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    Summary
    EudraCT Number:2020-003265-19
    Sponsor's Protocol Code Number:PD0053
    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:2021-06-07
    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 number2020-003265-19
    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
    Studio di fase 2a, randomizato, in doppio cieco, controllato con placebo, della durata di 18 mesi, per valutare l’efficacia, la sicurezza, la tollerabilità e la farmacocinetica di UCB0599 somministrato per via orale nei partecipanti allo studio con malattia di Parkinson allo stadio iniziale
    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
    Studio di 18 mesi, per valutare l’efficacia, la sicurezza, la tollerabilità e la farmacocinetica di UCB0599 nei partecipanti allo studio con malattia di Parkinson allo stadio iniziale
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    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 Trail 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 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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name DaTSCAN
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameDaTSCAN
    D.3.2Product code [DaTSCAN]
    D.3.4Pharmaceutical form Solution for injection
    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 INNIODIO IOFLUPANO-123I
    D.3.9.2Current sponsor codeDaTSCAN
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number74
    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 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 Yes
    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
    Malattia di Parkinson allo stadio iniziale
    E.1.1.1Medical condition in easily understood language
    Early-stage Parkinson's disease
    Malattia di Parkinson allo stadio iniziale
    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)
    Valutare la sicurezza e la tollerabilità di UCB0599 e dimostrare la superiorità di UCB0599 rispetto al placebo in termini di sintomi clinici di progressione della malattia nell’arco di 12 e 18 mesi nei partecipanti con diagnosi di malattia di Parkinson (MP) allo stadio iniziale
    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
    - Dimostrare la superiorità di UCB0599 rispetto al placebo in termini di neurodegenerazione dei neuroni dopaminergici nell’arco di 12 e 18 mesi nei partecipanti con diagnosi di MP allo stadio iniziale
    - Valutare l’effetto di UCB0599 rispetto al placebo per quanto concerne l’assunzione del trattamento sintomatico (TS) nell’arco di 18 mesi nei partecipanti con diagnosi di MP allo stadio iniziale
    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 ofsigning 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 clear family history of autosomal-dominant forms of PD or confirmation of such mutations by genetic testing. Historical genetic testing information will be considered but is not required and will not be conducted for Screening purposes
    - 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
    - Il partecipante allo studio deve avere un’età compresa tra più di 40 e massimo 70 anni compiuti al momento della firma del consenso informato.
    - Il partecipante allo studio è affetto da malattia di Parkinson (MP), con una diagnosi realizzata da un neurologo secondo i criteri del 2015 della Società per i disturbi del movimento entro 2 anni dalla Visita basale.
    - Dovranno essere soddisfatti i seguenti criteri diagnostici: bradicinesia E almeno UNO dei seguenti: rigidità muscolare o tremore a riposo.
    - Risultato alla diagnostica per immagini allo screening del trasportatore della dopamina valutato mediante tomografia computerizzata a emissione di fotone singolo (Dopamine Transporter Imaging with Single Photon Emission Computed Tomography, DaT-SPECT) in linea con la MP come determinato da un lettore centrale.
    - Il partecipante allo studio non presenta un’anamnesi familiare chiara di forme autosomiche dominanti di MP o una conferma di tali mutazioni mediante test genetici.
    Le informazioni storiche sui test genetici saranno prese in considerazione ma non sono richieste o non saranno condotte a scopo di screening.
    - Il partecipante allo studio si trova nello stadio =2 della scala modificata di Hoehn e Yahr allo screening.
    - Il partecipante allo studio non ha mai assunto farmaci per il trattamento dei sintomi motori della MP e, con un’elevata probabilità, non si prevede che richieda l’avvio di un trattamento sintomatico (TS) nei prossimi 6 mesi, per quanto consentito dal giudizio clinico.
    - Il partecipante allo studio non ha mai preso parte a studi di trattamento modificanti la malattia diretti alle malattie neurodegenerative (Neurodegenerative Disease, NND).
    - Il partecipante allo studio è disponibile, competente e in grado di rispettare tutti gli aspetti del protocollo, inclusi il programma di follow-up e la raccolta di campioni biologici.
    - Un partecipante di sesso maschile deve accettare di utilizzare la contraccezione durante il Periodo di trattamento e per almeno 90 giorni dopo l’ultima dose di farmaco dello studio e astenersi dal donare sperma durante questo periodo.
