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    Summary
    EudraCT Number:2017-000087-15
    Sponsor's Protocol Code Number:BP39529
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2017-05-17
    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 number2017-000087-15
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015/PRASINEZUMAB (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE WITH A 6-YEAR ALL-PARTICIPANTSON-TREATMENT EXTENSION (PASADENA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants with Early Parkinson's Disease with A 6-Year all- Participants-on-Treatment Extension (Pasadena)
    A.4.1Sponsor's protocol code numberBP39529
    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.
    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.5.6E-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/PRASINEZUMAB
    D.3.4Pharmaceutical form Concentrate for 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 INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeRO7046015
    D.3.9.3Other descriptive namePRX002, ELT2, anti-alpha-synuclein monoclonal antibody
    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 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 placeboConcentrate and solvent for solution 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
    E.1.1.1Medical condition in easily understood language
    Parkinson's disease is a progressive disorder of the nervous system that affects movement
    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 RO7046015 versus placebo at Week 52, in participants with early Parkinson's disease (PD) (H&Y Stages I-II) who are untreated or treated with monoamine oxidase-B (MAO-B) inhibitors since baseline, as measured by change from baseline on the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Total Score (sum of Parts I, II and III)
    E.2.2Secondary objectives of the trial
    • To evaluate the effects of RO7046015 versus placebo at Week 52, in participants with early PD (H&Y Stages I - II) who are untreated or treated with MAO-B inhibitors since baseline on the following:
    - MDS-UPDRS Parts IA, IB, I- III total and Part III sub scores
    - DaT-SPECT change in the ipsilateral (to the clinically-dominant side)putamen
    - MoCA total score
    - CGI-I
    - PGIC
    - SE-ADL score
    - Time to worsening in motor or non-motor symptoms
    - Time to start of dopaminergic PD treatment (levodopa or dopamine agonists)
    - Safety and tolerability of RO7046015.
    ● To evaluate the safety and tolerability of treatment with RO7046015 for up to 104 weeks plus the 12-week treatment-free follow-up (Part 2) and up to Part 3 Week 260 plus the 12-week treatment-free follow-up, with or without concomitant dopaminergic treatment.
    - To evaluate the immunogenicity of RO7046015.
    - To describe pharmacokinetics (PK) of RO7046015 using population PK modelling
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Idiopathic PD with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity) being present, without any other known or suspected cause of PD untreated or treated with MAO-B inhibitor
    - Male or female, 40 to 80 years of age, body weight range of >=45 kg/99 lbs to =< 110 kg/242 lbs and a body mass index (BMI) of 18 to 34 kg/m2
    - A diagnosis of PD for 2 years or less at screening
    - H&Y Stage I or II.
    - A screening brain Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) consistent with PD (central reading)
    - Clinical status does not require dopaminergic PD medication and is not expected to require dopaminergic treatment within 52 weeks from baseline
    - If presently being treated for PD, a stable dose of MAO-B inhibitor (rasagiline
    or selegiline) for at least 90 days prior to baseline and not expected to change within 52 weeks
    - For women of childbearing potential: use of highly effective contraceptive methods (that result in a failure rate of <1% per year) during the treatment period and for at least 30 days (or longer if required by local regulations) after the last dose of study drug
    - For men: use of contraceptive measures as defined below:
    With female partners of childbearing potential or pregnant female partners, men must use a condom during the treatment period and for at least 30 days (or longer if required by local regulations) after the last dose of study drug to avoid exposing the embryo. Men must refrain from donating sperm during this same period. The female partners should use a contraception method with a failure rate of <1% per year during the treatment period and for at least 30 days (or longer if required by local regulations) after the last dose of study drug.

    Note: Use of contraceptive measures is not required for male participants enrolled in Part 3.
    E.4Principal exclusion criteria
    Current or Past Medical History:
    - Medical history indicating a Parkinson syndrome other than idiopathic PD, including but not limited to, progressive supranuclear gaze palsy, multiple system atrophy, drug-induced parkinsonism, essential tremor, primary dystonia.
    - Known carriers of certain familial PD genes (Parkin, PINK1, DJ1) (GBA, synuclein, LRRK2 mutation carriers are allowed).
    - History of PD related freezing episodes or falls.
    - A diagnosis of a significant CNS disease other than Parkinson’s disease; history of repeated head injury; history of epilepsy or seizure disorder other than febrile seizures as a child.
    - Mini Mental State Examination (MMSE) =< 25
    - Reside in a nursing home or assisted care facility.
    - History of or screening brain MRI scan indicative of clinically significant abnormality
    - Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study or interfere with the participant’s ability to comply with study procedures or abide by study restrictions, or with the ability to interpret safety data:
    - Autoimmune disease
    - A history of cancer
    - Any active infectious disease at Baseline.
    - Current, or history of, alcohol or drug abuse or other dependence
    - Any febrile illness
    - Any current psychiatric diagnosis
    - The following cardiovascular conditions:
    - Myocardial infarction within 12 months of baseline
    - Uncontrolled hypotension or bradycardia
    - Confirmed hypotension
    - Uncontrolled hypertension:
    - Resting pulse rate (PR) greater than 100 or less than 45 bpm.
