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    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2013-004973-29
    Sponsor's Protocol Code Number:CL3-78989-019
    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:2014-08-06
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2013-004973-29
    A.3Full title of the trial
    A safety open-label study of Gevokizumab in the treatment of patients with chronic non-infectious Uveitis disease, an eXtension study. The EYEGUARD-X study.
    Estudio de extensión en abierto, de seguridad de Gevokizumab en el tratamiento de pacientes con uveítis crónica no infecciosa. Estudio EYEGUARD-X.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term safety of gevokizumab in the treatment of patients with chronic non-infectious uveitis, who previously well tolerated geovkizumab
    Estudio para evaluar la seguridad a largo plazo de gevokizumab en pacientes con uveítis crónica no infecciosa que previamente hayan tolerado bien gevokizumab
    A.4.1Sponsor's protocol code numberCL3-78989-019
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1151-7937
    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 SponsorLaboratorio Servier S.L.
    B.1.3.4CountrySpain
    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 supportLaboratorios Servier, S.L
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratorio Servier S.L.
    B.5.2Functional name of contact pointCentro Investigación y Desarrollo
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de los Madroños 33
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28043
    B.5.3.4CountrySpain
    B.5.4Telephone number3491 748 96 67
    B.5.5Fax number3491 300 32 49
    B.5.6E-mailbelen.diaz@es.netgrs.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1111
    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 nameGEVOKIZUMAB
    D.3.9.4EV Substance CodeSUB130497
    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.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    chronic non-infectious uveitis
    Uveítis crónica no infecciosa
    E.1.1.1Medical condition in easily understood language
    chronic non-infectious uveitis
    Uveítis crónica no infecciosa
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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 17.0
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10036370
    E.1.2Term Posterior uveitis
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10071139
    E.1.2Term Behcet's uveitis
    E.1.2System Organ Class 100000004866
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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 17.0
    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 17.0
    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 evaluate long-term safety of gevokizumab in patient with chronic non-infectious uveitis who previously well tolerated the study drug and may benefit from longterm treatment with gevokizumab
    El objetivo primario de este estudio es evaluar la seguridad a largo plazo de gevokizumab en pacientes con uveítis crónica no infecciosa que previamente hayan tolerado bien el medicamento en investigación y que puedan beneficiarse del tratamiento con gevokizumab a largo plazo
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - either completed participation to one of the following : CL3-78989-002 open label extension, or X052130/CL3-78989-005 double masked period or open label period, or X052131/CL3-78989-006 double masked period or open label period, or currently benefiting from gevokizumab compassionate use after participation in gevokizumab uveitis studies,
    - Able to receive the first injection of gevokizumab within 6 weeks after the last study drug administration
    - 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
    -Hombre o mujer, edad mayor o igual a 18 años (o mayoría de edad legal) en la visita de selección

    -Hayan completado uno de los siguientes periodos: la extensión del periodo en abierto de CL3-78989-002, el periodo de doble enmascarado o periodo en abierto de X052130/CL3-78989-005 o X052131/CL3-78989-006 o que estén recibiendo gevokizumab como uso compasivo tras su participación en los estudios de uveítis
    -Capaces de recibir la primera inyección de gevokizumab en las 6 semanas posteriores a la última administración del medicamento en investigación
    -Para pacientes con potencial reproductivo, la voluntad de utilizar un método anticonceptivo altamente eficaz
    E.4Principal exclusion criteria
    - Meeting criteria for discontinuation of any of gevokizumab uveitis previous study.
    - Infectious uveitis and masquerade syndrome.
    - History of severe allergic or anaphylactic reaction to study drug administration during previous study or to gevokizumab or any of its excipient.
    - Currently active Infectious disease.
    - Que cumplan alguno de los criterios de retirada prematura de los estudios previos de uveítis con gevokizumab
    - Uveítis infecciosa y síndromes mascarada
    - Antecedente de alergia grave o reacción anafiláctica a la administración del medicamento en investigación durante el estudio previo, a gevokizumab o a alguno de sus excipientes
    - Enfermedad infecciosa activa
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints (adverse events assessment, vital signs, laboratory parameters, ophtalmological assessments,...)
    Objetivos de seguridad (evaluación de los acontecimientos adversos, signos vitales, parámetros de laboratorio, parámetros oftalmológicos, ...)
    E.5.1.1Timepoint(s) of evaluation of this end point
    -Adverse events and vital signs : From inclusion until the end of the study
    -laboratory parameters and ophtalmologic assessment : each 16 weeks from inclusion until the end of the study
    - Acontecimientos adversos y signos vitales: desde la visita de inclusión hasta el final del estudio
    - parámetros de laboratorio y evaluaciones oftalmológicas: cada 16 semanas desde la visita de inclusión hasta el final del estudio
    E.5.2Secondary end point(s)
    Not Applicable
    No aplicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplicable
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    Armenia
    Australia
    Austria
    Brazil
    Canada
    China
    European Union
    France
    Germany
    Greece
    Hong Kong
    Israel
    Italy
    Korea, Republic of
    Mexico
    Poland
    Portugal
    Russian Federation
    South Africa
    Spain
    Taiwan
    Tunisia
    Turkey
    United Kingdom
    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 trial is defined as the Last Visit of the Last Participant as stated in the clinical protocol.
    El final del ensayo se define como la última visita del último paciente como indica 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 state15
    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. Arrangements after discontinuation of the IMP should be in agreement to local regulation of each country.
    Después del final del estudio, dado que gevokizumab no se encuentra comercializado, el medicamento en investigación no se encontrará disponible. El paciente recibirá otro tratamiento y/o tendrá acceso a otros cuidados adecuados de su médico. Los acuerdos después de la interrupción del medicamento en investigación deberán cumplir con la regulación local de cada país
    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 Decision2014-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-18
    P. End of Trial
    P.End of Trial StatusCompleted
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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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