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   41189   clinical trials with a EudraCT protocol, of which   6743   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) .
     
    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:2017-002195-13
    Sponsor's Protocol Code Number:CNTO1959CRD3001
    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:2021-01-22
    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 number2017-002195-13
    A.3Full title of the trial
    A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease
    Protocollo di fase 2/3, randomizzato, in doppio cieco, controllato verso placebo e contro controllo attivo, a gruppi paralleli, multicentrico per valutare la sicurezza e l’efficacia di guselkumab in partecipanti con morbo di Crohn attivo da moderato a grave.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease
    Studio della sicurezza e dell'efficacia di guselkumab in partecipanti con morbo di Crohn attivo da moderato a grave
    A.3.2Name or abbreviated title of the trial where available
    GALAXI
    GALAXI
    A.4.1Sponsor's protocol code numberCNTO1959CRD3001
    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 SponsorJANSSEN CILAG INTERNATIONAL NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPAREXEL International LLC
    B.5.2Functional name of contact point-
    B.5.3 Address:
    B.5.3.1Street Address-
    B.5.3.2Town/ city-
    B.5.3.3Post code-
    B.5.3.4CountryUnited States
    B.5.4Telephone number000000
    B.5.5Fax number000000
    B.5.6E-mailclinicaltrial.enquiries@parexel.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 nameguselkumab
    D.3.2Product code [CNTO1959]
    D.3.4Pharmaceutical form Solution for 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.3.8INN - Proposed INNGUSELKUMAB
    D.3.9.2Current sponsor codeCNTO 1959
    D.3.9.4EV Substance CodeSUB179789
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number101
    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
    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 nameguselkumab
    D.3.2Product code [CNTO1959]
    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 INNGuselkumab
    D.3.9.2Current sponsor codeCNTO 1959
    D.3.9.4EV Substance CodeSUB179789
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 nameUstekinumab
    D.3.2Product code [CNTO1275]
    D.3.4Pharmaceutical form Concentrate for solution for 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.3.8INN - Proposed INNUSTEKINUMAB
    D.3.9.1CAS number 815610-63-0
    D.3.9.2Current sponsor code-
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 nameUstekinumab
    D.3.2Product code [CNTO1275]
    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 INNUSTEKINUMAB
    D.3.9.1CAS number 815610-63-0
    D.3.9.2Current sponsor code-
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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
    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 infusion
    D.8.4Route of administration of the placeboIntravenous 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
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous 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 Crohn's Disease
    Morbo di Crohn attivo da moderato a grave
    E.1.1.1Medical condition in easily understood language
    Inflammatory bowel disease (IBD)
    Malattia infiammatoria intestinale (IBD)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 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
    Phase 2 and Phase 3 Studies:
    - To evaluate the clinical efficacy of guselkumab in participants with Crohn’s disease
    - To evaluate the safety of guselkumab
    Studi di fase 2 e fase 3:
    - Valutare l’efficacia clinica di guselkumab in partecipanti affetti dal morbo di Crohn
    - Valutare la sicurezza di guselkumab
    E.2.2Secondary objectives of the trial
    Phase 2:
    - To evaluate the dose-response of guselkumab to inform dose selection for the Phase 3 portion of this protocol
    - To evaluate the efficacy of guselkumab on endoscopic improvement
    - To evaluate the PK, immunogenicity, and pharmacodynamics (PD) of guselkumab therapy

    Phase 3:
    - To evaluate the efficacy of guselkumab on endoscopic improvement
    - To evaluate the impact of guselkumab on HRQOL
    - To evaluate the PK, immunogenicity, and PD of guselkumab therapy
    Fase 2:
    - Valutare la risposta al dosaggio di guselkumab, al fine di raccogliere informazioni per la selezione della dose per la fase 3 del protocollo
    - Valutare l’efficacia di guselkumab sul miglioramento endoscopico
    - Valutare la PK, l’immunogenicità e la farmacodinamica (PD) della terapia con guselkumab

    Fase 3:
    - Valutare l’efficacia di guselkumab sul miglioramento endoscopico
    - Valutare l’impatto di guselkumab sulla HRQOL
    - Valutare la PK, l’immunogenicità e la PD della terapia con guselkumab
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Pharmacogenomics
    Version: -
    Date: 06/12/2017
    Title: Phase 2 and 3 study. Optional pharmacogenomic sub-study
    Objectives: Collect DNA to allow for the identification of genetic factors that may influence the PK, PD, efficacy, safety, or tolerability of guselkumab and to identify genetic factors associated with Crohn's disease or the response to guselkumab or ustekinumab treatment.

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Phase 2 and 3 study. Optional Week 4 ileocolonoscopy sub-study: Exploratory analyses of intestinal mucosal tissue obtained by biopsy at Week 4 will be performed
    to delineate the mechanisms of action of guselkumab and ustekinumab.

    Farmacogenomica
    Versione: -
    Data: 06/12/2017
    Titolo: Studio di fase 2 e 3. Sottostudio facoltativo sulla farmacogenomica
    Obiettivi: Raccolta del DNA per consentire l’identificazione dei fattori genetici che possono influenzare PK, PD, efficacia, sicurezza o tollerabilità di guselkumab e identificare i fattori genetici associati al morbo di Crohn o la risposta al trattamento con guselkumab o ustekinumab.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Studio di fase 2 e 3. Sottostudio facoltativo con ileocolonscopia alla Settimana 4: verranno condotte analisi esplorative della mucosa intestinale acquisita tramite biopsia alla Settimana 4 allo scopo di determinare i meccanismi d’azione di guselkumab e ustekinumab
    E.3Principal inclusion criteria
    - Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
    - Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for
    Crohn's Disease (SES-CD)
    - Have screening laboratory test results within the protocol specified parameters
    - A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
    - Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
    - Presenza di morbo di Crohn (MC) o morbo di Crohn fistolizzante da almeno 3 mesi (definito come un minimo di 12 settimane), con colite, ileite o ileocolite, confermato in ogni momento nel passato da una radiografia, istologia e/o endoscopia
    - Presenza di MC da moderata a grave secondo il CDAI, frequenza delle feci (SF) e punteggi relativi al dolore addominale (AP) e Simple Endoscopic Score for Crohn’s Disease (SES-CD)
    - Risultati di laboratorio allo screening nei parametri specificati dal protocollo
    - Le partecipanti potenzialmente fertili devono avere un risultato per il test delle urine sulla gravidanza negativo allo screening e al baseline
    - Intolleranza dimostrata o risposta inadeguata alla terapia convenzionale o biologica per MC
    E.4Principal exclusion criteria
    - Current diagnosis of ulcerative colitis or indeterminate colitis
    - Has complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation
    - Unstable doses of concomitant Crohn's disease therapy
    - Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol
    - Prior exposure to p40 inhibitors or p19 inhibitors
    - Any medical contraindications preventing study participation
    - Attuale diagnosi di colite ulcerante o colite indeterminata
    - Presenza di complicazioni della MC, come strozzature o stenosi, sindrome dell’intestino corto, o qualsiasi altra manifestazione
    - Dosi instabili di terapia concomitante del morbo di Crohn
    - Assunzione di agenti biologici approvati per il morbo di Crohn, agenti sperimentali, o procedure estranee dal quadro permesso specificato nel protocollo
    - Precedente esposizione agli inibitori p40 o agli inibitori p19
    - Qualsiasi controindicazione medica che impedisca la partecipazione allo studio
    E.5 End points
    E.5.1Primary end point(s)
    Phase 2: Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12
    Phase 3: Clinical remission at week 12 (defined as CDAI score <150)
    Fase 2: Variazione dal basale nel punteggio CDAI alla Settimana 12
    Fase 3: Remissione clinica alla Settimana 12 (definita come punteggio CDAI <150)
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    settimana 12
    E.5.2Secondary end point(s)
    Phase 2:
    - Clinical remission at Week 12 (defined as CDAI score <150)
    - Clinical response at Week 12 (defined as =100-point reduction from baseline in CDAI score or CDAI score <150)
    - PRO-2 remission at Week 12 (defined based on average daily stool frequency (SF) and average daily abdominal pain (AP) score)
    - Clinical-biomarker response at Week 12 (clinical response based on CDAI score and reduction from baseline in CRP or fecal calprotectin)
    - Endoscopic response at Week 12 (measured by the Simple Endoscopic Score for Crohn's
    Disease (SES-CD). The SES-CD is based on the evaluation of 4 endoscopic components across 5 ileocolonic segments, with a total score ranging from 0 to 56.)
    Phase 3:
    - Clinical remission at Week 48 (defined as CDAI < 150)
    - Durable clinical remission at Week 48 (defined as CDAI<150 for the majority of visits between Week 12 and Week 48.)
    - Corticosteroid-free clinical remission at Week 48 (defined as CDAI score <150 at Week 48 and not receiving corticosteroids at Week 48)
    - PRO-2 remission at Week 12 and 48 (based on average daily stool frequency (SF) and average daily abdominal pain (AP) score)
    - Endoscopic response at Week 12 and 48 (measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD))
    • Fatigue response at Week 12 (based on the PROMIS Fatigue Short Form 7a)
    Fase 2:
    - Remissione clinica alla Settimana 12 (definita come punteggio CDAI <150)
    - Risposta clinica alla Settimana 12 (definita come riduzione di =100 punti dal basale nel punteggio CDAI oppure punteggio CDAI <150)
    - Remissione PRO-2 alla Settimana 12 (definita sulla base della media della frequenza delle feci giornaliera (SF) e del punteggio giornaliero medio del dolore addominale (AP))
    - Risposta dei biomarcatori clinici alla Settimana 12 (risposta clinica basata sul punteggio CDAI e su una riduzione dal basale della CRP o della calprotectina fecale)
    - Risposta endoscopica alla Settimana 12 (misurata dal Simple Endoscopic Score for Crohn’s Disease (SES-CD)). Il SES-CD si basa sulla valutazione dei 4 componenti endoscopici attraverso 5 segmenti ileocolonici, con un punteggio totale che varia da 0 a 56)

    Fase 3:
    - Remissione clinica alla Settimana 48 (definita come punteggio CDAI <150)
    - Remissione clinica duratura alla Settimana 48 (definita come punteggio CDAI <150 per la maggior parte delle visite tra la Settimana 12 e la Settimana 48)
    - Remissione clinica libera da corticosteroidi alla Settimana 48 (definita come punteggio CDAI <150 alla Settimana 48 e nessuna somministrazione di corticosteroidi alla Settimana 48)
    - Remissione PRO-2 alla Settimana 12 e 48 (basata sulla media della frequenza delle feci giornaliera (SF) e del punteggio giornaliero medio del dolore addominale (AP))
    - Risposta endoscopica alla Settimana 12 e 48 (misurata dal Simple Endoscopic Score for Crohn’s Disease (SES-CD))
    • Risposta all’affaticamento alla Settimana 12 (basata sul Modulo breve sull’affaticamento PROMIS 7a
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 12 or 48 as listed above
    settimana 12 o 48 come elencato sopra
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial9
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA121
    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
    Austria
    Belarus
    Belgium
    Bosnia and Herzegovina
    Brazil
    Canada
    China
    Colombia
    Croatia
    Czechia
    France
    Georgia
    Germany
    Greece
    Hungary
    Israel
    Italy
    Japan
    Jordan
    Korea, Republic of
    Latvia
    Lebanon
    Lithuania
    North Macedonia
    Netherlands
    New Zealand
    Poland
    Portugal
    Russian Federation
    Saudi Arabia
    Serbia
    Slovakia
    South Africa
    Spain
    Taiwan
    Tunisia
    Turkey
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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: 1800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 718
    F.4.2.2In the whole clinical trial 2000
    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 end their participation in the trial will return to the standard therapy according to their health care scheme.
    I pazienti al termine della loro partecipazione allo studio torneranno alla terapia standard secondo il loro schema di assistenza sanitaria.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-05
    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 © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA