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    Summary
    EudraCT Number:2011-002944-28
    Sponsor's Protocol Code Number:DM2115403
    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:2012-03-08
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-002944-28
    A.3Full title of the trial
    A phase 2, multi-national, multi-centre, double masked, randomised, placebo controlled, parallel-group study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of darapladib administered for 3 months to adult subjects with diabetic macular edema with centre involvement
    Uno studio di fase 2, multinazionale, multicentrico, con doppio mascheramento, randomizzato, controllato con placebo, a gruppi paralleli per valutare sicurezza, tollerabilita', farmacocinetica, farmacodinamica ed efficacia di darapladib somministrato per 3 mesi a soggetti adulti con edema maculare diabetico con coinvolgimento centrale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 3 month Study of Darapladib to Treat Diabetic Macular Edema (DME).
    Darapladib somministrato per 3 mesi per trattare edema maculare diabetico (DME).
    A.4.1Sponsor's protocol code numberDM2115403
    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 Limited
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Limited
    B.5.2Functional name of contact pointGSK Clinical Support Helpdesk
    B.5.3 Address:
    B.5.3.1Street Address980 Great West Road
    B.5.3.2Town/ cityBrentford
    B.5.3.3Post codeTW8 9GS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 (0)20 8990 4466 800786766
    B.5.5Fax number+44 (0)20 8990 1234
    B.5.6E-mailGSKClinicalSupportHD@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 nameDarapladib
    D.3.2Product code SB-480848
    D.3.4Pharmaceutical form Gastro-resistant tablet
    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 C36H38F4N4O2
    D.3.9.2Current sponsor codeSB-480848
    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 number160
    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 placeboGastro-resistant tablet
    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
    Diabetic macular edema with centre involvement
    Edema maculare diabetico con coinvolgimento centrale
    E.1.1.1Medical condition in easily understood language
    Swelling of the retina in patients with diabetes , due to leakage of fluid from blood vessels
    Ispessimento della retina nei pazienti con diabete, dovuta a perdita di fluido da vasi sanguigni
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10057934
    E.1.2Term Diabetic macular edema
    E.1.2System Organ Class 10015919 - Eye 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 determine the effect of darapladib administered as oral daily doses for 3 months on best-corrected visual acuity (BCVA) and spectral domain OCT (SD-OCT) centre subfield of the study eye in adult subjects with centre-involved DME.
    Determinare gli effetti di darapladib somministrato a dosi orali giornaliere per 3 mesi sulla migliore acuità visiva corretta (BCVA) e nel sottocampo centrale di SD-OCT (spectral domain OCT) dell’occhio in studio in soggetti adulti con edema maculare diabetico con coinvolgimento centrale.
    E.2.2Secondary objectives of the trial
    • To determine the effect of darapladib administered as oral daily doses for 3 months on retina anatomy of the study eye in adult subjects with centre-involved DME • To assess safety and tolerability of darapladib in adult subjects with centre-involved DME • To determine the pharmacokinetic and pharmacodynamic profiles of darapladib in adult subjects with centre-involved DME, as data permit
    •Determinare gli effetti di darapladib sull'anatomia della retina dell'occhio in studio •Valutare sicurezza e tollerabilità di Darapladib •Determinare i parametri farmacocinetici di darapladib •Determinare i parametri farmacodinamici di darapladib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Subject is at least 18 years of age inclusive. 2) A female subject is eligible if she is of non-childbearing potential or if she agrees to use one of the approved contraception methods for an appropriate period of time. 3) Diagnosis of diabetes mellitus (type 1 or type 2). 4) Confirmation of DME in the study eye by investigator-determined fluorescein angiography. 5) Retinal thickening (diabetic macular edema) involving the centre of the fovea in the study eye as defined by investigator-determined SD-OCT central subfield thickness > 330 microns (Heidelberg Spectralis) and >310 (Zeiss Cirrus); if both eyes are eligible, the eye with the greater OCT centre subfield score is selected as the study eye.6) Best corrected visual acuity score of 78-24 letters in the study eye.
    1) Soggetti di almeno 18 anni d'età (compresi). 2) I soggetti di sesso femminile devono essere non fertili oppure accettare di usare un metodo contraccettivo idoneo per un periodo adeguato. 3) Diagnosi di diabete mellito di tipo 1 o 2. 4) Edema maculare diabetico nell'occhio dello studio confermato dallo sperimentatore con angiografia con fluoresceina. 5) Ispessimento della retina (edema maculare diabetico) che interessa il centro della fovea nell'occhio dello studio, definito da uno spessore del sottocampo centrale, valutato dallo sperimentatore, &gt; 330 micron (con Heidelberg Spectralis) o &gt; 310 (con Zeiss Cirrus); se entrambi gli occhi sono eleggibili, sarà scelto per lo studio l'occhio che mostra il valore più alto. 6) Migliore acuità visiva corretta nell’occhio dello studio nell’ intervallo 78-24 lettere nell’occhio in studio.
