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   40669   clinical trials with a EudraCT protocol, of which   6638   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).
     
    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:2010-022382-10
    Sponsor's Protocol Code Number:CCX114151
    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:2012-03-02
    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 number2010-022382-10
    A.3Full title of the trial
    A Randomised, Double-blind, Placebo-Controlled Study to Investigate
    the Efficacy and Safety of GSK1605786A in the Treatment of Subjects
    with Moderately-to Severely Active Crohn's Disease
    Studio randomizzato, in doppio cieco, controllato verso placebo per valutare l'efficacia e la sicurezza di GSK1605786A nel trattamento di soggetti affetti da morbo di Crohn attivo da moderato a severo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomised, Double-blind, Placebo-Controlled Study to Investigate
    the Efficacy and Safety of GSK1605786A in the Treatment of Subjects
    with Moderately-to-Severely Active Crohn's Disease.
    Studio randomizzato, in doppio cieco, controllato verso placebo per valutare l'efficacia e la sicurezza di GSK1605786A nel trattamento di soggetti affetti da morbo di Crohn attivo da moderato a severo
    A.4.1Sponsor's protocol code numberCCX114151
    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 SponsorGLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.
    B.1.3.4CountryUnited Kingdom
    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 supportGSK R & D Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClincial Trials HelpDesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 208 990 44 66
    B.5.5Fax number+44 208 990 12 34
    B.5.6E-mailGSKClincialSupportHD@gsk.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 nameGSK1605786A
    D.3.2Product code GSK1605786A
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeGSK1605786A
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects with Moderately-to-Severely Active Crohn's Disease
    Soggetti affetti da morbo di Crohn attivo da moderato a severo
    E.1.1.1Medical condition in easily understood language
    Crohn's disease Inflammatory bowel disease
    Patologia infiammatoria intestinale di Crohn
    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 14.1
    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
    To assess the efficacy of GSK1605786A compared with placebo as an induction therapy in subjects with moderately-to-severely active Crohn's disease over 12 weeks.
    L'obiettivo primario è quello di valutare l'efficacia di GSK1605786A rispetto al placebo come terapia d'induzione in soggetti con morbo di Crohn attivo da moderato a severo durante le 12 settimane di trattamento.
    E.2.2Secondary objectives of the trial
    • To evaluate the safety of GSK1605786A compared with placebo • To investigate the effect of GSK1605786A compared with placebo on health related quality of life • To investigate the effect of GSK1605786A compared with placebo on healthcare related resource utilisation • To investigate the effect of GSK1605786A compared with placebo on work productivity and activity impairment • To investigate the effect of GSK1605786A compared with placebo on biomarkers of inflammation [C-reactive protein (CRP) and faecal calprotectin] • To explore the dose relationships between GSK1605786A plasma concentration and clinical response endpoints • To explore potential relationships between genetic variants and GSK1605786A efficacy and safety endpoints.
    •Valutare la sicurezza di GSK1605786A confrotandolo con il placebo •Valutare gli effetti di GSK1605786A confrotandolo con il placebo sulla qualità della vita in relazione alle condizioni di salute •Valutare gli effetti di GSK1605786A confrotandolo con il a placebo sull’utilizzo delle risorse sanitarie •Valutare gli effetti di GSK1605786A confrotandolo con il a placebo sulla produttività sul lavoro e sulla compromissione dell’attività •Valutare gli effetti di GSK1605786A confrotandolo con il a placebo sui biomarcatori di infiammazione [proteina C reattiva (PCR) e calprotectina fecale] •Analizzare le correlazioni con la dose tra la concentrazione plasmatica di GSK1605786A e gli endpoint di risposta clinica •Analizzare le potenziali correlazioni tra le varianti genetiche e gli endpoint di efficacia e sicurezza di GSK1605786A.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects aged ≥18 years; 2. Written informed consent prior to any of the screening procedures including discontinuation of prohibited medications; 3. A diagnosis of Crohn's disease for > 4 months duration with small bowel and/or colonic involvement; 4. Confirmation of Crohn's disease established by visualisation of the gastrointestinal tract within the 12 months prior to screening or by screening endoscopy at study entry. Acceptable methods for gastrointestinal tract visualization include, but are not limited to endoscopy, capsule endoscopy, MRI or barium X-ray. Subjects without visualisation of the gastrointestinal tract within 12 months of screening must be willing to undergo endoscopy within the screening period; 5. History of inadequate response and/or intolerance/adverse event leading to discontinuation of at least one of the following treatments