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    Summary
    EudraCT Number:2018-002135-19
    Sponsor's Protocol Code Number:0164
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-17
    Trial results View 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 number2018-002135-19
    A.3Full title of the trial
    A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC)
    Uno studio di 3 anni, multicentrico, a lungo termine sulla sicurezza (LTS) per valutare la sicurezza e la tollerabilità di TD-1473 in soggetti con colite ulcerosa (CU)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)
    Una sperimentazione clinica per studiare l'efficacia e la sicurezza di TD-1473 per il trattamento della colite ulcerosa (CU)
    A.3.2Name or abbreviated title of the trial where available
    TD-1473 LTS UC Study
    TD-1473 LTS Studio CU
    A.4.1Sponsor's protocol code number0164
    A.5.4Other Identifiers
    Name:US INDNumber:128299
    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 SponsorTheravance Biopharma Ireland Limited
    B.1.3.4CountryIreland
    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 supportTheravance Biopharma Ireland Limited
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTheravance Biopharma Ireland Limited
    B.5.2Functional name of contact pointClinical Operations - CC
    B.5.3 Address:
    B.5.3.1Street AddressConnaught House 1 Burlington Road
    B.5.3.2Town/ cityDublin 4
    B.5.3.3Post codeD04 C5Y6
    B.5.3.4CountryIreland
    B.5.4Telephone number35315532500
    B.5.5Fax number35315532501
    B.5.6E-mailIBDstudies@theravance.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 nameTD-1473
    D.3.2Product code [TD-1473]
    D.3.4Pharmaceutical form Coated 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 codeTD-1473
    D.3.9.4EV Substance CodeSUB192730
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 nameTD-1473
    D.3.2Product code [TD-1473]
    D.3.4Pharmaceutical form Coated 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 codeTD-1473
    D.3.9.4EV Substance CodeSUB192730
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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: 3
    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 nameTD-1473
    D.3.2Product code [TD-1473]
    D.3.4Pharmaceutical form Coated 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 codeTD-1473
    D.3.9.4EV Substance CodeSUB192730
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    Moderately-to-severely active Ulcerative Colitis (UC)
    Colite ulcerosa attiva da moderata a grave
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis (UC)
    Colite Ulcerosa (CU)
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of TD-1473 administered up to 3 years in subjects with moderate to severe UC after participation in the Maintenance Study of Protocol 0157.
    Valutare la sicurezza e la tollerabilità di TD-1473 somministrato fino a 3 anni in soggetti con colite ulcerosa da moderata a grave dopo la partecipazione allo studio di mantenimento del protocollo 0157.
    E.2.2Secondary objectives of the trial
    • To assess clinical remission and response rates over time
    • To assess endoscopic healing rates over time
    • To assess clinical remission and response in subjects entering the study after experiencing persistent loss of response or recurrent clinical flare after initial loss of response during the Maintenance Study (Protocol 0157)
    • To assess clinical remission and response in subjects entering the study after completing the Maintenance Study (Protocol 0157)
    • To determine the effect of long-term TD-1473 treatment on major inflammatory bowel disease (IBD)-related events (eg, hospitalizations, surgeries, and procedures)
    • To examine the effect of long-term TD-1473 treatment on health-related quality of life (QOL)
    • Valutare la remissione clinica e i tassi di risposta nel tempo
    • Valutare i tassi di guarigione endoscopica nel tempo
    • Valutare la remissione e la risposta clinica nei soggetti che entrano nello studio dopo aver manifestato una perdita di risposta persistente o una riacutizzazione clinica ricorrente dopo la perdita di risposta durante lo studio di mantenimento o l'uscita dallo studio di mantenimento in remissione dal protocollo 0157
    • Valutare i tassi a lungo termine dei principali eventi correlati alla malattia infiammatoria intestinale (IBD) (ad esempio, ospedalizzazioni, interventi chirurgici e procedure) in soggetti trattati con TD-1473
    • Valutare la qualità della vita correlata alla salute (QOL) in soggetti che ricevono un trattamento a lungo termine con TD-147
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Capable of providing informed consent, which must be obtained prior to any study-related procedures.
