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    Summary
    EudraCT Number:2012-001645-41
    Sponsor's Protocol Code Number:JAK115919
    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:2012-11-12
    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 number2012-001645-41
    A.3Full title of the trial
    An adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with mild to moderate systemic lupus erythematosus.
    Estudio Fase II adaptativo para evaluar la eficacia, farmacodinamia, seguridad y tolerabilidad de GSK2586184 en pacientes con lupus eritematoso sistémico de leve a moderado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the efficacy and safety of GSK2586184 in SLE
    Estudio para evaluar la eficacia y seguridad de GSK2586184 en el LES.
    A.4.1Sponsor's protocol code numberJAK115919
    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 SponsorGlaxoSmithKline, 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 supportGSK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4402089904466
    B.5.5Fax number+4402089901234
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 nameGSK2586184
    D.3.2Product code GSK2586184
    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 INNGSK2586184
    D.3.9.1CAS number 1206163-45-2
    D.3.9.2Current sponsor codeGSK2586184
    D.3.9.3Other descriptive nameN-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 nameGSK2586184
    D.3.2Product code GSK2586184
    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 INNGSK2586184
    D.3.9.1CAS number 1206163-45-2
    D.3.9.2Current sponsor codeGSK2586184
    D.3.9.3Other descriptive nameN-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Systemic Lupus Erythematosus
    Lupus eritematoso sistémico
    E.1.1.1Medical condition in easily understood language
    Systemic Lupus Erythematosus (chronic autoimmune disorder)
    Lupus eritematoso sistémico (enfermedad autoinmune crónica)
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    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
    - To estimate the relationship between dose of GSK2586184 and pharmacodynamic effect on expression of selected messenger ribonucleic acid (mRNA) transcripts following 2 weeks of treatment in SLE patients
    - To estimate the relationship between dose of GSK2586184 and clinical response as assessed by SELENA SLEDAI score following 12 weeks of treatment in SLE patients
    - To evaluate the safety and tolerability of repeat doses of GSK2586184 in SLE patients.
    - Estimar la relación entre la dosis de GSK2586184 y el efecto farmacodinámico sobre la expresión de transcripciones de ARN mensajero (ARNm) seleccionado tras 2 semanas de tratamiento en pacientes con LES.
    - Estimar la relación entre la dosis de GSK2586184 y la respuesta clínica evaluada por la puntuación de SELENA SLEDAI tras 12 semanas de tratamiento en pacientes con LES.
    - Evaluar la seguridad y tolerabilidad de dosis repetidas de GSK2586184 en pacientes con LES.
    E.2.2Secondary objectives of the trial
    - To estimate the relationship between dose of GSK2586184 and clinical response as assessed by the SRI following 12 weeks of treatment in SLE patients
    - To estimate the relationship between dose of GSK2586184 and clinical response as assessed by the SLEDAI-2K and S2K RI-50 scores following 12 weeks of treatment in SLE patients
    - To estimate the relationship between changes in the expression of selected mRNA transcripts following dosing with GSK2586184 and clinical response
    - To assess the pharmacokinetics of GSK2586184 in SLE patients.
    - To define the PK/PD relationship of JAK-1 inhibition on the interferon (IFN) transcriptional signature biomarker following 2 weeks of treatment.
    - To define the PK/PD relationship of JAK-1 inhibition on clinical response parameters following 12 weeks of treatment.
    - To estimate any impact of GSK2586184 treatment on patient reported outcomes.
    - Estimar la relación entre la dosis de GSK2586184 y la respuesta clínica evaluada por el índice de respondedor del LES (SRI) tras 12 semanas de tratamiento en pacientes con LES.
    - Estimar la relación entra la dosis de GSK2586184 y la respuesta clínica evaluada por las puntuaciones de SLEDAI-2K y S2K RI-50 tras 12 semanas de tratamiento en pacientes con LES.
    - Estimar la relación entre los cambios en la expresión de transcripciones de ARNm seleccionadas tras la administración de GSK2586184 y la respuesta clínica.
    - Evaluar la farmacocinética de GSK2586184 en pacientes con LES.
    - Definir la relación FC/FD de la inhibición de JAK-1 sobre el biomarcador de la firma transcripcional del interferón (IFN) tras 2 semanas de tratamiento.
    - Definir la relación FC/FD de la inhibición de JAK-1 sobre parámetros de respuesta clínica tras 12 semanas de tratamiento.
