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    Summary
    EudraCT Number:2014-005000-19
    Sponsor's Protocol Code Number:CNTO1275SLE2001
    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:2015-03-03
    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 number2014-005000-19
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus
    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, prueba de concepto de Ustekinumab en pacientes con Lupus Eritematoso Sistémico Activo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus
    Estudio Fase 2a, para evaluar la seguridad y eficacia de Ustekinumab en Lupus Eritematoso Sistémico Activo
    A.4.1Sponsor's protocol code numberCNTO1275SLE2001
    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 SponsorJanssen-Cilag International N.V.
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag S.A.
    B.5.2Functional name of contact pointGlobal Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28045
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917228100
    B.5.5Fax number+34917228628
    B.5.6E-mailagonza45@its.jnj.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 STELARA®
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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 nameUstekinumab
    D.3.2Product code CNTO1275
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNustekinumab
    D.3.9.1CAS number 815610-63-0
    D.3.9.2Current sponsor codeCNTO1275
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeMonoclonal Antibody
    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 STELARA®
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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 nameUstekinumab
    D.3.2Product code CNTO1275
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNustekinumab
    D.3.9.1CAS number 815610-63-0
    D.3.9.2Current sponsor codeCNTO1275
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeMonoclonal Antibody
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systemic Lupus Erythematosus
    Lupus Eritematoso Sistémico
    E.1.1.1Medical condition in easily understood language
    Lupus
    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 17.1
    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 evaluate the efficacy of ustekinumab as measured by a reduction in disease activity for subjects with active SLE
    El objetivo principal consiste en evaluar la eficacia de ustekinumab en función de la disminución de la actividad de la enfermedad en pacientes con LES activo.
    E.2.2Secondary objectives of the trial
    To evaluate:
    ? The safety and tolerability of ustekinumab in subjects with SLE.
    ? The effect of ustekinumab administration on health-related quality of life in subjects with SLE.
    ? The effects of ustekinumab on cutaneous manifestations of SLE.
    ? Pharmacokinetics and immunogenicity of ustekinumab in subjects with SLE
    Los objetivos secundarios consisten en evaluar:
    ? La seguridad y tolerabilidad de ustekinumab en pacientes con LES.
    ? El efecto de la administración de ustekinumab en la calidad de vida relacionada con la salud en pacientes con LES.
    ? Los efectos de ustekinumab en las manifestaciones cutáneas del LES.
    ? La farmacocinética y la inmunogenicidad de ustekinumab en pacientes con LES.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Protocol A0 - dated 18 December 2014 - Subjects who provide consent will be enrolled in the cutaneous lupus substudy evaluating the histology of cutaneous biopsies and/or skin photographs. Subjects participating in the cutaneous lupus substudy are not required to undergo biopsies, and may allow only photographs to document changes in an identified lesion or area of active disease
    Protocolo AO - del 18 de diciembre de 2014 - Los pacientes que otorguen su consentimiento serán reclutados en el subestudio del lupus cutáneo para evaluar la histología de las biopsias cutáneas y/o las fotografías de la piel. Los pacientes que participen en el subestudio del lupus cutáneo no tendrán por qué realizarse biopsias y podrán otorgar su consentimiento únicamente para la obtención de fotografías que documenten cambios en una lesión identificada o una zona de enfermedad activa.
    E.3Principal inclusion criteria
    - Subjects must have documented medical history to meet SLICC classification criteria for SLE for a minimum of 3 months
    prior to first dose
    - At least 1 well-documented (subject file, referring physician letter, or laboratory result), unequivocally positive, test for
    autoantibodies in medical history including either of the following: ANA, and/or anti-dsDNA antibodies, and/or anti-Smith antibodies
    - At least 1 unequivocally positive autoantibody test including ANA and/or anti-dsDNA antibodies and/or anti-Smith antibodies detected during screening
    - At least 1 BILAG A and/or 2 BILAG B domain scores observed at screening and/or at Week 0 prior to first administration of study agent
    - Demonstrate active disease based on SLEDAI-2K score greater than or equal to (>=) 6 observed during screening and assessed approximately 2 to 6 weeks prior to randomization (Week 0).
    - Must also have SLEDAI-2K score >= 4 for clinical features (ie, SLEDAI excluding laboratory-based items) at Week 0 prior to the first administration of study agent
    - Los pacientes deben tener antecedentes médicos documentados que cumplan los criterios de clasificación de SLICC para el LES desde por lo menos 3 meses antes de recibir la primera dosis
    - Al menos un análisis debidamente documentado (archivo del paciente, carta del médico que le ha derivado o resultado analítico) e inequívocamente positivo de autoanticuerpos en la historia clínica, incluido cualquiera de los siguientes: AAN, anticuerpos anti-ADNbc o anticuerpos anti-Smith
    -Al menos un resultado positivo en un análisis de autoanticuerpos (anticuerpos antinucleares [AAN], anticuerpos contra el ácido desoxirribonucléico bicatenario (anti-ADNbc) o anticuerpos anti-Smith) durante la selección
    - Al menos una puntuación BILAG A en un dominio y/o una puntuación BILAG B en dos dominios en la selección y/o en la semana 0 antes de la administración de la primera dosis del fármaco del estudio.
    - Presentar enfermedad activa basada en una puntuación de SLEDAI-2K ?6 observada durante la selección y evaluada aproximadamente entre 2 y 6 semanas antes de la aleatorización (semana 0).
    - Obtener también una puntuación SLEDAI-2K ?4 para las manifestaciones clínicas (es decir, SLEDAI excluidos los criterios analíticos) en la semana 0 antes de la administración de la primera dosis del fármaco del estudio.
    E.4Principal exclusion criteria
    - Have other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), RA/lupus overlap, psoriasis or Lyme disease
    - Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 4 months after receiving the last administration of study agent
    - Have received systemic immunosuppressives other than those described in inclusion criteria within the past 6 months prior to first administration of study agent
    - Have received more than 1 previous B cell targeting therapy including belimumab or epratuzamab within 6 months prior to first administration of the study agent or received B-cell depleting therapy (eg, rituximab) within 12 months prior to first administration of the study agent or have evidence of continued B-cell depletion following such therapy
    - Have ever received ustekinumab
    - Presentar enfermedades inflamatorias que puedan confundir las evaluaciones de la eficacia, como artritis reumatoide (AR), artritris psoriásica (APs), solapamiento de AR/lupus, psoriasis o enfermedad de Lyme.
    - Embarazo, lactancia o intención de quedarse embarazada o engendrar un hijo durante la participación en el estudio o en las 4 meses siguientes a la administración de la última dosis del fármaco del estudio.
    - Haber recibido tratamiento sistémico con inmunodepresores distintos a los descritos en los criterios de inclusión en los 6 meses previos a la administración de la primera dosis del fármaco del estudio.
    -Haber recibido más de un tratamiento previo dirigido a los linfocitos B, como belimumab o epratuzumab en los 6 meses previos a la administración de la primera dosis del fármaco del estudio, o haber recibido un tratamiento reductor de linfocitos B (p. ej., rituximab) en los 12 meses previos a la administración de la primera dosis del fármaco del estudio o presentar signos de reducción persistente de linfocitos B después de dicho tratamiento.
    -Haber recibido alguna vez antes ustekinumab.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of Participants With a Composite SRI-4 Response at Week 24
    La proporción de pacientes con una respuesta SRI-4 compuesta en la semana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Semana 24
    E.5.2Secondary end point(s)
    - Change From Baseline in SLEDAI-2K Score at Week 24.
    - Change From Baseline in Physician Global Assessment of Disease Activity (PGA) at Week 24
    - Percentage of Participants With BICLA Response at Week 24
    - Variación respecto al valor basal de SLEDAI-2K en la semana 24.
    - Variación respecto al momento basal de la EGM en la semana 24.
    - Proporción de pacientes con respuesta BICLA en la semana 24.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 No
    E.8.1.6Cross over Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Germany
    Hungary
    Mexico
    Poland
    Spain
    Taiwan
    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
    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 years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days13
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 47
    F.4.2.2In the whole clinical trial 100
    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 Decision2015-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-13
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