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    Summary
    EudraCT Number:2015-004404-35
    Sponsor's Protocol Code Number:I4V-MC-JAHH
    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:2016-04-04
    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 number2015-004404-35
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)
    Estudio de fase 2b de LY3009104 (baricitinib), aleatorizado, doble ciego, controlado con placebo, de grupos paralelos en pacientes con Lupus eritematoso sistémico (LES)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in Lupus
    Estudio realizado en Lupus
    A.4.1Sponsor's protocol code numberI4V-MC-JAHH
    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 SponsorLilly S.A.
    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 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 organisationLilly S.A.
    B.5.2Functional name of contact pointMaria Pilar López
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de la Industria 30
    B.5.3.2Town/ cityAlcobendas (Madrid)
    B.5.3.3Post code28108
    B.5.3.4CountrySpain
    B.5.4Telephone number003491623 12 18
    B.5.5Fax number003491663 34 81
    B.5.6E-maillopez_maria_pilar@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 nameBaricitinib
    D.3.2Product code LY3009104
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBaricitinib
    D.3.9.2Current sponsor codeLY3009104
    D.3.9.3Other descriptive nameBARICITINIB
    D.3.9.4EV Substance CodeSUB31583
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 nameBaricitinib
    D.3.2Product code LY3009104
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBaricitinib
    D.3.9.3Other descriptive nameBARICITINIB
    D.3.9.4EV Substance CodeSUB31583
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with Systemic Lupus Erythematosus (SLE)
    Pacientes con Lupus eritematoso sistémico (LES)
    E.1.1.1Medical condition in easily understood language
    Patients with Systemic Lupus Erythematosus (SLE)
    Pacientes con 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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10025139
    E.1.2Term Lupus erythematosus systemic
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of baricitinib 4-mg once daily (QD) or 2-mg daily QD compared to placebo on remission of SLE arthritis and/or rash in patients with SLE receiving concomitant standard therapy over 24 weeks.
    Comparar el efecto de la administración diaria (1 v/día) de 4 mg o 2 mg de baricitinib con el placebo en la remisión de la artritis o el exantema relacionados con el LES, en pacientes con LES que reciben el tratamiento habitual de forma concomitante, durante un período de 24 semanas.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of baricitinib 4-mg QD or 2-mg QD compared to placebo on overall SLE disease activity in patients with SLE receiving concomitant standard therapy over 24 weeks.
    To evaluate the effect of baricitinib 4-mg QD or 2-mg QD compared to placebo on the Patient?s Global Assessment of Disease Activity (PATGA) in patients with SLE receiving concomitant standard therapy over 24 weeks.
    To characterize the pharmacokinetics (PK) of baricitinib 4-mg QD or 2-mg QD in patients with SLE receiving concomitant standard therapy over 24 weeks.
    Comparar el efecto de la administración 1 v/día de 4 mg o 2 mg de baricitinib con el placebo en la actividad global de la enfermedad para el LES, en pacientes con LES que reciben el tratamiento habitual de forma concomitante, durante un período de 24 semanas.
    Comparar el efecto de la administración 1 v/día de 4 mg o 2 mg de baricitinib con el placebo sobre la evaluación global de la actividad de la enfermedad por el paciente, en pacientes con LES que reciben el tratamiento habitual de forma concomitante, durante un período de 24 semanas.
    Caracterizar la farmacocinética (FC) de baricitinib 4 mg 1 v/d o 2 mg 1 v/d de baricitinib en pacientes con LES que reciben el tratamiento habitual de forma concomitante, durante un período de 24 semanas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Are at least 18 years of age.
    [2] Have a positive ANA (HEp-2 ANA titer ?1:80) and/or a positive anti-dsDNA (? 30 IU) as assessed by a central laboratory at screening.
    [3] Have a SLEDAI-2K score ?4 based on clinical symptoms (not including lab values) at randomization.
    [4] Have active arthritis and/or active rash as defined by the SLEDAI-2K at randomization.
    [1]Tener al menos 18 años.
    [2]Presentar durante la selección AAN (títulos de AAN frente a las células HEp-2 > o igual a 1:80) o anticuerpos anti-ADNbc (> o igual a 30 UI), o ambos, de acuerdo con los análisis llevados a cabo en un laboratorio central.
    [3]Presentar en la aleatorización una puntuación SLEDAI-2K > o igual a 4, de acuerdo con los síntomas clínicos (sin incluir los valores analíticos).
    [4]Presentar en la aleatorización artritis activa, exantema activo o ambos, de acuerdo con el índice SLEDAI-2K.
    E.4Principal exclusion criteria
    [1] Have active severe lupus nephritis
    [2] Have active severe central nervous system (CNS) lupus
    [3] Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unaccepatable risk when taking investigational product or interfere with the interpretation of data.
    [4] Have a current or recent (<4 weeks prior to screening) clinically serious viral, bacterial, fungal, or parasitic infection.
    [5] Are currently receiving oral corticosteroids at doses >20-mg per day of prednisone (or equivalent) or have adjusted the dose of corticosteroids within 2 weeks of planned randomization.
    [6] Have started treatment with or adjusted the dose of NSAIDs (for which the NSAID use is intended for treatment of signs and symptoms of SLE) within 2 weeks of screening or within 4 weeks of planned randomization.
    [7] Have started treatment with or adjusted the dose of an antimalarial within 10 weeks of screening or within 12 weeks of planned randomization.
