Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42869   clinical trials with a EudraCT protocol, of which   7063   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-002485-12
    Sponsor's Protocol Code Number:RP1706
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-10-22
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-002485-12
    A.3Full title of the trial
    VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target
    Studio randomizzato controllato per la determinazione dell’obiettivo di trattamento ottimale nella colite ulcerosa in fase attiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Determination of the Optimal Treatment Target in Ulcerative Colitis
    VERDICT: Studio randomizzato controllato per la determinazione dell’obiettivo di trattamento ottimale nella colite ulcerosa in fase attiva
    A.3.2Name or abbreviated title of the trial where available
    VERDICT
    VERDICT
    A.4.1Sponsor's protocol code numberRP1706
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04259138
    A.5.4Other Identifiers
    Name:VERDICTNumber:RP1706
    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 SponsorALIMENTIV INC.
    B.1.3.4CountryCanada
    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 supportTakeda Development Center Americas, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRobarts Clinical Trials Inc.
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street Address100 Dundas St., Suite 200
    B.5.3.2Town/ cityLondon, ON
    B.5.3.3Post codeN6A 5B6
    B.5.3.4CountryCanada
    B.5.4Telephone number16479925897
    B.5.5Fax number15196792770
    B.5.6E-mailfsgroup@robartsinc.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 Yes
    D.2.1.1.1Trade name Entyvio
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameEntyvio
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Powder and solvent for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 943609-66-3
    D.3.9.2Current sponsor codeMLN0002
    D.3.9.3Other descriptive nameVEDULIZUMAB
    D.3.9.4EV Substance CodeSUB30452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product 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 Yes
    D.2.1.1.1Trade name Entyvio
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameEntyvio
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 943609-66-3
    D.3.9.2Current sponsor codeMLN0002
    D.3.9.3Other descriptive nameVEDOLIZUMAB
    D.3.9.4EV Substance CodeSUB3042
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number108
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product 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
    Ulcerative Colitis (UC)
    Colite ulcerosa (CU)
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    Colite ulcerosa
    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
    The primary objective of this trial is to determine whether, in subjects with moderately to severely active UC, treating to achieve a target of corticosteroid-free symptomatic + endoscopic + histological remission is superior to a treatment target of corticosteroid-free symptomatic remission, with regards to a primary endpoint of time to UC-related complication within up to 80 weeks of follow-up after achieving target.
    L'obiettivo principale di questo studio è determinare se, in soggetti con colite ulcerosa da moderata a gravemente attiva, il trattamento senza corticostroidi per raggiungere un target di remissione sintomatica + endoscopica + istologica è superiore a un trattamento target di di remissione sintomatica senza corticosteroidi, per quanto riguarda un endpoint primario di tempo alla complicazione correlata alla colite ulcerosa entro 80 settimane dal follow-up dopo aver raggiunto l'obiettivo.
    E.2.2Secondary objectives of the trial
    -Evaluate time to UC-related complication: - per (sub)group; - per (sub)group which reaches target and not higher by Week 48-Evaluate if treatment to target of: - symptomatic + endoscopic remission (Group 2) is superior to symptomatic remission (Group 1); - corticosteroid-free symptomatic + endoscopic + histological remission (Group 3) is superior to corticosteroid-free symptomatic + endoscopic remission (Group 2) -Assess time to achieve respective target per randomized group-Assess effect of treatment allocation on UC-related complication-Evaluate change in: - fecal calprotectin/CRP/HRQoL/WPAI-UC from baseline to all follow-up visits per (sub)group; - UC-100/Mayo Clinic/ Geboes/RHI/NHI scores from baseline to Weeks 16/32/48/96 per (sub)group-Evaluate numbers of AEs and SAEs per (sub)group-Explore urine, stool, colonic mucosa, and blood samples for biomarkers and drug concentrations that are associated with clinically important outcomes-Validate SIQ-UC tool
