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    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   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:2010-022101-18
    Sponsor's Protocol Code Number:H9B-MC-BCDX
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-05-21
    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 number2010-022101-18
    A.3Full title of the trial
    A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X)
    Estudio de fase 3b, multicéntrico y abierto, para evaluar la seguridad y la eficacia a largo plazo de LY2127399 subcutáneo en pacientes con lupus sistémico eritematoso (LSE) (ILLUMINATE-X)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X)
    Estudio de fase 3b, multicéntrico y abierto, para evaluar la seguridad y la eficacia a largo plazo de LY2127399 subcutáneo en pacientes con lupus sistémico eritematoso (LSE) (ILLUMINATE-X)
    A.3.2Name or abbreviated title of the trial where available
    ILLUMINATE-X
    A.4.1Sponsor's protocol code numberH9B-MC-BCDX
    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 SponsorEli Lilly and Company
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressCorporate Center
    B.5.3.2Town/ cityIndianapolis, Indiana
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.4Telephone number+441276483442
    B.5.5Fax number1276483378
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 nameLY2127399
    D.3.2Product code LY2127399
    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.3.9.2Current sponsor codeLY2127399
    D.3.9.3Other descriptive nameLA294; Anti LP40 antibody, subclass IgG4; Anti BAFF (B cell activating factor)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticuerpo monoclonal // Monoclonal antibody
    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
    Systemic Lupus Erythematosus (SLE)
    Lupus Eritematoso Sistémico (LES)
    E.1.1.1Medical condition in easily understood language
    Systemic Lupus Erythematosus (SLE)
    Lupus Eritematoso Sistémico (LES)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10025139
    E.1.2Term Lupus erythematosus systemic
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the safety and tolerability of LY2127399 (120 mg every 4 weeks [Q4W] + SoC or 120 mg every 2 weeks [Q2W] + SoC) in patients with SLE who have completed 52 weeks of treatment in either Study BCDS or Study BCDT. Safety and tolerability assessments for Study BCDX include the following:
    - Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
    - Laboratory evaluations (including chemistry, immunoglobulins, hematology, B cell counts, and urinalysis)
    - Immunogenicity (anti-LY2127399 antibodies)
    Evaluar la seguridad y la tolerabilidad del LY2127399 (120 mg cada 4 semanas [Q4W] + tratamiento estándar o 120 mg cada 2 semanas [Q2W] + tratamiento estándar) en pacientes con LSE que hayan completado 52 semanas de tratamiento en el estudio BCDS o en el estudio BCDT. Las evaluaciones de la seguridad y la tolerabilidad del estudio BCDX incluyen:
    -Acontecimientos adversos emergentes en el tratamiento, acontecimientos adversos de especial interés y acontecimientos adversos graves (SAE)
    -Evaluaciones de laboratorio (bioquímica, inmunoglobulinas, hemograma, recuento de linfocitos B y análisis de orina)
    -Inmunogenia (anticuerpos anti-LY2127399)
    E.2.2Secondary objectives of the trial
    Secondary objectives of this study will examine the effect over time during long-term administration of LY2127399 on the following outcomes:
    - Proportion of patients who achieve a response over time as defined by the SLE responder index-5.
    - Proportion of patients who achieve a response as defined by each subcomponent of SRI-5.
    - Proportion of patients who achieve a response as defined by the SRI-4, SRI-6, and SRI-7.
    - Proportion of patients able to decrease dose to 7.5 mg/day or less of prednisone or equivalent, with quiescent disease (BILAG C score or better in all 9 systems) and no flares (BILAG A or B) for at least 3 consecutive months.
    - Change in anti-double-stranded deoxyribonucleic acid (anti-dsDNA) level.
    - Change in SLE Disease Activity Index-2000 (SLEDAI-2K) score.
    - Proportion of patients with new severe SLE flares (modified SELENA-SLEDAI Flare Index [SFI]).
    - Patient-reported outcomes (PROs) as measured by Lupus Quality of Life (Lupus QoL)
    Los objetivos secundarios de este estudio examinarán el efecto en el transcurso del tiempo durante la administración a largo plazo de LY2127399 sobre los siguientes criterios de valoración:
    -Proporción de pacientes que alcancen con el tiempo una respuesta definida por el SRI-5.
    -Proporción de pacientes que alcancen una respuesta definida por cada uno de los subcomponentes del SRI-5 que se han señalado.
    -Proporción de pacientes que alcancen una respuesta definida por el SRI-4, el SRI-6 y el SRI-7.
    -Proporción de pacientes que puedan disminuir la dosis hasta 7,5 mg/día o menos de prednisona o equivalente, con enfermedad inactiva y ausencia de brotes durante al menos 3 meses consecutivos.
    -Cambio del nivel de anticuerpos contra el ácido desoxirribonucleico bicatenario.
    -Cambio de la puntuación SLEDAI-2K.
    -Proporción de pacientes con nuevos brotes severos de LSE.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are eligible to be included in the study only if they meet all of the following criteria:
    - Have completed 52 weeks of treatment in Study BCDS or Study BCDT.
    - For female patients of childbearing potential, must test negative for pregnancy at the time of enrollment and agree to use a reliable method of birth control or remain abstinent during the study or for at least 8 weeks following the last dose of study drug, whichever is longer, or
    - For female patients of non-childbearing potential, defined as:
    Women who have had surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation)
    Women 60 years of age or older
    Women 40 years and older and less than 60 years of age who have had a cessation of menses for at least 12 months and a follicle-stimulating hormone (FSH) test confirming non-childbearing potential (FSH > ó = 40 mIU/mL).