    E.4Principal exclusion criteria
    1) Additional eye disease in the study eye that could compromise assessment of BCVA or imaging of the posterior pole by fundus photography, fluorescein angiography, or spectral domain OCT, or is likely to require intervention during the ~4 months study. 2) Active proliferative diabetic retinopathy in the study eye. 3)Ischemic maculopathy on fluorescein angiography defined as a total area of capillary loss greater than 2 disc areas (> 5mm2) within the ETDRS macular grid or a foveal avascular zone greatest linear diameter of > 1000 microns. 4) History of choroidal neovascularization in the study eye, or current choroidal neovascularization in the fellow eye requiring treatment. 5)Intraocular surgery in the study eye within 3 months of dosing. 6) Laser photocoagulation in the study eye within 3 months of dosing. 7) Use of intravitreal ranibizumab in the study eye within 90 days of dosing. 8) Use of intravitreal bevacizumab in the study eye within 180 days of dosing. 9)Use of intraocular steroids in the study eye within 180 days of dosing. 10) Use of intravitreal bevacizumab in the fellow eye or expected need for intravitreal bevacizumab in the fellow eye during the course of the study. 11) Best corrected visual acuity score by electronic ETDRS < 56 letters in the fellow eye at screening. 12) Use of any systemically administered anti-angiogenic agent (e.g., bevacizumab, sunitinib, cetuximab, sorafenib, pazopanib) within 6 months of dosing. 13) Evidence of vitreomacular traction as determined by the Investigator. 14) Uncontrolled intraocular pressure >22 mmHg in the study eye despite treatment with glaucoma medication. 15) Within 6 months prior to the Screening Visit, use of medications known to be toxic to the retina, lens or optic nerve (e.g. desferoximine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, and ethambutol). 16) Uncontrolled diabetes as indicated by HbA1c >10% at screening. 17) Evidence of clinical instability or abnormal clinical laboratory findings prior to randomisation that, in the opinion of the Investigator, makes the subject unsuitable for the study. 18) Current liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones) or evidence of abnormal liver function tests. 19) Severe renal impairment. 20) Poorly controlled hypertension despite lifestyle modifications and pharmacotherapy. 21) Current severe heart failure (New York Heart Association class III or IV). 22) QTcF > 480msec in any subject including those with Bundle Branch Block. 23) Severe asthma that is poorly controlled on pharmacotherapy. 24) History of anaphylaxis, anaphylactoid reactions, or severe allergic responses.
    1)Ulteriore malattia oculare a carico dell'occhio dello studio che potrebbe compromettere la valutazione della BCVA o la diagnostica per immagini del polo posteriore con fotografia del fondo oculare, angiografia con fluoresceina o SD-OCT, o che probabilmente richiederà un intervento durante i circa 4 mesi di durata dello studio. 2) Retinopatia diabetica proliferativa attiva a carico dell'occhio dello studio. 3) Maculopatia ischemica all' angiografia con fluoresceina. 4) Storia di neovascolarizzazione coroidale nell'occhio dello studio, o neovascolarizzazione coroidale in corso nell'altro occhio tale da richiedere un trattamento. 5) Intervento chirurgico intraoculare nell'occhio dello studio nei 3 mesi precedenti il trattamento. 6) Fotocoagulazione laser nell'occhio dello studio nei 3 mesi precedenti il trattamento. 7) Uso di ranibizumab intravitreale nell'occhio dello studio nei 90 giorni precedenti il trattamento. 8) Uso di bevacizumab intravitreale nell'occhio dello studio nei 180 giorni precedenti il trattamento. 9) Uso di steroidi intraoculari nell'occhio dello studio nei 180 giorni precedenti il trattamento. 10) Uso di bevacizumab intravitreale nell'altro occhio o prevista necessità di bevacizumab intravitreale nell'altro occhio durante lo studio. 11) Migliore acuità visiva corretta nell’altro occhio &lt; 56 lettere allo screening. 12) Uso di un agente anti-angiogenico sistemico (ad es. bevacizumab, sunitinib, cetuximab, sorafenib, pazopanib), nei 6 mesi precedenti il trattamento. 13) Evidenze di trazione vitreomaculare secondo la determinazione dello Sperimentatore. 14) Pressione intraoculare incontrollata &gt; 22 mmHg nell'occhio dello studio nonostante il trattamento anti-glaucoma. 15) Nei 6 mesi precedenti la visita di screening, uso di farmaci notoriamente tossici per la retina, il cristallino o il nervo ottico (ad es. desferoximina, clorochina/idroclorochina, clorpromazina, fenotiazine, tamoxifene, etambutolo). 16) Diabete incontrollato indicato da HbA1c &gt; 10% allo screening. 17) Evidenze di instabilità clinica o valori di laboratorio clinico anomali prima della randomizzazione tali da rendere il soggetto non adatto allo studio a giudizio dello Sperimentatore. 