    tempo insorgenza complicazioni correlate alla CU:per (sotto) grup; per (sotto) grup che raggiunge l'obiettivo entro week 48,Valutare se il trattamento verso l'obiettivo di:remissione sintomatica+endoscopica (Grup2)è superiore alla remissione sintomatica (Grup 1);lremissione sintomatica+endoscopica+istologica senza corticosteroidi (Grup3) è superiore remissione sintomatica+endoscopica senza corticosteroidi (Gruppo2);tempo per raggiungere il rispettivo target per gruppo randomizzato-l'effetto dell'allocazione del trattamento sulla complicazione correlata alla CU-V del cambiamento in: calprotectina fecale/CRP/HRQoL /WPAI-UC dal basale a tutte le V di FU per (sotto) grup;-punteggi UC-100/Mayo Clinic/Geboes/RHI/NHI dal basale alle settimane 16/32/48/96 per (sotto) grup- il n di AE e SAE per (sotto) grup,Esami urine, feci, mucosa del colon e campioni di sangue per biomarcatori e concentrazioni di farmaci che sono associati a risultati clinicamente importanti,Validare il questionario SIQ-UC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet each of the following criteria for enrollment into the study:
    1. Age = 18 years
    2. Diagnosis of UC confirmed by clinical, endoscopic, and histopathological evidence prior to screening as per standard criteria
    3. Moderately to severely active UC with a Mayo rectal bleeding subscore = 1 and a MES = 2, with minimum disease extent of 15 cm and objective evidence of inflammation that can be visualized using central endoscopic imaging system
    4. Ability of subject to participate fully in all aspects of this clinical trial
    5. Written informed consent must be obtained and documented
    6. Agree not to participate in an investigational trial for the duration of the trial (observation trials without investigational product may be permitted at the discretion of the investigator)
    7. Negative standard of care tuberculosis (TB) test and hepatitis B and C test prior to randomization, unless negative results available from within 12 months prior
    8. A male subject who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception* from signing of informed consent throughout the duration of the study and for 18 weeks after last dose
    9. A female subject of childbearing potential* who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose
    10. Up to date with colorectal carcinoma surveillance according to local standards and guidelines. If a subject is not up to date at screening, a standard of care surveillance assessment may be performed during the screening period.
    1. Età = 18 anni
    2. Diagnosi di CU confermata da prove cliniche, endoscopiche e istopatologiche prima dello screening secondo i criteri standard.
    3.CU da moderatamente a gravemente attiva con un subscore emorragia rettale Mayo = 1 e un MES = 2, con estensione minima della malattia di 15 cm e evidenza oggettiva di infiammazione che può essere visualizzata utilizzando il sistema di imaging endoscopico centrale
    4. Capacità del soggetto di partecipare pienamente a tutti gli aspetti di questo studio clinico
    5. Il consenso informato scritto deve essere ottenuto e documentato
    6. Accettare di non partecipare a una sperimentazione per la durata della sperimentazione (le prove di osservazione senza prodotto sperimentale possono essere consentite a discrezione dello sperimentatore)
    7. Test di tubercolosi (TB) standard negativo di cura e test di epatite B e C prima della randomizzazione, a meno che non siano disponibili risultati negativi entro 12 mesi prima
    8. Un soggetto maschio non sterilizzato e sessualmente attivo con un partner femminile in età fertile accetta di utilizzare un'adeguata contraccezione * dalla firma del consenso informato per tutta la durata dello studio e per 18 settimane dopo l'ultima dose
    9. Un soggetto femminile in età fertile * che è sessualmente attivo con un partner maschio non sterilizzato accetta di usare una contraccezione regolarmente adeguata dalla firma del consenso informato per tutta la durata dello studio e per 18 settimane dopo l'ultima dose
    10. Aggiornato con la sorveglianza del carcinoma del colon-retto secondo gli standard e le linee guida locali. Se un soggetto non è aggiornato allo screening, durante il periodo di screening può essere eseguito uno standard di valutazione della sorveglianza dell'assistenza
    E.4Principal exclusion criteria
    Subjects who exhibit any of the following conditions are ineligible for the study:
    1. Subjects who have historically failed (i.e., had an inadequate response with, lost response to, or were intolerant to) 2 or more compounds or classes of advanced therapeutic options (biologics or small molecules; e.g., anti-TNFs, ustekinumab, or tofacitinib) for the treatment of their UC
    2. Current or previous treatment with vedolizumab, etrolizumab, or natalizumab
    3. Topical therapy (corticosteroid or 5-aminosalicylate [5-ASA]) use within 2 weeks prior to screening endoscopy
    4. Change to oral corticosteroid dosing within 2 weeks prior to randomization or a corticosteroid dose of > 30 mg of prednisone or equivalent at randomization
    5. Known diagnosis of CD, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis
    6. Short gut syndrome
    7. Positive stool culture for or known C. difficile infection
    8. Pregnant women
    9. Known hepatitis B or C infection. If a negative test result is available in the 12 months prior to randomization, retesting is not required
    10. Known active or latent TB. If a negative test results is available in the 12 months prior to randomization, confirmatory testing (per standard of care) is not required before randomization.