for Crohn's disease: corticosteroids, immunosuppressants; 6. Current evidence of moderately-to-severely active disease characterised by a CDAI score of ≥220 to ≤450 at Baseline [Criterion for Randomisation]; 7. Confirmation of current active Crohn's disease by either of the following [Criterion for Randomisation]:a. Luminal ulceration visualised by Screening endoscopy and as adjudicated by central endoscopy reader, or b. Elevated CRP (≥ 3 mg/L, the upper limit of normal (ULN) for the highly sensitive CRP test) plus elevated faecal calprotectin (> 200 μg/g stool) at Screening; 8. Stable doses of permitted concomitant medications or having previously received, but are not currently receiving, medications for Crohn's disease. Please refer to Section 5.5.1 Permitted Medications and Non Drug Therapies; 9. Demonstrated ability to comply with Crohn's disease symptom recording using the IVRS; to be eligible for rand. subject must complete recording of symptoms for at least 8 consecutive days prior to visit rand./baseline; 10. FCBP must be sexually inactive or commit to use of contraceptive methods with a failure rate of < 1% per year when used consistently and correctly and, when applicable, in accordance with the product label, for the duration of this study as defined by the following: Contraceptive Methods with a Failure Rate of < 1% • Abstinence from penile-vaginal intercourse, when this is the female's preferred and usual lifestyle • Oral contraceptive, either combined or progestogen alone • Injectable progestogen • Implants of etonogestrel or levonorgestrel • Estrogenic vaginal ring • Percutaneous contraceptive patches • IUD or IUS that meets the <1% failure rate as stated in the product label • Male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject. The information on the male sterility can come from the site personnel's: review of subject's medical records; medical examination of the subject and/or semen analysis; or interview with the subject on his medical history. • Male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository) • Male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository) These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The Investigator is responsible for ensuring subjects understand how to properly use these methods of contraception. This list does not apply to FCBP with same sex partners, when this is their preferred and usual lifestyle. Female subjects should not be enrolled if they are pregnant or lactating or if they plan to become pregnant during the time of study participation. A serum pregnancy test is required of all FCBP at Screening. In addition, a urine pregnancy test will be performed at the rand. visit and at Weeks 4,8,12 and at the Early Withdrawal or Fup visits if applicable.
    1.Soggetti di sesso maschile o femminile di età &gt;18 anni; 2.Consenso informato firmato prima di qualsiasi procedura di screening inclusa l’interruzione dei farmaci vietati; 3.Diagnosi di morbo di Crohn da &gt; 4 mesi di durata con coinvolgimento dell'intestino tenue e/o del colon; 4.Conferma del morbo di Crohn stabilito dalla visualizzazione del tratto gastrointestinale entro i 12 mesi precedenti allo screening o mediante endoscopia di screening al momento dell’ingresso nello studio. I metodi accettabili per la visualizzazione del tratto gastrointestinale includono, ma non sono limitati a endoscopia, capsula endoscopica, risonanza magnetica o radiografia con bario. I soggetti senza visualizzazione del tratto gastrointestinale entro 12 mesi dallo screening devono essere disposti a sottoporsi a un endoscopia entro il periodo di screening; 5.Anamnesi di risposta inadeguata e/o intolleranza/eventi avversi che hanno portato all'interruzione di almeno uno dei seguenti trattamenti per il morbo di Crohn: corticosteroidi, immunosoppressori; 6.Attuale evidenza di malattia attiva da moderata a severa caratterizzata da un punteggio CDAI da ≥ 220 a &lt; 450 al Baseline (Settimana 0) [criterio per la randomizzazione]; 7.Conferma del morbo di Crohn attivo in corso mediante uno dei seguenti [criterio di randomizzazione]: a.Ulcerazione luminale visualizzata mediante endoscopia di screening e diagnosticata dal lettore centrale delle endoscopie, oppure b.Elevata PCR (≥ 3 mg/l, il limite superiore della norma (ULN) per il test altamente sensibile della PCR) più l'elevata calprotectina fecale (&gt; 200 μg/g di feci) allo Screening; 8.Dosi stabili di farmaci concomitanti ammessi o aver assunto in precedenza farmaci, che attualmente non vengono assunti, per il morbo di Crohn. Si prega di fare riferimento alla Sezione 5.5.1 Farmaci consentiti e terapie non farmacologiche; 9.Dimostrata capacità di attenersi alla registrazione dei sintomi del morbo di Crohn utilizzando l’IVRS; per essere idoneo alla randomizzazione, il soggetto deve completare la registrazione dei sintomi per almeno 8 giorni consecutivi prima della visita di randomizzazione/baseline (Settimana 0); 10.Le donne in età fertile devono essere sessualmente inattive, o devono impegnarsi ad usare metodi anticoncezionali con un tasso di insuccesso &lt; 1% all'anno se utilizzati in modo costante e corretto e, se applicabile, in conformità con l'etichetta del prodotto, per la durata di questo studio. Per un dettaglio completo del criterio di inclusione No.10 fare riferimento al protocollo di studio.
    E.4Principal exclusion criteria
    1. If female, is pregnant, has a positive pregnancy test or is breastfeeding; 2. Known coeliac disease, those who follow a gluten-free diet to manage symptoms of suspected coeliac disease and subjects with a positive screening test for coeliac disease (elevated anti- tissue transglutaminase antibodies); 3. Diagnosis of ulcerative or indeterminate colitis; 4. Enterocutaneous, abdominal or pelvic fistulae with abscesses or fistulae likely to require surgery during the study period; 5. Bowel surgery, other than appendectomy, within 12 weeks prior to screen and/or has surgery planned or deemed likely for CD during the study period; 6. Extensive colonic resection, subtotal or total colectomy; 7. Presence of ileostomies, colostomies or rectal pouches; 8. Fixed symptomatic stenoses of small bowel or colon; 9. History of more than 3 small bowel resections or diagnosis of short bowel syndrome; 10. Chronic use of narcotics for chronic pain defined as daily use of one or more doses of narcotic containing medication; 11. Use of prohibited medications, including enteral feeding or elemental diet, within their specified timeframes and throughout the study (Section 5.5.2 Prohibited Medications and Non Drug Therapies). Biologic use: Use of any TNF inhibitor (eg. infliximab, adalimumab or certolizumab) or natalizumab within 10 weeks prior to randomisation Corticosteroid use: Use of parenteral glucocorticoids within 4 weeks prior to screening Immunospressant use: Use of cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil within 4 weeks prior to screening. For further information please view protocol pages 31-32 12. Positive immunoassay for C. difficile [Subjects who test positive and receive antibiotic treatment may be re-screened after 4 months if the retest is negative]; 13. Known HIV infection; 14. Known varicella, herpes zoster, or other severe viral infection within 6 weeks of screening; 15. Subjects who have received immunisation with a live vaccine e.g. measles, mumps, rubella (each as in MMR vaccine), oral polio, varicella, yellow fever, within 4 weeks of screening and throughout the study, with the exception of influenza vaccine; 16. Active or latent tuberculosis (TB) infection: All subjects will be tested with QuantiFERON TB Gold test and those with a positive test result will be excluded. Please view protocol page 31 for further information; 17. Current sepsis or infections requiring intravenous antibiotic therapy >2 weeks; 18. Previous infections characterised by opportunistic pathogens, and/or dissemination suggestive of clinically significant immunocompromise; 19. The subject has congenital or acquired immunodeficiency or has evidence of immunocompromise manifested by current opportunistic infection; 20. The subject exhibits evidence of hepatic dysfunction, viral hepatitis, or exhibits serum ALT (SGPT) and/or AST (SGOT) values ≥2 times the upper limit of normal; has a total bilirubin value >1.5 times the upper limit of normal (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%); has alkaline phosphatase >1.5 times the upper limit of normal; has current or chronic history of liver disease including non-alcoholic steatohepatitis (NASH). Please view protocol page 32 for further information; 21. A positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) test or positive Hepatitis C test result at screening 22. QTc ≥450 msec (≥480 msec for those with Bundle Branch Block) a. either QTcb or QTcf, machine or manual overread, males or females. The QT correction formula used to determine exclusion and discontinuation should be the same throughout the study b. based on single or average QTc value of an ECG obtained over a brief recording period. For a complete list of the exclusion criteria please refer to the study protocol.
    1.Per i soggetti di sesso femminile, gravidanza, test di gravidanza positivo o allattamento; 2.Nota malattia celiaca, coloro che seguono un'alimentazione senza glutine per gestire i sintomi di sospetta malattia celiaca e i soggetti con risultati positivi al test di screening per la celiachia (elevati anticorpi anti-transglutaminasi tissutale); 3.Diagnosi di colite ulcerosa o indeterminata; 4. Fistole enterocutanee, addominali o pelviche con ascessi o fistole che probabilmente richiedono un intervento chirurgico durante il periodo dello studio; 5.Chirurgia dell'intestino, diversa dall'appendicectomia, entro 12 settimane prima dello screening e/o ha in previsione o si ritiene probabile che debba sottoporsi a intervento chirurgico per morbo di Crohn durante il periodo dello studio; 6.Ampia resezione del colon, colectomia sub-totale o totale; 7.Presenza di ileostomie, colostomie, sacchetti rettali; 8.Stenosi sintomatiche fisse dell’intestino tenue o del colon; 9.Anamnesi di più di 3 resezioni del intestino tenue o diagnosi di sindrome dell'intestino corto; 10.Uso cronico di narcotici per il dolore cronico definito come uso giornaliero di una o più dosi di farmaci contenenti narcotici; 11.Uso di farmaci vietati, incluse alimentazione enterale o dieta elementare, all’interno dei loro intervalli specificati e per il corso dell'intero studio (Sezione 5.5.2 Farmaci vietati e terapie non farmacologiche). Uso di agenti biologici: Uso di inibitori del TNF (es. infliximab, adalimumab o certolizumab) o natalizumab entro 10 settimane prima della randomizzazione. Uso di corticosteroidi: Uso di glucocorticoidi per via parenterale entro 4 settimane prima dello screening. Uso di immunosoppressori: Uso di ciclosporina, tacrolimus, sirolimus o micofenolato mofetile entro 4 settimane prima dello screening. Uso di antibiotici per via endovenosa: Uso di antibiotici per via endovenosa per il morbo di Crohn entro 4 settimane prima dello screening. Uso di trattamento rettale con clisteri/supposte di 5-ASA o di corticosteroidi entro 2 settimane prima dello screening. Uso di alimentazione con sonda o enterale, dieta elementare, o alimentazione parenterale entro 2 settimane prima dello screening. Leucocitaferesi o granulocitoaferesi entro 2 settimane prima dello screening. Uso di digossina o glicosidi cardiaci associati (ad es. digitossina, deslanoside, lanatoside C, metildigossina) entro 7 giorni prima dello screening e durante l'intero studio; 12.Immunodosaggio positivo per C. difficile [I soggetti che hanno esito positivo e ricevono trattamento antibiotico possono essere nuovamente sottoposti a screening dopo 4 mesi se il controllo ulteriore risultasse negativo]; 13.Infezione da HIV nota; 14. Varicella, herpes zoster, o altre gravi infezioni virali note entro 6 settimane dallo screening; 15. Soggetti che hanno ricevuto immunizzazione con un vaccino vivo, ad es. morbillo, parotite, rosolia (ciascuno come nel vaccino trivalente), antipolio orale, varicella, febbre gialla, entro 4 settimane dallo screening e per tutto lo studio, ad eccezione del vaccino antinfluenzale; 16.Infezione da tubercolosi (TB) attiva o latente: Tutti i soggetti saranno sottoposti a test QuantiFERON TB Gold, e coloro che otterranno un risultato positivo dal test saranno esclusi. [Nota: I soggetti con un risultato del test indeterminato possono sottoporsi nuovamente al test; un successivo risultato indeterminato o positivo li escluderà dalla partecipazione]. Potranno essere eseguite radiografie toraciche se lo Sperimentatore dovesse stabilire che sono clinicamente indicate e qualsiasi risultato anomalo che suggerisca tubercolosi attiva o latente escluderà il paziente; 17.Sepsi o infezioni in corso che richiedano terapia antibiotica endovenosa &gt;2 settimane. Per i criteri di esclusione dal 18 al 29 fare riferimento al protocollo di studio.
    E.5 End points
    E.5.1Primary end point(s)
    • Proportion of subjects achieving clinical response, defined by CDAI decrease from baseline of ≥100 points, at Week 12 Safety Endpoints: • Incidence of adverse events/serious adverse events • Change from baseline in vital signs: heart rate and blood pressure • Change from baseline in haematology and clinical chemistry parameters • Change from baseline in liver function test parameters • Change from baseline in 12 lead ECG abnormalities.
    La percentuale di soggetti che ottiene risposta clinica, definita come una riduzione dalla baseline del punteggio CDAI ≥ 100 punti, alla Settimana 12. Endpoint di sicurezza: •Incidenza di eventi avversi/eventi avversi seri •Variazione dalla baseline nei segni vitali: frequenza cardiaca e pressione sanguigna •Variazione dalla baseline nei parametri di ematologia e chimica clinica •Variazione dalla baseline nei parametri dei test di funzionalità epatica •Variazione dalla baseline nelle anomalie dell’ECG a 12 derivazioni
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety assessments at Week 0, 4, 8, 12 and post 4 week follow-up at Week 16, if subject does not enrol in follow on study. 12 lead ECG at Screening and Week 12. CDAI assessments at Week 0, 4, 8, 12, and post 4 week follow-up at Week 16, if subject does not enrol in follow on study.
    Valutazioni di sicurezza alla settimana 0, 4, 8, 12 e dopo 4 settimane di follow up alla settimana 16, se il soggetto non viene arruolato nel successivo studio. ECG a 12 derivazioni allo screening e alla settimana 12. Valutazioni CDAI alla settimana 0, 4, 8, 12 e dopo 4 settimane di follow up alla settimana 16 se il soggetto non viene arruolato nel successivo studio.
    E.5.2Secondary end point(s)
    Key Secondary Efficacy Endpoint: • Proportion of subjects in clinical remission, defined as a CDAI score of < 150 points, at Week 12
    •Percentuale di soggetti in remissione clinica, definita come un punteggio CDAI < 150 punti alla Settimana 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety assessments at Week 0, 4, 8, 12 and post 4 week follow-up at Week 16, if subject does not enrol in follow on study. 12 lead ECG at Screening and Week 12. CDAI assessments at Week 0, 4, 8, 12, and post 4 week follow-up at Week 16, if subject does not enrol in follow on study.
    Valutazioni di sicurezza alla settimana 0, 4, 8, 12 e dopo 4 settimane di follow up alla settimana 16, se il soggetto non viene arruolato nel successivo studio. ECG a 12 derivazioni allo screening e alla settimana 12. Valutazioni CDAI alla settimana 0, 4, 8, 12 e dopo 4 settimane di follow up alla settimana 16 se il soggetto non viene arruolato nel successivo studio.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy 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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA62
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Israel
    Japan
    New Zealand
    South Africa
    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 years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months19
    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.1.1Number of subjects for this age range: 0
    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: 574
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 600
    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)
    Subjects who are a responder (CDAI decrease =>100 points) or in remission (CDAI < 150 points) at the Week 12 are eligible to enter a 52 week maintenance study (Study CCX114157). Other subjects who complete the Week 12 assessment are eligible for the open-label extension study (Study CCX114644). Subjects who do not enter either CCX114157 or CCX114644 will return for a f-up visit at Week 16. Subsequent treatment for Crohn's disease will be at the discretion of the Investigator.
    I sogg. con risposta clinica (diminuzione di CDAI ≥100 punti) o in remissione clinica (CDAI <150 punti) alla Sett 12 saranno eleggibili per lo studio di mantenimento di 52 Sett (CCX114157). Altri sogg. che completano la valutazione di Sett 12 saranno idonei per l’ingresso nello studio di estensione in aperto (CCX114644). I sogg. che non parteciperanno agli studi CCX114157 o CCX114644, ritorneranno per una visita di Fup alla Sett 16. Il successivo trattamento sarà a discrezione del PI
    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 Decision2012-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
    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