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    Summary
    EudraCT Number:2012-001609-25
    Sponsor's Protocol Code Number:X052131/CL3-78989-006
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-02-19
    Trial 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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-001609-25
    A.3Full title of the trial
    A RandomizEd, Double-masked, Placebo-controlled Study of the SafetY and Efficacy of GevokizUmAb in the TReatment of Subjects with Non-infectious IntermeDiate, Posterior, or Pan- uveitis Currently Controlled with Systemic Treatment. The EYEGUARD?-C study.
    Estudio aleatorizado, frente a placebo, doble enmascarado de eficacia y seguridas de gevokizumab en el tratamiento de pacientes con uveitis no infecciosa intermedia, posterior o panuveitis, actualmente controlada con tratamiento sistémico. Estudio EYEGUARD-C
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of gevokizumab in the treatment of patients with active non-infectious uveitis currently controlled with systemic treatment
    Eficacia y seguridad de Gevokizumab en el tratamiento de pacientes con uveitis no infecciosa activa actualmente controlada con tratamiento sistémico
    A.3.2Name or abbreviated title of the trial where available
    The EYEGUARD?-C study
    Estudio EYEGUARD-C
    A.4.1Sponsor's protocol code numberX052131/CL3-78989-006
    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 SponsorXOMA (US) LLC
    B.1.3.4CountryUnited States
    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.4.2CountryFrance
    B.4.1Name of organisation providing supportServier Research and Development Ltd
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportLaboratorios Servier, S.L.
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportXOMA US LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recherches Internationales Servier
    B.5.2Functional name of contact pointClinical Studies Department
    B.5.3 Address:
    B.5.3.1Street Address50 Rue Carnot
    B.5.3.2Town/ citySuresnes
    B.5.3.3Post code92284
    B.5.3.4CountryFrance
    B.5.4Telephone number+33155 72 43 66
    B.5.5Fax number+33155 72 54 12
    B.5.6E-mailclinicaltrials@servier.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 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.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 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.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 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 number30
    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) 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 injection
    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
    Non-infectious Intermediate, Posterior, or Pan- Uveitis
    Uveitis no infecciosa intermedia, posterior o panuveitis
    E.1.1.1Medical condition in easily understood language
    chronic non-infectious uveitis
    Uveitis no infecciosa crónica
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10022557
    E.1.2Term Intermediate uveitis
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10069034
    E.1.2Term Tubulointerstitial nephritis and uveitis syndrome
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10036370
    E.1.2Term Posterior uveitis
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10071139
    E.1.2Term Behcet's uveitis
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10042745
    E.1.2Term Sympathetic uveitis
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10012692
    E.1.2Term Diabetic uveitis
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    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 compared to placebo in reducing the risk of recurrent uveitic disease in subjects with non-infectious intermediate, posterior, or pan- uveitis currently controlled with systemic treatment.
    El objetivo del estudio es demostrar la superioridad de Gevokizumab comparado con placebo en la reducción de uveitis recurrente en sujetos con uveitis no infecciosa intermedia, posterior o panuveitis actualmente controlado con tratamiento sistémico
    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.
    Los objetivos secundarios son evaluar los efectos de gevokizumab en otras medidas diferentes de la eficacia y evaluar su seguridad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnosis of non-infectious intermediate, posterior, or pan-uveitis in at least one eye fulfilling the International Study Group Classification Criteria ([SUN] criteria) of intermediate, posterior, or pan- uveitis confirmed by documented medical history
    - Controlled uveitic disease in both eyes, defined by no active inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber cell grade ? 0.5+ according to SUN criteria, Vitrous Haze grade ? 0.5+ according to the SUN/NEI Scoring for Vitrous Haze,
    - Best Corrected Visual Acuity of 35 letters or more in both eyes,
    - Patients with a stable dose of oral corticosteroids, alone or in combination with selected stable immunosuppressive therapy .
    - 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.