    11. Received any investigational drug within 30 days prior to enrollment/target assignment
    12. Serious underlying disease other than UC that in the opinion of the investigator may interfere with the subject’s ability to participate fully in the study or would compromise subject safety (such as history of malignancies, major neurological disorders, or any unstable or uncontrolled medical disorder)
    13. History of alcohol or drug abuse that in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures
    14. The subject has active cerebral/meningeal disease, signs, symptoms, or any history of progressive multifocal leukoencephalopathy (PML) prior to randomization
    15. Hypersensitivity to any excipient of vedolizumab
    16. Active severe infection such as sepsis, cytomegalovirus, listeriosis, or opportunistic infection.

    1. Soggetti che hanno storicamente fallito (cioè hanno avuto una risposta inadeguata con, hanno perso la risposta o sono stati intolleranti a) 2 o più composti o classi di opzioni terapeutiche avanzate (prodotti biologici o piccole molecole; ad esempio, anti-TNF, ustekinumab, o tofacitinib) per il trattamento della loro UC
    2. Trattamento attuale o precedente con vedolizumab, etrolizumab o natalizumab
    3. L'uso della terapia topica (corticosteroidi o 5-aminosalicilato [5-ASA]) entro 2 settimane prima dell'endoscopia di screening
    4. Modifica della dose orale di corticosteroidi entro 2 settimane prima della randomizzazione o di una dose di corticosteroidi> 30 mg di prednisone o equivalente alla randomizzazione
    5. Diagnosi nota di DC, colite indeterminata, colite ischemica, colite da radiazioni, malattia diverticolare associata a colite o colite microscopica
    6. Sindrome dell'intestino corto
    7. Cultura positiva delle feci per o nota infezione da C. difficile
    8. Donne in gravidanza
    9. Infezione nota per epatite B o C. Se nei 12 mesi precedenti la randomizzazione è disponibile un risultato negativo del test, non è necessario ripetere il test
    10. TB nota attiva o latente. Se nei 12 mesi precedenti la randomizzazione sono disponibili risultati di test negativi, prima della randomizzazione non sono richiesti test di conferma (per standard di cura).
    11. Ricevuto qualsiasi farmaco sperimentale entro 30 giorni prima dell'arruolamento / assegnazione del target
    12. Grave malattia di base diversa dalla CU che, secondo l'opinione dello sperimentatore, potrebbe interferire con la capacità del soggetto di partecipare pienamente allo studio o comprometterebbe la sicurezza del soggetto (come anamnesi di tumori maligni, gravi disturbi neurologici o qualsiasi disturbo medico instabile o non controllato )
    13. Storia di abuso di alcol o droghe che, secondo l'opinione dello sperimentatore, può interferire con la capacità del soggetto di conformarsi alle procedure di studio
    14. Il soggetto ha una malattia cerebrale / meningea attiva, segni, sintomi o qualsiasi storia di leucoencefalopatia multifocale progressiva (PML) prima della randomizzazione
    15. Ipersensibilità a qualsiasi eccipiente di vedolizumab
    16. Infezione grave attiva come sepsi, citomegalovirus, listeriosi o infezione opportunistica.
    E.5 End points
    E.5.1Primary end point(s)
    Time to UC-related complication.
    Tempo alle complicazioni correlate alla colite ulcerosa
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 80 weeks of follow-up after achieving target of corticosteroid-free symptomatic + endoscopic + histological remission.
    Fino a 80 settimane di follow-up dopo aver raggiunto l'obiettivo senza corticosteroidi di remissione sintomatica + endoscopica + istologica
    E.5.2Secondary end point(s)
    1. Time to UC-related complications in the full analysis set, including subgroups on and off corticosteroids at the time of achieving other relevant components of the treatment target
    2. Whether treatment to the target of symptomatic + endoscopic remission (Group 2) is superior to a treatment target of symptomatic remission (Group 1) in terms of the primary endpoint (both in the full and the achieved target populations)
    3. Whether treatment to the target of corticosteroid-free symptomatic + endoscopic + histologic remission (Group 3) is superior to a treatment target of corticosteroid-free symptomatic + endoscopic remission (Group 2) in terms of the primary endpoint (both in the full and the achieved-target populations)
    4. Time to UC-related complication (as in the primary outcome and secondary outcomes 2 and 3) in the subgroup of subjects who exclusively reach their assigned target and not a higher target by Week 48
    5. Time taken to achieve the respective targets among the 3 randomized groups. Time will be censored for subjects who do not achieve their assigned target by Week 48
    6. Across the 3 randomized groups, time to each type of UC-related complication separately that comprises the primary endpoint (both in the full and achieved-target populations)
    7. The effect of treatment allocation on UC-related complication that is mediated through treatment targets
    8. Change in fecal calprotectin levels from baseline to Weeks 8, 16, 32, 48, and 96 (both in the full and the achieved-target populations)
    9. Change in C-reactive protein (CRP) concentration from baseline to Weeks 8, 16, 32, 48, 64, 80, and 96 (both in the full and the achieved-target populations)
    10. Change in the UC-100 score from baseline to Weeks 16, 32, 48, and 96 (both in the full and the achieved target populations)
    11. Change in health-related quality of life (HRQoL) using the Inflammatory Bowel Disease Questionnaire (IBDQ) from baseline to Weeks 16, 32, 48, 64, 80, and 96 (both in the full and the achieved-target populations)
    12. Change in the Work Productivity and Activity Impairment-UC (WPAI-UC) questionnaire from baseline to Weeks 16, 32, 48, 64, 80, and 96 (both in the full and the achieved-target populations)
    13. Change in Mayo Clinic Score (MCS; and subcomponents including the MES) from baseline to Weeks 16, 32, 48, and 96 (both in the full and the achieved-target populations)
    14. Change in Geboes scores from baseline to Weeks 16, 32, 48, and 96 (both in the full and the achieved-target populations)
    15. Change in Robarts Histological Index (RHI) scores from baseline to Weeks 16, 32, 48, and 96 (both in the full and the achieved-target populations)
    16. Change in Nancy Histological Index scores from baseline to Weeks 16, 32, 48, and 96 (both in the full and the achieved-target populations)
    17. The numbers of AEs and SAEs among the 3 randomized groups
    18. Evaluation of urine, stool, colonic mucosa, and blood samples for biomarkers and drug concentrations that are associated with clinically important outcomes
    19. Validation of the SIQ-UC tool in English-fluent subjects, as described in the SAP
    SECONDARI PUNTI FINE
    1. Tempo necessario per le complicanze correlate alla CU nella serie completa di analisi, compresi i sottogruppi di attivazione e disattivazione dei corticosteroidi al momento del raggiungimento di altri componenti rilevanti dell'obiettivo del trattamento
    2. Se il trattamento verso il target della remissione sintomatica + endoscopica (Gruppo 2) è superiore a un target del trattamento della remissione sintomatica (Gruppo 1) in termini di endpoint primario (sia nella popolazione target completa che in quella raggiunta)
    3. Se il trattamento verso il target di remissione sintomatica + endoscopica + istologica senza corticosteroidi (Gruppo 3) è superiore a un target di trattamento di remissione sintomatica + endoscopica senza corticosteroidi (Gruppo 2) in termini di endpoint primario (entrambi in pieno e le popolazioni target raggiunte)
