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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   43929   clinical trials with a EudraCT protocol, of which   7307   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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    EudraCT Number:2013-002778-38
    Sponsor's Protocol Code Number:CL2-78989-012
    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:2013-10-18
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-002778-38
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis
    Estudio aleatorizado, doble siego, controlado con placebo, de prueba de concepto sobre la eficacia y seguridad del gevokizumab en el tratamiento de pacientes con arteritis de células gigantes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis
    Estudio controlao frente a placebo, prueba de concepto sobre la seguridad y la eficacia de gevokizumab en el tratameitno de pacientes con arteritis de células gigantes
    A.4.1Sponsor's protocol code numberCL2-78989-012
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1144-7133
    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 SponsorLaboratorios Servier SL
    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 SL
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratorios Servier SL
    B.5.2Functional name of contact pointLoreto TABOADA
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de los Madroños 33
    B.5.3.2Town/ cityMADRID
    B.5.3.3Post code28043
    B.5.4Telephone number0034917489630178
    B.5.5Fax number0034913003249NA
    B.Sponsor: 2
    B.1.1Name of SponsorInstitut de Recherches Internationales Servier ( IRIS )
    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 Servier
    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.5.4Telephone number0033155 72 43 6
    B.5.5Fax number0033155 72 54 1
    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. 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 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
    Giant cell arteritis
    Arteritis de células gigantes
    E.1.1.1Medical condition in easily understood language
    Giant cell arteritis
    Arteritis de células gigantes
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10018250
    E.1.2Term Giant cell arteritis
    E.1.2System Organ Class 100000004866
    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 the efficacy and safety of gevokizumab on symptoms of giant cell arteritis (GCA) in relapsing patients receiving systemic oral corticosteroids (CS)
    El objetivo de este estudio es evaluar la eficacia y seguridad de gevokizumab en los síntomas de la arteritis de células gigantes ( ACG ) de pacientes con recaída que reciban corticoterapia sistémica oral
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Relapsing GCA with systemic symptoms,
    - Diagnosis of GCA according to ACR criteria and at least one previous GCA relapse,
    - Oral CS therapy,
    - Male or female, age ? 50 years,
    - Weight ­> 40 kg at selection,
    - For subjects with reproductive potential, a willingness to use highly effective contraceptive measures.
    - ACG recidivantes con síntomas sistémicos
    - Diagnóstico de ACG de acuerdo con los criterios ACR y con al menos una recaída previa,
    - Corticoterapia oral
    - Hombres o mujeres de edad > 50 años ,
    - Peso > 40 kg en la selección
    - Para sujetos fértiles, la voluntad de utilizar métodos anticonceptivos altamente eficaces
    E.4Principal exclusion criteria
    - relapse of GCA with symptoms indicative of a risk of ischemic event,
    - History of recent, permanent or transient visual loss due to GCA and the presence of any specific visual abnormality,
    - History of major ischemic event, unrelated to GCA,
    - History of fibromyalgia,
    - Evidence of active pulmonary infection, active TB disease, or malignancy, or suspicion of active or latent TB, or exposition to TB,
    - History of severe allergic or anaphylactic reactions to monoclonal antibodies,
    - History of malignancy within 5 years prior to selection,
    - Known immunodeficiency,
    - Infectious disease,
    - Pregnancy, breastfeeding or possibility to become pregnant during the study
    - recaída de ACG cuyos síntomas denoten riesgo de isquemia
    - Antecedentes de ceguera reciente, permanente o transitoria debida a ACG y la presencia de cualquier anomalía visual específica
    - Episodio isquémico importante, no relacionado con la CGA
    - Antecedentes de fibromialgia
    - Evidencia de infección pulmonar activa, tuberculosis activa o neoplasia o sospecha de TB activa o latente o exposición a la TB .
    - Antecedentes de reacción alérgica o anafilactica grave a los anticuerpos monoclonales
    - Antecedentes de neoplasis maligna en los 5 años anteriores a la selección
    - Inmunodeficiencia conocida
    - Embarazo, lactancia o posibilidad de quedar embarazada durante el estudio
    E.5 End points
    E.5.1Primary end point(s)
    - Proportion of responders to treatment,
    - Physician Global Assessment,
    - Patient Global Assessment,
    - PMR activity score (PMR-AS),
    - Quality of life (SF-36),
    - Inflammation markers,
    - Corticosteroids use.
    - Proporción de respondedores al tratamiento
    - Evaluación global del médico
    - Evaluación global del paciente
    - Indice de actividad PMR ( PMR-AS)
    - Calidad de vida ( SF-36 )
    - Marcadores inflamatorios
    - uso de corticoides
    E.5.1.1Timepoint(s) of evaluation of this end point
    Response to treatment: at week 4,
    Physician/Patient Global Assessment, PMR-AS, inflammation markers, remission, CS use: at each visit from selection to end of study visit,
    SF-36 : at week 0, week 4, week 12, week 24, week 36 and end of study visit
    Respuesta al tratamiento: en W4,
    Evaluación global del paciente /médico, PMR-AS, marcadores inflamatorios, remisión, uso de CS: en cada visita desde seleción hasta el final de las visitas de estudio,
    SF-36: en semana 0, semana 4, semana 12, semana 24, semana 36 y al final del estudio
    E.5.2Secondary end point(s)
    Not Applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    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 Yes
    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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Russian Federation
    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
    Ultima visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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: 20
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 50
    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 continue his/her other treatment and/or have access to other appropriate care by his doctor.
    después del final del estudio, y dado que gevokizumab no estará comercializado, el fármaco no estará disponible. El sujeto deberá continuar su otro tratameinto y/o acceder o otro cuidado adecuado 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 Decision2014-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
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