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    Summary
    EudraCT Number:2016-004610-95
    Sponsor's Protocol Code Number:228PD201
    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:2021-01-14
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-004610-95
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson¿s Disease
    Studio multicentrico, randomizzato, in doppio cieco, controllato con placebo, con un periodo di trattamento attivo in cieco rispetto alla dose, volto a valutare la sicurezza, la farmacocinetica e la farmacodinamica di BIIB054 in soggetti con malattia di Parkinson
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson¿s Disease
    Valutazione della sicurezza, la farmacocinetica e la farmacodinamica di BIIB054 in soggetti con malattia di Parkinson
    A.3.2Name or abbreviated title of the trial where available
    SPARK
    SPARK
    A.4.1Sponsor's protocol code number228PD201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03318523
    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 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 pointMedical Director
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namend
    D.3.2Product code [BIIB054]
    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 INNHA 1A ANTICORPO MONOCLONALE UMANO CLASSE IGM
    D.3.9.2Current sponsor codeBIIB054
    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 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 Yes
    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 typerecombinant human 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
    Parkinson's Disease
    malattia di Parkinson
    E.1.1.1Medical condition in easily understood language
    Parkinson's Disease
    malattia di Parkinson
    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 dose-related safety of BIIB054.
    valutare la sicurezza di BIIB054 correlata alla dose
    E.2.2Secondary objectives of the trial
    - To evaluate the pharmacodynamic effects of BIIB054 on the integrity of nigrostriatal dopaminergic nerve terminals in Year 1 of the study.
    - To assess the PK profile of BIIB054.
    - To evaluate the immunogenicity of BIIB054.
    - Valutare gli effetti farmacodinamici di BIIB054 sull¿integrit¿ delle terminazioni nervose dopaminergiche nigro-striatali nell¿Anno 1 dello studio
    - Valutare il profilo farmacocinetico (PK) di BIIB054
    - Valutare l¿immunogenicit¿ di BIIB054
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Presence of freezing of gait.
    - Montreal cognitive assessment (MOCA) score <23 or other significant cognitive
    impairment or clinical dementia that, in the opinion of the Investigator, would
    interfere with study evaluation.
    - History of or screening brain magnetic resonance imaging (MRI) scan indicative of
    clinically significant abnormality, as read by central reader.
    - History of severe allergic or anaphylactic reactions, or history of hypersensitivity
    to BIIB054 or any of the inactive ingredients in the drug product or to radioligands or
    iodine used in the study.
    - Participation in any active immunotherapy study targeting alpha-synuclein.
    - Use of allowed medications not previously specified at doses that have not been stable
    for at least 8 weeks before Day 1, and/or that are not expected to remain stable for the
    duration of the study.
    - Clinically significant abnormal laboratory test values at Screening, as determined by
    the Investigator.
    - Blood donation (1 unit or more) within 8 weeks before Day 1 (must also refrain from
    donating blood for the duration of the study).
    - Presenza di congelamento dell’andatura.
    - Punteggio Montreal cognitive assessment (MOCA) < 23 o altro deterioramento cognitivo
    significativo o demenza clinica che, secondo lo sperimentatore, interferirebbe con la
    valutazione dello studio.
    - Anamnesi di o risonanza magnetica del cervello allo screening indicativa di
    un’anomalia clinicamente rilevante, in base alla lettura avvenuta a livello centrale.
    - Anamnesi di reazioni allergiche gravi o anafilattiche oppure anamnesi di
    ipersensibilità a BIIB054 o a qualunque ingrediente inattivo nel prodotto farmacologico
    oppure ai radioligandi o allo iodio utilizzati nello studio.
    - Partecipazione a qualunque studio di immunoterapia attiva mirato all’alfa sinucleina.
    - Uso dei farmaci permessi non specificato precedentemente a dosi che non sono rimaste
    stabili per almeno 8 settimane prima del Giorno 1 e/o che non si prevede che rimangano
    stabili per la durata dello studio.
    - Valori degli esami di laboratorio con anomalie clinicamente significative, secondo lo
    sperimentatore, al momento dello screening.
    - Donazione di sangue (1 unità o più) nelle 8 settimane precedenti il Giorno 1 (bisogna,
    inoltre, evitare di donare il sangue per la durata dello studio).
    E.4Principal exclusion criteria
    - Presence of freezing of gait.
    - Montreal cognitive assessment (MOCA) score <23 or other significant cognitive
    impairment or clinical dementia that, in the opinion of the Investigator, would
    interfere with study evaluation.
    - History of or screening brain magnetic resonance imaging (MRI) scan indicative of
    clinically significant abnormality, as read by central reader.