    - Estimar cualquier impacto del tratamiento con GSK2586184 sobre variables notificadas por el paciente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age and Gender: Male or female between 18 and 75 years of age inclusive, at the time of signing the informed consent.
    2. SLE classification: Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria, with 4 or more of the 11 ACR criteria present, serially or simultaneously during any interval or observation.
    3. Severity of disease: Have clinically active SLE disease defined as a SELENA SLEDAI score >=8 at screening.
    4. Auto antibodies: Are serologically active having unequivocally positive antinuclear antibody (ANA) or anti-double stranded DNA (anti-dsDNA) antibody test results from 2 independent time points as follows:
    - Positive test results from 2 independent time points within the study screening period. Screening results must be based on the study's central laboratory results. A positive test is defined as a positive ANA test equivalent to a titre >=1:80 as defined in the central laboratory manual and/or a positive anti-dsDNA (>=30 IU/mL) serum antibody.
    OR
    - One positive historical test result and 1 positive test result for either ANA or anti-dsDNA during the screening period.
    Historical documentation of a positive test of ANA (e.g., ANA by HEp-2 titre) or anti-dsDNA antibody (e.g., anti-dsDNA by Farr assay) must include the date and type of the test, the name of the testing laboratory, numerical reference range, and a key that explains values provided as positive vs. negative OR negative,
    equivocal/borderline positive). Only unequivocally positive values as defined in the laboratory's reference range are acceptable; borderline values will not be accepted.
    5. Treatment for SLE: patient stable on either no treatment or on a stable dose of corticosteroids (<=15mg/day prednisone or prednisone equivalent or less) stable for a minimum of 30 days prior to screening and through to Day 0/Randomisation and /or hydroxychloroquine (<=400mg daily dose) for a minimum of 60 days prior to the Day 0/Randomisation Visit. Subjects receiving azathioprine (<= 2mg/kg/day or <= 150mg/day, whichever is greater) or mycophenolate mofetil (<= 1.5g/day), or MTX (<= 20mg/week), either alone or in addition to steroids and / or
    hydroxychloroquine, if they have been on a stable dose of azathioprine OR
    mycophenolate mofetil OR MTX for a minimum of 90 days prior to the Day 0 /Randomisation Visit.
    For those subjects on alternating day dosing of steroids, use the average of 2 daily doses to calculate the average daily steroid dose.
    6. ECG: Single QTc, < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
    7. Prevention of Pregnancy:
    Females: A female subject is eligible to participate if she is not pregnant, as confirmed by a negative serum human chorionic gonadotrophin (hCG) test, or lactating and at least one of the following conditions applies: Please refer to page 37 bullet point 7 of the study protocol for details.
    8. Informed consent: Capable of giving written informed consent, including confirmation that the subject is not mentally or legally incapacitated, and compliance with the requirements and restrictions listed in the consent form.
    French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
    1. Edad y sexo: Hombres o mujeres de edad comprendida entre 18 y 75 años, ambos inclusive, en el momento de firmar el consentimiento informado.
    2. Clasificación de LES: Diagnóstico clínico de LES de acuerdo con los criterios de clasificación del American College of Rheumatology (ACR), con presencia de 4 o más de los 11 criterios, de forma seriada o simultánea durante cualquier intervalo de observación.
    3. Gravedad de la enfermedad: LES clínicamente activo definido como una puntuación SELENA SLEDAI >=8 en la selección.
    4. Autoanticuerpos: Sujetos serológicamente activos con resultados inequívocamente positivos en las pruebas de anticuerpos antinucleares (ANA) o anticuerpos anti-ADN de doble hélice (anto-ADNdh) realizadas en dos momentos diferentes, de la siguiente forma:
    - Resultados positivos en dos momentos diferentes dentro del periodo de selección del estudio. Los resultados de la selección deben estar basados en los resultados del laboratorio central del estudio. Una prueba positiva se define como una prueba de ANA positiva equivalente a un título >=1:80 definido en el manual del laboratorio central y/o un resultado positivo en la prueba de anticuerpos anti-ADNdh en suero (>=30 UI/mL).
    O
    - Un resultado positivo en una prueba previa y un resultado positivo en el análisis de ANA o anti-ADNdh durante el periodo de selección.
    La documentación de una prueba positiva previa de ANA (por ejemplo, ANA por título de Hep-2) o de anticuerpos anti-ADNdh (por ejemplo, anti-ADNdh por el método Farr) debe incluir la fecha y el tipo de prueba, el nombre del laboratorio, el rango de referencia y una clave que explique los valores proporcionados como positivos frente a negativos O negativos, equívocos/positivos límite). Sólo son aceptables los valores inequívocamente positivos según se define en el rango de referencia del laboratorio; no se aceptarán los valores límite.
