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    Summary
    EudraCT Number:2020-003265-19
    Sponsor's Protocol Code Number:PD0053
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-12-04
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-003265-19
    A.3Full title of the trial
    A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson’s Disease
    Étude de phase 2a d’une durée de 18 mois, randomisée, menée en double insu, contrôlée contre placebo, permettant d’évaluer l'efficacité, la tolérance, la sécurité d’emploi et la pharmacocinétique du traitement ucb0599 administré par voie orale chez des participants à l'étude atteints de maladie de parkinson de stade précoce
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 18-month study to evaluate the efficacy, safety, tolerability and pharmacokinetics of oral UCB0599 in study participants with early-stage Parkinson’s Disease
    Étude de phase 2a, randomisée, en double insu, contrôlée contre placebo du traitement UCB0599 administré par voie orale chez des participants à l’étude atteints de maladie de Parkinson de stade précoce
    A.4.1Sponsor's protocol code numberPD0053
    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 SponsorUCB Biopharma SRL
    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 supportUCB Biopharma SRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.6E-mailclinicaltrials@ucb.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 nameUCB0599
    D.3.2Product code UCB0599
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1802518-92-8
    D.3.9.2Current sponsor codeUCB0599
    D.3.9.4EV Substance CodeSUB206499
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Early-stage Parkinson's disease
    Maladie de Parkinson de stade précoce
    E.1.1.1Medical condition in easily understood language
    Early-stage Parkinson's disease
    Maladie de Parkinson de stade précoce
    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
    Assess the safety and tolerability of UCB0599 and to demonstrate the superiority of UCB0599 over placebo with regard to clinical symptoms of disease progression over 12 and 18 months in participants diagnosed with early-stage Parkinson’s Disease (PD)
    Démontrer la supériorité de l’UCB0599 par rapport au placebo en ce qui concerne les symptômes cliniques de progression de la maladie sur 12 et 18 mois chez des participants ayant reçu un diagnostic de MP de stade précoce
    E.2.2Secondary objectives of the trial
    - Demonstrate the superiority of UCB0599 over placebo with regard to neurodegeneration of dopaminergic neurons over 12 and 18 months in participants diagnosed with early-stage PD
    - Assess the effect of UCB0599 vs placebo with regard to intake of symptomatic treatment (ST) over 18 months in participants diagnosed with early-stage PD
    -Démontrer la supériorité de l’UCB0599 par rapport au placebo en ce qui concerne la neurodégénérescence des neurones dopaminergiques sur 12 et 18 mois chez des participants ayant reçu un diagnostic de MP de stade précoce
    -Évaluer l’effet de l’UCB0599 par rapport au placebo en ce qui concerne la prise d’un TS sur 18 mois chez des participants ayant reçu un diagnostic de MP de stade précoce
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Study participant must be 40 to 70 years of age inclusive, at the time of signing the informed consent
    - Study participant has Parkinson’s Disease (PD), with a diagnosis made by a neurologist according to the 2015 Movement Disorder Society criteria within 2 years of Baseline Visit
    - The following diagnostic criteria must be met: bradykinesia AND at least ONE of the following: muscular rigidity, or resting tremor
    - A Screening Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) is consistent with PD as determined by a central reader
    - Study participant has no known personal or family history of autosomal-dominant forms of PD.