    - Una partecipante di sesso femminile è idonea a partecipare se non è in gravidanza, se non sta allattando al seno e se è compatibile con almeno una delle seguenti condizioni:
    (i) Non è una donna in età fertile (Woman of childbearing potential, WOCBP)
    OPPURE
    È una WOCBP che accetta di seguire le linee guida in materia di contraccezione durante il periodo di trattamento e per almeno 1 mese dopo l’ultima dose del farmaco dello studio. La partecipante allo studio deve avere un test di gravidanza sul siero negativo allo screening (Visita 1), che deve essere confermato come negativo mediante il test sulle urine prima della prima dose di farmaco dello studio al Basale (Visita 3). Se vengono utilizzati contraccettivi per via orale, nel corso dello studio si dovrà far uso anche di un metodo di barriera aggiuntivo.
    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
    - Il partecipante allo studio presenta un’ipersensibilità nota a qualsiasi componente (e/o ai suoi eccipienti) del farmaco dello studio o dei farmaci comparativi come indicato nel protocollo.
    - Il partecipante allo studio è stato sottoposto allo screening a una risonanza magnetica (RM) cerebrale che ha indicato un’anomalia clinicamente significativa o a una scansione RM storica durante i 6 mesi prima della Visita di screening 1 di qualità sufficiente per mostrare tali anomalie. In caso di dubbi, la significatività viene determinata caso per caso in stretta collaborazione con il medical monitor e non dovrà includere anomalie quali atrofia cerebrale associata all’età, minore con segnali associati alla materia, o vasculopatia lieve.
    - Il partecipante allo studio presenta qualsiasi controindicazione per la RM cerebrale o la diagnostica per immagini del trasportatore della dopamina valutato mediante tomografia computerizzata a emissione di fotone singolo (DaT-SPECT).
    - Il partecipante allo studio ha un punteggio alla Montreal Cognitive Assessment (MoCA) minore di 23, indicante una compromissione cognitiva lieve o altra compromissione cognitiva significativa o demenza clinica allo screening che, a giudizio dello sperimentatore, interferirebbe con la valutazione dello studio.
    - Il partecipante allo studio presenta anomalie nel tratto lombare della colonna vertebrale già note o determinate mediante una radiografia lombare di screening (se condotta) che potrebbero precludere la puntura lombare, a giudizio dello sperimentatore.
    - Il partecipante allo studio presenta un’anomalia clinicamente significativa all’elettrocardiogramma (ECG) allo screening, a giudizio dello sperimentatore.
    - Il partecipante allo studio ha un’anamnesi precedente di uso di farmaci per il trattamento dei sintomi motori della MP (ad eccezione dei brevi test farmacologici per la conferma della diagnosi) o farmaci con un potenziale effetto modificante la malattia PD.
    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. Punteggio Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-IIIsum
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: From Baseline up to 18 Months
    1: Dal Basale fino a 18 Mesi
    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. Sub-scala MDS-UPDRS Parte III
    2. Sub-scala MDS-UPDRS Parte II
    3. Sub-scala MDS-UPDRS Parte I
    4. Tempo al peggioramento della malattia sulla scala MDS-UPDRS Parte III
    5. Variazione del punteggio alla Montreal Cognitive Assessment (MoCA)
    6. Variazione nella diagnostica per immagini del trasportatore della dopamina valutato mediante tomografia computerizzata a emissione di fotone singolo (DaT-SPECT) relativamente al rapporto medio del legame specifico nel corpo striato (Striatum-specific Binding Ratio, SBR)
    7. Tempo all’inizio del trattamento sintomatico (TS)
    8. Assunzione del trattamento sintomatico
    9. Incidenza di eventi avversi emergenti dal trattamento (Treatment-Emergent Adverse Event, TEAE)
    10. Incidenza di eventi avversi seri (Serious Adverse Event, SAE)
    11. Incidenza di TEAE che portano al ritiro del partecipante
    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: Dal Basale fino a 18 Mesi
    5+6: Dallo Screening fino a 18 Mesi
    10: Dallo Screening fino a 19 Mesi
    9+11: Dal Basale fino a 18 Mesi
    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
    Tollerabilità
    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 concerned3
    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 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
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months1
    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 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 state13
    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).
    I partecipanti allo studio che completano il periodo di trattamento avranno l'opportunità di passare in uno studio di estensione in aperto (OLE) (PD055).
    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 Opinion2021-07-15
    P. End of Trial
    P.End of Trial StatusOngoing
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