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    Summary
    EudraCT Number:2010-022506-41
    Sponsor's Protocol Code Number:IM129-005
    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:2011-12-28
    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 number2010-022506-41
    A.3Full title of the trial
    A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)
    Studio Randomizzato, Placebo-Controllato di Fase IIb, per la Valutazione dell`™Efficacia Clinica e della Sicurezza della Terapia di Induzione e Mantenimento con BMS-936557 in Soggetti con Colite Ulcerosa (CU) Attiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)
    Studio Randomizzato, Placebo-Controllato di Fase IIb, per la Valutazione dell’Efficacia Clinica e della Sicurezza della Terapia di Induzione e Mantenimento con BMS-936557 in Soggetti con Colite Ulcerosa (CU) Attiva
    A.3.2Name or abbreviated title of the trial where available
    Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis
    IM129-005
    A.4.1Sponsor's protocol code numberIM129-005
    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 SponsorBristol-Myers Squibb International Corporation
    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 supportBristol Myers Squibb
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol Myers Squibb
    B.5.2Functional name of contact pointRCO
    B.5.3 Address:
    B.5.3.1Street AddressVia Virgilio Maroso 50
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00142
    B.5.3.4CountryItaly
    B.5.4Telephone number+39.06.50396.330
    B.5.5Fax number+39.06.50396.353
    B.5.6E-mailmariagrazia.lopiparo@bms.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 nameHuman anti-IP10 monoclonal antibody
    D.3.2Product code BMS-936557
    D.3.4Pharmaceutical form Solution for injection
    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 INNHuman anti-IP10 monoclonal antibody
    D.3.9.2Current sponsor codeBMS-936557
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number10
    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 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) Yes
    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.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 nameHuman anti-IP10 monoclonal antibody
    D.3.2Product code BMS-936557
    D.3.4Pharmaceutical form Solution for injection
    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 INNHuman anti-IP10 monoclonal antibody
    D.3.9.2Current sponsor codeBMS-936557
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number10
    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 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) Yes
    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 placeboSolution for injection
    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 placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Colitis, Ulcerative
    colite ulcerosa
    E.1.1.1Medical condition in easily understood language
    Colitis, Ulcerative
    colite ulcerosa
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10009900
    E.1.2Term Colitis ulcerative
    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
    The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis.
    Confrontare l`€™efficacia di BMS-936557 verso placebo nell`€™indurre la remissione clinica (definita come un Mayo score ï‚£ 2 punti senza alcun subscore individuale &gt; 1 punto) alla Settimana 7 [Periodo di Induzione-50 (IP-50)].
    E.2.2Secondary objectives of the trial
    1) Compare the efficacy of BMS-936557 vs. placebo for induction of clinical response (defined as reduction from baseline in Mayo score `‰¥3 points and `‰¥30% and decrease from baseline in rectal bleeding subscore `‰¥1 point or absolute rectal bleeding subscore `‰¤1 point) at Week 7 (IP-50). 2) Compare the efficacy or BMS-936557 vs. placebo for induction of mucosal healing (defined as endoscopy subscore of `‰¤1 point) at Week 7 (IP-50). 3) Assess health-related quality of life outcome (IBDQ) of BMS-936557 and placebo in the induction period. 4) Assess the safety of BMS-936557 in the induction period
    - Confrontare l`€™efficaciadi BMS-936557 vs placebo per l`€™induzione della risposta clinica (definita come la riduzione dal baseline con Mayo score  3 punti e  30%, e diminuizione dal baseline del sanguinamento rettale subscore  1 punto o sanguinamento rettale assoluto subscore ï‚£ 1 punto) alla Settimana 7 (IP-50). - Confrontare l`€™efficacia di BMS-936557 vs placebo per l`€™induzione della guarigione della mucosa (definita con subscore endoscopico di ï‚£ 1 punto) alla settimana 7 (IP-50). - Valutare l`€™esito del questionario sulla qualita` di Vita in relazione al vostro stato di salute outcome (IBDQ) di BMS-936557 e placebo nel periodo d`€™induzione. - Valutare la sicurezza di BMS-936557 nel periodo d`€™induzione.
