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    EudraCT Number:2017-003021-15
    Sponsor's Protocol Code Number:CL011_140
    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:2020-11-10
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-003021-15
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Focal Segmental Glomerulosclerosis (FSGS)
    Studio per la determinazione della dose, randomizzato, in doppio cieco, controllato mediante placebo, volto a valutare la sicurezza e l’efficacia di CCX140-B in soggetti affetti da glomerulosclerosi focale segmentaria (GSFS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy og CCX140-B in patients with FSGS
    Uno studio per valutare l'efficacia di CCX140-B in pazienti con FSGS
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberCL011_140
    A.5.4Other Identifiers
    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 SponsorCHEMOCENTRYX, INC.
    B.1.3.4CountryUnited States
    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 supportChemoCentryx, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace Germany GmbH
    B.5.2Functional name of contact pointRegulatory Submissions
    B.5.3 Address:
    B.5.3.1Street AddressTheresienhöhe 30
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code80339
    B.5.4Telephone number00498956551780
    B.5.5Fax number00442033183827
    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 name-
    D.3.2Product code [CCX140-B]
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeCCX140-B
    D.3.9.4EV Substance CodeSUB30896
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Focal Segmental Glomerulosclerosis (FSGS)
    Glomerulosclerosi Focale Segmentale (FSGS)
    E.1.1.1Medical condition in easily understood language
    A type of glomerular disease (disease damaging the glomeruli, the filtering units inside the kidney where blood is cleaned) that causes scarring (sclerosis) in kidney.
    Un tipo di patologia glomerulare (malattia che danneggia i glomeruli, ovvero l'unità filtrante dei reni dove il sangue viene pulito) che causa cicartici (sclerosi) nei reni.
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10067757
    E.1.2Term Focal segmental glomerulosclerosis
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • The primary safety objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with FSGS with proteinuria.
    • The primary efficacy objective of this study is to evaluate the effect of CCX140-B treatment
    on urinary protein excretion in subjects with FSGS, as assessed by change from baseline in
    the urine protein to creatinine ratio (UPCR).
    • L’obiettivo primario di sicurezza del presente studio è valutare la sicurezza e la tollerabilità di CCX140-B in soggetti affetti da GSFS con proteinuria.
    • L’obiettivo primario di efficacia del presente studio è valutare l’effetto del trattamento con CCX140-B sull’escrezione urinaria di proteine in soggetti con GSFS, misurato sulla base della variazione del rapporto urinario proteine/creatinina (UPCR) rispetto al basale.
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of CCX140-B on renal function, as assessed by estimated glomerular filtration rate (eGFR) at Week 12 and 24;
    • To evaluate the effect of CCX140-B treatment on fraction of subjects achieving complete and partial renal remission (by 2 different partial remission definitions)
    • To evaluate the pharmacokinetic (PK) profile of CCX140-B in subjects with FSGS.
    • Valutare l'effetto di CCX140-B sulla funzionalità renale, valutato mediante la velocità di filtrazione glomerulare stimata (eGFR) alla settimana 12 e 24;
    • Valutare l'effetto del trattamento con CCX140-B su frazione di soggetti che raggiungono la remissione renale completa e parziale (di 2 diverse definizioni di remissione parziale)
    • Valutare il profilo farmacocinetico (Pharmacokinetics, PK) di CCX140-B in soggetti con GSFS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects aged 18-75 years inclusive
    2. Urinary total protein:creatinine ratio (UPCR) = 1 g protein/g creatinine at screening (or UPCR at 113 mg/mmol).
    3. Diagnosis of FSGS based on at least one of the following:
    o Renal biopsy demonstrating the FSGS lesion and characteristic clinical presentation and course
    o High risk genetic variant and characteristic clinical presentation and course
    4. Diagnosis of one of the following subtypes of FSGS:
    o Primary FSGS based on characteristic histopathology, medical history, and clinical course, or
    o FSGS secondary to a genetic variant associated with increased risk or severity, which may include NPHS1, NPHS2, WT-1, LAMB2, CD2AP, TRPC6, ACTN4 or INF2
    5. Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73m2, with eGFR calculated
    using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (using creatinine or cystatin C)
    6. The typical blood pressure of the patient should be clinically stable prior to enrollment and not exceed 145/95 mmHg.
    7. If using RAAS blockers, dose must be stable for a minimum of 4 weeks prior to Screening, and projected to remain stable through Study Week 12, unless adjustment is required for management of hypertension. Blood pressure should be clinically stable prior to enrollment.
