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    Summary
    EudraCT Number:2010-018565-26
    Sponsor's Protocol Code Number:SL0010
    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:2010-12-23
    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 number2010-018565-26
    A.3Full title of the trial
    Estudio en fase III, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY2).
    A.3.2Name or abbreviated title of the trial where available
    EMBODY 2
    A.4.1Sponsor's protocol code numberSL0010
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUCB Inc.
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameEpratuzumab
    D.3.2Product code CDP3194
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEpratuzumab
    D.3.9.1CAS number 205923-57-5
    D.3.9.2Current sponsor codeCDP3194
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Lupus Sistémico Eritematoso
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal del estudio es confirmar la eficacia clínica de epratuzumab en el tratamiento de
    pacientes con SLE general moderado a intenso a pesar de estar recibiendo ratamientos convencionales (es decir, corticosteroides y posiblemente antipalúdicos e inmunodepresores) de forma ininterrumpida desde el momento basal.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios del estudio son evaluar la seguridad, la tolerabilidad y la inmunogenia de
    epratuzumab, y evaluar los efectos de ahorro de esteroides del tratamiento con epratuzumab.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-estudio incluido en el protocolo: Análisis exploratorios de biomarcadores genómicos, genéticos yproteómicos.Donde las regulaciones locales lo permitan, muestras adicionales de sangre seránrecogidas de sujetos que hayan consentido en momentos puntuales y almacenadas a - 80ºC durante 20años para permitir análisis exploratorios de biomarcadores genómicos, genéticos y proteómicosrelevantes para los procesos de respuesta inmune e inflamatoria.
    E.3Principal inclusion criteria
    - El paciente da resultados positivos en un análisis de anticuerpos antinucleares (ANA) en la visita de
    selección (visita 1).
    - El paciente ha sido diagnosticado de SLE por un médico con los criteriosrevisados más recientes de la ACR, de forma que cumpla al menos 4 de los 11 criterios.
    - El paciente presenta SLE de actividad moderada a intensa, como se demuestra por un nivel de actividad A BILAG (British Isles Lupus Assessment Group Index).
    - El paciente presenta SLE de actividad moderada a
    intensa, como se demuestra por una puntuación total SLEDAI de al menos 6 en la visita de selección
    (visita 1). - El paciente está recibiendo pauta estable de tratamiento de SLE, incluyendo corticosteroides e Inmunodepresores o antipalúdicos.
    E.4Principal exclusion criteria
    -Mujeres en período de lactancia, embarazadas o que prevean quedarse embarazadas.
    -Sujetos con SLE intenso activo que afecta al sistema renal.
    -Sujetos con SLE neuropsiquiátrico intenso activo, que sedefine como la calificación de nivel A BILAG.
    -Sujetos con evidencia de un estado inmunodepresivo.
    -Pacientes que, en opinión del investigador, presenten un riesgo especialmente alto de infección
    significativa por el tipo de vida y/o de trabajo.
    - Antecedentes de trastorno maligno, excepto los
    siguientes que hayan recibido tratamiento: carcinoma de cuello uterino in situ, carcinoma de células basales o carcinoma epidermoide.
    -Pacientes que reciban cualquier vacuna viva en las 8 semanas previas a la selección (visita 1)
    -Pacientes con antecedentes de infecciones crónicas, como (entre otros)los antecedentes de hepatitis B o C viral crónica.
    - Pacientes con toxicomanía/dependencia u otros
    trastornos médicos concurrentes que puedan confundir la interpretación del estudio o afectar la
    capacidad del paciente de participar plenamente en el estudio.
    - Paciente con antecedentes de episodios
    tromboembólicos en el año previo a la selección (visita 1).
    - Anomalías hematológicas significativas.
    -El paciente ha recibido tratamiento con otros anticuerpos células anti-B en el año previo a la selección.
    -El paciente ha utilizado anticoagulante oral (no incluyendo) fármacos anti-inflamatorios no esteroideos(NSAIDs) en el año previo a la visita de selección.
    - El paciente ha participado previamente en este
    estudio o ha recibido previamente tratamiento con epratuzumab.
    E.5 End points
    E.5.1Primary end point(s)
    La variable de eficacia principal es la tasa de pacientes con respuesta en la semana 48, según un índicede respuesta combinado.
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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.8.3 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    El final del estudio está definido como la fecha de la última visita del último paciente en el estudio.
    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 months5
    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 months5
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 245
    F.4.2.2In the whole clinical trial 780
    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)
    Sujetos que terminen prematuramente a la semana 16 (visita 12) o más tarde debido a una falta de
    eficacia y sujetos que completen SL0010 a través de la semana 48 tendrán la oportunidad de participar en
    un estudio abierto de extensión (SL0012).
    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 Decision2011-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-03
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