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    Summary
    EudraCT Number:2020-004997-23
    Sponsor's Protocol Code Number:BN42358
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-08
    Trial 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 number2020-004997-23
    A.3Full title of the trial
    A PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS PRASINEZUMAB IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE
    STUDIO DI FASE IIB, RANDOMIZZATO, IN DOPPIO CIECO, CONTROLLATO CON PLACEBO E MULTICENTRICO PER VALUTARE L’EFFICACIA E LA SICUREZZA DI PRASINEZUMAB PER VIA ENDOVENOSA IN PARTECIPANTI CON MALATTIA DI PARKINSON IN FASE INIZIALE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's Disease
    Uno studio per valutare l'efficacia e la sicurezza di prasinezumab per via endovenosa in pazienti con malattia di Parkinson in fase iniziale
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberBN42358
    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 SponsorF. HOFFMANN - LA ROCHE LTD.
    B.1.3.4CountrySwitzerland
    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 supportF.Hoffmann La-Roche Ltd - Basel
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number00000000
    B.5.5Fax number0000000
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameaSyn Mab
    D.3.2Product code [RO7046015]
    D.3.4Pharmaceutical form Concentrate for solution for injection/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 INNPrasinezumab
    D.3.9.2Current sponsor codeRO7046015
    D.3.9.3Other descriptive namePRX002, ELT2, anti-alpha-synuclein monoclonal antibody
    D.3.9.4EV Substance CodeSUB194018
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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 No
    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 injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/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
    Early Parkinson's disease
    malattia di Parkinson in fase iniziale
    E.1.1.1Medical condition in easily understood language
    Parkinson's disease is a brain disorder that leads to shaking, stiffness, and difficulty with walking, balance, and coordination. Parkinson's symptoms usually begin gradually and get worse over time.
    La malattia di Parkinson è una malattia del cervello che porta a tremori, rigidità e difficoltà a camminare, equilibrio e coordinazione. I sintomi del P. iniziano gradualmente e peggiorano nel tempo.
    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 10061536
    E.1.2Term Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of prasinezumab compared with placebo on basis of time to meaningful progression on motor signs of the disease
    Per valutare l'efficacia di prasinezumab rispetto al placebo sulla base del tempo alla progressione significativa dei segni motori della malattia
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of prasinezumab compared with placebo on basis of time-to-worsening of patient’s motor function as reported by the patient and confirmed by the clinician, time to meaningful worsening in the overall disease as reported by the patient and by the clinician, change from baseline in motor function, change from baseline in bradykinesia and change from baseline in motor aspects of experiences of daily living
    • To evaluate the safety of prasinezumab compared with placebo
    • To characterize the prasinezumab pharmacokinetic (PK) profile
    • To evaluate the immune response to prasinezumab
    - valutare l’efficacia di prasinezumab rispetto al placebo in base al tempo di peggioramento della funzione motoria del paziente secondo quanto riferito dal paziente stesso e confermato dal medico, tempo di peggioramento significativo della malattia generale come riportato dal paziente e dal medico, variazione rispetto al basale della funzione motoria, variazione rispetto al basale nella bradicinesia e variazione degli aspetti motori delle esperienze della vita quotidiana dal basale
    - valutare la sicurezza di prasinezumab rispetto al placebo
    - caratterizzare il profilo farmacocinetico (PK) di prasinezumab
    - valutare la risposta immunitaria a prasinezumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age >=50-85 years at time of signing the Informed Consent Form
    • Diagnosis of idiopathic Parkinson's disease (PD) based on Movement disorder society (MDS) criteria with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism
    • On symptomatic PD medication for at least 6 months, with stable doses for 3 months prior to baseline
    • A diagnosis of PD for at least 6 months to maximum 3 years at screening
    • Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV score= 0
    • Hoehn and Yahr (H&Y) Stage I or II in ON and OFF states
    • Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) imaging consistent with dopamine transporter deficit, as assessed by the central reader