18) Malattia epatica in corso, anomalia epatica o biliare nota (a eccezione di sindrome di Gilbert o calcoli biliari asintomatici) o evidenze di valori anomali della funzionalità epatica o altre anomalie epatiche che a giudizio dello Sperimentatore precluderebbero la partecipazione del soggetto allo studio. 19) Disfunzione renale grave o sottoposti a nefrectomia o trapianto di reni (a prescindere dalla funzionalità renale). 20) Ipertensione mal controllata nonostante le modifiche dello stile di vita e la terapia farmacologica. 21) Insufficienza cardiaca grave in corso (classe III o IV secondo la New York Heart Association). 22) QTcF &gt; 480 msec in qualsiasi soggetto, anche se con blocco di branca. 23) Asma grave scarsamente controllata dalla farmacoterapia. 24)Storia di anafilassi, reazioni anafilattoidi o risposte allergiche gravi
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from baseline in ETDRS Best Corrected Visual Acuity (BCVA) and SD-OCT centre subfield retinal thickness in the study eye.
    Variazione media dal basale di ETDRS BCVA e dello spessore retinico nel sottocampo centrale di SD-OCT nell'occhio dello studio. ETDRS = Early Treatment in Diabetic Retinopathy Study SD-OCT = Spectral Domain Optical Coherence Tomography
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 MONTHS
    3 MESI
    E.5.2Secondary end point(s)
    • Changes in retinal anatomy as assessed by fluorescein angiography (leakage area), fundus photography (retinal thickening area) and SD-OCT (macular volume, subretinal fluid, intraretinal cysts) in the study eye • Safety and tolerability assessed by complete ophthalmic examination, visual acuity, vital sign measures (heart rate and blood pressure), clinical laboratory tests, clinical monitoring and adverse event reporting • Plasma pharmacokinetic parameters (Cmax, AUC0-t, apparent volume of distribution and apparent clearance, etc) of darapladib as data permit • Pharmacodynamic parameters (Lp-PLA2 activity inhibition) of darapladib as data permit Exploratory Endpoints: • Mean change from baseline in ETDRS Best Corrected Visual Acuity (BCVA) and SD-OCT centre subfield retinal thickness in the fellow eye, as data permit • Changes in retinal anatomy as assessed by fluorescein angiography (leakage area), fundus photography (retinal thickening area) and SD-OCT (macular volume, subretinal fluid, intraretinal cysts) in the fellow eye, as data permit.
    •Variazioni dell'anatomia della retina valutate con angiografia con fluoresceina (area della fuoriuscita), fotografia del fondo oculare (area di ispessimento retinico) e SD-OCT (volume maculare, liquido subretinico, cisti intraretiniche) nell'occhio in studio •Sicurezza e tollerabilità valutate con esame oculistico completo, acuità visiva, segni vitali (frequenza cardiaca e pressione arteriosa), esami di laboratorio su campioni di sangue e urine, monitoraggio e segnalazione degli eventi avversi •Parametri farmacocinetici plasmatici (Cmax, AUC0-t, volume di distribuzione apparente e clearance apparente) di darapladib •Parametri farmacodinamici (inibizione dell'attività di Lp-PLA2) di darapladib
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 MONTHS
    3 MESI
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic 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) 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 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 trial2
    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 EEA12
    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
    E.8.7Trial has a data monitoring committee No
    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 months9
    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 months9
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 60
    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 will not receive any additional treatment after completion of the study because darapladib does not have proven efficacy in this indication and other treatment options are available. Subjects may be treated as deemed appropriate by the Investigator following the end of the Treatment Phase. IP will not be available to subjects after the Treatment Phase of this study. Please see pg 48 of Protocol for further details.
    Soggetti non riceveranno alcun ulteriore trattamento dopo il completamento dello studio perché darapladib non ha efficacia dimostrata in questa indicazione e sono disponibili altre opzioni di trattamento. I soggetti possono essere trattati come ritenuto opportuno dallo sperimentatore dopo la fine della fase di trattamento. Il farmaco dello studio non è disponibile per i soggetti dopo la fase di trattamento di questo studio. Per ulteriori informazioni, vedere pg 48 del protocollo.
    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 Decision2012-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-16
    P. End of Trial
    P.End of Trial StatusCompleted
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