    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 SUBSTUDIES:
    Sez.5.4.1.2 Biopsy Substudy pp.89 main protocol IM 129-005 vers. 1.0 del 04.10.2010

    ALTRI SOTTOSTUDI:
    Sez.5.4.1.2 Biopsy Substudy pp.89 main protocol IM 129-005 vers. 1.0 del 04.10.2010

    E.3Principal inclusion criteria
    • Clinical diagnosis of moderate to severe UC confirmed by endoscopic and histologic evidence • Mayo score `‰¥6 with an endoscopic subscore of `‰¥2 • Inadequate response and/or intolerance to one or more conventional therapy (i.e. oral aminosalicylates, immunosuppressants, corticosteroids, and/or TNF antagonist)
    1) Consenso Informato Scritto Popolazione Target 2) CU per almeno 6 mesi dalla diagnosi iniziale. La diagnosi di CU deve essere stata confermata endoscopicamente e istologicamente. Se non fosse disponibile una diagnosi confermata precedentemente o se la stessa non fosse ritenuta certa, al momento della endoscopia di screening dovra` essere effettuato un esame istologico per confermare la diagnosi di CU. 3) Deve soddisfare uno dei seguenti criteri: a) Pregressa risposta insufficiente ad uno o piu` dei seguenti trattamenti: 1. Amminosalicilati orali (es, mesalamina, sulfasalazina, olsalazina, balsalizide) a dosaggio uguale o superiore a quello approvato come terapia di induzione per almeno 6 settimane; 2. Prednisone  40 mg/die (o equivalente) per almeno 2 settimane; 3. Immunosuppressori [azatioprina  2 mg/kg/die o 6-mercaptopurina  1.0 mg/kg/die, o documentazione di concentrazioni terapeutiche di 6-tioguanina nucleotide] per almeno 12 settimane; 4. Idrocortisone endovena  400 mg/die (o equivalente) per almeno 1 settimana; 5. Un anti-TNF indicato al dosaggio approvato per almeno 8 settimane. Lo studio includera` al massimo circa un 40% di soggetti che abbiano avuto una trattamento con un anti-TNF. Una volta raggiunto il numero massimo di tali soggetti, questi non potranno piu` entrare nello studio. E/O b) Intolleranza a uno o piu` dei summenzionati trattamenti [es, non in grado di raggiungere dosaggi o del periodi di trattamento a causa degli effetti collaterali (es., leucopenia, psicosi, diabete non controllato, pancreatite)]. E/O c) Terapia in atto con uno o piu` dei seguenti trattamenti: 1. Aminosalicilati orali (es, mesalamina, sulfasalazina, olsalazina, balsalizide) a dosaggio uguale o superiore a quello approvato per almeno 6 settimane; 2. Prednisone  20 mg/die (o equivalente) per almeno 4 settimane; 3. Immunosuppressori [azatioprina  2 mg/kg/die o 6-mercaptopurina  1.0 mg/kg/die, o documentazione di una concentrazione terapeutica di 6- tioguanina nucleotide] per almeno 12 settimane. 4) Mayo score  6 con un subscore endoscopico di  2; 5) Necessita` di terapie stabilizzate (per soggetti che entrano nello studio con uno o piu` dei seguenti farmaci) a) Trattamento con corticosteroidi orali deve essere stato ï‚£ 30 mg/die di prednisone (o equivalente) a dose stabile per almeno 2 settimane prima della randomizzazione al Periodo d`€™Induzione; b) Aminosalicilati orali devono essere ad una dose stabile per almeno 2 settimane prima della randomizzazione al Periodo d`€™Induzione; c) Azatioprina o 6-mercaptopurina devono essere ad una dose stabile per almeno 8 settimane prima della randomizzazione al Periodo d`€™Induzione. Eta` e Stato Riproduttivo 6) Uomini e donne  18 anni; 7) Donne potenzialmente fertili (WOCBP) e uomini devono usare un metodo di contraccezione adeguato al fine di evitare una gravidanza nel corso dello studio e fino a 8 settimane dopo l`€™ultima dose di farmaco in studio in modo tale da minimizzare il rischio di una gravidanza. Vedi Paragrafo 3.3.3 per la definizione di WOCBP; 8) WOCBP devono avere il test di gravidanza su siero o urine negativo (sensibilita` minima 25 UI/L o unita` equivalenti di HCG) 48 ore prima dell`€™inizio del farmaco sperimentale; 9) Donne non in allattamento.
