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    Summary
    EudraCT Number:2017-003818-11
    Sponsor's Protocol Code Number:M-41008-42
    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:2020-06-24
    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 number2017-003818-11
    A.3Full title of the trial
    An open-label clinical study to evaluate the long-term efficacy and tolerability of treatment with dimethyl fumarate (DMF) in adults with chronic plaque psoriasis (Study DIMESKIN 2).
    Studio clinico in aperto per valutare l'efficacia e la tollerabilita' a lungo termine del trattamento con dimetilfumarato (DMF) in adulti affetti da psoriasi cronica a placche (Studio DIMESKIN 2).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To evaluate the long-term efficacy and tolerability of treatment with dimethyl fumarate in adults with chronic plaque psoriasis.
    Valutare l’efficacia e la tollerabilità a lungo termine del trattamento con dimetilfumarato in adulti affetti da psoriasi cronica a placche .
    A.3.2Name or abbreviated title of the trial where available
    DIMESKIN 2
    DIMESKIN 2
    A.4.1Sponsor's protocol code numberM-41008-42
    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 SponsorALMIRALL SPA
    B.1.3.4CountryItaly
    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 supportAlmirall Italia S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOPIS s.r.l.
    B.5.2Functional name of contact pointDipartimento Medico
    B.5.3 Address:
    B.5.3.1Street AddressPalazzo Aliprandi, Via Matteotti 10
    B.5.3.2Town/ cityDesio
    B.5.3.3Post code20832
    B.5.3.4CountryItaly
    B.5.4Telephone number003903626331
    B.5.5Fax number00390362633633
    B.5.6E-mailosservatorio@opis.it
    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 Yes
    D.2.1.1.1Trade name Skilarence
    D.2.1.1.2Name of the Marketing Authorisation holderAlmirall, S.A.
    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 name-
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Gastro-resistant tablet
    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.3.8INN - Proposed INN-
    D.3.9.2Current sponsor codeLAS41008
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeLAS41008
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    chronic plaque psoriasis
    psoriasi cronica a placche
    E.1.1.1Medical condition in easily understood language
    chronic plaque psoriasis
    psoriasi cronica a placche
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071117
    E.1.2Term Plaque psoriasis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study is to evaluate the efficacy of dimethyl fumarate (DMF) in adults with moderate-to-severe chronic plaque psoriasis. Efficacy is expressed as the percentage of patients with a = 75% reduction from baseline of the PASI after 1 year of treatment.
    The second main objective is to test the new drug on the Italian population.
    L’obiettivo principale dello studio è di valutare l’efficacia del dimetilfumarato (DMF) in adulti affetti da psoriasi cronica a placche da moderata a grave attraverso la valutazione della percentuale di pazienti con una riduzione dal basale dell’indice PASI = 75% dopo 1 anno di trattamento.
    Secondo obiettivo principale è quello di testare il nuovo farmaco sulla popolazione italiana.
    E.2.2Secondary objectives of the trial
    • To evaluate the evolution of the disease in patients treated with DMF during 52 weeks of treatment through the following assessments:
    - Psoriasis Area and Severity Index (PASI)
    - Physician’s Global Assessment (PGA)
    - Body Surface Area (BSA)
    • To evaluate the percentage of patients with a = 75% reduction from baseline of the PASI after 24 weeks of treatment.
    • To evaluate the quality of life of patients through the Dermatology Life Quality Index (DLQI)
    • To evaluate itching and patient satisfaction through the Visual Analogue Scale (VAS)
    • To evaluate the tolerability profile
    • To characterize the patients participating in the study from a demographic and clinical point of view
    • To gather information from patients about psoriasis medications used prior to their entry in the study (topical, systemic, phototherapy)
    • Valutare l'evoluzione della malattia nei pazienti trattati con DMF nel corso delle 52 settimane di trattamento, attraverso la valutazione di:
    - Psoriasis Area and Severity Index (PASI)
    - Physician’s Global Assessment (PGA)
    - Body Surface Area (BSA)
    • Valutare la percentuale di pazienti con una riduzione dal basale dell’indice PASI = 75% dopo 24 settimane di trattamento
    • Valutare la qualità di vita dei pazienti attraverso il Dermatology Life Quality Index (DLQI)
    • Valutare il sintomo prurito e il grado di soddisfazione dei pazienti con la Scala Analogica Visiva (VAS)
    • Valutare il profilo di tollerabilità
    • Caratterizzare i pazienti partecipanti allo studio da un punto di vista demografico e clinico