    - Study participant is in the ≤2 modified Hoehn and Yahr stage at Screening
    - Study participant has never taken medications for the treatment of motor symptoms of PD and is not expected to require starting symptomatic treatment (ST) with a high likelihood in the next 6 months as far as clinical judgement allows
    - Study participant has never taken part in disease-modifying treatment studies directed at neurodegenerative disease (NDD)
    - Study participant is willing, competent, and able to comply with all aspects of the protocol, including follow-up schedule and biospecimen collection
    - A male participant must agree to use contraception during the Treatment Period and for at least 90 days after the last dose of study medication and refrain from donating sperm during this period
    - A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
    (i) Not a woman of childbearing potential (WOCBP)
    OR
    A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 1 month after the last dose of study medication. The study participant must have a negative serum pregnancy test at Screening (Visit 1), which is to confirmed negative by urine testing prior to the first dose of study medication at Baseline (Visit 3). If oral contraception is used, an additional barrier method will be required during the study
    - L’âge du participant à l’étude doit être compris entre 40 à 70 ans inclus au moment de la signature du consentement éclairé
    - Le participant à l’étude doit présenter une MP, avec un diagnostic établi par un neurologue selon les critères de 2015 de la Movement Disorder Society dans les 2 ans précédant la visite d’entrée dans l’étude
    - Les critères de diagnostic suivants doivent être atteints : bradykinésie ET au moins l’UN des éléments suivants : rigidité musculaire ou tremblement au repos
    - Une DaT-SPECT effectuée lors de la période de sélection doit être en cohérence avec une MP, d’après l’avis de l’évaluateur du laboratoire central
    -Le participant à l’étude ne présente aucun antécédent personnel ou familial connu laissant supposer la présence de formes autosomiques dominantes de la MP.
    - Le participant à l’étude doit présenter un score ≤ 2 sur l’échelle de Hoehn et Yahr modifiée lors de la période de sélection
    - Le participant à l’étude doit être naïf de tout médicament destiné au traitement des symptômes moteurs de la MP et ne pas nécessiter, dans la limite du jugement clinique possible, l’instauration d’un TS dans les 6 prochains mois
    - Le participant à l’étude doit ne jamais avoir participé à des études portant sur un traitement dirigé contre les maladies neurodégénératives modifiant la maladie
    - Le participant à l’étude doit être disposé, motivé et capable de se conformer à tous les aspects du protocole, y compris le calendrier de suivi et le prélèvement d’échantillons biologiques
    - Le participant de sexe masculin doit accepter d’utiliser la méthode de contraception dépendant la période de traitement et pendant au moins 90 jours après la dernière dose du médicament à l’étude et s’abstenir de faire de don de sperme pendant cette période
    -La participante est éligible si elle n’est pas enceinte et n’allaite pas, et si elle remplit au moins l’une des conditions suivantes :
    ◦ N’est pas une femme en âge de procréer (FAP)
    OU
    Est une FAP qui accepte de suivre les recommandations en matière de contraception pendant la période de traitement et pendant au moins 1 mois après la dernière dose du médicament à l’étude. La participante à l’étude doit présenter un test de grossesse sérique négatif à la visite de sélection (Visite 1), qui doit être confirmé par un test urinaire négatif avant la première dose du médicament à l’étude (Visite 3). Si une contraception orale est utilisée, une méthode supplémentaire de type barrière sera requise pendant l’étude
    E.4Principal exclusion criteria
    - Study participant has a known hypersensitivity to any components (and/or its excipients) of the study medication or comparative drugs as stated in the protocol
    -Study participant has a brain magnetic resonance imaging (MRI) scan performed during Screening indicative of a clinically significant abnormality or a historical MRI scan during the 6 months before Screening Visit 1 of sufficient quality to show such abnormalities. In case of doubt, the significance is determined on a case-by-case basis in close collaboration with the Medical Monitor and should not include abnormalities like age-appropriate brain atrophy, minor white matter signals, or mild vasculopathy
    - Study participant has any contraindication for the brain MRI or Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) imaging
    - Study participant has a Montreal Cognitive Assessment (MoCA) score less than 23, indicating mild cognitive impairment or other significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation
    - Study participant has abnormalities in lumbar spine previously known or determined by a Screening lumbar x-ray (if conducted) that could preclude lumbar puncture, in the opinion of the Investigator