    - Clinically significant cardiovascular disease
    - Clinically significant abnormalities in lab tests results
    - Lactating women
    Medications and treatments:
    - Prior treatment with dopaminergic medication (e.g., levodopa or a dopaminergic agonist) with no clinical treatment response or a clinical treatment response inconsistent with PD.
    - Use of any of the following: catechol-O-methyl transferase (COMT) inhibitors (entacapone, tolcapone), amantadine or anticholinergics, or dopaminergic medication (levodopa and both ergot and non-ergot [pramipexole, ropinirole, rotigotine] dopamine agonists) for more than a total of 60 days or within 60 days of baseline.
    - Anti-epileptic medication for non seizure related treatment which has not remained stable for at least 60 days prior to baseline
    - Anti-depressant or anxiolytic use that has not remained stable for at least 90 days prior to baseline
    - Use of any of the following medication within 90 days prior to baseline;
    antipsychotics (including clozapine and olanzapine), metoclopramide,
    alpha methyldopa, flunarizine, amoxapine, amphetamine derivatives,
    reserpine, bupropion, buspirone, cocaine, mazindol, methamphetamine,
    methylphenidate, norephedrine, phentermine, phenylpropanolamine,
    and modafinil.
    - Participated in an investigational drug, device, surgical, or stem cell
    study in PD
    - Any prior treatment with an investigational PD-related vaccinevaccine
    (including active immunization or passive immunotherapy with
    monoclonal antibodies).
    - Prior participation in any RO7046015 or PRX002 study.
    - Receipt of any non-PD investigational product or device, or participation in a
    drug research study within a period of 30 days (or 5 half-lives of the
    drug, whichever is longer) before baseline
    - Receipt of any monoclonal antibody or an investigational
    immunomodulator within 180 days (or 5 half-lives, whichever is longer)
    before baseline
    - Immunomodulating drugs within 30 days prior to baseline
    - Allergy to any of the components of RO7046015 or a known
    hypersensitivity or an IRR to the administration of any other monoclonal
    antibody

    Procedural
    - Any contraindications to obtaining a brain MRI
    - For participants consenting to provide optional CSF samples by lumbar puncture (LP): LP will only be performed if the participant does not have any contraindication to undergoing an LP
    - For skin biopsy at the cervical paravertebral region: Condition that either precludes the safe performance of the skin punch biopsy or may interfere with obtaining evaluable skin tissue biopsies
    - Donation of blood over 500 mL within three months prior to screening
    E.5 End points
    E.5.1Primary end point(s)
    Change in total MDS-UPDRS score (sum of Parts I, II and III) from baseline at Week 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and Week 52
    E.5.2Secondary end point(s)
    1.Change from baseline in MDS-UPDRS Part IA, Part IB, Part I total, Part II total, Part III total and Part III subscores.
    2.Change from baseline in DaT-SPECT in ipsilateral (to the clinically dominant side) putamen binding ratio values.
    3.Change from baseline in MoCA total score.
    4.Change from baseline in Clinical Global Impression of Improvement (CGI-I).
    5.Change from baseline in Patient Global Impression of Change (PGIC).
    6.Change from baseline in Schwab and England Activities of Daily Living (SE-ADL).
    7.Time to worsening of motor or non-motor symptoms as measured by MDS-UPDRS.
    8.Time to start of dopaminergic PD treatment (levodopa or dopamine agonists).
    9. Incidence and severity of adverse events (AEs) and serious AEs (SAEs).
    10.Incidence of Anti-drug antibodies (ADAs).
    11.Population and individual primary PK parameter estimations.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-8.Baseline and Week 52.
    9.Up to Week 104 plus the 12-week treatment-free follow-up (Part 2)
    and up to Part 3 Week 260 plus the 12-week treatment-free follow-up
    10.Baseline, Week 4, 20, 36, 52, 56, 68, 80 and Week 104 plus the 12-
    week treatment-free follow-up, Part 3 Week 1, Week 24, Week 52, Week
    80, Week 104, Week 132, Week 156, Week 184, Week 208, Week 236
    and Week 260 plus the 12-week treatment-free follow-up.
    11.Day 7, Day 14, Weeks 4, 20, 36, 52, 56, 68, 80 and 104 plus the 12-
    week treatment-free follow-up, Part 3 Week 1, Week 24, Week 52, Week
    80, Week 104, Week 132, Week 156, Week 184, Week 208, Week 236
    and Week 260 plus the 12-week treatment-free follow-up.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    -Evaluate the immunogenicity of RO7046015
    - To evaluate clinical and biomarker outcomes
    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 trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Austria
    France
    Germany
    Spain
    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 end of the study is defined as the date when the last participant last observation (LPLO) occurs at the follow-up visit. LPLO is expected to occur approximately 388 weeks after the last participant is enrolled, or earlier in the case that the study is discontinued following any of the planned interim analyses.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months5
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 300
    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)
    The Sponsor will offer continued access to study drug (RO7046015)
    free of charge to eligible patients in accordance with the Roche Global
    Policy on Continued Access to Investigational Medicinal Product, as
    outlined in Section 4.4.4 of the Protocol.
    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 Decision2017-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-21
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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