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    Summary
    EudraCT Number:2018-002136-24
    Sponsor's Protocol Code Number:0157
    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 number2018-002136-24
    A.3Full title of the trial
    A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis
    Insieme di studi di Fase 2b/3 multicentrico, randomizzato, a doppio cieco, a più dosi, controllato con placebo, a gruppi paralleli per valutare l'efficacia e la sicurezza della terapia di induzione e di mantenimento con TD - 1473 in soggetti con colite ulcerosa attiva da moderata a grave
    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 Moderately-to-Severely Active Ulcerative Colitis
    Una sperimentazione clinica per studiare l'efficacia e la sicurezza di TD-1473 per il trattamento della colite ulcerosa attiva da moderata a grave
    A.3.2Name or abbreviated title of the trial where available
    Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis
    Rhea: efficacia e sicurezza di TD-1473 nella colite ulcerosa
    A.4.1Sponsor's protocol code number0157
    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 code D04 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    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
    Moderately-to-Severely Active Ulcerative Colitis
    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
    Phase 2b Dose-Finding Induction
    • Assess the effect of TD-1473 taken daily for 8 weeks at daily doses of 20 mg, 80 mg, and 200 mg on the change in total Mayo score
    • Assess the effect of TD-1473 on rates of clinical remission, endoscopic healing, clinical response, and mucosal (ie, histologic and endoscopic) healing
    • Upon completion, select dose(s) of TD-1473, based on safety, tolerability, and efficacy data, including exposure-response data, for continued evaluation in the Phase 3 dose-confirming Induction Study and the Phase 3 Maintenance Study

    Phase 3 Dose-Confirming Induction
    • Assess the clinical remission rates associated with TD-1473 compared to placebo treatment at Week 8
    • Assess the safety and tolerability of TD-1473 taken for up to 16 weeks

    Phase 3 Maintenance
    • Assess the clinical remission rates associated with TD-1473 compared to placebo treatment at mWeek 44
    • Assess the safety and tolerability of TD-1473 with up to 44 additional weeks of treatment
    Stud. di induz. di Fase 2b di definiz. del dosag. :Valutare l'effetto di TD-1473 assunto ogni giorno per 8 settim. a dosi giornaliere di 20 mg, 80 mg e 200 mg alla variaz. rispet. al basale in base al punteg. Mayo totale;Valutare l'effetto di TD-1473 sulla base dei tassi di remis. clinica, guarigione endoscopica, risposta clinica e guarigione della mucosa ;Al termine, selez. la o le dosi di TD-1473 sulla base dei dati di sicurezza, tollerab. ed efficacia da valutare nello studio di induz. di Fase 3 di conferma del dosag. e nello studio di Fase 3 di mantenim.Studio di induz. di conferma del dosaggio di Fase 3:Stabilire il tasso di remis. clinica associato a TD-1473 rispetto al trattam. con placebo alla settimana 8;Stabilire la sicurezza e la tollerab. di TD-1473 assunto per un massimo di 16 set..Studio di mant.:Stabilire il tasso di remis. clinica associato a TD-1473 rispetto al trattam. con placebo alla sett. 44;Stabilire la sicurezza e la tollerabilità di TD-1473 per un max di 44 sett
    E.2.2Secondary objectives of the trial
    Phase 3 Dose-Confirming Induction
    Assess the rates of the following associated with TD-1473 compared to placebo treatment:
    • Endoscopic healing, symptomatic remission, clinical response, mucosal healing (endoscopic and histologic) and deep symtomatic remission at week 8
    • Assess at Week 16 the clinical response rate following extended induction treatment with TD-1473 in subjects who did not demonstrate clinical response at Week 8

    Phase 3 Maintenance
    Assess the rates of the following associated with TD-1473 compared to placebo treatment:
    • Clinical response, endoscopic healing, symptomatic remission, mucosal healing and deep symptomatic remission at mWeek 44
    • Corticosteroid-free remission at mWeek 44
    • Maintenance of clinical remission at mWeek 44 in those who were in clinical remission at mWeek 0
    Fase 3 di conferma della dose:Stabilire il tasso di remissione clinica associato a TD-1473 rispetto al trattamento con placebo:
    • Risposta clinica, guarigione endoscopica, remissione sintomatica e guarigione della mucosa (endoscopica ed istologica) e remissione sintomatica profonda alla settimana 8• Stabilire alla settimana 16 il tasso di risposta clinica a seguito del trattamento d'induzione esteso con TD-1473 in soggetti che non hanno dimostrato risposta clinica alla settimana 8
    Fase 3 di mantenimento:Valutare le percentuali dei seguenti fattori associati a TD-1473 rispetto al trattamento con placebo:
    • Risposta clinica, guarigione endoscopica, remissione sintomatica e guarigione della mucosa e remissione sintomatica profonda alla settimana di mantenimento 44
    • Remissione senza corticosteroidi alla settimana di mantenimento 44
    • Mantenimento della remissione clinica alla settimana di mantenimento 44 nei soggetti che erano in remissione alla settimana di mantenimento 0
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Optional Genetic Test
    An optional genetic testing will be performed in all subjects who agree to
    participate and provide their additional specific consent. The genetic
    blood sample should be collected at the Day 1 visit

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Test genetico opzionale
    Un test genetico facoltativo verrà eseguito nei pazienti che accettano di partecipare e di fornire il loro ulteriore consenso specifico. Il campione di sangue genetico deve essere raccolto alla visita del giorno 1
    E.3Principal inclusion criteria
    1. Are male or female 18 years of age or older at Screening
    2. Has > o = 3 months history of UC prior to screening (with involvement beyond the rectum to at least 15 cm from the anal verge)
    a. Diagnosed by sigmoidoscopy or colonoscopy AND
    b. If possible, corroborated by histology report or documentation of histological results in a physician note. However, if there was no biopsy done previously or if no prior endoscopy or histology report is available for review, the subject must have a colonoscopy instead of a sigmoidoscopy at screening.
    3. Must be willing to have a sigmoidoscopy or colonoscopy at screening. Colonoscopy will be performed instead of a sigmoidoscopy at screening in the following scenarios, (outlined in Section 6.4.1.20):
    a. If UC diagnosis precedes screening by > o = 8 years for pan-colitis or > o = 12 years for left sided colitis and the subject does not have documentation of a surveillance colonoscopy within 12 months prior to screening to rule out dysplasia (report must be reviewed by the investigator and included in the source documents). During colonoscopy, if chromoendoscopy or surveillance biopsies are indicated as per locally adopted guidelines, these should be performed.
    b. If UC diagnosis precedes screening by < 12 years and the subject does not have documentation of a colonoscopy within 2 years prior to screening (report must be reviewed by investigator and included in the source documents).
    c. If there is no documented histology report from prior endoscopy showing chronic colitis or other signs of UC. In this case, consideration should be made to do biopsies during the screening endoscopy with histology sent locally to confirm diagnosis of UC, if there is doubt of diagnosis
    If chromoendoscopy has to be performed or > o = 10 biopsies are to be collected for dysplasia surveillance, either should be done after completion of a full colonoscopy to avoid chromoendoscopy dye or biopsy-related bleeding artifact from interfering with endoscopic images for central reading.
    4. Has moderately-to-severely active UC, defined as having:
    a. a centrally read Mayo endoscopic subscore of > or = 2 points based on the results of the Screening Stage 2 endoscopy
    AND
    b. an adapted Mayo score between 4 and 9 points, inclusive, on Day 1.

    5. Is corticosteroid-dependent or had intolerance or inadequate response to any of the following: corticosteroids, immunomodulators (azathioprine or 6 mercaptopurine), or biologics (anti-TNF, anti-integrin, or anti-IL-12/23) [Refer to Appendix 7]
    Please see the protocol for the complete list
    1. Essere di sesso maschile o femminile e di età pari o superiore a 18 anni allo screening
    2. Avere un'anamnesi di colite ulcerosa > o = 3 mesi prima dello screening (con interessamento oltre il retto fino ad almeno 15 cm dal margine anale)
    a. Diagnosticata mediante sigmoidoscopia o colonscopia E
    b. Se possibile, confermata da referto istologico o documentazione dei risultati istologici in una nota del medico. Tuttavia, se non è stata precedentemente effettuata una biopsia o non è disponibile una precedente endoscopia o un referto istologico per l'esame, allo screening il soggetto deve sottoporsi a una colonscopia invece che a una sigmoidoscopia.
    3. Devono essere disposti a sottoporsi a una sigmoidoscopia o a una colonscopia allo screening. La colonscopia verrà eseguita al posto di una sigmoidoscopia allo screening nelle seguenti situazioni (descritte al paragrafo 6.4.1.20):
    a. Se la diagnosi di colite ulcerosa precede lo screening di > o = 8 anni in caso di pancolite o > o = 12 anni in caso di colite distale e il soggetto non dispone di documentazione attestante l'esecuzione di una colonscopia di controllo eseguita nei 12 mesi precedenti allo screening per escludere la displasia (il referto deve essere esaminato dallo sperimentatore e incluso nei documenti di origine). Durante la colonscopia si dovrà procedere con una cromoendoscopia o biopsie di controllo se previste dalle linee guida adottate a livello locale.
    b. Se la diagnosi di colite ulcerosa precede lo screening di <12 anni e il soggetto non ha la documentazione attestante l'esecuzione della colonscopia eseguita nei 2 anni precedenti allo screening (il referto deve essere esaminato dallo sperimentatore e incluso nei documenti di origine).
    c. Se non sono presenti referti istologici documentati di precedenti endoscopie che mostrano una colite cronica o altri segni di colite ulcerosa. In questo caso, si dovrebbe considerare se effettuare biopsie durante l'endoscopia di screening con l'istologia inviata localmente per confermare la diagnosi di colite ulcerosa, ove emergano dubbi sulla diagnosi.
    Se deve essere eseguita la cromoendoscopia o devono essere raccolte > o = 10 biopsie per indagare la presenza di displasia, si dovrà procedere in entrambi i casi dopo l'esecuzione di una colonscopia completa per evitare che il colorante della cromoendoscopia o l'artefatto sanguinante in seguito a biopsia interferiscano con le immagini endoscopiche ai fini della lettura centralizzata.
    4. Sono affetti da colite ulcerosa in fase attiva di grado moderato-severo, come da:
    a. sottopunteggio endoscopico Mayo di > o = 2 punti con lettura centralizzata, dai risultati dell'endoscopia eseguita nella fase di screening 2
    E
    b. da un punteggio Mayo adattato compreso tra 4 e 9 punti, estremi inclusi, il Giorno 1.