    8. If using immunosuppressive or immunomodulatory therapy, dose must be stable for a
    minimum of 4 weeks prior to Screening, and projected to remain stable through Study
    Week 12
    9. If using glucocorticoids, dose must be stable for a minimum of 4 weeks prior to Screening and projected to remain stable through Study Week 12
    10. Female subjects of childbearing potential may participate if adequate contraception is used during, and for at least 1 month after last dose of study drug. Male subjects with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or if adequate contraception is used during, and for at least one month after the last dose of study drug. Adequate contraception is defined as resulting in a failure rate of less than 1% per year (combined estrogen and progestogen [oral, intravaginal, or transdermal], or progestogen-only hormonal contraception (oral, injectable, or implantable), intra-uterine device, intra-uterine hormone releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence). In addition, a barrier method (i.e. cervical cap, diaphragm or condom) must be used during intercourse between a male subject and a female of child-bearing potential.
    11. Willing and able to give written Informed Consent and to comply with the requirements
    of the study protocol
    12. Judged to be otherwise fit for the study by the Investigator, based on medical history,
    physical examination, and clinical laboratory assessments. Subjects with clinical laboratory values that are outside of normal limits (other than those specified in the Exclusion Criteria) and/or with other abnormal clinical findings that are judged by the Investigator not to be of clinical significance, may be entered into the study.
    1. Soggetti di sesso maschile o femminile di età pari a 18-75 anni
    2. Rapporto urinario proteina totale/creatinina (UPCR) =1 g proteina/g creatinina allo screening (o UPCR pari a 113 mg/mmol)
    3. Diagnosi di GSFS sulla base di almeno uno dei seguenti fattori:
    o Biopsia renale che evidenzia una lesione da GSFS, come anche presentazione e decorso clinici caratteristici
    o Variante genetica ad alto rischio e presentazione e decorso clinici caratteristici
    4. Diagnosi di uno dei seguenti sottotipi di GSFS:
    o GSFS primaria sulla base di istopatologia, anamnesi medica e decorso clinico caratteristici, oppure
    o GSFS secondaria a variante genetica associata a un aumento del rischio o della gravità, che può includere NPHS1, NPHS2, WT-1, LAMB2, CD2AP, TRPC6, ACTN4 oppure INF2
    5. Velocità di filtrazione glomerulare stimata (eGFR) >30 ml/min/1,73 m2, con eGFR calcolata utilizzando l’equazione sviluppata dalla Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) (utilizzando la creatinina o la cistatina C)
    6. La pressione arteriosa tipica del paziente deve essere clinicamente stabile prima dell’arruolamento e non superare 145/95 mmHg.
    7. Se si usano i bloccanti del SRAA, la dose deve essere stabile per almeno 4 settimane prima dello screening e si deve prevedere che rimanga stabile fino alla settimana 12 dello studio, a meno che l’aggiustamento del dosaggio non sia necessario per la gestione dell’ipertensione
    8. Se si usano gli immunosoppressori o immunomodulatori, la dose deve essere stabile per almeno 4 settimane prima dello screening e si deve prevedere che rimanga stabile fino alla settimana 12 dello studio
    9. Se si usano i glucocorticoidi, la dose deve essere stabile per almeno 4 settimane prima dello screening e si deve prevedere che rimanga stabile fino alla settimana 12 dello studio
    10. I soggetti di sesso femminile in età fertile possono partecipare allo studio se accettano di utilizzare un metodo contraccettivo adeguato durante il trattamento con il farmaco sperimentale e per almeno 1 mese dopo l’ultima somministrazione. I soggetti di sesso maschile che hanno partner in età fertile possono partecipare allo studio se si sono sottoposti a vasectomia almeno 6 mesi prima della randomizzazione o se accettano di utilizzare un metodo contraccettivo adeguato durante il trattamento con il farmaco sperimentale e per almeno un mese dopo l’ultima somministrazione. Per metodo contraccettivo adeguato s’intende il metodo che ha una percentuale di insuccesso inferiore all’1% all’anno (combinazione di estrogeno e progestinico [orale, intravaginale o transdermico] oppure il contraccettivo ormonale a base solo di progestinico (orale, iniettabile o impiantabile), il dispositivo intrauterino, il sistema intrauterino a rilascio ormonale, l’occlusione tubarica bilaterale, partner vasectomizzato oppure astinenza sessuale. Inoltre, deve essere usato un metodo barriera (ovvero, cappuccio cervicale, diaframma o preservativo) nel corso di rapporti sessuali tra un soggetto di sesso maschile e un soggetto di sesso femminile in età fertile.
