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    Summary
    EudraCT Number:2017-005028-11
    Sponsor's Protocol Code Number:I4V-MC-JAIM
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-05-31
    Trial 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 number2017-005028-11
    A.3Full title of the trial
    A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)
    Estudio de fase 3, doble ciego, multicéntrico, para evaluar la seguridad y la eficacia a largo plazo de baricitinib 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 of Baricitinib in patients with Lupus
    Estudio con baricitinib en pacientes con lupus.
    A.4.1Sponsor's protocol code numberI4V-MC-JAIM
    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 Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34900834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 Yes
    D.2.1.1.1Trade name Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V, Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Film-coated 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 Yes
    D.2.1.1.1Trade name Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V, Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Film-coated 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 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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Systemic Lupus Erythematosus (SLE)
    Lupus Eritematoso Sistémico (LES)
    E.1.1.1Medical condition in easily understood language
    Systemic Lupus Erythematosus ( SLE) also known as Lupus
    Lupus Eritematoso Sistémico (LES) también conocido como Lupus
    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 20.0
    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 long-term safety and tolerability of baricitinib in patients with SLE.
    Evaluar la seguridad y la tolerabilidad a largo plazo de baricitinib en pacientes con LES.
    E.2.2Secondary objectives of the trial
    - To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD and background standard-of-care therapy on SLE disease activity
    - To evaluate the long-term corticosteroid sparing effect of baricitinib 4-mg or 2-mg QD
    - To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on SLE flares
    - To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on mucocutaneous manifestations of SLE
    - To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on musculoskeletal manifestations of SLE
    - To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on individual organ system disease activity.
    - To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on damage.
    - To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on patient-reported outcomes (PROs)
    - Evaluar el efecto a largo plazo de 4 o 2 mg de baricitinib una vez al día y del tratamiento de referencia de base sobre la actividad del LES.
    - Evaluar el efecto ahorrador de corticosteroides a largo plazo de 4 o 2 mg de baricitinib una vez al día.
    - Evaluar el efecto a largo plazo de 4 o 2 mg de baricitinib una vez al día sobre los brotes de LES.
    - Evaluar el efecto a largo plazo de 4 o 2 mg de baricitinib una vez al día sobre las manifestaciones mucocutáneas del LES.
    - Evaluar el efecto a largo plazo de 4 o 2 mg de baricitinib una vez al día sobre las manifestaciones osteomusculares del LES.
    - Evaluar el efecto a largo plazo de 4 o 2 mg de baricitinib una vez al día sobre la actividad de la enfermedad de órganos, sistemas y aparatos individuales.
    - Evaluar el efecto a largo plazo de 4 o 2 mg de baricitinib una vez al día sobre los daños.
    - Evaluar el efecto a largo plazo de 4 o 2 mg de baricitinib una vez al día sobre los resultados comunicados por los pacientes (RCP).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [ [1] Are at least 18 years of age.
    [2] Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
    [3] Have documentation of having met at least 4 of 11 Revised Criteria
    for Classification of Systemic Lupus Erythematosus according to the
    1997 Update of the 1982 ACR criteria for classification of SLE (Tan et al.
    1982; Hochberg et al. 1997) prior to randomization.
    [4] Have 1 or more of the following as assessed by the central lab during
    screening: a positive antinuclear antibody (ANA; titer ≥1:80), and/or a positive anti-dsDNA, and/or a positive anti-Smith (anti Sm). Patients with an ANA <1:80 at screening with documentation of a historical ANA ≥1:80 may be eligible, as assessed by the eligibility review committee.
    [5] Have a total SLEDAI-2K score ≥6 during screening, with at least 4
    points attributed to clinical items (not including items requiring
    laboratory value assessment). SLEDAI-2K items requiring laboratory
    values should be assessed based on the results from the labs drawn
    during the screening period.
    [6] Have a clinical SLEDAI-2K score ≥4 at baseline (Visit 2); not
    including any items requiring laboratory value assessment.
    [7] Have at least 1 BILAG A score or 2 BILAG B scores during the
