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    Summary
    EudraCT Number:2014-003824-36
    Sponsor's Protocol Code Number:GA29144
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 number2014-003824-36
    A.3Full title of the trial
    A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE
    STUDIO MULTICENTRICO DI FASE III, RANDOMIZZATO, IN DOPPIO CIECO, CONTROLLATO CON PLACEBO, PER VALUTARE L¿EFFICACIA E LA SICUREZZA DI ETROLIZUMAB COME TRATTAMENTO DI INDUZIONE E MANTENIMENTO NEI PAZIENTI AFFETTI DA MORBO DI CROHN IN FASE ATTIVA DI GRADO DA MODERATO A GRAVE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease
    Studio di fase III per valutare l'efficacia e la sicurezza di Etrolizumab in pazienti affetti da Morbo di Crohn da moderato a grave.
    A.3.2Name or abbreviated title of the trial where available
    A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with
    Studio di fase III per valutare l'efficacia e la sicurezza di Etrolizumab in pazienti affetti da Mor
    A.4.1Sponsor's protocol code numberGA29144
    A.5.4Other Identifiers
    Name:GA29144Number:GA29144
    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 SponsorF. HOFFMANN - LA ROCHE LTD.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0
    B.5.5Fax number0
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameEtrolizumab
    D.3.2Product code Ro 549-0261/F04-02
    D.3.4Pharmaceutical form Solution for injection
    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.3.8INN - Proposed INNEtrolizumab
    D.3.9.1CAS number 1044758-60-2
    D.3.9.2Current sponsor codeRO5490261
    D.3.9.3Other descriptive nameEtrolizumab
    D.3.9.4EV Substance CodeSUB75320
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number105
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticorpo monoclonale umanizzato
    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 nameEtrolizumab
    D.3.2Product code Ro 549-0261/F08-02
    D.3.4Pharmaceutical form Solution for injection
    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.3.8INN - Proposed INNetrolizumab
    D.3.9.1CAS number 1044758-60-2
    D.3.9.2Current sponsor codeRO5490261
    D.3.9.4EV Substance CodeSUB75320
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number210
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticorpo monoclonale umanizzato
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn's Disease
    Morbo di Crohn
    E.1.1.1Medical condition in easily understood language
    A form of inflammatory bowel disease
    Malattia infiammatoria intestinale
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy Objectives
    Induction Phase
    ¿ To evaluate the efficacy of etrolizumab dose regimens compared with placebo in inducing CDAI remission, defined as a CDAI score < 150 at the end of the Induction Phase (Week 14)
    Maintenance Phase
    ¿ To evaluate the efficacy of etrolizumab compared with placebo in maintaining corticosteroid (CS)-free CDAI remission for 1 year (52 weeks) among patients who achieved sustained CDAI remission at the end of the Induction Phase (Weeks 10 and 14)
    Safety Objectives
    ¿ To evaluate the overall safety and tolerability of etrolizumab compared with placebo during Induction and Maintenance Phases of therapy
    Obiettivi di Efficacia
    Fase di Induzione
    ¿ Valutare l¿efficacia di regimi posologici di etrolizumab rispetto a placebo nell¿indurre una remissione CDAI, definita come punteggio CDAI < 150 al termine della Fase di induzione (Settimana 14).
    Fase di Mantenimento
    ¿ Valutare l¿efficacia di etrolizumab rispetto a placebo nel mantenimento di una remissione CDAI senza corticosteroidi (CS) per 1 anno (52 settimane) nei pazienti che hanno ottenuto una remissione CDAI sostenuta al termine della Fase di induzione (Settimane 10 e 14).
    Obiettivi di sicurezza
    ¿ Valutare la sicurezza e la tollerabilit¿ complessive di etrolizumab rispetto a placebo durante le Fasi di induzione e mantenimento della terapia.
