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    Summary
    EudraCT Number:2018-003206-58
    Sponsor's Protocol Code Number:CNTO1959PSO3013
    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:2021-06-15
    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 number2018-003206-58
    A.3Full title of the trial
    A Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis
    Uno studio di fase 3b, multicentrico, interventistico, randomizzato, controllato con placebo che valuta l’efficacia e la sicurezza di guselkumab per il trattamento della psoriasi non pustolosa palmoplantare
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar Psoriasis
    Uno studio per valuta l’efficacia e la sicurezza di guselkumab per il trattamento della psoriasi non pustolosa palmoplantare
    A.3.2Name or abbreviated title of the trial where available
    G-PLUS
    G-PLUS
    A.4.1Sponsor's protocol code numberCNTO1959PSO3013
    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 SponsorJANSSEN CILAG INTERNATIONAL NV
    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 supportJanssen Pharmaceutica NV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Biologics B.V.
    B.5.2Functional name of contact pointClinical Registry group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031715242166
    B.5.5Fax number0031715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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.2.1.1.1Trade name TREMFYA
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameGUSELKUMAB
    D.3.2Product code [CNTO1959]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGUSELKUMAB
    D.3.9.1CAS number 1350289-85-8
    D.3.9.2Current sponsor codeCNTO1959
    D.3.9.3Other descriptive nameGUSELKUMAB
    D.3.9.4EV Substance CodeSUB179789
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 typeANTICORPO MONOCLONALE
    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
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Palmoplantar non-Pustular Psoriasis
    Psoriasi non pustolosa palmoplantare
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    Psoriasi
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue 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 guselkumab for the treatment of palmoplantar psoriasis
    Valutare l’efficacia di guselkumab nel trattamento della psoriasi palmoplantare
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of guselkumab in improving work productivity and limitations in participants with palmoplantar psoriasis.
    •To evaluate the efficacy of guselkumab in improving clinician assessments and disease related patient-reported quality-of-life measures in participants with palmoplantar psoriasis.
    •To evaluate the efficacy, patient-reported quality-of-life assessments and other scores in the placebo-crossover group at different time points.
    •To evaluate the efficacy, quality-of-life assessments and other scores in the placebo-crossover group at different time points.
    •To evaluate the efficacy of guselkumab in improving work productivity and limitations in participants with palmoplantar psoriasis.
    •To evaluate safety of guselkumab in participants with palmoplantar psoriasis.
    - Valutare l’efficacia di guselkumab nel migliorare la produttività e le limitazioni sul lavoro nei partecipanti con psoriasi palmoplantare
    -Valutare l'efficacia di guselkumab nel miglioramento delle valutazioni cliniche e delle misure relative alla qualità della vita riportate dai pazienti in relazione alla malattia nei partecipanti con psoriasi palmoplantare.
    - Valutare l'efficacia, le valutazioni della qualità della vita riportate dal paziente e altri punteggi nel gruppo placebo-crossover in diversi punti temporali.
    - Valutare efficacia, considerazioni sulla qualità della vita e altri punteggi nel gruppo crossover placebo in diversi momenti temporali
    - Valutare l'efficacia di guselkumab nel migliorare la produttività del lavoro e le limitazioni nei partecipanti con psoriasi palmoplantare
    - Valutare la sicurezza di guselkumab nei partecipanti con psoriasi palmoplantare
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participant population-related inclusion criteria
    1. Male or female =18 years of age.
    2. Should have a confirmed diagnosis of moderate-to-severe palmoplantar non-pustular psoriasis with palm and/or sole involvement and at least 1 plaque at a body site other than the palms, and soles for at last 6 months, to confirm a diagnosis of chronic of psoriasis.
    -PASI score =3 and <10 at screening and at baseline
    -ppIGA score =3 at screening and at baseline
    3. Should be eligible to receive biological treatments; only participants who are naive to biological treatments can be included.