    screening period. BILAG items requiring laboratory values should be
    assessed based on the results from the labs drawn during the screening
    period.
    [8] Are receiving at least one of the following SoC medications for SLE:
    - A single antimalarial (such as hydroxychloroquine, chloroquine,
    quinacrine) at a stable therapeutic dose for at least 8 weeks prior to
    screening (Visit 1).
    - A single immunosuppressant (such as methotrexate [MTX],
    azathioprine, mycophenolate, tacrolimus, leflunomide, cyclosporine) at a
    stable therapeutic dose for at least 8 weeks prior to screening (Visit 1).
    - An oral corticosteroid, initiated at least 4 weeks prior to screening
    (Visit 1), at a stable dose ≤40 mg/day prednisone (or equivalent) for at
    least 2 weeks prior to screening (Visit 1) and through baseline (Visit 2).
    If the patient is not receiving an antimalarial or immunosuppressant, the
    dose of corticosteroid must be ≥7.5 mg/day prednisone (or equivalent).
    [9] Male or nonpregnant, nonbreastfeeding female patient
    - Patients of child-bearing potential who are abstinent (if this is
    complete abstinence, as their preferred and usual lifestyle) or in a samesex
    relationship (as part of their preferred and usual lifestyle) must
    agree to either remain abstinent or stay in a same-sex relationship
    without sexual relationships with the opposite sex.
    - Total abstinence is defined as refraining from intercourse during the
    entirety of the study and for at least 1 week following the last dose of
    investigational product.
    - Otherwise, patients of child-bearing potential must agree to use 2
    effective methods of contraception, where at least 1 form is highly
    effective, for the entirety of the study and for at least 1 week following
    the last dose of investigational product.
    - The following contraception methods are considered acceptable (the
    patient should choose 2, and 1 must be highly effective [defined as less
    than 1% failure rate per year when used consistently and correctly]):
    • Highly effective birth control methods:
    - Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
    - Progestogen-only containing hormonal contraception associated with
    inhibition of ovulation: oral, intravaginal, or transdermal
    - intrauterine device (IUD)/intrauterine hormone-releasing system (IUS)
    -vasectomized male (with appropriate postvasectomy documentation of the absence of sperm in the ejaculate).
    • Effective birth control methods:
     Male or female condom with spermicide. It should be noted that the
    use of male and female condoms as a double barrier method is not considered
    acceptable due to the high failure rate when these methods are combined.
     Diaphragm with spermicide
     Cervical sponge
     Cervical cap with spermicide
    Patients of non‒child-bearing potential are not required to use birth control and they are defined as:
    • Women who are infertile due to surgical sterilization (hysterectomy,
    bilateral oophorectomy, or tubal ligation)
    • Post-menopausal – defined either as
     A woman at least 50 years of age with an intact uterus
    • Women aged 55 years or older who are not on hormone therapy, and
    who have had at least 6 months of spontaneous amenorrhea
    • Women aged 55 years or older who have a diagnosis of menopause
    [10] Must read and understand the informed consent approved by Eli Lilly and Company (Lilly), or its designee, and the institutional review board (IRB)/ethics review board (ERB) governing the site, and provide written informed consent.
    1 Al menos 18 años de edad.
    2 Diag. clínico de LES al menos 24 sem. antes de la selección.
    3 Docum. de haber cumplido al menos 4 de los 11 Criterios modificados para la clasif. del lupus eritematoso sistém. según la actualización de 1997 de los criterios ACR de 1982 para la clasif. del LES (Tan y cols. 1982; Hochberg y cols. 1997) antes de la aleatorización.
    4 Presentar uno o más de los siguientes resultados evaluados por el lab. central durante la selección: resultado positivo para anticuerpos antinucleares (ANA; título ≥ 1:80) y/o resultado positivo para antic. anti-ADNbc y/o antic. anti-Smith (anti Sm). Podrán participar pac. con ANA < 1:80 en la selección y documentación de un ANA histórico ≥ 1:80, según la evaluación del comité de revisión de la elegibilidad.
    5 Puntuación total en la SLEDAI-2K ≥ 6 durante la selección, con al menos 4 puntos atribuidos a ítems clínicos (sin incluir ítems que requieran valoración analítica). Los ítems de SLEDAI-2K que requieran valores analíticos deben evaluarse basándose en los resultados de los análisis realizados durante el período de selección.
    6 Puntuación clínica en la SLEDAI-2K ≥ 4 en el momento basal (V2); no se incluyen los ítems que requieran una evaluación analítica.