    [8] Have started treatment with or adjusted the dose of an immunosuppressant within 10 weeks of screening or within 12 weeks of planned randomization.
    [9] Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.
    [1]Presentar nefritis lúpica activa y grave, según se define en el criterio de exclusión
    [2]Presentar lupus activo y grave en el sistema nervioso central (SNC)
    [3]Tener antecedentes o presentar trastornos cardiovasculares, respiratorios, hepáticos, gastrointestinales, endocrinos, hematológicos, neurológicos o neuropsiquiátricos, o cualquier otra enfermedad grave y/o inestable que, en opinión del investigador, podrían constituir un riesgo inaceptable si se toma el producto en fase de investigación o podrían interferir con la interpretación de los datos.
    [4]Presentar o haber presentado recientemente (< 4 semanas antes de la selección) una infección vírica, bacteriana, fúngica o parasitaria que se considere grave desde un punto de vista clínico.
    [5]Estar recibiendo en la actualidad corticosteroides orales en dosis > 20 mg/día de prednisona (o equivalente) o haber ajustado la dosis de los corticosteroides en el transcurso de las 2 semanas anteriores a la fecha prevista de aleatorización.
    [6]Haber comenzado a recibir tratamiento con AINE o haber ajustado la dosis de estos (para tratar los signos y síntomas de LES) en el transcurso de las 2 semanas anteriores a la selección o de las 4 semanas anteriores a la fecha de aleatorización prevista.
    [7]Haber comenzado a recibir tratamiento con un antipalúdico o haber ajustado la dosis de este en el transcurso de las 10 semanas anteriores a la selección o de las 12 semanas anteriores a la fecha de aleatorización prevista.
    [8]Haber comenzado a recibir tratamiento con un inmunodepresor o haber ajustado la dosis de este en el transcurso de las 10 semanas anteriores a la selección o de las 12 semanas anteriores a la fecha de aleatorización prevista.
    [9]Haber recibido ciclofosfamida (o cualquier otro fármaco citotóxico) en el transcurso de las 12 semanas anteriores a la selección.
    E.5 End points
    E.5.1Primary end point(s)
    Change in the proportion of patients who achieve remission of arthritis and/or rash as defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) at Week 24 compared to baseline.
    Variación en la semana 24 respecto al período basal en el porcentaje de pacientes que alcancen una remisión de la artritis o del exantema, de acuerdo con el Índice 2000 de la actividad de la enfermedad para el lupus eritematoso sistémico (SLEDAI-2K).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The change will be evaluated from the baseline time point to the study week 24 time point
    La variación será evaluada desde el punto basal del estudio hasta la semana 24.
    E.5.2Secondary end point(s)
    ? Change in the proportion of patients achieving SLE Responder Index (SRI)-4 response at Week 24 compared to baseline. SRI-4 response is defined as:
    o Reduction of ?4 points from baseline in SLEDAI-2K score;
    o No new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores; and
    o No worsening (defined as an increase of ?0.3 points [10mm] from baseline) in the Physician?s Global Assessment of Disease Activity.
    ? Change in the proportion of patients achieving a reduction of ?4 points from baseline in SLEDAI-2K score at Week 24 compared to baseline.
    ? Change in SLEDAI-2K total score at Week 24 compared to baseline.
    ? Change in patient?s global assessment of disease activity at Week 24 compared to baseline.
    ? Plasma baricitinib concentrations will be analyzed using a population PK (PopPK) approach.
    ?Variación en la semana 24 respecto al período basal en el porcentaje de pacientes que alcancen una respuesta de acuerdo con el Índice de respuesta 4 (SRI-4). La respuesta SRI-4 se define de acuerdo con los parámetros siguientes:
    o Reducción ? 4 puntos respecto a la puntuación basal SLEDAI-2K;
    o Ninguna nueva puntuación de la actividad de la enfermedad de tipo A de acuerdo con los criterios del British Isles Lupus Assessment Group (BILAG) o como máximo 1 nueva puntuación de la actividad de la enfermedad de tipo B de acuerdo con los criterios BILAG.
    o Ausencia de empeoramiento (que se define como un aumento > o igual a 0,3 puntos [10 mm] respecto al período basal) en la Evaluación global de la actividad de la enfermedad por el médico.
    ?Variación en la semana 24 respecto al período basal en el porcentaje de pacientes que alcancen una reducción > o igual a 4 puntos en la puntuación SLEDAI-2K.
    ?Variación en la semana 24 respecto al período basal en la puntuación total SLEDAI-2K.
    ?Variación en la semana 24 respecto al período basal en la evaluación global de la actividad de la enfermedad por el paciente.
    ?Las concentraciones plasmáticas de baricitinib se analizarán mediante una estrategia de FC poblacional (FCpob).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The change will be evaluated from the baseline time point to the study week 24 time point
    La variación será evaluada desde el punto basal del estudio hasta la semana 24.
    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 No
    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 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) 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Austria
    France
    Japan
    Korea, Republic of
    Mexico
    Poland
    Romania
    Spain
    Taiwan
    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
    End of the trial is the date of the last visit, last scheduled procedure shown in the Schedule of Activities, or date of discontinued participation for the last patient.
    El final del ensayo es la fecha de la última visita o del último procedimiento programado, según se detalla en el calendario de actividades o la fecha en la que el último paciente interrumpa definitivamente su participación en el estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    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)
    None
    Ninguno
    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 Decision2016-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-09
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