    - Have given written informed consent approved by Lilly or its designee and the Investigational Review Board/Ethical Review Board (IRB/ERB) governing the site.
    - Haber completado 52 semanas de tratamiento en el estudio BCDS o en el estudio BCDT.
    - Las mujeres potencialmente fértiles deben presentar una prueba de embarazo negativa en el momento del reclutamiento y comprometerse a utilizar un método anticonceptivo fiable o a abstenerse de mantener relaciones sexuales durante el estudio o durante al menos las 8 semanas siguientes a la última dosis del medicamento del estudio, eligiéndose el plazo que sea mayor.
    Se define como mujeres no potencialmente fértiles a:
    -Las mujeres intervenidas de esterilización quirúrgica (histerectomía u ovariectomía bilateral o ligadura de trompas)
    -Las mujeres de 60 años de edad o mayores.
    -Las mujeres de 40 años o mayores y menores de 60 años de edad que no han tenido la menstruación desde hace por lo menos 12 meses y presentan una prueba de foliculina (FSH) que confirma que no son potencialmente fértiles (FSH >ó=40 mUI/ml).
    -Haber otorgado su consentimiento informado por escrito de acuerdo con el documento aprobado por Lilly o su delegado y el comité ético correspondiente al centro.
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they meet any of the following criteria:
    - Presence of significant uncontrolled cerebrocardiovascular (for example: myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic or neuropsychiatric disorders, or abnormal laboratory values at baseline that in the opinion of the Investigator pose an unacceptable risk to the patient if study drug would be administered.
    - Have any other condition that renders the patient unable to understand the nature, scope, and possible consequences of the study or precludes the patient from following and completing the protocol, in the opinion of the Investigator.
    - Are unwilling or unable to comply with study procedures.
    - Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
    - Are Lilly employees or representatives of a third party organization (TPO) involved in the study who require exclusion of their employees.
    Se excluirá del estudio a los pacientes que cumplan cualquiera de los criterios siguientes:
    -Presencia en el momento basal de trastornos importantes no controlados de tipo cerebro-cardiovascular (por ejemplo: infarto de miocardio, angina inestable, hipertensión arterial inestable, insuficiencia cardiaca severa o accidente cerebrovascular), respiratorio, hepático, renal, gastrointestinal, endocrino, hematológico o neuropsiquiátrico, o valores de laboratorio anormales, que, en opinión del investigador, supondrían un riesgo inaceptable para el paciente si se le administrara el medicamento del estudio.
    -Cualquier otro trastorno que haga que el paciente sea incapaz de comprender la naturaleza, alcance y posibles consecuencias del estudio o que impida al paciente seguir y completar el protocolo, en opinión del investigador
    -No poder o no estar dispuesto a cumplir los procedimientos del estudio.
    -Ser personal del centro del investigador relacionado directamente con este estudio y/o sus familiares inmediatos. Se define como familiar inmediato al cónyuge, progenitor, hijo o hermano, ya sea biológico o adoptado legalmente.
    -Ser empleado de Lilly o representante de otras entidades independientes (TPO) involucradas en el estudio que exijan la exclusión de sus empleados.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of Study BCDX is to evaluate the safety and tolerability of LY2127399 in patients with SLE who have completed 52 weeks of treatment in either Study BCDS or Study BCDT. Safety and tolerability assessments will include frequency of TEAEs and SAEs and laboratory evaluations.
    El objetivo principal de este estudio consiste en evaluar la seguridad y la tolerabilidad del LY2127399 en pacientes con LSE que hayan completado 52 semanas de tratamiento en el estudio BCDS o en el estudio BCDT. Evaluaciones de seguridad y tolerabilidad incluirán frecuencia de Acontecimientos adversos emergentes en el tratamiento (TEAE)y acontecimientos adversos graves (SAE).
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study
    Fin del estudio
    E.5.2Secondary end point(s)
    None
    Ninguno
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Dosing intervals of 120 mg every 2 weeks versus every 4 weeks
    Dosis de 120 mg a intervalos cada 2 semanas frente a cada 4 semanas.
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    estudio de 2 ramas para investigar los intervalos de dosis (2 semanas frente a 4 semanas)
    2 arm study to investigate dosing intervals (2 weeks versus 4 weeks)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No aplicable
    Not applicable
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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
    Belarus
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Ecuador
    Egypt
    France
    Germany
    Guatemala
    Hungary
    India
    Israel
    Italy
    Japan
    Korea, Democratic People's Republic of
    Latvia
    Macedonia, the former Yugoslav Republic of
    Malaysia
    Mexico
    New Zealand
    Peru
    Philippines
    Poland
    Romania
    Russian Federation
    Serbia
    Singapore
    South Africa
    Spain
    Taiwan
    Thailand
    Tunisia
    Turkey
    Ukraine
    United Kingdom
    United States
    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
    End of study (trial) is the date of the last visit or last scheduled procedure shown in the Study Schedule for the last active patient in the study.
    El final del estudio es la fecha de la última visita o último procedimiento programado mostrado en el Plan de Investigación para el último para el último paciente activo en el estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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: 1148
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 128
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 412
    F.4.2.2In the whole clinical trial 1276
    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)
    See protocol section 7.1 "Summary of Study Design" and 10.3.1.4 "Safety Related Biomarkers".
    Véase sección 7.1 del protocolo "Resumen del diseño del estudio" y 10.3.1.4 "Biomarcadores Relativos a la Seguridad".
    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 Decision2012-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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
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