    2. One of the following:
    a. Those who demonstrated persistent loss of response (no improvement 8 weeks after meeting loss of response criteria) or
    b. two Clinical Flares after an episode of loss of response during the Maintenance Study. Loss of response must be documented by sigmoidoscopy/colonoscopy for the subject to be eligible. Subjects who declined the Clinical Flare Assessment #2 or endoscopic examination at the first Clinical Flare Assessment of Maintenance Study 0157 will not be eligible,
    OR
    c. Those who have completed the Maintenance Study and confirmation of clinical remission status results are available
    3. During the study and for 7 days after receiving the last dose of the study drug, females of childbearing potential or men capable of fathering children must agree to use highly effective birth control measures (failure rate <1% when used consistently and correctly) or agree to abstain from sexual intercourse. Females of childbearing potential must test negative for pregnancy at Day 1.
    4. All male subjects must agree to refrain from semen donation during the study and for 7 days after the last dose of study drug.
    5. Must be able and willing to adhere to the study visit schedule and comply with other study requirements.
    1. Devono essere in grado di fornire il consenso informato, che è necessario ottenere prima di qualsiasi procedura correlata allo studio.
    2. Uno qualunque dei seguenti:
    a. Coloro che hanno dimostrato una perdita di risposta persistente (nessun miglioramento 8 settimane dopo la perdita dei criteri di risposta) OPPURE
    b. Due riacutizzazioni cliniche dopo un episodio di perdita di risposta durante lo studio di mantenimento. La perdita di risposta deve essere documentata mediante sigmoidoscopia/colonscopia per il soggetto che può essere ritenuto idoneo. I soggetti che hanno rifiutato la valutazione della riacutizzazione clinica (CFA) n. 2 o l'esame endoscopico alla prima valutazione della riacutizzazione clinica dello studio di mantenimento 0157 non saranno considerati idonei, OPPURE
    c. Coloro che hanno completato lo studio di mantenimento e la conferma dei risultati dello stato di remissione clinica sono disponibili
    3. Durante lo studio e per 7 giorni dopo aver ricevuto l’ultima dose del farmaco dello studio, le donne in età fertile o gli uomini in grado di generare figli devono acconsentire all’utilizzo di misure contraccettive altamente efficaci (tasso di fallimento <1% se usate sistematicamente e in modo corretto) o ad astenersi dai rapporti sessuali. Le donne in età fertile devono risultare negative al test di gravidanza al giorno 1 (fare riferimento alla Sezione 4.3).
    4. Tutti i soggetti di sesso maschile devono accettare di astenersi dal donare sperma durante lo studio e per 7 giorni dopo l’ultima dose del farmaco dello studio.
    5. Devono essere in grado e disposti ad aderire al programma delle visite dello studio e a rispettare gli altri requisiti dello studio.
    E.4Principal exclusion criteria
    1. Has current symptoms or signs suggestive of fulminant colitis, toxic megacolon, intestinal perforation
    2. Has a high risk of requiring surgery for UC or any other type of major surgery (eg, requiring general anesthesia) during the study
    3. Has been diagnosed during Protocol 0157 with Crohn’s disease, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, indeterminate colitis, or the subject has a current or past diagnosis of a fistula or abdominal abscess
    4. Has endoscopic findings during Protocol 0157 of colitis-associated colonic dysplasia; however, subjects with spontaneous (non-colitis-associated) adenomas that have been completely resected are eligible
    5. Taking any prohibited medications of exclusion as listed in the protocol currently or previously during Protocol 0157 Maintenance
    6. Deemed by the investigator to be inappropriate for this study; or has any condition which would confound or interfere with the evaluation of the safety or tolerability of the study drug (eg, developed unstable or uncontrolled and clinically significant condition/disease during Protocol 0157); or is unable or unwilling to comply with the study protocol