    - History of severe allergic or anaphylactic reactions, or history of hypersensitivity
    to BIIB054 or any of the inactive ingredients in the drug product or to radioligands or
    iodine used in the study.
    - Participation in any active immunotherapy study targeting alpha-synuclein.
    - Use of allowed medications not previously specified at doses that have not been stable
    for at least 8 weeks before Day 1, and/or that are not expected to remain stable for the
    duration of the study.
    - Clinically significant abnormal laboratory test values at Screening, as determined by
    the Investigator.
    - Blood donation (1 unit or more) within 8 weeks before Day 1 (must also refrain from
    donating blood for the duration of the study).
    - Presenza di congelamento dell’andatura.
    - Punteggio Montreal cognitive assessment (MOCA) < 23 o altro deterioramento cognitivo
    significativo o demenza clinica che, secondo lo sperimentatore, interferirebbe con la
    valutazione dello studio.
    - Anamnesi di o risonanza magnetica del cervello allo screening indicativa di
    un’anomalia clinicamente rilevante, in base alla lettura avvenuta a livello centrale.
    - Anamnesi di reazioni allergiche gravi o anafilattiche oppure anamnesi di
    ipersensibilità a BIIB054 o a qualunque ingrediente inattivo nel prodotto farmacologico
    oppure ai radioligandi o allo iodio utilizzati nello studio.
    - Partecipazione a qualunque studio di immunoterapia attiva mirato all’alfa sinucleina.
    - Uso dei farmaci permessi non specificato precedentemente a dosi che non sono rimaste
    stabili per almeno 8 settimane prima del Giorno 1 e/o che non si prevede che rimangano
    stabili per la durata dello studio.
    - Valori degli esami di laboratorio con anomalie clinicamente significative, secondo lo
    sperimentatore, al momento dello screening.
    - Donazione di sangue (1 unità o più) nelle 8 settimane precedenti il Giorno 1 (bisogna,
    inoltre, evitare di donare il sangue per la durata dello studio).
    E.5 End points
    E.5.1Primary end point(s)
    - Percentage of Participants With Adverse Event (AEs) and Serious Adverse Event (SAEs)
    - Percentuale dei partecipanti con eventi avversi (AE) ed eventi avversi seri (SAE).
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Basale, Settimana 52
    - Basale e fino a Settimana 144
    - Basale e fino a Settimana 144
    - Basale, Settimana 52
    - Basale e fino a Settimana 144
    - Basale e fino a Settimana 144
    E.5.2Secondary end point(s)
    - Change in Striatal Binding Ratio (SBR) in Putamen,Striatum, and Caudate as Measured by Striatal-Photon Emission Computed Tomography (SPECT) Imaging of the Dopamine Transporter With Ioflupane I123 (DaTscan¿) - Concentration of BIIB054 in the Serum - Percentage of Participants With Anti-BIIB054 Antibodies in the Serum
    - Variazione nel rapporto di legame striatale (SBR) nel putamen, nello striato e nel caudato, misurato mediante esame di diagnostica per immagini dello striato con tomografia computerizzata a emissione di fotone singolo (SPECT) del trasportatore della dopamina (DaT) con 123I-ioflupano (DaTscan¿).
    - Concentrazione sierica di BIIB054
    - Percentuale di partecipanti con anticorpi anti-BIIB054 nel siero
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Baseline, Week 52
    - Baseline and at multiple time points (up to 2 years)
    - Baseline and at multiple time points (up to 2 years)
    - Basale, Settimana 52
    - Basale e in punti temporali multipli (fino a 2 anni)
    - Basale e in punti temporali multipli (fino a 2 anni)
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 trial4
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    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
    Australia
    Canada
    Israel
    United States
    France
    Germany
    Italy
    Spain
    Sweden
    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 study will end when the last subject in the study has completed the Final Visit at
    the end of Year 2, 12 weeks after administration of the last dose at Week 96.
    Lo studio terminerà quando l'ultimo soggetto nello studio avrà completato la visita
    finale alla fine del secondo anno, 12 settimane dopo la somministrazione dell'ultima
    dose alla settimana 96.
    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 months8
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days20
    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: 31
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 280
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 149
    F.4.2.2In the whole clinical trial 311
    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)
    Subjects who complete the Week 48 Visit and do not discontinue study drug treatment may be offered the option to enter an extension study, under a separate protocol, provided they meet all eligibility criteria for that study.
    Ai soggetti che completano la visita alla Settimana48 e non sono stati discontinuati dal trattamento potrebbe veire offerto la possibilit¿ di entrare in uno studio di estensione, sotto un protocollo separato, se soddisfano tutti i criteri di eligibilt¿ per quello studio
    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 Decision2018-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-22
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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