    4. Willing to participate in the study.
    Reproduction-related inclusion criteria
    5. Before the first administration of guselkumab, a woman must be either:
    • Not of childbearing potential
    • Of childbearing potential and practicing a highly effective method of contraception
    • User-dependent methods of contraception: combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, and transdermal; progestogenonly hormone contraception associated with inhibition of ovulation: oral and injectable
    • Agree to remain on a highly effective method throughout the study and for at least 12 weeks after the last dose of study intervention.
    6. A woman of childbearing potential must have a negative urine pregnancy test at Week 0.
    7. A woman must agree not to donate eggs for the purposes of assisted reproduction from the first administration of study intervention through at least 12 weeks after receiving the last administration of guselkumab.
    8. A man who is sexually active with a woman of childbearing potential and who has not had a vasectomy must agree to use a barrier method of birth control, during the study and for at least 12 weeks after receiving the last administration of study intervention. All men must also agree to not donate sperm during the study and for at least 12 weeks after receiving the last administration of study intervention.
    Infectious disease-related inclusion criteria
    9. Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention.
    10. Agree not to receive a BCG vaccination during the study, and within 12 months after the last administration of study intervention.
    For full inclusion criteria, refer page number 21 to 24 of the protocol
    Criteri di inclusione
    Criteri di inclusione correlati alla popolazione di partecipanti
    1. Uomo o donna di età pari o superiore a 18 anni.
    2. Diagnosi confermata di psoriasi non pustolosa palmoplantare da moderata a grave con coinvolgimento della palma e / o della suola e almeno 1 placca in un sito del corpo diverso dai palmi e suole per almeno 6 mesi, per confermare una diagnosi di cronica della psoriasi.
    -PASI punteggio =3 e <10 allo screening e al basale
    -ppIGA punteggio =3 allo screening e al basale
    3. Idoneità a ricevere trattamenti biologici; solo i partecipanti naive ai trattamenti biologici possono essere inclusi.
    4. Intenzione di partecipare allo studio.
    Criteri di inclusione correlati alla riproduzione
    5. Prima della prima somministrazione di guselkumab, le donne devono rientrare in uno dei seguenti casi:
    ¿ Donne non potenzialmente fertili
    ¿ Donne potenzialmente fertili che utilizzano un metodo contraccettivo altamente efficace
    ¿ Metodi contraccettivi : contraccezione ormonale combinata (contenente estrogeni e progestinici) associata all'inibizione dell'ovulazione: orale, intravaginale e transdermica; contraccezione ormonale progestinica associata a inibizione dell'ovulazione: orale e iniettabile
    ¿ Consenso all’utilizzo di un metodo contraccettivo altamente efficace per l'intera durata dello studio e per almeno 12 settimane dopo l'ultima dose dell’intervento sperimentale.
    6. Le donne in età fertile devono sottoporsi a un test di gravidanza sulle urine alla settimana 0 con esito negativo.
    7. Le donne devono accettare di non donare ovuli (ovuli, ovociti) per scopi di riproduzione assistita dalla prima somministrazione dell’intervento dello studio fino ad almeno 12 settimane dopo l’ultima somministrazione di guselkumab.
    8. Gli uomini sessualmente attivi con donne potenzialmente fertili e che non sono stati sottoposti a vasectomia devono acconsentire a usare un metodo contraccettivo di barriera
    9. Consenso a non ricevere vaccinazioni con virus o batteri vivi durante lo studio o nelle 12 settimane successive all'ultima somministrazione dell’intervento dello studio. Per il vaccino Bacillus Calmette-Guerin (BCG), vedere criterio 11.
    10. Consenso a non ricevere un vaccino BCG durante lo studio e nei 12 mesi successivi all'ultima somministrazione dell’intervento dello studio
    Per la lista completa dei criteri di inclusione si prega di far riferimento alle pagine da 21 a 24 del protocollo di studio.
