    11) Number of Participants with Drug Antibodies (anti-BIIB092) in
    Serum
    12) Percent Change from Baseline of Brain Volumes as Determined by
    MRI
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Baseline, Week 52
    2) Week 52
    3) Baseline, Week 52
    4) Baseline, Week 52
    5) Baseline, Week 48
    6) Baseline, Week 52
    7) Baseline, Week 48
    8) Baseline, Week 48
    9) Baseline, Week 48
    10) Baseline, Week 48
    11) Up to Week 52
    12) Up to Week 52
    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 concerned15
    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
    Greece
    Italy
    Japan
    Korea, Republic of
    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.
    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 months8
    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: 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.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 state80
    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)
    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 Decision2017-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-02-07
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