    7. Develops hypersensitivity to excipients or contents of the study drug as noted in Protocol 0157.
    8. Participating in or interested in participating in another investigational study (exception Protocol 0157)
    9. Has clinically significant abnormalities in the results of laboratory evaluations at the most recent laboratory evaluation prior to LTS Day 1 visit as determined by the investigator, including:
    • AST, ALT, or alkaline phosphatase = 2x the upper limit of normal (ULN)
    • Total bilirubin > 2x ULN (unless diagnosis of Gilbert’s syndrome)
    • Creatinine clearance as calculated by the Cockcroft-Gault formula < 30 mL/min
    • Total white blood cell count (WBC) < 3 x 10^9/L
    • Absolute neutrophil count < 1.5 x 10^9/L
    • Absolute lymphocyte count < 0.8 x 10^9/L
    • Hemoglobin < 8 g/dL
    • Platelet count < 100 x 10^9/L.
    1. Presentano sintomi o segni correnti indicativi di colite fulminante, megacolon tossico, perforazione intestinale
    2. Presentano un alto rischio di trovarsi nella necessità di sottoporsi a un intervento chirurgico per colite ulcerosa o a un qualsiasi altro tipo di intervento chirurgico importante (ad esempio, che richiede un'anestesia generale) durante lo studio.
    3. Nel corso del protocollo 0157, hanno ricevuto una diagnosi di morbo di Crohn, colite microscopica, colite ischemica, colite da radiazioni, malattia diverticolare associata a colite, o colite indeterminata, oppure hanno avuto o hanno una diagnosi di fistola o ascesso addominale.
    4. Hanno risultati endoscopici durante il protocollo 0157 per displasia colonica associata alla colite; tuttavia, i soggetti con adenomi spontanei (non associati alla colite) che sono stati completamente resecati sono idonei
    5. Assumono eventuali farmaci vietati di esclusione come elencato nell'Appendice 4, attualmente o in precedenza, durante il mantenimento del protocollo 0157
    6. Sono ritenuti dallo Sperimentatore inadeguati per questo studio; oppure presentano una qualsiasi condizione che potrebbe confondere o interferire con la valutazione della sicurezza o tollerabilità del farmaco dello studio (ad esempio, abbiano sviluppato una condizione medica/malattia instabile o incontrollata e clinicamente significativa durante il protocollo 0157); non sono in grado o non sono disposti a rispettare il protocollo dello studio
    7. Hanno sviluppato un’ipersensibilità nota agli eccipienti o al contenuto del farmaco dello studio
    8. Partecipano o desiderano partecipare a un altro studio sperimentale (ad eccezione del protocollo 0157)
    9. Presentano anomalie clinicamente significative nei risultati delle valutazioni di laboratorio alla più recente valutazione di laboratorio prima della visita del giorno 1 dello studio LTS, come stabilito dallo Sperimentatore, tra cui:
    • AST, ALT o fosfatasi alcalina =2x il limite superiore della norma (ULN)
    • Bilirubina totale >2x ULN (a meno che non sia stata diagnosticata la sindrome di Gilbert)
    • Clearance della creatinina calcolata con la formula di Cockcroft-Gault <30 ml/min (fare riferimento all’Appendice 2)
    • Conta leucocitaria totale (globuli bianchi) <3 x 109/l
    • Conta assoluta dei neutrofili <1,5 x 109/l
    • Conta linfocitaria assoluta <0,8 x 109/l
    • Emoglobina <8 g/dl, o
    • Conta delle piastrine <100 x 109/l
    E.5 End points
    E.5.1Primary end point(s)
    Incidence and severity of treatment-emergent adverse events, changes in laboratory safety tests, ECGs, and vital sign measurements.
    Incidenza e gravità degli eventi avversi emergenti dal trattamento; variazioni nei test di laboratorio sulla sicurezza, nell'ECG e nelle misurazioni dei segni vitali.