    E.4Principal exclusion criteria
    Medical history-related exclusion criteria
    1. Currently has palmoplantar pustulosis, pustular psoriasis, or any other forms other than plaque-type psoriasis, or hyperkeratotic eczema.
    2. Has current drug-induced psoriasis.
    3. Has had major surgery within 8 weeks before screening, or will not have fully recovered from such surgery, or has such surgery planned during the time the participant is expected to participate in the study.
    4. Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
    5. Is pregnant, nursing, or planning a pregnancy while enrolled in this study, and for at least 12 weeks after the last administration of study intervention.
    Concomitant or previous medical therapies-related exclusion criteria
    6. Has used topical anti-psoriatic medications/treatments that could affect efficacy evaluations within 2 weeks of the planned first administration of study intervention.
    7. Has received prior treatment with biological agents for palmoplantar-non-pustular psoriasis.
    8. Has had prior exposure, known and reported intolerance to guselkumab or excipients, or ineligible to treatment with biological agents.
    10. Has previously MTX within 2 weeks, or Disease Modifying Anti Rheumatic Drugs , including cyclosporin, fumarates and Psoralen UVA.
    For full exclusion criteria, refer page number 24 to 27 of the protocol
    I potenziali partecipanti in possesso di uno qualsiasi dei criteri seguenti saranno esclusi dalla partecipazione allo studio:
    Criteri di esclusione legati all’anamnesi medica
    1. pustolosi palmoplantare, psoriasi pustolosa o qualsiasi altra forma diversa dalla psoriasi a placche o eczema ipercheratotico
    2. Psoriasi indotta da farmaci (ad es. una nuova manifestazione di psoriasi o una esacerbazione della psoriasi da betabloccanti, bloccanti dei canali del calcio o litio) in atto.
    3. Intervento chirurgico maggiore (che ha richiesto ad es. anestesia generale e ricovero in ospedale) entro le 8 settimane precedenti allo screening, mancata remissione completa dall’intervento chirurgico o intervento chirurgico in programma durante il periodo in cui è prevista la partecipazione allo studio.
    Nota: i soggetti con procedure chirurgiche programmate da effettuarsi in anestesia locale possono partecipare.
    4. Storia oppure segni o sintomi in atto di disturbi renali, cardiaci, vascolari, polmonari, gastrointestinali, endocrini, neurologici, ematologici, reumatologici, psichiatrici o metabolici giudicati gravi, progressivi o incontrollati.
    5. Stato di gravidanza o allattamento o sta pianificando una gravidanza durante la partecipazione a questo studio e per almeno 12 settimane dopo l'ultima somministrazione dell'intervento di studio.
    Criteri di esclusione correlati a terapie mediche concomitanti o precedenti
    6. Ha utilizzato farmaci / trattamenti antipsoriatici topici che potrebbero influenzare le valutazioni di efficacia entro 2 settimane dalla prima somministrazione prevista dell'intervento.
    7. Precedente trattamento con agenti biologici per psoriasi non pustolosa palmoplantare.
    8. Precedente esposizione, intolleranza nota e riferita a guselkumab o relativi eccipienti oppure mancata idoneità al trattamento con agenti biologici.
    10. Assunzione di MTX entro 2 settimane o farmaci anti reumatici modificanti la malattia, tra cui ciclosporina, fumarati e Psoralen UVA.