    E.2.2Secondary objectives of the trial
    Evaluate in Induction Phase the efficacy of etrolizumab:
    -dose regimens compared with placebo in inducing endoscopic improvement at Wk14, defined as a =50% reduction from the baseline SES-CD score
    -dose regimens compared with placebo in inducing CDAI-100 response, defined as a decrease of at least 100 points from the baseline CDAI score at Wk14
    -compared with placebo in achieving sustained induction of CDAI remission at Wks10 and 14
    Evaluate in Maintenance Phase the efficacy of etrolizumab:
    -dose regimens compared with placebo in achieving endoscopic improvement at Wk66 (compared to endoscopic score at Wk0), among
    patients achieving CDAI-70 response (defined as a decrease of at least 70 points from the baseline CDAI score) at Wk14
    -compared with placebo in maintaining CDAI remission at Wk66, among patients achieving CDAI remission at Wk14
    -compared with placebo in achieving CDAI-100 response at Wk66 (compared to CDAI at Wk0) among patients achieving CDAI-70 response
    at Wk14
    Valutare nella Fase di Induzione l'efficacia di etrolizumab:
    - regimi posologici rispetto a placebo nell¿indurre un miglioramento endoscopico alla Settimana 14, definito come una riduzione =50% rispetto al punteggio endoscopico semplice per il morbo di Crohn riscontrato al basale.
    - regimi posologici rispetto a placebo nell¿indurre una risposta CDAI-100, definita come una riduzione di almeno 100 punti rispetto al punteggio CDAI basale alla Settimana 14.
    - rispetto a placebo nell¿ottenere un¿induzione sostenuta della remissione CDAI alle Settimane 10 e 14.
    Valutare nella Fase di Mantenimento l'efficacia di etrolizumab:
    - regimi posologici rispetto a placebo nel raggiungere un miglioramento endoscopico alla Settimana 66 (rispetto al punteggio endoscopico alla Settimana 0) nei pazienti che hanno ottenuto una risposta CDAI-70 (definita come una riduzione di almeno 70 punti rispetto al punteggio CDAI basale) alla Settimana 14
    - rispetto a placebo nel mantenimento della remissione CDAI alla
    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: The main protocol contains all details of the sub-study. There are no separate documents (with title, date and version) for the substudy.
    The objective of the substudy is to determine the relationship between etrolizumab exposure and receptor occupancy in peripheral blood in patients with CD. To achieve this objective, it is planned to enroll approximately 150 patients in the substudy. Blood sampling for the PK/PD substudy will continue in the Maintenance Phase. Patients in all cohorts will provide blood samples for population PK analysis and PD characterization.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Il protocollo principale contiene tutti i dettagli del sottostudio. Non ci sono documenti separati (con titolo, data e versione) per il sottostudio. Obiettivo del sottostudio ¿ quello di determinare la relazione tra l' esposizione ad etrolizumab e l' occupazione del recettore nel sangue periferico in pazienti con Morbo di Crohn.. Per raggiungere questo obiettivo, si prevede di arruolare circa 150 pazienti nel sottostudio. Prelievo di sangue per la PK / PD sottostudio continuer¿ nella fase di mantenimento. I pazienti in tutto coorti forniranno campioni di sangue per l'analisi farmacocinetica di popolazione e per il profilo di farmacodinamica.
    E.3Principal inclusion criteria
    - 18-80 years of age (inclusive)
    - Moderately to severely active Crohn's disease as determined by the Crohn's Disease Activity Index (CDAI), patient reported outcomes and endoscopically defined disease activity in the ileum and/or colon
    - Intolerance, loss of response or failure to respond to corticosteroids (CS) or, immunosuppressants (IS), or TNF inhibitors within the previous 5 years
    - Use of effective contraception as defined by the protocol
    - Età dai 18 agli 80 anni (inlcusi)
    - Malattia di Crohn in fase attiva da moderata a grave determinata dal Disease Activity Index di Crohn (CDAI), da quanto riferito dal paziente e dall'attività patologica endoscopicamente definita nell'ileo e / o del colon
    - Intolleranza, perdita di risposta o mancata risposta ai corticosteroidi (CS) o, immunosoppressori (IS), o inibitori del TNF nei precedenti 5 anni
    - Uso di contraccettivi effettivi come definiti nel protocollo.
    E.4Principal exclusion criteria
    - A history of, or current conditions affecting the digestive tract, such as
    ulcerative colitis, indeterminant colitis, fistulizing disease, abdominal or
    perianal abscess, adenomatous colonic polyps, colonic mucosal
    dysplasia, and short bowel syndrome
    - Planned surgery for CD
    - Ileostomy or colostomy
    - Has received non-permitted inflammatory bowel disease (IBD)
    therapies (including natalizumab, vedolizumab, and efalizumab, as
    stated in the protocol)
    - Chronic hepatitis B or C infection, HIV, active or latent tuberculosis
    (patients with prior history of BCG vaccination must pass protocol defined screening criteria)
    - Una storia di, o condizioni attuali che interessano l'apparato digerente, come la colite ulcerosa, colite indeterminata, ascesso addominale o perianale, polipi adenomatosi del colon, displasia della mucosa colica e la sindrome dell'intestino corto
    - Fistola con secrezione purulenta
    - Intervento chirurgico programmato per CD
    - Ileostomia o colostomia
    - Trattamento precedente non consentito per malattia infiammatoria intestinale (IBD) (tra cui vedolizumab, natalizumab ed efalizumab, come indicato nel protocollo).