    5. Dipendono dai corticosteroidi, hanno avuto un'intolleranza o una risposta inadeguata a uno qualsiasi dei seguenti: corticosteroidi, immunomodulatori (azatioprina o 6-mercaptopurina) o farmaci biologici (anti TNF , anti-integrina o anti IL-12/23) [Fare riferimento all'Appendice 7]
    Per l'elenco completo si prega di visualizzare il protocollo
    E.4Principal exclusion criteria
    Subjects may not be enrolled if they:
    1. Has symptoms or signs suggestive of fulminant colitis, toxic megacolon, intestinal perforation
    2. Has primary sclerosing cholangitis
    3. Is likely to require surgery for UC or any other type of major surgery (ie, surgical procedure requiring general anesthesia) during the Study
    4. Has had a clinically significant prior intestinal resection for UC or for other GI diseases
    5. Has carried/carries a diagnosis of Crohn’s disease, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or indeterminate colitis, or the subject has a current or past diagnosis of a fistula or abdominal abscess.
    6. Has unresected colonic mucosal dysplasia or history of resected high-grade colonic dysplasia within 3 years prior to screening.
    7. Taken or taking any prohibited medications as listed in the protocol
    8. If subject has recently discontinued aminosalicylates or corticosteroids, these must have been stopped at minimum of 2 weeks before screening endoscopic procedure.
    9. Has had inadequate response > or = 3 biologics of > or = 3 different mechanisms of action (i.e., anti TNF,anti-integrin, and anti-IL12/23
    10. Currently taking or has taken within 14 days prior to Day 1 any concomitant medication, herbal supplement or dietary substance known to be a strong inhibitor or inducer of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), or CYP450 3A4 or is a substrate of P-gp or BCRP and has a narrow therapeutic index
    11. Taking non-UC concomitant prescription medications that may confound the safety assessment of the study drug and that have started or have had a dose adjustment within 28 days prior to Day 1. Anti-diarrheal medications and probiotics are allowed only if dose has been stable for minimum of 14 days prior to Day 1.
    12. Taking OTC medications or dietary supplements that may confound the safety assessment of the study drug and that have started or with a dose adjustment within 14 days prior to Day 1 with the exception of up to 3 times per week use of NSAID or acetaminophen used on an as needed basis, aspirin < or = 325 mg per day for cardiovascular prophylaxis, and OTC doses of vitamin D
    13. Subject is positive for:
    a. HBV surface antigen
    b. HBV core antibody (unless subject has positive HB surface antibody and undetectable serum hepatitis HB DNA).
    c. HCV antibody unless there is evidence of undetectable viral load measured twice 6 months apart after successful completion of treatment regimen and viral load during Screening is undetectable
    d. Hepatitis E IgM antibody
    e. HIV antibody
    14. Subject has had a live viral vaccine within 4 weeks prior to screening and/or is unwilling or unable to avoid live viral vaccines during the Study and for 8 weeks following completion of the Study. Subject must be willing to avoid contact with any household member who has been vaccinated with a live attenuated vaccine within 2 weeks after vaccination.
    15. Has or may have untreated active or latent TB
    16. Has any of the following:
    a. An active, clinically significant, bacterial, parasitic, fungal, mycobacterial (including atypical infection), or viral infection, except for local skin or nail bed infection, within 2 weeks prior to Day 1. Please see the protocol for the complete list
    I soggetti non possono essere arruolati se:
    1. Presentano sintomi o segni indicativi di colite fulminante, megacolon tossico, perforazione intestinale
    2. Sono affetti da colangite sclerosante primitiva
    3. Possono richiedere un intervento chirurgico per colite ulcerosa o qualsiasi altro tipo di intervento chirurgico importante (ad es. una procedura chirurgica che richiede anestesia generale) durante lo studio
    4. Sono stati sottoposti in precedenza a resezione intestinale clinicamente rilevante (secondo il giudizio dello sperimentatore) per colite ulcerosa o altre malattie gastrointestinali
    5. Hanno ricevuto in passato o al momento 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.
    6. Hanno displasia della mucosa del colon non sottoposta a resezione o un'anamnesi di displasia del colon di grado elevato sottoposta a resezione nei 3 anni precedenti lo screening (i soggetti con grandi adenomi che sono stati sottoposti a resezione completa o con risultati di patologie di displasia indefinita con atipia reattiva sono ugualmente considerati idonei)
    7. Assunzione pregressa o in corso di farmaci vietati come elencati nel protocollo
    8. Se il soggetto ha sospeso di recente l'assunzione di aminosalicilati o corticosteroidi, questa dovrà essere avvenuta almeno 2 settimane prima della procedura endoscopica di screening.
    9. Ha mostrato risposta inadeguata (ovvero mancanza di risposta primaria o secondaria)a > o = 3 farmaci biologici con = o > 3 diversi meccanismi di azione (ovvero, anti-TNF, anti-integrina e anti-IL 12/23)
    10. Sta assumendo o ha assunto entro 14 giorni prima del Giorno 1 qualsiasi farmaco concomitante, integratore a base di erbe o sostanza alimentare (ad es. pompelmo) noti per essere forti inibitori o induttori della P-glicoproteina (P-gp), della proteina di resistenza del cancro della mammella (BCRP) o del CYP450 3A4 o sono un substrato di P-gp o di BCRP e hanno uno stretto indice terapeutico
    Per l'elenco completo si prega di visualizzare il protocollo
    E.5 End points
    E.5.1Primary end point(s)
    Ph2b Induction Efficacy Endpoints - Change in total Mayo score from baseline at Week 8
    Ph3 Induction Efficacy Endpoints - Clinical remission by adapted Mayo score components at Week 8
    Ph3 Maintenance Efficacy Endpoints - Clinical remission by adapted Mayo score components at mWeek 44
    Endpoint di efficacia dello studio di induzione di Fase 2b:
    • Variazione del punteggio Mayo totale rispetto al basale alla settimana 8

