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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42891   clinical trials with a EudraCT protocol, of which   7066   are clinical trials conducted with subjects less than 18 years old.
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    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

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    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2012-001125-27
    Sponsor's Protocol Code Number:CL3-78989-002
    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:2012-09-21
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-001125-27
    A.3Full title of the trial
    A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet’s Disease uveitis. The EYEGUARD B study.
    Studio randomizzaato, in doppio cieco, controllato verso placebo, dell`efficacia di gevokizumab nel trattamento di pazienti affetti da uveite di Behcet- Lo studio EYEGUARD B
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of gevokizumab in the treatment of patients with Behcet`s disease uveitis
    Efficacia di gevokizumab nel trattamento di pazienti affetti da malattia di Behçet
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberCL3-78989-002
    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.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 supportADIR
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISTITUTO DI RICERCA SERVIER SRL
    B.5.2Functional name of contact pointPROJECT MANAGER CHIARA PERTICA
    B.5.3 Address:
    B.5.3.1Street AddressVIA LUCA PASSI, 85
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00166
    B.5.4Telephone number06-669081
    B.5.5Fax number06-66908738
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/796
    D.3 Description of the IMP
    D.3.1Product nameGEVOKIZUMAB
    D.3.2Product code S78989
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGEVOKIZUMAB
    D.3.9.1CAS number 1129435-60-4
    D.3.9.2Current sponsor codeS78989
    D.3.9.3Other descriptive nameXOMA 052
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product 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 infusion
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Behçet's disease uveitis
    Uveite nella malattia di Behçet
    E.1.1.1Medical condition in easily understood language
    Behçet's disease uveitis
    Uveite nella malattia di Behçet
    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 SOC
    E.1.2Classification code 10021428
    E.1.2Term Immune system disorders
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10046851
    E.1.2Term Uveitis
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to demonstrate the superiority of gevokizumab as compared to placebo on top of current standard of care in reducing the risk of Behçet’s disease uveitis exacerbations
    L’obiettivo di questo studio è dimostrare la superiorità di gevokizumab verso placebo in aggiuta alla corrente terapia medica nella riduzione del rischio di esacerbazione dell’uveite nella malattia di Behçet
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the effect of gevokizumab on the other efficacy endpoints and to evaluate its safety.
    Gli obiettivi secondari sono valutare gli effetti di gevokizumab sugli altri endopoints di efficacia e valutare la sua sicurezza
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Behçet’s disease diagnosis fulfilling the International Study Group Classification Criteria. - History of Behçet’s disease uveitis with ocular involvement of the posterior segment. - Patients with a stable backgroud treatment of oral corticosteroid and at least one immunosuppressive drug. - Male or female, age ≥18 (or legal age of majority in the country) at selection - For subjects with reproductive potential, a willingness to use highly effective contraceptive measures
    Diagnosi di malattia di Behçet che soddisfa i criteri di classificazione del gruppo di studio internazionale – storia di uveite nella malattia di Behcet con coinvolgimento oculare del segmento posteriore.- pazienti con terapia di base stabile con corticosteroidi orali e almeno un farmaco immunosoppressore.—Uomini e Donne, età &gt; a 18 anni alla selezione- per soggetti potenzialmente fertili volontà all’uso di efficaci metodi contraccettivi.
    E.4Principal exclusion criteria
    - Infectious uveitis, uveitis due to causes other than Behçet’s disease. - Monocular vision - Presence of severe cataract or severe posterior capsular opacification. - Contraindication to mydriasis or presence of posterior synechiae. - Active TB disease. - History of severe allergic or anaphylactic reactions to monoclonal antibodies - History of malignancy within 5 years prior to Selection. - Infectious disease. - Known immunodeficiency.
    Uveite infettiva, uveite dovuta a cause diverse dalla malattia di Behçet. – Visione monoculare – presenza di cataratta grave od opacizzazione capsulare posteriore grave. – controindicazioni alla midriasi o presenza di sinechia posteriore.- Tubercolosi attiva. Storia di allergia grave o reazione anafilattica agli anticorpi monoclonali - storia di tumori maligni nei 5 anni precedenti la selezione- Malattie infettive, Immunodeficienza conosciuta
    E.5 End points
    E.5.1Primary end point(s)
    Time to first acute ocular exacerbation (number of days)
    Tempo di occorrenza della prima esacerbazione oculare acuta (espresso in numero di giorni)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time to first acute ocular exacerbation (number of days).
    Tempo di occorrenza della prima esacerbazione oculare acuta (numero di giorni).
    E.5.2Secondary end point(s)
    Ocular exacerbations - Visual acuity - Vitreous haze - Retinal infiltrates or acute retinal vasculitis - Anterior chamber - Safety measurements (adverse events, non ocular manifestations of Behçet's Disease, vital signs, chest X rays, standard 12-lead ECG, laboratory parameters,...)
    Esacerbazione oculare- acuità visiva -offuscamento del Corpo Vitreo – Infiltrazione retinica o vasculite retinica acuta- Cellule della Camera anteriore- Valutazione della sicurezza (eventi avversi , manifestazioni non oculari della malattia di Behçet, segni vitali, raggi X del torace, EGC standard a 12 derivazioni- Parametri di laboratorio,…)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Ocular exacerbations : from inclusion to the end of the trial, -Vitreous haze, retinal infiltrates, acute retinal vasculitis, anterior chamber, visual acuity : at each visit of Part 1. Part 2 : at month 4 and end of trial, -Safety measurements : from selection to the end of the trial.
    Esacerbazione oculare: dall’inclusione alla fine dello studio, - offuscamento del Corpo Vitreo - Infiltrazione retinica, vasculite retinica acuta- Cellule della camera anteriore, acuità visiva: a ciascuna visita della Parte 1. Parte 2: alla visita al Mese 4 e alla fine dello studio, valutazione della sicurezza: dalla selezione alla fine dello 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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. 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 Yes
    E. trial design description
    Valutaz.comparsa esacerbazioni oculari ed estensione doppi cieco+parte in aperto
    Occurence of ocular execerbation and double blind extention+ open part
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Hong Kong
    Korea, Republic of
    Russian Federation
    Saudi Arabia
    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
    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 months58
    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 months58
    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: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 110
    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)
    After the end of the study, as gevokizumab is not licensed, study drug will not be available. The subject will receive other treatment and/or have access to other appropriate care by his doctor
    Dopo la fine dello studio poichè gevokizumab non è autorizzato, il farmaco dello studio non sarà disponibile. Il soggetto riceverà altri trattamenti e/o avrà accesso ad altre appropriate cure da parte del suo medico.
    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 Decision2012-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-29
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