    - Epatite B o C cronica, HIV, tubercolosi attiva o latente (pazienti con precedente storia di vaccinazione BCG devono superare criteri di selezione definiti nel protocollo)
    E.5 End points
    E.5.1Primary end point(s)
    a, Induction Phase
    • Proportion of patients in CDAI remission
    b, Maintenance Phase
    • Proportion of patients in CS-free CDAI remission after = 52 weeks of CS-free maintenance treatment, among patients who achieved CDAI
    remission at both Weeks 10 and 14.
    a, Fase di induzione
    • Remissione CDAI alla Settimana 14
    b, Fase di mantenimento
    • Mantenimento della remissione CDAI dopo un minimo di 52 = settimane, con libertà dai CS per tutta la sua durata, tra i pazienti che hanno ottenuto una remissione CDAI alle Settimane 10 e 14.
    E.5.1.1Timepoint(s) of evaluation of this end point
    a, at Week 14
    b, CDAI remission for this endpoint will be assessed at Weeks 66, 70, or 74 depending on the baseline CS dose level, and the required CS-free intervals
    a, alla settimana 14
    b, fase di remissione La remissione CDAI per questo endpoint sarà valutata alla Settimana 66, 70 o 74, a seconda del livello basale della dose di CS e degli gli intervalli senza CS.
    E.5.2Secondary end point(s)
    Induction Phase
    a, Proportion of patients with endoscopic improvement at Week 14
    b, Proportion of patients who achieve CDAI-100 response at Week 14
    c, Proportion of patients in CDAI remission at both Week 10 and Week 14
    d, Changes from baseline to Week 14 in CD-PRO/SS score
    e, Charges from baseline to Week 14 in IBDQ score
    f, Proportion of patients in PRO2 remission at Week 14
    Maintenance Phase
    a, Proportion of patients with endoscopic improvement at Week 66,
    among CDAI-70 responders at Week 14
    b, Proportion of patients who maintain CDAI remission at Week 66,
    among CDAI-remitters at Week 14
    c, Proportion of patients who achieve CDAI remission at Week 66, among CDAI-70 responders at Week 14
    d, Proportion of patients who achieve CDAI-100 response at Week 66
    e, Proportion of patients in CDAI remission at Week 66 who have been CS-free for 24 weeks, among patients who achieved CDAI remission at Weeks 10 and 14
    f, Proportion of patients in CDAI remission at Week 66 who have been CS-free for 24 weeks, among patients who achieved CDAI-70 response at Week 14
    g, Proportion of patients in durable CDAI remission during the Maintenance Phase, among CDAI-70 responders at Week 14
    h, Proportion of patients who maintain endoscopic improvement at Week 66 among patients who achieved endoscopic improvement and CDAI-70 response at Week 14
    i, Resolution of mucosal inflammation (SES-CD score 0) at Week 66
    j, Change from baseline to Week 66 in CD-PRO/SS score
    k, Change from baseline to Week 66 in IBDQ score
    l, Proportion of patients in PRO2 remission at Week 66, among patients who achieved PRO2 remission at Week 14
    Fase di Induzione
    a, Miglioramento endoscopico alla Settimana 14
    b, Risposta CDAI-100 alla Settimana 14
    c, Remissione CDAI alla Settimana 10 e alla Settimana 14
    c, Variazione dal basale alla Settimana 14 nella HRQOL riferita dai pazienti, valutata mediante questionario IBDQ
    d, Variazione dal basale alla Settimana 14 nei segni e sintomi di CD, come valutato in base alla misura CD-PRO/SS
    e, Remissione CDAI alla Settimana 14
    f, Remissione PRO2 alla Settimana 14
    Fase di Mantenimento
    Miglioramento endoscopico alla Settimana 66 (rispetto alla Settimana 0)
    Remissione CDAI alla Settimana 66 nei pazienti che hanno ottenuto una remissione CDAI alla Settimana 14
    Remissione CDAI alla Settimana 66 nei pazienti che hanno ottenuto una risposta clinica alla Settimana 14
    Risposta CDAI-100 alla Settimana 66 (rispetto alla Settimana 0)
    Remissione CDAI durevole (ottenuta in corrispondenza di ¿ 6 delle seguenti Settimane: 24, 28, 32, 44, 56, 66, 70 e 74)
    Remissione CDAI senza CS alla Settimana 66 nei
    pazienti che hanno ottenuto una risposta CDAI-70 alla Settimana 14
    Remissione CDAI alla Settimana 66 e libert¿ dai CS per 24 settimane prima della Settimana 66 nei pazienti che hanno ottenuto una remissione CDAI alle Settimane 10 e 14