    - Diagnóstico de uveitis no infecciosa intermedia, posterior o panuveitis en al menos un ojo que cumpla los criterios de clasificación del grupo de Estudio Internacional ( Criterios SUN ) confirmada por la historia clínica documentada
    - Uveitis controlada en ambos ojos. definida como ausencia de lesiones coreoretinianas inflamartorias y/o vasculares retinianas inflamatorias activas, grado de células de la cámara anterior? 0.5+ según criterios de SUN, grado de opacidad del vítreo ? 0.5+ según SUN/NEI para la puntuación de la opacidad del vítreo
    - mejor agudeza visual corregida de 35 letras o mas en ambos ojos
    - Régimen estable de corticosteroides, solos o en combinación con terapias inmunosupresores seleccionada
    - Hombre o mujer , edad ?18 ( o mayorái de edad legal en el país ) en la selección
    - Para sujetos con potencial reproductivo, la voluntad de utilizar un método anticonceptivo altamente eficaz
    E.4Principal exclusion criteria
    - Infectious uveitis and masquerade syndromes
    - Isolated anterior uveitis
    - Best corrected visual acuity < 35 letters in both eyes or monocular vision
    - Presence of severe cataract or severe posterior capsular opacification.
    - Contraindication to mydriatics or presence of posterior synechiae, in either eye.
    - 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.
    - Pregnancy, breastfeeding or possibility to become pregnant during the study
    - Uveitis infecciosa y síndrome de mascarada
    - Uveitis anterior aislada
    - Major agudeza visual corregida < 35 letras en ambos ojos o visión monocular
    - Presencia de cataratas graves u opacificación capsular posterior grave
    - Contraindicación con midriáticos, o presencia de sinequias posteriores en cualquier ojo.
    - Tuberculosis activa
    - Antecedente de reacciones alérgicas o anafilácticas graves a los anticuerpos monoclonales
    - Antecedente de neoplasia en los 5 años previos a la selección
    - Enfermedad infecciosa
    - Inmunodefiiciencia conocida .
    - Embarazo, lactancia o posibilidad de embarazo durante el estudio
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects with an occurence of uveitic disease
    proporción de sujetos con una aparición de uveitis
    E.5.1.1Timepoint(s) of evaluation of this end point
    From inclusion to D168
    Desde la inclusión a D168
    E.5.2Secondary end point(s)
    - Time to first occurence of uveitic disease,
    - Mean change from baseline BCVA at D168
    - Proportion of subjects who reach zero corticosteroids without an occurence of uveitic disease
    - Ophthalmologic assessments (visual acuity, vitreous haze score, ...)
    - Safety measurements (adverse events, optical coherence tomography, intraocular pressure, vital signs, chest X rays, standard 12-lead ECG, laboratory parameters,...)
    - Tiempo hasta la primera aparición de uveitis ,
    - Cambio medio de BCVA desde el valor basal en D168
    - Proporción de sujetos que alcanzan cero en corticosteroides sin una aparición de uveitis
    - Evaluaciones oftalmológicas (agudeza visual, puntuación en la opacidad del vítreo, ...)
    - medidas de seguridad (acontesimientos adversos, tomografía de coherencia óptica, Presión intaocular, signos vitales, radiografías, ECG de 12 derivaciones estándar, parámetros de laboratorio ,...)
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Ophthalmologic endpoints: at each visit until D168, and at D280, D392, OL-0, OL-112, and OL-224.
    -Safety measurements : from selection to the end of the trial.
    - Objetivos oftalmológicos: en cada visita hasta D168, y en D280, D392, OL-0, OL-112, y OL-224
    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 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 Yes
    E.8.1.7.1Other trial design description
    Esquema de tratamieno en abierto para pacientes que hayan sido rescatados con éxito durante el estu
    Open label treatment schedule for patients successfully rescued during the study
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    Austria
    Brazil
    China
    France
    Germany
    Greece
    Hong Kong
    India
    Italy
    Korea, Republic of
    Mexico
    Poland
    Portugal
    Russian Federation
    Saudi Arabia
    Spain
    Switzerland
    Taiwan
    Tunisia
    Turkey
    United Kingdom
    United States
    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
    The end of trial is defined as the Last Visit of the Last Participant as stated in the clinical protocol.
    El final de este estudio se define como la última visita del último paciente tal y como se especifica en el protocolo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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.1.1.1In 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: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 60
    F.4.2.2In the whole clinical trial 300
    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.
    Después del final del estudio, dado que gevokizumab no está comercializado, el fármaco en estudio no estará disponible. El sujeto recibirá otro tratamiento y/o tendrá acceso a otro cuidado adecuado por parte de su médico
    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 Decision2013-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-11
    P. End of Trial
    P.End of Trial StatusCompleted
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