    Per la lista completa dei criteri di inclusione si prega di far riferimento alle pagine da 24 a 27 del protocollo di studio.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of ppPASI75 responders in the guselkumab group versus the placebo group at Week 16
    Proporzione di soggetti con risposta ppPASI75 nel gruppo guselkumab rispetto al gruppo placebo alla Settimana 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    settimana 16
    E.5.2Secondary end point(s)
    Change from baseline in BSA e absolute PASI scores, and percentage change in PASI score (PASI 75,90 and 100) in the guselkumab group at Weeks 24 and 48; Change from baseline in ppQLI, DLQI, EQ-5D-5L and ppIGA scores in the guselkumab group versus the placebo group at Week 16; Change from baseline in f-PGA scores in the guselkumab group versus the placebo group at Week 16; Change from baseline in ppQLI, DLQI, EQ-5D-5L and ppIGA scores in the guselkumab group at Weeks 24 and 48; Change from baseline in f-PGA scores in the guselkumab group at Weeks 24 and 48; Change from baseline in BSA, PASI and absolute ppPASI75 scores in the guselkumab group versus the placebo group at Week 16; DLQI, ppQLI, EQ-5D-5L, ppIGA, f-PGA, WPAI:PSO, NRS:P at Weeks 24and 48; Change from baseline in ppPASI scores in the guselkumab group at Weeks 24 and 48; Change from baseline in WPAI:PSO and NRS:P scores in the guselkumab group versus the placebo group at Week 16; Change from baseline in WPAI:PSO and NRS:P scores in the guselkumab group at Weeks 24 and 48; Rate of adverse events in the guselkumab and placebo/placebocrossover groups
    Change from baseline in BSA and absolute PASI scorer, and percentage chenge in PASI scores (PASI 75,90 and 100) in the guselkumab group versus the placebo group at Week 16; Variazione dalla baseline dei punteggi BSA e PASI assoluto, e percerntuale di cambiamento nel punteggio di PASI nel gruppo guselkumab rispetto al gruppo placebo alla Settimana 16; Variazione dalla baseline dei punteggi BSA E PASI assoluto, e percentuale di cambiamento dei punteggi PASI (PASI 75,90 e 100) nel gruppo guselkumab alle Settimane 24 e 48; Variazione dalla baseline dei punteggi ppQLI, DLQI, EQ-5D-5L e ppIGA nel gruppo guselkumab rispetto al gruppo placebo alla Settimana 16; Variazione dalla baseline dei punteggi f-PGA nel gruppo guselkumab rispetto al gruppo placebo alla Settimana 16; Variazione dalla baseline dei punteggi ppQLI, DLQI, EQ-5D-5L e ppIGA nel gruppo guselkumab alle Settimane 24 e 48; Variazione dalla baseline dei punteggi f-PGA nel gruppo guselkumab alle Settimane 24 e 48; Variazione dalla baseline dei punteggi BSA, PASI assoluto e ppPASI75 nel gruppo guselkumab rispetto al gruppo placebo alla Settimana 16; DLQI, ppQLI, EQ-5D-5L, ppIGA, f-PGA, WPAI:PSO, NRS:P Settimane 24 e 48; Variazione rispetto al basale nei punteggi ppPASI nel gruppo guselkumab alle Settimane 24 e 48; Variazione rispetto al basale nel WPAI: punteggi PSO e NRS: P nel gruppo guselkumab rispetto al gruppo placebo alla settimana 16; Variazione rispetto al basale nei punteggi WPAI: PSO e NRS: P nel gruppo guselkumab alle settimane 24 e 48; Tasso di eventi avversi nei gruppi guselkumab e crossover placebo/placebo
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 16; Weeks 24 and 48; week 16; week 16; week 24 and 48; Weeks 24 and 48; Week 16; Weeks 24 and 48; Weeks 24 and 48; Weeks 16; Weeks 24 and 48; intero periodo di studio
    settimana 16; settimana 24 e 48; settimana 16; Settimana 16; Settimana 24 e48; Settimane 24 e 48; Settimana 16; Settimane 24 e 48; Settimane 24 e 48; Settimane 16; Settimane 24 e 48; intero periodo 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker analysis and Tolerability
    Valutazione dei biomarcatori e 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 concerned4
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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
    LPLV
    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 months2
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days1
    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: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 105
    F.4.2.2In the whole clinical trial 105
    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)
    None
    nessuno
    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 Decision2019-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-16
    P. End of Trial
    P.End of Trial StatusCompleted
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