    11. Essere disposti e in grado di esprimere il proprio Consenso informato per iscritto e di conformarsi ai requisiti del protocollo dello studio
    12. Essere considerati idonei per lo studio dallo sperimentatore, sulla base dell’anamnesi medica, dell’esame obiettivo e delle valutazioni cliniche di laboratorio. Possono accedere allo studio i soggetti con valori clinici di laboratorio al di fuori dei limiti della norma (tranne quelli specificati nei criteri di esclusione) e/o con altri referti clinici anormali che, secondo lo sperimentatore, non sono clinicamente significativi.
    E.4Principal exclusion criteria
    1Pregnant or nursing 2History of organ transplantation, including renaltransplantation 3Currently on an organ transplant waiting list or there’s a reasonable possibility of getting an organ transplant within 6 months of screening 4. Subjects who used rituximab or other B-cell depleting monoclonal antibodies within 20 weeks prior to screening are excluded while subjects that used rituximab or other B-celldepleting monoclonal antibodies prior to 20weeks of screening are allowed with confirmed recovery of the B-cell population to within normal range at the time of screening 5. Plasmapheresis within 12 weeks prior to screening 6. Body mass index (BMI) =40 7. Participated in any clinical study of an investigational product within 12 weeks prior to screening, or within 5 half-lives after taking the last dose of investigational product 8. Currently on dialysis or likely to require dialysis during the projected blinded treatmentperiod of 12 weeks 9. History or presence of any form of cancer within the 5 years prior to screening, with theexception of excised basal cell or squamous cell carcinoma of the skin, or carcinoma in situ such as cervical or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis 10. Positive HBV, HCV, or HIV viral screening test. Subjects who have received highly effective therapy for HCV demonstrated to have negative viral titers for at least 6 months following discontinuation of treatment, will be considered to have a negative HCV screening test 11. Renal disease associated with disorders other than FSGS (e.g. lupus nephritis, C3 glomerulopathy, proliferative glomerulonephritis, IgA nephropathy, reflux nephropathy,surgical segmental renal ablation, sickle cell disease ) that is active, or has significant risk of progressing during the course of the study 12. Disorders other than those listed in Inclusion Criterion 4 that are associated with FSGSlesion (e.g. single kidney, surgical segmental renal ablation, sickle cell disease, diabetic nephropathy; others) 13. Evidence of tuberculosis based on interferon ¿ release assay (IGRA) within 6 weeks prior to screening 14. Evidence of hepatic disease; AST, ALT, alkaline phosphatase >3x ULN, or total bilirubin > 2x ULN or INR > 1.5 x ULN at baseline prior to dosing with the exception that isolated INR elevation in the absence of other significant liver enzyme abnormalities is explained by anticoagulant therapy, (e.g. warfarin). 15. Clinically significant peripheral neuropathy. 16. Hematologic abnormalities as follows: Hb < 8 g/dL, platelets < 50,000, ANC < 1000 cells/µL) at baseline 17. Clinically significant abnormal ECG during screening, e.g., QTcF greater than 450 msec 18. History of alcohol or illicit drug abuse. Recreational use of cannabis is not excluded where legal.19. History of gastrointestinal conditions that may interfere with study medication compliance, e.g., severe gastroparesis, with regurgitation of food or oral medication 20. Known hypersensitivity to CCX140-B or inactive ingredients of the CCX140-B tablets (including microcrystalline cellulose, starch, crospovidone, magnesium stearate, or silicon dioxide) 21. History or presence of systemic disorder other than FSGS that requires, or is expected to require, systemic glucocorticoids or immune modulators during the study; topical or inhaled glucocorticoids and immune modulators are not excluded 22. History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation 23. Subjects taking strong CYP3A4 inducers or strong CYP3A4 inhibitors within two weeks prior to screening 24. Subjects taking lithium, pamidronate, or interferon; subjects taking non-steroidal anti-inflammatory agents (NSAIDS) chronically