    - Study participant has clinically significant electrocardiogram (ECG) abnormality at Screening, in the opinion of the Investigator
    - Study participant has past history of use of medications for the treatment of motor symptoms of PD (with the exception of short pharmacological testing for confirmation of diagnosis) or drugs with a potential PD disease modifying effect
    - Le participant à l’étude présente une hypersensibilité connue à l’un quelconque des composants (et/ou à ses excipients) du médicament à l’étude ou des médicaments comparateurs indiqués dans le protocole
    - Le participant à l’étude disposant d’un cliché d’imagerie par résonance magnétique (IRM) du cerveau réalisé pendant la période de sélection qui indique une anomalie cliniquement significative ou disposant d’un cliché d’IRM obtenu au cours des 6 mois précédant la visite 1 de sélection dont la qualité est suffisante pour montrer de telles anomalies. En cas de doute, la significativité sera déterminée au cas par cas en étroite collaboration avec le moniteur médical et ne doit pas inclure d’anomalies telles qu’une atrophie cérébrale âge dépendante, des signaux mineurs concernant la substance blanche ou une vasculopathie légère
    - Le participant à l’étude présentant une contre-indication à la réalisation d’un IRM du cerveau ou à d’une imagerie DaT-SPECT
    - Le participant à l’étude présentant un score MoCA inférieur à 23 à l’évaluation MoCA, indiquant un trouble cognitif léger, un autre trouble cognitif significatif ou une démence cliniquement diagnostiquée à la sélection qui, selon l’opinion de l’investigateur, interfèrerait avec l’évaluation de l’étude
    - Le participant à l’étude présente des anomalies du rachis lombaire précédemment connues ou déterminées par une radiographie lombaire à la sélection (le cas échéant) qui pourraient empêcher une ponction lombaire, selon l’opinion de l’investigateur
    - Le participant à l’étude présentant une anomalie à l’ECG cliniquement significative à la sélection, selon l’opinion de l’investigateur
    - Le participant à l’étude présentant des antécédents d’utilisation de médicaments pour le traitement des symptômes moteurs de la MP (à l’exception des analyses pharmacologiques succinctes pour la confirmation du diagnostic) ou de médicaments présentant un effet potentiel modificateur de la MP
    E.5 End points
    E.5.1Primary end point(s)
    1. Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-IIIsum score
    1 Score total aux parties I à III de l’échelle MDS-UPDRS
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: From Baseline up to 18 Months
    1. de la référence à 18 mois
    E.5.2Secondary end point(s)
    1. MDS-UPDRS Part III subscale
    2. MDS-UPDRS Part II subscale
    3. MDS-UPDRS Part I subscale
    4. Time to worsening of the disease on MDS-UPDRS Part III scale
    5. Change in Montreal Cognitive Assessment (MoCA)
    6. Change in Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) mean striatum specific binding ratios (SBR)
    7. Time to start of symptomatic treatment (ST)
    8. Symptomatic treatment intake
    9. Incidence of treatment-emergent adverse events (TEAEs)
    10. Incidence of serious adverse events (SAEs)
    11. Incidence of TEAEs leading to participant withdrawal
    1. Sous-échelle de la partie III de l’échelle MDS-UPDRS
    2. Sous-échelle de la partie II de l’échelle MDS-UPDRS
    3. Sous-échelle de la partie I de l’échelle MDS-UPDRS
    4. Délai écoulé jusqu’à apparition d’une aggravation de la maladie
    5. Variation par rapport à la valeur de référence de l’évaluation MoCA
    6. Variation du rapport de liaison spécifique (SBR) moyen dans le striatum à l’imagerie DaT-SPECT
    7. Délai écoulé jusqu’au début du traitement symptomatique (TS)
    8. Prise d’un TS
    9. Incidence des EIET
    10. Incidence des EIG
    11. Incidence des EIET entraînant le retrait du participant
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4+7+8: From Baseline up to 18 Months
    5+6: From Screening up to 18 Months
    10: From Screening up to 19 Months
    9+11: From Baseline up to 19 Months
    1-4+7+8: de la référence à 18 mois
    5+6: de la sélection à 18 mois
    10: de la sélection à 19 mois
    9+11: de la référence à 19 mois
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Canada
    United States
    France
    Germany
    Italy
    Netherlands
    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
    LVLS
    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 months5
    E.8.9.1In the Member State concerned days7
    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 days22
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 169
    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)
    Study participants who complete the Treatment Period will have the option to transition into an open label extension (OLE) study (PD0055).
    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 Decision2021-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-09
    P. End of Trial
    P.End of Trial StatusOngoing
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