    7 Al menos una puntuación BILAG A o dos puntuaciones BILAG B durante el período de selección. Los ítems de BILAG que requieran valores analíticos deben evaluarse basándose en los resultados de los análisis realizados durante el período de selección.
    8 Estar recibiendo al menos uno de los siguientes medicam. de ref. para el LES:
    - Un único antipalúdico (como hidroxicloroquina, cloroquina, quinacrina) en una dosis terap. estable durante al menos 8 sem. antes de la selección (V1).
    - Un único inmunodepresor (como metotrexato [MTX], azatioprina, micofenolato, tacrolimús, leflunomida, ciclosporina) en una dosis terapéutica estable durante al menos 8 sem. antes de la selección (V1).
    - Un corticosteroide oral, iniciado al menos 4 sem. antes de la selección (V1), en una dosis estable < o = 40 mg/día de prednisona (o equivalente) durante al menos 2 sem. antes de la selección (V1) y hasta el momento basal (V2).
    Si el pac. no está recibiendo un antipalúdico ni un inmunodepresor, la dosis de corticosteroide deberá ser ≥ 7,5 mg/día de prednisona (o equivalente).
    9 Varones o mujeres no embarazadas ni en periodo de lactancia.
    - Las pac. en edad fértil que practiquen la abstinencia (si se trata de una abst. completa, como su forma de vida preferida y habitual) o una relación homosexual (como parte de su modo de vida preferido y habitual) deben comprometerse a mantener la abst. o a mantener solo relaciones homosex., sin relaciones heterosex.
    La abstinencia total se define como la ausencia de relaciones sexuales durante todo el estudio y durante al menos 1 sem. después de la última dosis del producto en investigación.
    -De lo contrario, las pac. que puedan quedarse embarazadas deberán comprometerse a utilizar dos métodos anticonceptivos eficaces, uno de ellos al menos muy eficaz, a lo largo de todo el estudio y durante al menos 1 sem. después de la última dosis del producto en investigación.
    -Los siguientes métodos anticonceptivos se consideran aceptables (la paciente debe elegir dos y uno debe ser muy eficaz [definido como un método con una tasa de fallos inferior al 1% anual cuando se utiliza de forma sistemática y correcta]):
    •Métodos anticonceptivos muy eficaces:
    -Anticonceptivos hormonales con estrógenos y progestágenos asociados a inhibición de la ovulación: orales, intravaginales o transdérmicos.
    -Anticonceptivos hormonales solo con progestágenos que inhiben la ovulación: orales, intravaginales o transdérmicos.
    -Dispositivo intrauterino (DIU) o sist. intrauterino de liberación de hormonas (SIU).
    -Vasectomía del varón (con comprobación apropiada tras la vasectomía de la ausencia de espermatoz. en el semen).
    •Métodos anticonceptivos eficaces:
    -Preservativo masculino o femenino con espermicida. Hay que señalar que el uso de preservativos masc. o fem. como método de doble barrera no se considera aceptable debido a la elevada tasa de fallos cuando se combinan estos métodos.
    -Diafragma con espermicida.
    -Esponja cervical.
    -Capuchón cervical con espermicida.
    Las pac. sin capacidad de procrear no están obligadas a utilizar anticonceptivos y se definen como:
    •Mujeres infértiles por esterilización quirúrgica (histerectomía, ovariectomía bilateral o ligadura de trompas).
    •Mujeres posmenopáusicas, definidas como:
    -Mujeres de al menos 50 años de edad con útero intacto.
    •Mujeres de 55 años o más que no estén recibiendo tratamiento hormonal y que hayan tenido al menos 6 meses de amenorrea espontánea.
    •Mujeres de 55 años o más con diagnóstico de menopausia.
    10 El pac. debe leer y comprender el consentimiento informado aprobado por Lilly, o su representante, y el Comité de Ética de la Investigación con medicamentos que regula el centro, y otorgar su consentimiento informado por escrito.
    E.4Principal exclusion criteria
    [11] Have severe active lupus nephritis defined clinically and/or by
    histologic evidence of proliferative glomerulonephritis on renal biopsy (if
    available) within the 24 weeks prior to screening, or urine
    protein/creatinine ratio >200 mg/mmol (as an estimate of approximate
    proteinuria >2 g/day) or eGFR (Modification of Diet in Renal Disease
    [MDRD]) <40 mL/min/1.73 m 2 at screening, or as determined by the
    eligibility review committee.
    [12] Have active CNS lupus as defined by ACR nomenclature for
    neuropsychiatric lupus syndromes and as captured by SLEDAI-2K
    (seizure, psychosis, organic brain syndrome, visual disturbance, cranial
    nerve disorder, lupus headache, and cerebrovascular accident).
    [13] Have active fibromyalgia that, in the investigator's opinion, would
    make it difficult to appropriately assess SLE activity for the purposes of
    this study.
    [14] Have been treated for or had an active occurrence of a systemic
    inflammatory condition other than SLE.
    [15] Have had any major surgery within 8 weeks prior to screening or
    will require major surgery during the study that, in the opinion of the
    investigator in consultation with Lilly or its designee, would pose an
    unacceptable risk to the patient.
    [16] Have screening electrocardiogram (ECG) abnormalities that, in the
    opinion of the investigator, are clinically significant and indicate an
    unacceptable risk for the patient's participation in the study.
    [17] Have experienced any of the following within 12 weeks of
    screening: VTE (DVT/pulmonary embolism [PE]), myocardial infarction
    (MI), unstable ischemic heart disease, stroke, or New York Heart
    Association Stage III/IV heart failure.
    [18] Have a history of recurrent (≥2) VTE (DVT/PE).
    [19] Have a history or presence of cardiovascular, respiratory, hepatic,
    gastrointestinal, endocrine, hematological, neurological, or
    neuropsychiatric disorders or any other serious and/or unstable illness.
    [20] Have a history of lymphoproliferative disease
    [21] Have a current or recent clinically serious viral, bacterial, fungal, or
    parasitic infection or any other active or recent infection.
    [22] Have symptomatic herpes simplex at the time of randomization.
    [23] Have had symptomatic herpes zoster infection within 12 weeks
    prior to randomization.
    [24] Have a history of disseminated/complicated herpes zoster (for
    example, ophthalmic zoster or CNS involvement).
    [25] Have a positive test for hepatitis B virus (HBV)
    [26] Have hepatitis C virus (HCV) infection (hepatitis C antibody-positive
    and HCV ribonucleic acid [RNA]-positive).
    [27] Have evidence of HIV infection and/or positive HIV antibodies.
    [28] Have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB.
    [29] Have evidence of active TB or latent TB
    [20] Have a history of lymphoproliferative disease;
    [21] Have a current or recent clinically serious viral, bacterial, fungal, or
    parasitic infection or any other active or recent infection.
    [22] Have symptomatic herpes simplex at the time of randomization.
    [23] Have had symptomatic herpes zoster infection within 12 weeks
    prior to randomization.
    [24] Have a history of disseminated/complicated herpes zoster (for
    example, ophthalmic zoster or CNS involvement).
    [25] Have a positive test for hepatitis B virus (HBV)
    [26] Have hepatitis C virus (HCV) infection (hepatitis C antibody-positive
    and HCV ribonucleic acid [RNA]-positive).
    [27] Have evidence of HIV infection and/or positive HIV antibodies.
    [28] Have had household contact with a person with active TB and did
    not receive appropriate and documented prophylaxis for TB.
    [29] Have evidence of active TB or latent TB
    [30] Have received parenteral corticosteroids within 6 weeks of
    screening (Visit 1), or are expected to require parenteral corticosteroids
    during the study.
    [31] Have received any of the following medications (please refer to
    protocol).
    [32] Have received a JAK inhibitor.
    [33] Have been treated with probenecid that cannot be discontinued for
    the duration of the study.
    [34] Have received plasmapheresis within 12 weeks of screening.
    [35] Have been exposed to a live vaccine within 12 weeks of
    randomization or are expected to need/receive a live vaccine during the
    course of the study (with the exception of herpes zoster vaccination).
    [36] Are currently enrolled in or have discontinued within 4 weeks of
    screening from, any other clinical trial.
    [37] Have previously completed or been randomized and withdrawn
    from this study or have received baricitinib in any other study.
    [38] Have screening laboratory test values, in the opinion of the
    investigator, pose an unacceptable risk for the patient's participation in
    the study.
    [39] Have any of the following specific abnormalities on screening
    laboratory tests from the central laboratory (please refer to the
    protocol)
    Other Exclusions (please refer to the protocol)
    [11] Nefritis lúpica activa grave definida clínicamente o por signos histológicos de glomerulonefritis proliferativa en la biopsia renal (si está disponible) en las 24 sem. previas a la selección, o cociente entre proteínas y creatinina en orina > 200 mg/mmol (como estimación de una proteinuria aproximada > 2 g/día) o FGe (Modificación de la dieta en enferm. renales [MDRD]) < 40 ml/min/1,73 m2 en la selección o según lo determinado por el comité de revisión de la elegibilidad.
    [12] Lupus del SNC activo según la nomenc. del ACR para los sínd. lúpicos neuropsiq. y según el SLEDAI-2K (crisis convulsivas, psicosis, sínd. cerebral orgánico, alt. visuales, trast. de pares craneales, cefalea lúpica y accidente cerebrov.).
    [13] Fibromialgia activa que, en opinión del invest., dificulte una evaluación adecuada de la act. del LES para los fines de este estudio.
    [14] Haber recibido tto. o haber presentado un episodio activo de un proceso inflam. sistémico distinto del LES.
    [15] Haberse sometido a una intervención de cirugía mayor en las 8 sem. previas a la selección o requerir una intervención de cirugía mayor durante el estudio que, en opinión del invest. tras consultar con Lilly o su representante, suponga un riesgo inaceptable para el pac.
    [16] Anomalías en el electroc. (ECG) de selección que, en opinión del inv., tengan importancia clínica e indiquen un riesgo inaceptable para la participación del pac. en el estudio.
    [17] Haber experimentado algo de lo siguiente en las 12 sem. previas a la selección: TEV (TVP/embolia pulmonar [EP]), infarto de miocardio (IM), cardiopatía isquémica inestable, ictus o insuf. cardíaca en estadio III/IV de la New York Heart Association.
    [18] Antecedentes de TEV (TVP/EP) recurrente (≥ 2).
    [19] Antecedentes o presencia de trast. cardiov., respiratorios, hepáticos, digestivos, endocrinos, hematológicos, neurológicos o neuropsiquiátricos o de cualquier otra enf.grave o inestable.
    [20] Antecedentes de enf. linfoproliferativa.
    [21] Infección viral, bacteriana, micótica o parasitaria clínicamente grave, actual o reciente, o cualquier otra infección activa o reciente.
    [22] Herpes simple sintomático en el momento de la aleatorización.
    [23] Infección sintomática por herpes zóster en las 12 sem. previas a la aleatorización.
    [24] Antecedentes de herpes zóster diseminado o complicado (por ejemplo, zóster oftálmico o afectación del SNC).
    [25] Resultado es positivo para el virus de la hepatitis B (VHB).
    [26] Infección por el virus de la hepatitis C (VHC) (positividad de antic. contra el virus de la hepatitis C y positividad del ácido ribonucleico [ARN] del VHC).
    [27] Signos de infec. por el VIH o positividad de antic. contra el VIH.
    [28] Haber tenido contacto doméstico con una persona con TB activa y no haber recibido profilaxis adecuada y documentada de la TB.
    [29] Signos de TB activa o TB latente.
    [20] Antecedentes de enf. linfoproliferativa.
    [21] Infección viral, bacteriana, micótica o parasitaria clínicamente grave, actual o reciente, o cualquier otra infección activa o reciente.
    [22] Herpes simple sintomático en el momento de la aleatorización.
    [23] Infección sintom. por herpes zóster en las 12 sem. previas a la aleatorización.
    [24] Antecedentes de herpes zóster diseminado o complicado (por ejemplo, zóster oftálmico o afectación del SNC).
    [25] Resultado es positivo para el virus de la hepatitis B (VHB).
    [26] Infección por el virus de la hepatitis C (VHC) (positividad de antic. contra el virus de la hepatitis C y posit. del ácido ribonucleico [ARN] del VHC).
    [27] Signos de infección por el VIH o positividad de antic. contra el VIH.
    [28] Haber tenido contacto doméstico con una persona con TB activa y no haber recibido
    profilaxis adecuada y docum. de la TB.
    [29] Signos de TB activa o TB latente.
    [30] Haber recibido corticost. por vía parenteral en las 6 sem. previas a la selección (V1) o previsión de recibirlos durante el estudio.
    [31] Haber recibido alguno de los medicam. siguientes (véase prot.).
    [32] Haber recibido un inhibidor de JAK.
    [33] Haber recibido tto. con probenecid que no pueda suspenderse durante el estudio.
    [34] Haber recibido plasmaféresis en las 12 sem. previas a la selección.
    [35] Exposición a una vacuna de microorg. vivos en las 12 sem. previas a la aleatorización o previsión de necesitar o recibir una vacuna de microorg. vivos durante el estudio (con la excepción de la vacunación contra herpes zóster).
    [36] Estar participando en cualquier otro ensayo clínico o haberlo abandonado en las 4 sem. previas a la selección.
    [37] Haber completado previamente o haber sido aleatorizado y retirado de este estudio o haber recibido baricitinib en cualquier otro estudio.
    [38] Valores analíticos en la selección que, en opinión del inv., supongan un riesgo inaceptable para la particip. del pac. en el estudio.
    [39] Alguna de las sig. anomalías específicas en las pruebas analíticas de selección del lab. central (véase prot.).
    Otros motivos (véase prot.)
    E.5 End points
    E.5.1Primary end point(s)
     Proportion of patients with treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs).
     Proportion of patients with temporary investigational product interruptions and permanent discontinuations.
    Proporción de pacientes con acontecimientos adversos aparecidos durante el tratamiento (AAAT), acontecimientos adversos de interés especial (AAIE) y acontecimientos adversos graves (AAG).
    Proporción de pacientes con interrupciones temporales y suspensiones permanentes del producto en investigación.
    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 156 time point
    El cambio será evaluado desde el tiempo de referencia basal hasta la semana 156 del estudio.
    E.5.2Secondary end point(s)
    Proportion of patients achieving SRI-4 response through Week 156, defined as:
    - Reduction of ≥4 points from baseline in SLEDAI-2K score; and
    - No new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity score; and
    - No worsening (defined as an increase of ≥0.3 points [10 mm] from baseline) in the Physician’s
    Global Assessment of Disease Activity.

    Proportion of patients achieving an SRI-5, -6, -7, or -8 response through Week 156.

    Proportion of patients achieving an LLDAS response through Week 156.

    Change from baseline in mean total SLEDAI-2Kscores through Week 156.

    Change from baseline in Physician’s Global Disease Activity score through Week 156.

    Proportion of patients receiving >7.5 mg prednisone (or equivalent) at baseline able to decrease dose by ≥25% to a prednisone equivalent dose of ≤7.5 mg/day maintained for at least 12 weeks through Week 156.

    Change from baseline in prednisone dose through Week 156.

    Proportion of patients taking corticosteroids at baseline able to discontinue use through Week 156.

    Annualized mild/moderate flare rate

    Annualized severe flare rate

    Annualized flare rate (any severity).

    Proportion of patients with CLASI total activity score ≥ 10 at baseline with ≥50% reduction in CLASI total activity score through Week 156.

    Change from baseline in tender joint count through Week 156.

    Change from baseline in swollen joint count through Week 156.

    Proportion of patients with improvement in each SLEDAI-2K organ system versus baseline through Week 156.

    Proportion of patients with worsening in each SLEDAI-2K organ system versus baseline through Week 156.

    Change from baseline in SLICC/ACR damage index total score through Week 156.

    Change from baseline in Worst Pain NRS through Week 156.

    Change from baseline in Worst Joint Pain NRS through Week 156.

    Change from baseline in Worst Fatigue NRS through Week 156.

    Change from baseline in Patient Global Impression of Severity through Week 156.

    Change from baseline in mental component score (MCS), physical component score (PCS), and domain scores in the Short-Form 36-item health
    survey version 2 (SF- 36v2) acute through Week 156.

    Change from baseline in FACIT-F total score through Week 156.

    Change from baseline in the EQ-5D-5L through Week 156.

    Change from baseline in the WPAI-Lupus through Week 156.
    • Proporción de pacientes que logran una respuesta en el índice SRI-4 hasta la semana 156, definida como:
    ○ Reducción ≥ 4 puntos de la puntuación del índice SLEDAI-2K con respecto al valor basal y
    ○ Ninguna nueva puntuación de actividad de la enfermedad BILAG (British Isles Lupus Assessment Group) A o no más de 1 nueva puntuación de actividad de la enfermedad BILAG B; y
    ○ Ausencia de empeoramiento (definido como un aumento > o = 0,3 puntos [10 mm] con respecto al valor basal) en la Evaluación global de la actividad de la enfermedad por el médico.

    Proporción de pacientes que logren una respuesta en el índice SRI-5, -6, -7 u -8 hasta la semana 156.
    Proporción de pacientes que obtengan una respuesta en el índice LLDAS en la semana 156.
    Variación de la puntuación total media del índice SLEDAI-2K entre el momento basal y la semana 156.
    Variación de la puntuación de la actividad global de la enfermedad por el médico entre el momento basal y la semana 156.
    Porcentaje de pacientes tratados con > 7,5 mg de prednisona (o equivalente) en el momento basal capaces de reducir la dosis en ≥ 25 % hasta una dosis equivalente de prednisona de ≤ 7,5 mg/día mantenida durante, como mínimo, 12 semanas hasta la semana 156.
    Variación de la dosis de prednisona entre el momento basal y la semana 156.
    Proporción de pacientes tratados con corticosteroides en el momento basal capaces de suspenderlos hasta la semana 156.
    Tasa anualizada de brotes leves/moderados.
    Tasa anualizada de brotes graves.
    Tasa anualizada de brotes (cualquier intensidad).
    Proporción de pacientes con una puntuación de actividad total del CLASI ≥ 10 en el momento basal con una reducción ≥ 50 % de dicha puntuación en la semana 156.
    Variación del recuento de articulaciones dolorosas entre el momento basal y la semana 156.
    Variación del recuento de articulaciones inflamadas entre el momento basal y la semana 156.
    Proporción de pacientes con mejoría en cada órgano, sistema y aparato del SLEDAI-2K en comparación con el momento basal en la semana 156.
    Proporción de pacientes con empeoramiento en cada órgano, sistema y aparato del SLEDAI-2K en comparación con el momento basal en la semana 156.
    Variación de la puntuación total del índice de daño SLICC/ACR entre el momento basal y la semana 156.
    Variación de la EVN del peor dolor entre el momento basal y la semana 156.
    Variación de la EVN del peor dolor articular entre el momento basal y la semana 156.
    Variación de la EVN del peor cansancio entre el momento basal y la semana 156.
    Variación de la Impresión global de la intensidad por el paciente entre el momento basal y la semana 156.
    Variación con respecto al momento basal de la puntuación del componente mental (MCS), la puntuación del componente físico (PCS) y las puntuaciones de los dominios del Cuestionario breve de salud SF-36, versión 2 (SF-36v2) hasta la semana 156.
    Variación de la puntuación total del FACIT-F en la semana 156 con respecto al momento basal.
    Variación de la puntuación EQ-5D-5L entre el momento basal y la semana 156.
    Variación del índice WPAI-Lupus entre el momento basal y la semana 156.
    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 156 time point
    El cambio será evaluado desde el tiempo de referencia basal hasta la semana 156 del estudio.
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA98
    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
    Belgium
    Brazil
    Chile
    China
    Colombia
    Czech Republic
    France
    Germany
    Hungary
    India
    Italy
    Japan
    Korea, Republic of
    Mexico
    Philippines
    Poland
    Romania
    Russian Federation
    Serbia
    South Africa
    Spain
    Switzerland
    Taiwan
    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 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 será la fecha de la última visita, el último procedimiento programado que se indica en el calendario de actividades o la fecha de retirada del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months4
    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: 990
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 302
    F.4.2.2In the whole clinical trial 1100
    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 Decision2019-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-24
    P. End of Trial
    P.End of Trial StatusOngoing
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