    1Gravidanza o allattamento2Pregresso trapianto d’organo,incluso il trapianto renale3Essere attualmente in lista d’attesa per trapianto oppure esistenza di una ragionevole possibilità di ricevere un trapianto d’organo entro 6mesi dallo screening4soggetti che hanno usato rituximab o altri anticorpi monoclonali con deplezione delle cellule B entro 20 settimane prima dello screening sono esclusi mentre i soggetti che hanno usato rituximab o altri anticorpi monoclonali con cellule B prima di 20 settimane di screening sono consentiti con recupero confermato della popolazione delle cellule B all'interno intervallo normale al momento dello screening5Plasmaferesi entro 12settimane prima dello screening6Indice di massa corporea (IMC)=40 7Pregressa partecipazione a un qualunque studio clinico di un prodotto sperimentale entro 12settimane prima dello screening o entro 5emivite dopo l’assunzione dell’ultima dose del prodotto sperimentale8Essere al momento in dialisi oppureprobabilità di essere sottoposti a dialisi durante il periodo previsto di trattamento in cieco di 12 settimane9Neoplasia di qualunque tipo,pregressa o in atto,entro 5 anni prima dello screening,fatta eccezione per carcinoma della pelle a cellule basali o a cellule squamose escisso o carcinoma in situ come carcinoma cervicale o mammario in situ che sia stato escisso o resecato completamente e non vi sia evidenza di metastasi o recidiva locale10Test di screening per la ricerca di virus positivo per HBV,HCVoHIV.I soggetti sottoposti a una terapia altamente efficace per HCV che hanno evidenziato titoli virali negativi per almeno 6 mesi dopo l’interruzione del trattamento saranno considerati negativi al test di screening per l’HCV11Nefropatia associata a disturbi differenti dalla GSFSin atto oppure con significativo rischio di progressione durante lo svolgimento dello studio12Disturbi differenti da quelli elencati nel Criterio di inclusione 4 che sono associati a lesione da GSFS 13. Prove di tubercolosi basata sul test di rilascio dell'interferone ¿ (IGRA) entro 6 settimane prima dello screening14Evidenza di malattia epatica; AST,ALT,fosfatasi alcalina>3volte l’ULN(upper limit of normal o bilirubina totale > 2 volte l’ULN o l’INR(International Normalized Ratio)>1,5volte l’ULN al basale(prima della somministrazione),fatto salvo il caso in cui l’innalzamento isolato dell’INR in assenza di altre anomalie significative a livello di enzimi epatici è giustificato dalla terapia anticoagulante (es. warfarin)15Neuropatia periferica clinicamente significativa. 16. I seguenti valori ematologici anormali: Hb <8 g/dl, piastrine <50.000, ANC<1.000 cellule/µl) al basale 17. ECG anormale clinicamentesignificativo durante lo screening, es. QTcF maggiore di 450msec18Storia di abuso di alcool o droghe illecite. L’uso della cannabis a scopo ricreativo non è escluso laddove legale19Storia di malattie gastrointestinali che potrebbero non essere in conformità con il farmaco dello studio, es. gastroparesi grave, con rigurgito di cibo o farmaco orale 20.Nota ipersensibilità alCCX140-B o agli eccipienti delle compresse di CCX140-B21. Disturbo sistemico pregresso o in atto, che non sia la GSFS, che richiede, o si prevede che richieda, la somministrazione di glucocorticoidi o immunomodulatori sistemici durante lo studio; glucocorticoidi e immunomodulatori per uso topico o per via inalatoria non sono esclusi 22Qualunque condizione medica o malattia pregressa o in atto che, a giudizio dello sperimentatore, potrebbe esporre il soggetto a un rischio inaccettabile in caso di partecipazione allo studio 23. Soggetti in terapia con forti induttori del CYP3A4 oppure forti inibitori del CYP3A4 entro due settimane prima dello screening24Soggetti che assumono litio, pamndrotato, o interferone; soggetti che assumono antinfiammatori nonsteroidei(FANS)cronicamente
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in urine protein:creatinine ratio (UPCR) at week 12
    • Subject incidence of treatment-emergent adverse events, adverse
    events leading to study