    4. Tempo alla complicazione correlata alla CU (come nell'outcome primario e negli outcome secondari 2 e 3) nel sottogruppo di soggetti che raggiungono esclusivamente il target assegnato e non un target più elevato entro la Settimana 48
    5. Tempo impiegato per raggiungere i rispettivi obiettivi tra i 3 gruppi randomizzati. Il tempo verrà censurato per i soggetti che non raggiungono l'obiettivo assegnato entro la settimana 48
    6. Attraverso i 3 gruppi randomizzati, tempo a ciascun tipo di complicazione correlata alla CU separatamente che comprende l'endpoint primario (sia nella popolazione completa che in quella raggiunta)
    7. Effetto dell'allocazione del trattamento sulla complicazione correlata alla CU mediata attraverso gli obiettivi del trattamento
    8. Variazione dei livelli fecali di calprotectina dal basale alle settimane 8, 16, 32, 48 e 96 (sia nella popolazione completa che in quella raggiunta)
    9. Modifica della concentrazione di proteina C-reattiva (CRP) dal basale alle settimane 8, 16, 32, 48, 64, 80 e 96 (sia nella popolazione completa che in quella raggiunta)
    10. Modifica del punteggio CU-100 dal basale alle settimane 16, 32, 48 e 96 (sia nella popolazione target completa che in quella raggiunta)
    11. Modifica della qualità della vita correlata alla salute (HRQoL) utilizzando il questionario sulla malattia infiammatoria intestinale (IBDQ) dal basale alle settimane 16, 32, 48, 64, 80 e 96 (sia nella popolazione completa che in quella raggiunta)
    12. Modifica del questionario sulla produttività del lavoro e sulla compromissione dell'attività (WPAI-UC) dal basale alle settimane 16, 32, 48, 64, 80 e 96 (sia nella popolazione completa che in quella raggiunta)
    13. Modifica del punteggio della Mayo Clinic (MCS; e dei sottocomponenti incluso il MES) dal basale alle settimane 16, 32, 48 e 96 (sia nella popolazione completa che in quella raggiunta)
    14. Variazione dei punteggi Geboes dal basale alle settimane 16, 32, 48 e 96 (sia nella popolazione completa che in quella raggiunta)
    15. Modifica dei punteggi dell'indice istologico di Robarts (RHI) dal basale alle settimane 16, 32, 48 e 96 (sia nella popolazione completa che in quella raggiunta)
    16. Modifica dei punteggi dell'indice istologico di Nancy dal basale alle settimane 16, 32, 48 e 96 (sia nella popolazione completa che in quella raggiunta)
    17. Il numero di eventi avversi e eventi avversi tra i 3 gruppi randomizzati
    18. Valutazione di urine, feci, mucosa del colon e campioni di sangue per biomarcatori e concentrazioni di farmaci associati a risultati clinicamente importanti
    19. Convalida dello strumento SIQ-UC in soggetti fluenti in inglese, come descritto nel SAP
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and Weeks 8/16/32/48/64/80/96 (as specified in E.5.2 Secondary end point(s))
    Al basale e alle settimane 8/16/32/48/64/80/96 (come specificato nella sezione E.5.2 End point secondari)
    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 Yes
    E.6.13.1Other scope of the trial description
    Comparison of treatment algorithms to reach treatment target.
    Confronto degli algoritmi di trattamento per raggiungere l'obiettivo del trattamento.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    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
    I soggetti in studio saranno in cieco, mentre gli investigatori saranno in aperto
    Study subjects will be blinded to group allocation, whereas investigators will be unblinded.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    I pazienti saranno randomizzatti al trattamento target
    Participants are randomized to treatment target.
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    Belarus
    Belgium
    Canada
    France
    Italy
    Netherlands
    Poland
    Russian Federation
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    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: 561
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 99
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state56
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 660
    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)
    After a subject has ended their participation in the trial, they will return to standard of care and may remain on vedolizumab at the discretion of their investigator.
    Dopo che un soggetto ha completato lo studio, tornerà allo standard di cura e può continuare ad assumere vedolizumab a discrezione del medico sperimentatore
    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 Decision2020-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-23
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA