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    Summary
    EudraCT Number:2010-022383-12
    Sponsor's Protocol Code Number:CCX114157
    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 number2010-022383-12
    A.3Full title of the trial
    A 52 week Randomised, Double-blind, Placebo-controlled Study to
    Investigate the Efficacy and Safety of GSK1605786A in the Maintenance
    of Remission in Subjects with Crohn's Disease
    Studio di 52 settimane, randomizzato, in doppio cieco, controllato verso placebo per valutare l'™efficacia e la sicurezza di GSK1605786A nel mantenimento della remissione in soggetti affetti da morbo di Crohn.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 52 week Randomised, Double-blind, Placebo-controlled Study to
    Investigate the Efficacy and Safety of GSK1605786A in the Maintenance
    of Remission in Subjects with Crohn's Disease
    Studio di 52 settimane, randomizzato, in doppio cieco, controllato verso placebo per valutare l’efficacia e la sicurezza di GSK1605786A nel mantenimento della remissione in soggetti affetti da morbo di Crohn.
    A.4.1Sponsor's protocol code numberCCX114157
    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 supportGlaxoSmithKline Research & Development 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 Crohn's Disease
    Soggetti con Morbo di Crohn
    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 in maintaining clinical remission in subjects with Crohn's disease over 52 weeks.
    Valutare l’efficacia di GSK1605786A rispetto al placebo nel mantenimento della remissione in soggetti affetti da morbo di Crohn nel corso di 52 settimane.
    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 health-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 unemployment and disability rates • 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.
    •Valutare la sicurezza di GSK1605786A rispetto al placebo •Valutare gli effetti di GSK1605786A rispetto al placebo sulla qualità della vita in relazione alle condizioni di salute •Valutare gli effetti di GSK1605786A rispetto al placebo sull’utilizzo delle risorse sanitarie •Valutare gli effetti di GSK1605786A rispetto al placebo sulla produttività sul lavoro e sulla compromissione dell’attività •Valutare gli effetti di GSK1605786A rispetto al placebo sui tassi di disoccupazione e disabilità •Valutare gli effetti di GSK1605786A rispetto al placebo sui biomarcatori di infiammazione [proteina C reattiva (CRP) 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
    Subjects achieving clinical response (CDAI decrease ≥ 100points) and/or remission (CDAI <150) upon completion of treatment in Study CCX114151 or Study CCX114643 2. Written informed consent prior to any CCX114157 specific study procedures. 3.Females of child-bearing potential (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 • Intrauterine device (IUD) or intrauterine system (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. For women of child-bearing potential, a urine pregnancy test will be performed at repeated intervals throughout the study and at the Early Withdrawal or Follow-up visits if applicable. 4. Any medications being currently received for Crohn's disease must remain stable throughout the study period with the exception of tapering of corticosteroids and dose reductions of immunosuppressants for the management of drug toxicity. See Study Procedures Manual. 5. Subjects on corticosteroids at entry must be willing to undergo corticosteroid dose tapering. Note: Country-specific requirement for French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
    I soggetti idonei all’arruolamento nello studio devono soddisfare tutti i seguenti criteri: 1. Soggetti che hanno ottenuto una risposta clinica (diminuzione di punti di CDAI ≥ 100) e/o la remissione (CDAI &lt; 150) alla conclusione del trattamento nell’ambito dello Studio CCX114151 o dello Studio CCX114643 2. Consenso informato scritto prima delle procedure specifiche dello studio CCX114157 3. Le pazienti di sesso femminile in età fertile devono essere sessualmente inattive o impegnarsi a utilizzare metodi contraccettivi con un tasso di insuccesso &lt; 1% l’anno se impiegati in modo costante e corretto, ove applicabile, secondo quanto riportato sull’etichetta del prodotto, per tutta la durata dello studio come descritto di seguito: Metodi contraccettivi con un tasso di insuccesso &lt; 1% • Astinenza da rapporto sessuale pene-vagina, quando essi rappresentino lo stile di vita prescelto e abituale del soggetto di sesso femminile • Contraccettivo orale, sia combinato che progestinico da solo • Progestinico iniettabile • Impianti di etonogestrel o levonorgestrel • Anello vaginale a rilascio di estrogeni • Cerotti contraccettivi percutanei • Dispositivo intrauterino (IUD) o sistema intrauterino (IUS) con tasso di insuccesso &lt; 1% secondo quanto riportato sull’etichetta del prodotto • Sterilizzazione del partner maschile prima dell’ingresso del soggetto di sesso femminile nello studio, ove tale partner maschile sia l’unico partner del soggetto. Le informazioni relative alla sterilità del partner maschile possono essere raccolte dal personale del centro eseguendo: l’esame delle cartelle cliniche del soggetto; l’esame medico del soggetto e/o l’analisi del liquido seminale; un colloquio con il soggetto sulla sua anamnesi medica. • Preservativo maschile in combinazione con spermicida vaginale (schiuma, gel, pellicola, crema o supposta) • Preservativo maschile in combinazione con diaframma femminile, con o senza spermicida vaginale (schiuma, gel, pellicola, crema o supposta) Questi metodi contraccettivi consentiti sono efficaci solo se utilizzati correttamente e costantemente, in conformità con l'etichetta del prodotto. Lo Sperimentatore è responsabile di assicurarsi che i soggetti capiscano come usare correttamente i metodi di contraccezione. Questo elenco non si applica ai soggetti di sesso femminile in età fertile con partner dello stesso sesso, ove questo sia il loro stile di vita prescelto e abituale. I soggetti di sesso femminile non devono essere arruolati se sono in stato di gravidanza o allattamento, o se prevedono di iniziare una gravidanza durante il periodo di partecipazione allo studio. Le pazienti in età fertile saranno sottoposte a un test di gravidanza sulle urine a intervalli ripetuti nel corso dello studio e alle visite di Interruzione anticipata o di Follow-up ove applicabile. 4. Gli eventuali farmaci attualmente assunti per il morbo di Crohn devono rimanere stabili per l’intera durata dello studio, fatta eccezione per la graduale riduzione dei corticosteroidi e la riduzione della dose degli immunosoppressori per la gestione della tossicità. Per informazioni più dettagliate circa i farmaci consentiti, fare riferimento al Manuale delle procedure dello studio. 5. I soggetti trattati con corticosteroidi al momento dell’ingresso devono essere disposti a sottoporsi a una graduale riduzione della dose di corticosteroidi Nota: Requisiti nazionali specifici per i soggetti francesi: in Francia un soggetto sarà idoneo all'inclusione nello studio solo se affiliato a o beneficiario di una categoria di previdenza sociale.
    E.4Principal exclusion criteria
    1. If female, is pregnant, has a positive pregnancy test or is breastfeeding 2. Subjects with known or suspected coeliac disease or a positive screening test (antitissue transglutaminase (anti-tTG) antibodies) should have been excluded from enrolment into the induction studies. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should be tested for anti-tTG antibodies and excluded or withdrawn from study upon positive result 3 Fixed symptomatic stenoses of small bowel or colon. 4. Enterocutaneous , abdominal or pelvic fistulae likely to require surgery during the study period 5. Current sepsis or infections requiring intravenous antibiotic therapy >2 weeks 6. Use of prohibited medications at baseline and throughout the study (Section 5.5.3 of the protocol). 7. 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); has known hepatic or biliary abnormalities with the exception of Gilbert's syndrome or asymptomatic gallstones Note: At randomisation into the study, liver function tests results from the final visit in the preceding induction study will not be available . Subjects who have abnormalities as per the exclusion above will need to be withdrawn.