    • Raccogliere informazioni in merito ai trattamenti per la psoriasi precedentemente sostenuti dai pazienti partecipanti allo studio (trattamenti topici, fototerapia o trattamenti sistemici).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Informed consent signed and dated personally
    2) Male or female
    3) Age = 18 years
    4) Diagnosis of chronic plaque psoriasis at least 6 months prior to inclusion in the study
    5) Moderate-to-severe plaque psoriasis defined by at least one of the following criterion:
    a. PASI = 10
    b. BSA = 10 and PASI = 5
    c. DLQI = 10 and PASI = 5
    6) Good general health or stable medical condition that does not interfere with the conduct of the study, as decided by the Investigator based on medical history, physical examination and laboratory exams
    7) documented vaccination against hepatitis B or negativity to the HBsAg, HBsAb and HBcAb tests
    8) negativity to the HCV test
    9) negativity to the HIV test
    10) documented vaccination against TBC or negativity to the Elispot TBC test
    11) indication for a systemic treatment of psoriasis
    12) wash-out period of at least 4 half-lives in case of previous treatment with biological drugs with anti-psoriatic activity
    13) known anamnesis for at least 6 months of other previous topical and/or systemic treatments
    14) Compliance with the following washout periods of the following drugs:
    - Corticosteroids, Vitamin A analogues, Vitamin D analogues, Coal tar, Salicylic acid preparations (2 weeks)
    - Systemic treatment (Washout period)
    - Conventional systemic antipsoriatic drugs (methotrexate, cyclosporine, acitretin), apremilast and phototherapy (4 weeks)
    15) For women of child-bearing potential: negative serum pregnancy test at screening and willingness to use highly effective contraception during the study and for the following 30 days after the end of the treatment.
    16) For sexually active men with female partners of childbearing age: availability to protected relationships through condom use and availability of the partner(s) to use highly effective contraceptive methods during the study period and for the next 30 days after the end of the treatment
    Per partecipare allo studio i pazienti devono soddisfare tutti i seguenti criteri di inclusione:
    1) consenso informato firmato e datato personalmente
    2) maschi o femmine
    3) età = 18 anni
    4) diagnosi di psoriasi cronica a placche formulata almeno 6 mesi prima dell’inclusione nello studio
    5) presenza di psoriasi a placche di entità da moderata a grave, definita da almeno uno dei seguenti criteri:
    - PASI = 10
    - BSA = 10 e PASI = 5
    - DLQI = 10 e PASI = 5
    6) buono stato di salute generale o condizione medica stabile che non interferisce con la conduzione dello studio clinico, secondo il giudizio dello Sperimentatore sulla base dell’anamnesi, dell’esame obiettivo e dei risultati degli esami di laboratorio
    7) documentata vaccinazione contro l’epatite B o negatività al test HBsAg, HBsAb e HBcAb
    8) negatività al test HCV
    9) negatività al test HIV
    10) documentata vaccinazione contro la TBC o negatività al test Elispot TBC
    11) indicazione per un trattamento sistemico della psoriasi
    12) periodo di wash-out di almeno 4 emivite in caso di precedente trattamento con farmaci biologici ad attività anti-psoriasica
    13) anamnesi nota di almeno 6 mesi di altri trattamenti topici e/o sistemici precedenti
    14) aderenza ai seguenti periodi di astensione da trattamenti farmacologici:
    - Corticosteroidi, Analoghi della vitamina A, aloghi della vitamina D, Catrame di carbone, Preparazioni di acido salicilico (2 settimane)
    - Trattamento sistemico (Periodo di astensione)
    - Farmaci antipsoriasi sistemici convenzionali (metotrexate, ciclosporina, acitretina), apremilast e fototerapia (4 settimane)
    15) Per le donne in età fertile: test sierico di gravidanza negativo alla visita di selezione e disponibilità ad utilizzare metodi contraccettivi di elevata efficacia durante il periodo di studio e per i successivi 30 giorni dopo il termine del trattamento.
    16) Per gli uomini sessualmente attivi con partner femminili in età fertile: disponibilità a rapporti protetti mediante uso di condom e disponibilità della/delle partner ad utilizzare metodi contraccettivi di elevata efficacia durante il periodo di studio e per i successivi 30 giorni dopo il termine del trattamento.
    E.4Principal exclusion criteria
    1) Pregnant or lactating women or women planning to become pregnant
    2) Diagnosis of guttate, erythrodermic or pustular psoriasis
    3) Abnormal hematological values such as leukocyte count ¿ 3.000 cells/mm3 or lymphocyte count ¿ 1.000 cells/l
    4) History of cancer except for non-melanoma skin cancer, in the 5 years prior to enrollment in the study
    5) Significant gastrointestinal problems (e.g. peptic ulcer, diarrhea, etc.)
    6) Severe renal failure, with estimated glomerular filtration rate (eGFR) less than 30 ml/min using the CKD-EPI Creatinine Equation*, or using the MDRD (Modification of Diet in Renal Diseases)**, or significant proteinuria (3+ or higher) measured with reactive strips at screening.