    E.5.1.1Timepoint(s) of evaluation of this end point
    throughout study duration
    per tutta la durata dello studio
    E.5.2Secondary end point(s)
    • Proportion of subjects who achieve clinical remission by various definitions at Week 12 among subjects entering the LTS study from Protocol 0157 Maintenance Study with persistent loss of response or recurrent clinical flare after loss of response
    • Proportion of subjects who achieve clinical response by various definitions at Week 12 among subjects entering the LTS study from Protocol 0157 Maintenance Study with persistent loss of response or recurrent clinical flare after loss of response
    • Time to major IBD-related events (hospitalizations, surgeries, or procedures)
    • Changes from baseline in IBDQ, WPAI-UC, and EuroQual (EQ-5D) scores
    • Proportions of subjects achieving clinical remission as defined by various definitions at scheduled time points.
    • Proportions of subjects maintaining clinical response at scheduled time points by various definitions in subjects who entered the LTS study in clinical response from the Maintenance Study in Protocol 0157
    • Proportion of subjects who enter study in clinical remission and maintain clinical remission by various definitions at scheduled time points
    • Proportion of subjects who enter the study in clinical response and maintain clinical response by various definitions at scheduled time points
    • Changes from baseline in partial, adapted, and total Mayo scores at scheduled time points (both Protocol 0157 Induction and Protocol 0157 Maintenance baseline)
    • Proportion of subjects achieving endoscopic response at scheduled time points
    • Proportion of subjects achieving endoscopic remission at scheduled time points
    • Percentuale di soggetti che raggiungono la remissione clinica con varie definizioni alla settimana 12 tra i soggetti che entrano nello studio LTS dallo studio di mantenimento del protocollo 0157 con perdita di risposta persistente o riacutizzazione clinica ricorrente dopo perdita di risposta
    • Percentuale di soggetti che raggiungono la risposta clinica con varie definizioni alla settimana 12 tra i soggetti che entrano nello studio LTS dallo studio di mantenimento del protocollo 0157 con perdita di risposta persistente o riacutizzazione clinica ricorrente dopo perdita di risposta
    • Tempo trascorso fino ai principali eventi correlati all'IBD (ospedalizzazioni, interventi chirurgici o procedure)
    • Variazioni rispetto al basale nei punteggi IBDQ, WPAI-UC e EuroQual (EQ 5D) agli intervalli programmati e tra i domini
    • Percentuali di soggetti che raggiungono la remissione clinica, come stabilito da varie definizioni agli intervalli programmati.
    • Percentuali di soggetti che mantengono la risposta clinica agli intervalli programmati secondo le varie definizioni nei soggetti che sono entrati nello studio LTS in risposta clinica dallo studio di mantenimento del protocollo 0157
    • Percentuale di soggetti che entrano nello studio in remissione clinica e mantengono la remissione clinica secondo le varie definizioni agli intervalli programmati
    • Percentuale di soggetti che entrano nello studio in risposta clinica e mantengono la risposta clinica secondo le varie definizioni agli intervalli programmati
    • Variazioni rispetto al basale nei punteggi Mayo parziali, adattati e totali agli intervalli programmati (sia per il basale dello studio di induzione del protocollo 0157 che per il basale dello studio di mantenimento del protocollo 0157)
    • Percentuale di soggetti che raggiungono la risposta endoscopica agli intervalli programmati
    • Percentuale di soggetti che raggiungono la remissione endoscopica agli intervalli programmati
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12 and at scheduled time points throughout study duration
    Settimana 12 e time points prestabiliti per tutta la durata dello 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 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 No
    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 Yes
    E.8.1.7.1Other trial design description
    Doppio cieco e a gruppi paralleli
    Double blind and parallel group
    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 trial3
    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 EEA100
    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
    Australia
    Canada
    Georgia
    Israel
    Japan
    Korea, Republic of
    Russian Federation
    Serbia
    South Africa
    Taiwan
    Ukraine
    United States
    Bulgaria
    Croatia
    France
    Germany
    Greece
    Hungary
    Italy
    Poland
    Portugal
    Romania
    Slovakia
    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
    Ultima Visita dell'ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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 years10
    E.8.9.2In all countries concerned by the trial months5
    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: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 500
    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 of Care
    Standard di cura
    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 Decision2020-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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