    withdrawal, and serious adverse events;
    • Change from baseline and shifts from baseline in all safety laboratory
    • Change from baseline in vital signs;
    • Change form baseline in score on the ACTG BPNST
    • Clinically significant abnormal ECG findings
    • Physical examinations
    ¿ Variazione del rapporto urinario proteine/creatinina (UPCR) rispetto al basale
    ¿ incidenza per soggetto di eventi avversi seri emergenti dal trattamento, di eventi avversi che inducono il ritiro dallo studio e di eventi avversi seri;
    ¿ variazione rispetto al basale e scostamenti rispetto al basale in tutti i parametri di laboratorio di sicurezza;
    ¿ variazione dei segni vitali rispetto al basale;
    ¿ variazione del punteggio alla scala ACTG-BPNST rispetto al basale;
    ¿ risultati anomali degli ECG, clinicamente significativi;
    ¿ esami obiettivi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12, Week 24
    Day1, Week12, Week16, Week24, Week28
    Settimana 12, Settimana 24
    Giorno1, Settimana12, Settimana16, Settimana24, Settimana28
    E.5.2Secondary end point(s)
    • Change from baseline in eGFR calculated by the CKD-EPI cystatin C
    equation, CKD-EPI Creatinine equation, CKD-EPI Creatinine-Cystatin C equation and MDRD Creatinine equation at Weeks 12 and 24
    • Proportion of subjects achieving complete renal remission at Weeks 12 and 24 Completed Remission (includes all of the following):
    - Reduction in UPCR to < 0.3 g/g
    - Serum albumin within normal range
    - For subjects with abnormal serum creatinine levels at baseline, return
    to normal levels for that age group
    - For subjects with normal serum creatinine levels at baseline, final
    value within 20% of baseline levels
    • Proportion of subjects achieving partial remission at Weeks 12 and 24
    by the following two different definitions:
    - UPCR reduction of = 50% from baseline and UPCR <3.5g/g
    - decrease in UPCR to less than 1.5 g/g and at least a 40% reduction in
    proteinuria from baseline
    • Cambiamento rispetto al basale in eGFR calcolato dalla cistatina CKD-EPI equazione, equazione della creatinina CKD-EPI, CKD-EPI Creatinina-cistatina C equazione e equazione della creatinina MDRD alle settimane 12 e 24
    • Proporzione di soggetti che raggiungono la completa remissione renale a settimane 12
    e 24 Remissione Completata (include tutto quanto segue):
    - Riduzione UPCR a <0,3 g / g
    - Albumina sierica entro il range di normalità
    - Per i soggetti con livelli anormali di creatinina sierica al basale, ritorno
    a livelli normali per quella fascia di età
    - Per i soggetti con livelli normali di creatinina sierica al basale, finale
    valore entro il 20% dei livelli di base
    • Proporzione di soggetti che ottengono una remissione parziale alle settimane 12 e 24 dalle seguenti due definizioni diverse:
    - Riduzione UPCR = 50% rispetto al basale e UPCR <3,5 g / g
    - diminuzione in UPCR inferiore a 1,5 g / ge riduzione di almeno il 40% in
    proteinuria dal basale
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: Weeks 12, Week 24
    Efficacia: Settimana 12, Settimana 24
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    Determinazione della dose
    Dose Ranging
    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 trial4
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA 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
    New Zealand
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    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 months5
    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 months9
    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: 30
    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 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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 40
    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)
    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 Decision2018-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-18
    P. End of Trial
    P.End of Trial StatusCompleted
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