    *Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation (2009):
    eGFR = 141 x min(SCr/¿, 1)a x max(SCr /¿, 1)-1.209 x 0.993 Age x 1.018 [if female] x 1.159 [if afro-american]
    Abbreviations/units:
    eGFR (estimated glomerular filtration rate) = mL/min/1.73 m2
    SCr (standardized serum creatinine) = mg/dL
    ¿ = 0.7 (women) or 0.9 (men)
    a = -0.329 (women) or -0.411 (men)
    Min = minimum of SCr/¿ or 1
    Max = maximum of SCr/¿ or 1
    Age = years
    ** MDRD (Modification of Diet in Renal Diseases)
    eGFR = 175 × (Scr)-1.154 × (Age)-0.203 × (0.742 women) × (1.212 if afro-american)
    Abbreviations/units:
    eGFR (estimated glomerular filtration rate) = mL/min/1.73 m2
    SCr (standardized serum creatinine) = mg/dL
    Age = years
    7) Abnormal hepatic enzymes:
    • At least three times the Upper Limit of Normal (ULN/LSN):
    aspartate aminotransferase/ Serum glutamic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/ Serum glutamic pyruvic transaminase (ALT/SGPT), gamma-glutamyl transferase (gamma-GT), alkaline phosphatase (AP)
    • At least two times Upper Limit of Normal (ULN/LSN): bilirubin
    8) Current infectious diseases
    9) History of drug or alcohol abuse
    10) Known HIV-positivity, any other immunosuppressive pathology or treatment with immunosuppressive drugsnota positività ad HBV e/o HCV
    11) Known positivity to HBV and / or HCV
    12) active tuberculosis
    13) known hypersensitivity to the components of the DMF
    14) Known lactose intolerance
    15) previous enrollment in this study or participation in other clinical-pharmacological studies within the previous 30 days (or 5 half-lives, depending on which interval is the longest).
    16) previous treatment with anti-psoriatic biological drugs without a wash-out period of at least 4 half-lives
    17) inability to meet the study requirements or the Investor's negative judgment about participation in the study..
    1) per le donne: stato di gravidanza, previsione di gravidanza o periodo di allattamento
    2) diagnosi di psoriasi guttata, eritrodermica o pustolosa
    3) anomalie ematologiche, come conta leucocitaria ¿ 3.000 cellule/mm3 o conta linfocitaria ¿ 1.000 cellule/l.
    4) anamnesi positiva per neoplasie, eccetto tumori cutanei non melanomatosi, nei 5 anni precedenti l’arruolamento nello studio
    5) disturbi gastrointestinali significativi (per esempio ulcera peptica, diarrea. etc.)
    6) nota insufficienza renale grave, con tasso di filtrazione glomerulare stimato (eGFR) inferiore a 30 ml/min usando la formula CKD-EPI Creatinine Equation*, * o la formula MDRD (Modification of Diet in Renal Diseases)**, o significativa proteinuria (3+ o superiore) misurata con striscia reattiva al momento della visita di selezione
    *Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation (2009):
    eGFR = 141 x min(SCr/¿, 1)a x max(SCr /¿, 1)-1.209 x 0.993 Età x 1.018 [se donna] x 1.159 [se razza afro-americana]
    Abbreviazioni/unità:
    eGFR (tasso di filtrazione glomerulare stimato) = mL/min/1.73 m2
    SCr (creatinina serica standardizzata) = mg/dL
    ¿ = 0.7 (donne) o 0.9 (uomini)
    a = -0.329 (donne) o -0.411 (uomini)
    Min = indica il minimo di SCr/¿ o 1
    Max = indica il massimo di SCr/¿ o 1
    Etá = anni
    ** MDRD (Modification of Diet in Renal Diseases)
    eGFR = 175 × (Scr)-1.154 × (Age)-0.203 × (0.742 se donna) × (1.212 se afro-americana)
    Abbreviazioni/unità:
    eGFR (tasso di filtrazione glomerulare stimato) = mL/min/1.73 m2
    SCr (creatinina serica standardizzata) = mg/dL
    Età = anni
    7) enzimi epatici anormali:
    - almeno 3 volte il limite superiore del range di normalità (ULN/LSN):
    aspartato aminotransferasi/ transaminasi sierica glutammico-ossalacetica (AST/SGOT), alanina aminotransferasi/transaminasi sierica glutamico piruvica (ALT/SGPT), gamma-glutamiltransferasi (gamma-GT), fosfatasi alcalina (FA)
    - almeno 2 volte il limite superiore del range di normalità (ULN/LSN): bilirubina
    8) patologie infettive in atto.
    9) anamnesi positiva per abuso di alcol o droga.