    5. Tratamiento del LES: Pacientes sin tratamiento o con una dosis estable de corticosteroides (<=15 mg/día o menos de prednisona o equivalente de la prednisona) durante un mínimo de 30 días antes de la selección y hasta el Día 0/Aleatorización y/o hidroxicloroquina (<=400 mg al día) durante un mínimo de 60 días antes de la Visita del Día 0/Aleatorización. Los sujetos que estén recibiendo azatioprina (<=2 mg/kg/día o ?150 mg/día, lo que sea mayor) o micofenolato de mofetilo (<=1,5 g/día) o MTX (<=20 mg/semana), solo o además de los esteroides y/o hidroxicloroquina, si han permanecido con una dosis estable de azatioprina O de micofenolato de mofetilo O de MTX durante un mínimo de 90 días antes de la Visita del Día 0/Aleatorizacón.
    En los sujetos que tomen esteroides en días alternos, se utilizará la media de 2 dosis diarias para calcular la dosis media diaria de esteroides.
    6. ECG: QTc <450 mseg o QTc <480 mseg en sujetos con bloqueo de rama.
    7. Prevención del embarazo:
    Mujeres: Una mujer será elegible para participar si no está embarazada, confirmado por un análisis de gonadotropina corionica humana (hCG) en suero negativa, o en periodo de lactancia y cumple al menos una de las siguientes condiciones: (Por favor, consulte la página 36 de Protocolopara más detalles).
    8. Consentimiento informado: Sujetos capaces de dar el consentimiento informado por escrito, incluida la confirmación de que el sujeto no está mentalmente ni legalmente incapacitado, y el cumplimiento de los requisitos y restricciones que se citan en el documento del consentimiento.
    Sujetos franceses: En Francia, un sujeto sólo será elegible para participar en el estudio si está afiliado o es beneficiario de alguna categoría de la seguridad social.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria must not be enrolled in the study:
    1. Kidney Disease
    2. CNS Disease
    3. Alcohol Abuse
    4. Substance Abuse
    5. Hepatitis B
    6. Hepatitis C
    7. HIV
    8. Previous investigational product exposure
    9. Previous and current medication
    10. Prior biological therapies
    11. Transplantation
    12. Uncontrolled Other Diseases
    13. Surgery and Other Conditions
    14. Cancer
    15. Infections
    16. Haematology
    17. Serum immunoglobulin (Ig) levels
    18. Liver Function Tests
    19. Other laboratory abnormalities
    20. Drug sensitivity
    21. Blood donation
    * Please refer to the study protocol section 5.3 Exclusion Criteria pages 38-40 for further details.
    Los sujetos que cumplan cualquiera de los siguientes criterios no deben ser reclutados en el estudio:
    1. Nefropatía
    2. Enfermedad del SNC
    3. Abuso de alcohol
    4. Abuso de sustancias
    5. Hepatitis B
    6. Hepatitis C
    7. VIH
    8. Exposición previa a un producto en investigación
    9. Medicación previa y actual
    10. Terapias biológicas previas
    11. Trasplante
    12. Otras enfermedades no controladas
    13. Cirugía y otros trastornos
    14. Neoplasias
    15. Infecciones
    16. Hematología
    17. Niveles séricos de inmunoglobulinas (Ig)
    18. Pruebas de función hepática
    19. Otras anomalías de laboratorio
    20. Sensibilidad a fármacos
    21. Donación de sangre
    Por favor, consulte en el Protocolo del estudio el apartado 5.3 Criterios de exclusión para más información.
    E.5 End points
    E.5.1Primary end point(s)
    1. Interferon transcriptional signature biomarker expression over time (Interim Analysis 1, Primary Endpoint)
    2. SELENA SLEDAI score over time (Interim Analysis 2, 3 and final analysis, Primary Endpoint)
    3. Change from baseline for blood pressure, heart rate and temperature over time.
    4. Change from baseline in clinical chemistry and hematology parameters over time.
    5. Number and severity of adverse events during the study period.
    1. Interferon transcriptional signature biomarker expression over time (Interim Analysis
    1, Primary Endpoint)
    2. SELENA SLEDAI score over time (Interim Analysis 2, 3 and final analysis, Primary Endpoint)
    3. Change from baseline for blood pressure, heart rate and temperature over time.
    4. Change from baseline in clinical chemistry and hematology parameters over time.
    5. Number and severity of adverse events during the study period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    * Primary endpoints 1 to 5 will be evaluated during the 12 week treatment period.
    * Primary endpoint 1 is the key decision making pharmacodynamic endpoint at Interim Analysis 1 after the first 25 subjects have been treated for 2 weeks
    * Primary endpoint 2 is the key decision making clinical efficacy primary endpoint at Interim Analyses 2 and 3 (if conducted)
    * Las variables primarias 1 a 5 serán evaluadas durante el periodo de tratamiento de 12 semanas.
    * La variable primaria 1 es la variable farmacodinámica clave para la toma de decisiones en el Análisis Intermedio 1, después de que los primeros 25 sujetos hayan recibido tratamiento durante 2 semanas.
    * La variable primaria 2 es la variable primaria de eficacia clínica clave para la toma de decisiones en los Análisis Intermedios 2 y 3 (si se realizan).
    E.5.2Secondary end point(s)
    1. SRI Response Rate over time. Response is defined as:
    >= 4 point reduction from baseline in the SELENA SLEDAI score,
    AN No worsening (increase of <0.30 points from baseline) in Physicians Global Assessment (PGA)
    AND
    No new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with baseline.
    To evaluate the response over time, the percentage of subjects achieving a response on the composite endpoint, and each of the components of this endpoint, will be presented by visit.
    2. Change from baseline in SLEDAI-2K score and the S2K RI-50 score during 12 weeks of treatment with GSK2586184
    3. Individual plasma concentrations of GSK2586184 and data permitting, summary PK parameters.
    4. Mean change from baseline in Short Form-36 Health Survey (SF-36) score (8 domains) at Week 12.
    5. Mean change from baseline in Brief Fatigue Inventory (BFI) score (9 items) at Weeks 2, 4, 6, 8, 10 and 12.
    6. Mean change from baseline in Brief Pain Inventory (BPI) (short form) score (15 items) at weeks 2, 4, 6, 8, 10 and 12.
    1. Tasa de respuesta del Índice de Respondedor del LES (SRI) con el tiempo. Respuesta se define como:
    - reducción >=4 puntos en la puntuación de SELENA SLEDAI respecto a la evaluación basal,
    Y
    - No empeoramiento (incremento <0,30 puntos respecto al valor basal) en la evaluación global del médico (PGA)
    Y
    - Ninguna nueva puntuación de categoría A en un área orgánica del British Isles Lupus Assessment Group (BILAG) A o nuevas puntuaciones de categoría B en 2 áreas orgánicas del BILAG en comparación con la evaluación basal
    Para evaluar la respuesta con el tiempo, se presentará por visita el porcentaje de sujetos que alcanzan una respuesta en la variable compuesta y en cada uno de los componentes de esta variable.
    2. Cambio respecto al valor basal en la puntuación de SLEDAI-2K y S2K RI-50 durante las 12 semanas de tratamiento con GSK2586184
    3. Concentraciones plasmáticas individuales de GSK2586184 y, si los datos lo permiten, resumen de los parámetros FC.
    4. Cambio medio respecto al valor basal en la puntuación de la SF-36 Health Survey (8 áreas) en la Semana 12.
    5. Cambio medio respecto al valor basal en el Brief Fatigue Inventory (BFI) (cuestionario breve de la fatiga) (9 apartados) en las semanas 2, 4, 6, 8, 10 y 12.
    6. Cambio medio respecto al valor basal en la puntuación del Brief Pain Inventory (BPI) (cuestionario breve del dolor) (15 apartados) en las semanas 2, 4, 6, 8, 10 y 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints 1 through 6 will be evaluated during the 12 week treatment period.
    Las variables secundarias 1 a 6 seran evaluadas durante el periodo de tratamiento de 12 semanas.
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability of GSK2586184 in adult patients with active SLE.
    tolerabilidad de GSK2586184 en pacientes adultos con LES activo.
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Adaptive
    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 trial5
    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 EEA44
    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
    Brazil
    Chile
    Hong Kong
    India
    Korea, Republic of
    Mexico
    Peru
    Russian Federation
    South Africa
    Thailand
    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
    LSLV
    Última visita del último paciente.
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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: 175
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 137
    F.4.2.2In the whole clinical trial 250
    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)
    The investigator is responsible for ensuring that consideration has been given to the poststudy
    care of the patient?s medical condition whether or not GSK is providing specific post study treatment.
    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 Decision2012-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-03-31
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