    E.4Principal exclusion criteria
    • Diagnosis of Crohn`€™s Disease or Indeterminate Colitis • Diagnosis of UC that is limited to the rectum • Evidence of fulminant colitis, toxic megacolon, or bowel perforation • Current need for a colostomy or ileostomy • Previous total or subtotal colectomy
    Eslusioni rispetto alla Malattia in Studio 1) Diagnosi di Morbo di Crohn o Colite Indeterminata o evidenze cliniche indicative di Morbo di Crohn (es, fistole o granulomi all`€™esame bioptico); 2) Diagnosi di CU limitata al retto (proctite ulcerosa); 3) Colite fulminante, megacolon tossico o perforazione intestinale in atto; 4) Necessita` di colostomia o ileostomia; 5) Precedente colectomia totale o subtotale o qualunque resezione per CU; 6) Resezione chirurgica intestinale nei 6 mesi precedenti lo screening per qualunque ragione diversa da CU; 7) Colangite primaria sclerosante (PSC); Storia Clinica e Malattie Concomitanti 8) Displasia colon o precedente evidenza di displasia colica certa che non sia stata trattata in maniera definitiva; 9) Soggetti per i quali sia stata fissato o sia programmato un intervento chirurgico, ad eccezione diprocedure dermatologiche; 10) Soggetti che con storia clinicamente significativa di abuso di farmaci o alcol a discrezione dell`€™investigatore; 11) Malattie concomitanti che, secondo l`€™opinione dell`€™Investigatore, necessitano di terapia sistemica con glucocorticosteroidi nel corso dello studio (es, asma da moderata a severa); 12) Presenza di sintomi di malattia renale, epatica, ematologia, polmonare, cardiaca, neurologica, oftalmologica o cerebrale grave, progressiva, o non controllata. Condizioni mediche concomitanti che secondo l`€™opinione dell`€™Investigatore potrebbero esporre il soggetto a un inaccettabile rischio con la partecipazione a questo studio; 13) Soggetti con storia o evidenza di neoplasia; in particolare, soggetti con: a. Storia di neoplasia negli ultimi cinque anni (escluso tumore della pelle non-melanoma curato con resezione locale), o b. Evidenza di neoplasia (inclusa quella rilevata dalle procedure di screening), o c. Segni di possibile neoplasia rilevati nel corso delle procedure di screening per i quali non sia stato ancora possibile escludere una neoplasia. NOTA: I seguenti soggetti possono essere arruolati; quelli con: o Neoplasie della pelle non-melanoma rimosse con margini chirurgici definiti prima della randomizzazione, o Carcinoma in situ, trattato con intervento chirurgico definitivo, o Nessuna evidenza di neoplasia a conclusione delle valutazioni successive ad un sospetto emerso durante le procedure di screenign. 14) Soggetti a rischio di tuberculosi (TB)attiva. In particolare, soggetti con: a) Storia di TB attiva negli ultimi 3 anni anche se trattata; b) Storia di TB attiva oltre i 3 anni precedenti a meno che non sia documentato che il precedente trattamento anti-TB fosse stato appropriato per durata e tipo; c) Evidenza clinica, radiografica o laboratoristica di TB attiva; d) TB latente non trattata con successo. Soggetti con test di screening positivo per TB indicativo di TB latente non saranno eleggibili nello studio a meno che un`€™infezione TB attiva sia stata esclusa e abbiano iniziato un trattamento per TB latente con isoniazide (INH) (o trattamenti di profilassi localmente accettati) per almeno 2 settimane precedenti la randomizzazione nel Periodo d`€™Induzione e abbiano la Rx del torace negativa per TB attiva all`€™arruolamento. Questi soggetti devono completare 9 mesi di trattamento con INH o l`€™intero ciclo di un altro trattamento di profilassi localmente accettato. 15) Soggetti con infezione batterica seria negli ultimi 3 mesi, a meno che trattata e risolta con antibiotici, o qualunque infezione batterica cronica (come pielonefrite, osteomielite e bronchiectasia); 16) Soggetti con evidenza (valutata dall`€™Investigatore) di infezioni batteriche o virali attive o croniche latenti, inclusi soggetti con evidenza di HIV, epatite B o epatite C; per ulteriori informazioni consultare il protocollo
    E.5 End points
    E.5.1Primary end point(s)
    Compare the efficacy of BMS-936557 vs placebo for induction of clinical remission (defined as Mayo score `‰¤ 2 points with no individual subscore > 1 point) at Week 7 [Induction Period-50 (IP-50)]
    Confrontare l`€™efficacia di BMS-936557 verso placebo nell`€™indurre la remissione clinica (definita come un Mayo score ï‚£ 2 punti senza alcun subscore individuale > 1 punto) alla Settimana 7 [Periodo di Induzione-50 (IP-50)].  Condizione clinica Colite Ulcerosa (CU) Attiva
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 years 0 months 0 days
    4 anni 0 mesi 0 giorni
    E.5.2Secondary end point(s)
    N.A.
    N.A.
    E.5.2.1Timepoint(s) of evaluation of this end point
    N.A.
    N.A.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others 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) No
    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 Yes
    E.8.1.4Double blind No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Brazil
    Canada
    Mexico
    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
    The end of the study is the last visit of the last subject in Open Label. For further information consult protocol
    La fine dello studio e' l`ultima visita dell`ultimo soggetto nella fase Open Label . Per ulteriori informazioni consultare il protocollo
    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 months0
    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 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.1.1Number 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.1.3Elderly (>=65 years) Yes
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 138
    F.4.2.2In the whole clinical trial 386
    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 Decision2011-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-02
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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