    10) nota HIV-positività, qualsiasi altra patologia immunosoppressiva o trattamento con farmaci immunosoppressori
    11) nota positività ad HBV e/o HCV
    12) tubercolosi attiva
    13) nota ipersensibilità ai componenti del DMF
    14) nota intolleranza al lattosio
    15) precedente arruolamento in questo studio o partecipazione ad altri studi clinico-farmacologici nei 30 giorni precedenti (o 5 emivite, secondo quale intervallo sia il più lungo).
    16) precedente trattamento con farmaci biologici ad azione anti-psoriasica senza un periodo di wash-out di almeno 4 emivite
    17) incapacità a soddisfare i requisiti dello studio o giudizio negativo dello Sperimentatore circa la partecipazione allo studio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the percentage of patients with a = 75% reduction from baseline of the Psoriasis Area and Severity Index (PASI 75).
    L’endpoint primario di questo studio è la percentuale di pazienti con una riduzione vs basale uguale o superiore al 75% del Psoriasis Area and Severity Index (PASI 75).
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 1 year of treatment.
    Dopo 1 anno di trattamento.
    E.5.2Secondary end point(s)
    Percentage of patients that achieve PASI 75 (reduction = 75% of PASI).; Percentage of patients that achieve PASI 50 (reduction = 50% of PASI) .; Percentage of patients that achieve PASI 90 (reduction = 90% of PASI); Percentage of patients that achieve PASI 100 (reduction = 100% of PASI).; Variations of PASI.; Variations of PGA score.; Variations of BSA index.; Variations of DLQI.; Percent variation from baseline score of the VAS for itching.; Variation from baseline score of the VAS for patient satisfaction.; Evaluation of tolerability profile.; Treatment exposure.; Incidence of adverse events during the treatment period identified through spontaneous communication, periodic follow-up or variations of laboratory parameters (hematology, clinical chemistry, urine analysis):
    - Percentage of patients with adverse events (AE) and serious adverse events (SAE).
    - Absolute frequency and percentage for each type of event classified by dosage.
    - Percentage of patients that permanently interrupted treatment with DMF.
    Percentuale di pazienti che raggiungono PASI 75 (riduzione uguale o superiore al 75% del PASI).; Percentuale di pazienti che raggiungono PASI 50 (riduzione uguale o superiore al 50% del PASI).; Percentuale di pazienti che raggiungono PASI 90 (riduzione uguale o superiore al 90% del PASI); Percentuale di pazienti che raggiungono PASI 100 (riduzione uguale o superiore al 100% del PASI).; Variazione dell’indice PASI.; Variazione del punteggio PGA.; Variazione dell’indice BSA.; Variazione dell’indice DLQI.; Variazione percentuale rispetto al punteggio basale della VAS per il prurito.; Valutazione del punteggio della VAS per il grado di soddisfazione del paziente.; Valutazione del profilo di tollerabilità.; Esposizione al trattamento.; Incidenza di eventi avversi durante il periodo di trattamento identificati tramite comunicazione spontanea, follow-up periodico o variazione dei parametri di laboratorio (ematologia, ematochimica, esame delle urine):
    - percentuale di pazienti che riportano eventi avversi (AE) ed eventi avversi seri (SAE)
    - frequenza assoluta e percentuale di ogni tipo di evento avverso classificato per dosaggio
    - percentuale di pazienti che hanno interrotto definitivamente il trattamento con DMF.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 4, 8, 12, 36 and 48 of treatment.; At week 4, 8, 12, 36, 48 e 52 of treatment.; At week 4, 8, 12, 36, 48 e 52 of treatment.; At week 4, 8, 12, 36, 48 e 52 of treatment.; During the 52 weeks of treatment.; During the 52 weeks of treatment.; During the 52 weeks of treatment.; During the 52 weeks of treatment.; During the 52 weeks of treatment.; At week 24 and 52 of treatment.; During the 52 weeks of treatment.; During the 52 weeks of treatment.; During the 52 weeks of treatment.
    Alle settimane 4, 8, 12, 24, 36 e 48 di trattamento.; Alle settimane 4, 8, 12, 24, 36, 48 e 52 di trattamento.; Alle settimane 4, 8, 12, 24, 36, 48 e 52 di trattamento.; Alle settimane 4, 8, 12, 24, 36, 48 e 52 di trattamento.; Durante le 52 settimane di trattamento.; Durante le 52 settimane di trattamento.; Durante le 52 settimane di trattamento.; Durante le 52 settimane di trattamento.; Durante le 52 settimane di trattamento.; Alle settimane 24 e 52 di trattamento.; Durante le 52 settimane di trattamento.; Durante le 52 settimane di trattamento.; Durante le 52 settimane di trattamento.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned36
    E.8.5The trial involves multiple Member States No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    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)
    Standard treatment.
    Trattamento standard.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-12
    P. End of Trial
    P.End of Trial StatusOngoing
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