    • No anticipated changes in PD medication from baseline throughout the study duration based on clinical status during screening
    • Willingness and ability to use a smartphone application to measure PD-related symptoms for the duration of the study
    • Willingness and ability to wear a smartwatch to measure PD-related motor signs
    - Età>=50-85 anni al momento della sottoscrizione del modulo di consenso informato
    -Diagnosi di PD idiopatica in base ai criteri MDS, con bradicinesia più uno degli altri segni cardinali di PD (tremore a riposo, rigidità), senza altre cause note o sospette di parkinsonismo
    -Trattamento sintomatico diPD per almeno 6 mesi, con dosi stabili per 3 mesi prima del basale
    -Diagnosi di PD da almeno 6 mesi fino a un massimo di 3 anni allo screening
    -Punteggio MDS UPDRS Parte IV= 0
    -Stadio I o II secondo la scala di Hoehn e Yahr negli stati ON e OFF
    -Referto della DaT SPECT compatibile con deficit del trasportatore della dopamina secondo la lettura effettuata a livello centrale
    -Nessuna previsione di modifica dei farmaci per la PD a partire dal basale per l’intera durata dello studio in base allo stato clinico durante lo screening
    -Volontà e capacità di usare un’applicazione per smartphone per valutare i sintomi correlati alla PD per l’intera durata dello studio
    -Volontà e capacità di indossare uno smartwatch per valutare i segni motori correlati alla PD
    E.4Principal exclusion criteria
    • Medical history indicating a Parkinsonian syndrome other than idiopathic PD
    • Diagnosis of PD dementia
    • Diagnosis of a significant central nervous system (CNS) disease other than Parkinson’s disease
    • Within the last year, unstable or clinically significant cardiovascular disease
    • Uncontrolled hypertension
    • Drug and/or alcohol abuse within 12 months prior to screening, in the investigator's judgment (Nicotine is allowed, Marijuana use is not allowed)
    • Clinically significant abnormalities in laboratory test results at the screening visit, including hepatic and renal panels, complete blood count, chemistry panel and urinalysis
    • Allergy to any of the components of prasinezumab, a known hypersensitivity, or a previous IRR following administration of any other monoclonal antibody
    • Any contraindications to obtaining a brain MRI
    • Any contraindications to DaT-SPECT imaging
    -Anamnesi positiva per sindrome parkinsoniana diversa da PD idiopatica
    -Diagnosi di demenza associata a PD
    -Diagnosi di malattia significativa del sistema nervoso centrale diversa da PD
    -Cardiovasculopatia instabile o clinicamente significativa nell’ultimo anno
    -Ipertensione non controllata
    -Abuso di sostanze e/o alcol nei 12 mesi precedenti lo screening, secondo il giudizio dello sperimentatore (la nicotina è ammessa, non è ammessa la marijuana)
    -Anomalie clinicamente significative nei risultati degli esami di laboratorio alla visita di screening, compresi pannelli epatici e renali, emocromo, pannello chimico e analisi delle urine
    -Allergia a uno qualsiasi dei componenti di prasinezumab, ipersensibilità nota o precedente IRR dopo la somministrazione di altri anticorpi monoclonali
    -Controindicazioni alla RM cerebrale
    - Controindicazioni alla DaT SPECT
    E.5 End points
    E.5.1Primary end point(s)
    Time to meaningful progression on motor signs of the disease, as assessed by >5 points increase in MDS-UPDRS Part III score from baseline
    Tempo alla progressione significativa dei segni motori della malattia, valutato da un aumento> 5 punti del punteggio MDS-UPDRS Parte III rispetto al basale
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    Durante tutto lo studio
    E.5.2Secondary end point(s)
    1. Time-to-worsening of patient’s motor function as reported by the patient in MDS-UPDRS Part II and confirmed by the clinician in MDS-UPDRS Part III
    2. Time to meaningful worsening in Patient Global Impression of Change (PGI-C, Overall Disease Subscale)
    3. Time to meaningful worsening in Clinician Global Impression of Change (CGI-C, Overall Disease Subscale)
    4. Change in motor function from baseline to Week 76, as measured by the MDS-UPDRS Part III total score
    5. Change in bradykinesia from baseline to Week 76, as measured by the MDS-UPDRS Part III bradykinesia subscore
    6. Change in motor aspects of experiences of daily living from baseline to Week 76, as measured by MDS-UPDRS Part II
    7. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
    8. Incidence of adverse events of special interest
    9. Incidence of treatment discontinuation due to adverse events
    10. Incidence and severity of infusion-related reactions (IRRs)
    11. Change from baseline in vital signs
    12. Incidence of abnormal vital sign measurements
    13. Change from baseline in electrocardiogram (ECG) assessments
    14. Incidence of abnormal ECG assessments
    15. Change from baseline in laboratory measurements