    Endpoint di efficacia dello studio di induzione di Fase 3:
    • Remissione clinica secondo il punteggio Mayo adattato alla settimana 8

    Endpoint di efficacia dello studio di mantenimento di Fase 3:
    • Remissione clinica secondo il punteggio Mayo adattato alla settimana di mantenimento (m) 44
    E.5.1.1Timepoint(s) of evaluation of this end point
    Ph2b Induction Efficacy Endpoints - Week 8
    Ph3 Induction Efficacy Endpoints - Week 8
    Ph3 Maintenance Efficacy Endpoints - Maintenance Phase Week 44
    Endpoint di efficacia dello studio di induzione di Fase 2b: settimana 8
    Endpoint di efficacia dello studio di induzione di Fase 3: settimana 8
    Endpoint di efficacia dello studio di mantenimento di Fase 3: fase di mantenimento settimana 44
    E.5.2Secondary end point(s)
    Ph2b Induction Efficacy Key Secondary Endpoints (with multiplicity control):
    • Clinical remission by adapted Mayo score components at Week 8

    Ph3 Induction Efficacy Key Secondary (with multiplicity control) Endpoints:
    • Endoscopic healing at Week 8
    • Symptomatic remission at Week 8
    • Clinical response by adapted Mayo score definition at Week 8
    • Mucosal healing at Week 8

    Ph3 Maintenance Efficacy Key Secondary (with multiplicity control) Endpoints:
    • Maintenance of clinical response by adapted Mayo score at mWeek 44
    • Endoscopic healing at mWeek 44
    • Symptomatic remission at mWeek 44
    • Corticosteroid-free remission at mWeek 44
    • Maintenance of clinical remission at mWeek 44 in those who were in clinical remission at mWeek 0
    • Mucosal healing at mWeek 44
    Endpoint secondari di efficacia dello studio di induzione di Fase 2b (con controllo della molteplicità):
    • Remissione clinica secondo il punteggio Mayo adattato alla settimana 8
    Endpoint secondari di efficacia dello studio di induzione di Fase 3 (con controllo della molteplicità):
    • Guarigione endoscopica alla settimana 8
    • Remissione sintomatica alla settimana 8
    • Risposta clinica secondo la definizione adattata del punteggio Mayo alla settimana 8
    • Guarigione delle mucose alla settimana 8
    Endpoint secondari di efficacia dello studio di mantenimento di fase 3:
    • Mantenimento della risposta clinica alla settimana (m) 44
    • Guarigione endoscopica alla settimana (m) 44
    • Remissione sintomatica alla settimana (m) 44
    • Remissione libera da corticosteroidi alla settimana (m) 44
    • Mantenimento della remissione clinica alla settimana (m) 44 in coloro che erano in remissione alla settimana (m) 0
    • Guarigione delle mucose alla settimana (m) 44
    E.5.2.1Timepoint(s) of evaluation of this end point
    Ph2b Induction Efficacy Endpoints - Week 8
    Ph3 Induction Efficacy Endpoints - Week 8
    Ph3 Maintenance Efficacy Endpoints - Maintenance Phase Week 44
    Endpoint di efficacia dello studio di induzione di Fase 2b: settimana 8
    Endpoint di efficacia dello studio di induzione di Fase 3: settimana 8
    Endpoint di efficacia dello studio di mantenimento di Fase 3: fase di mantenimento settimana 44
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 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
    last subject study visit (including the 4 week follow up visit) in the Phase 3 Maintenance study.
    Visita dello studio dell'ultimo paziente ( inclusa la visita di follow up di 4 settimane) nello studio di mantenimento di fase 3.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    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: 800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 342
    F.4.2.2In the whole clinical trial 880
    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 Decision2020-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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