    Mantenimento del miglioramento endoscopico alla
    Settimana 66 nei pazienti che hanno ottenuto un
    miglioramento endoscopico e una risposta CDAI-70 alla Settimana 14
    Risoluzione dell¿infiammazione mucosa (punteggio
    SES-CD pari a 0) entro la Settimana 66
    Variazione nella HRQOL riferita dai pazienti dal basale alla Settimana 66 in base al questionario IBDQ
    Variazione nei segni e sintomi di CD dal basale alla
    Settimana 66, come valutato in base alla misura
    CD-PRO/SS
    Mantenimento della remissione CDAI dopo un minimo di 52 settimane, con libert¿ dai CS per tutta la sua durata, nei pazienti che hanno ottenuto una remissione CDAI alle Settimane 10 e 14
    Remissione PRO2 alla Settimana 66 nei pazienti che hanno ottenuto una remissione PRO2 e una risposta CDAI-70 alla Settimana 14
    E.5.2.1Timepoint(s) of evaluation of this end point
    Induction Phase
    a, At Week 14
    b, At Week 14
    c, At both Week 10 and Week 14
    d, From baseline to Week 14
    e, From baseline to Week 14
    f, At Week 14
    Maintenance Phase
    a to i. at Week 66
    j-k. From baseline to Week 66
    l. at Week 66
    Fase di Induzione
    a, alla settimana 14
    b, alla settimana 14
    c, sia alla settimana 10 e la settimana 14
    d, dal basale alla settimana 14
    e, dal basale alla settimana 14
    f, alla settimana 14
    Fase di Mantenimento
    Tutte le misure di efficacia saranno valutate alla settimana 66.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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
    Exploratory biomarkers
    Biomarkers esplorativi
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial8
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA200
    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
    Brazil
    Canada
    Korea, Democratic People's Republic of
    Mexico
    New Zealand
    Russian Federation
    Serbia
    South Africa
    Turkey
    Ukraine
    United States
    Austria
    Belgium
    Bulgaria
    Croatia
    Estonia
    France
    Germany
    Hungary
    Italy
    Latvia
    Lithuania
    Netherlands
    Poland
    Romania
    Slovakia
    Spain
    Sweden
    Switzerland
    United Kingdom
    Czechia
    Argentina
    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
    The end of the study is defined as the last patient's last safety follow up visit that defined in the protocol of study GA29144, or the final visit for the last patient transferred to the OLE study (Study GA29145, Part 2), whichever is later.
    La fine dello studio ¿ definito come l' ultima visita di follow up di sicurezza dell'ultimo paziente definito nel protocollo di studio GA29144, o la visita finale per l'ultimo paziente trasferito allo studio di estensione in aperto OLE (Study GA29145, Part 2), se successiva.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    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: 1200
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 565
    F.4.2.2In the whole clinical trial 1250
    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)
    Patients: who experience disease worsening at W10 in the Induction Phase (IP),who do not achieve a clinical response at W14 of IP, who experience a clinical relapse during the Maintenance Phase
    (MP),patients who complete W74 of MP have option of enrolling into the OLE Study GA29145 Part 1 and they will receive open-label etrolizumab treatment. Those who do not enroll in Part 1 will continue to W12 of safety follow-up in this study and then ask to enroll in OLE Part 2 for W92 of monitoring for PM
    I pazienti: che avvertono peggioramento della malattia alla settimana 10 della fase di induzione, che non raggiungono una risposta clinica alla settimana 14 della fase di induzione, che hanno una ricaduta clinica durante la fase di mantenimento, i pazienti che completano la settimana 74 della fase di mantenimento hanno la possibilit¿ di essere arruolati nella OLE Parte 1 dello Studio GA29145 e riceveranno il trattamento di etrolizumab in aperto.
    Coloro che non saranno arruolati nella Parte 1 c
    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 Decision2016-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-09-08
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