    16. Incidence of abnormal laboratory measurements
    17. Incidence of physical and neurologic examination abnormalities
    18. Change from baseline in suicidal ideation, as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
    19. Serum concentration of prasinezumab at specified timepoints
    20. Prevalence of anti-drug antibodies (ADAs) against prasinezumab at baseline
    21. Incidence of ADAs against prasinezumab during the study
    1.Tempo al peggioramento della funzione motoria del paziente secondo quanto riferito dal paziente stesso nel MDS UPDRS Parte II e confermato dal medico nel MDS UPDRS Parte III
    2. Tempo al peggioramento significativo nella Patient Global Impression of Change (PGI C, sottoscala relativa alla malattia generale)
    3.Variazione della funzione motoria dal basale alla Settimana 76 valutata mediante il punteggio MDS UPDRS Parte III totale
    4. Variazione della funzione motoria dal basale alla Settimana 76 valutata mediante il punteggio MDS UPDRS Parte III totale
    5. Variazione della bradicinesia dal basale alla Settimana 76 valutata mediante il sottopunteggio relativo alla bradicinesia della MDS UPDRS Parte III
    6. Variazione degli aspetti motori delle esperienze della vita quotidiana dal basale alla Settimana 76 misurati dalla MDS UPDRS Parte II
    7. incidenza, gravità e severità degli eventi avversi, con severità stabilita in funzione dei Common Terminology Criteria for Adverse Events del National Cancer Institute, versione 5.0 (NCI CTCAE v5.0)
    8.Incidenza di eventi avversi di interesse particolare
    9.Incidenza di interruzioni del trattamento dovute a eventi avversi
    10.Incidenza e severità delle reazioni correlate all’infusione (IRR)
    11.Variazione dei segni vitali rispetto al basale
    12.incidenza di misurazioni anomale dei segni vitali
    13.Variazione delle valutazioni all’elettrocardiogramma (ECG) rispetto al basale
    14.incidenza di valutazioni ECG anomale
    15.Variazione rispetto al basale delle anomalie di laboratorio
    16.incidenza delle anomalie di laboratorio
    17.Incidenza di anomalie negli esami obiettivi e neurologici
    18.Variazione dell’ideazione suicidaria rispetto al basale valutata mediante la Columbia Suicide Severity Rating Scale (C SSRS)
    19.Concentrazione sierica di prasinezumab a specifici timepoint
    20.Prevalenza di anticorpi anti-farmaco (ADA) al basale
    21.incidenza di ADA durante lo studio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3. Throughout the study
    4-6. Baseline (Day 0) to 76 weeks
    7-10. Up to end of study visit
    11. Baseline to end of study visit
    12. Up to end of study visit
    13. Baseline to end of study visit
    14. Up to end of study visit
    15. Baseline to end of study visit
    16-17. Up to end of study visit
    18. Baseline end of study visit
    19. At weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76 and after week 76 every 12 weeks until the end of the study. 20. At Baseline
    21. Up to end of study visit
    1-3. Durante tutto lo studio
    4-6. Basale (giorno 0) a 76 settimane
    7-10. Fino alla fine della visita di studio
    11. Dal basale alla fine della visita di studio
    12. Fino alla fine della visita di studio
    13. Dal basale alla fine della visita di studio
    14. Fino alla fine della visita di studio
    15. Dal basale alla fine della visita di studio
    16-17. Fino alla fine della visita di studio
    18. Baseline alla fine della visita di studio
    19. Alle settimane 1, 2, 4, 8, 12, 24, 36, 52, 64, 76 e dopo la settimana 76 ogni 12 settimane fino alla fine dello studio. 20. Al basale
    21. Fino alla fine della visita di studio
    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 No
    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 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 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 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 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 EEA67
    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
    Canada
    United States
    Austria
    France
    Italy
    Poland
    Spain
    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
    Last Patient Last Visit
    Ultimo paziente Ultima visita
    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 months6
    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 months6
    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: 259
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 316
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state76
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 319
    F.4.2.2In the whole clinical trial 575
    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)
    N/A
    NA
    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 Decision2021-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-24
    P. End of Trial
    P.End of Trial StatusOngoing
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