    Malgrado i soggetti siano già stati arruolati in un precedente studio sponsorizzato da GSK con GSK1605786A, lo Sperimentatore deve garantire l’esclusione dei soggetti qualora si verificasse una delle seguenti circostanze: 1. Per i soggetti di sesso femminile, gravidanza, test di gravidanza positivo o allattamento 2. I soggetti affetti da celiachia nota o sospetta o con test di screening positivo per gli anticorpi anti-transglutaminasi tissutale (anti-tTG) devono essere stati esclusi dall’arruolamento negli studi di induzione. I soggetti nei quali venga successivamente sospettata diagnosi di celiachia devono essere sottoposti a test per gli anticorpi anti-tTG, e esclusi o ritirati dallo studio se ricevono risultato positivo dal test 3. Stenosi sintomatiche fisse dell'intestino tenue o del colon 4. Fistole enterocutanee, addominali o pelviche che possono richiedere un intervento chirurgico durante il periodo dello studio 5. Sepsi o infezioni in corso che richiedano terapia antibiotica endovenosa &gt;2 settimane 6. Uso di farmaci vietati alla baseline e per tutta la durata dello studio (Sezione 5.5.3) 7. Il soggetto presenta evidenza di disfunzione epatica, epatite virale o valori sierici di ALT (SGPT) e/o AST (SGOT)  2 volte il limite superiore della norma; ha un valore di bilirubina totale &gt; 1,5 volte il limite superiore della norma (bilirubina isolata &gt; 1,5 x ULN è accettabile se la bilirubina è frazionata e la bilirubina diretta è &lt; 35%); ha un valore di fosfatasi alcalina &gt; 1,5 volte il limite superiore della norma; presenta attualmente o ha un’anamnesi cronica di patologie epatiche inclusa la steatoepatite non alcolica; presenta anomalie epatiche o biliari note fatta eccezione per la sindrome di Gilbert o la colelitiasi asintomatica Nota: alla randomizzazione nello studio, non saranno disponibili i risultati dei test di funzionalità epatica provenienti dalla visita finale del precedente studio di induzione. I soggetti che presentano anomalie come indicato nei criteri di esclusione sopra esposti dovranno essere esclusi.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy endpoints: Proportion of subjects in clinical remission (CDAI score <150 points) at both Weeks 28 and 52 of the 52-week treatment period 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.
    • Percentuale di soggetti in remissione clinica (punteggio CDAI < 150 punti) alle Settimane 28 e 52 del periodo di trattamento di 52 settimane Endpoint di Sicurezza • Incidenza di eventi avversi/eventi avversi gravi • 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, 20, 28, 36, 44, 52 and post 4 week follow-up at Week 56, if subject does not enrol in follow on study. 12 lead ECG at Week 0, 28, 52 and post 4 week follow-up at Week 56, if subject does not enrol in follow on study. CDAI assessments at Week 0, 4, 8, 12, 20, 28, 36, 44, 52 and post 4 week follow-up at Week 56, if subject does not enrol in follow on study.
    Valutazione della sicurezza alla settimana 0,4, 8, 12, 20, 28, 36, 44, 52, e dopo 4 settimane di follow up alla settimana 56, se il paziente non entra nello studio in aperto. Valutazione ECG alla settimana 0, 28, 52, e dopo 4 settimane di follow up alla settimana 56, se il paziente non entra nello studio in aperto. Valutazione CDAI alla settimana 0,4, 8, 12, 20, 28, 36, 44, 52, e dopo 4 settimane di follow up alla settimana 56, se il paziente non entra nello studio in aperto.
    E.5.2Secondary end point(s)
    Key Secondary efficacy endpoint: Proportion of subjects in clinical remission (CDAI score <150 points) and not taking corticosteroids at both Weeks 28 and 52 of the 52-week treatment period.
    • Percentuale di soggetti in remissione clinica (punteggio CDAI < 150 punti) e che non assumono corticosteroidi alle Settimane 28 e 52 del periodo di trattamento di 52 settimane.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 28 and 52
    Settimana 28 e 52
    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 EEA158
    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
    Argentina
    Australia
    Brazil
    Canada
    China
    Hong Kong
    Israel
    Japan
    Korea, Republic of
    New Zealand
    Russian Federation
    Switzerland
    Taiwan
    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 months28
    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 months34
    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: 718
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 750
    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)
    The investigator is responsible for maintaining the post study care of a patient's medical condition. Subjects, on completion of the study after 52 weeks, may be eligible for an open-label study with GSK1605786A (study CCX114644). Subjects who do not enter study CCX114644 will not receive further treatment provided by GSK but will return for a Follow-up visit at Week 56. Subsequent treatment for Crohn's disease will be at the discretion of the investigator.
    Lo sperimentatore è responsabile del trattamento delpaziente al termine dello studio. Altermine delle 52 settimane il paziente potrebbe entrare nello studioin aperto CCX114644 con GSK1605786A. I soggetti non eligibili non riceveranno più alcun trattamento fornito da GSK ma ritorneranno all 56 settimana per la visita di follow up. Il trattamento susseguente sarà a discrezione dello 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 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
    P.Date of the global end of the trial2013-10-15
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