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    The EU Clinical Trials Register currently displays   42564   clinical trials with a EudraCT protocol, of which   7007   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-000625-39
    Sponsor's Protocol Code Number:D3461C00009
    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:2016-07-15
    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 number2016-000625-39
    A.3Full title of the trial
    A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus
    Estudio de extensión, de fase 3, multicéntrico, aleatorizado, doble ciego, controlado con placebo, para caracterizar la tolerabilidad y seguridad a largo plazo de anifrolumab en pacientes adultos con lupus eritematoso sistémico activo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus
    Estudio para caracterizar la seguridad y tolerabilidad de Anifrolumab en pacientes adultos con Lupus Eritematoso Sistemico
    A.3.2Name or abbreviated title of the trial where available
    Tulip SLE LTE
    A.4.1Sponsor's protocol code numberD3461C00009
    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 SponsorAstraZeneca AB
    B.1.3.4CountryUnited Kingdom
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressKarlebyhus, Astraallén
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post code151 85
    B.5.3.4CountrySweden
    B.5.6E-mailinformationcenter@astrazeneca.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 nameAnifrolumab
    D.3.2Product code MEDI-546
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNAnifrolumab
    D.3.9.1CAS number 1326232-46-5
    D.3.9.2Current sponsor codeMEDI 546
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 placeboConcentrate for solution for infusion
    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 Sistemico
    E.1.1.1Medical condition in easily understood language
    Lupus, an autoimmune disease
    Lupus, una enfermedad autoinmune
    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 19.0
    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 characterise long-term safety and tolerability of intravenous anifrolumab.
    Caracterizar la tolerabilidad y la seguridad a largo plazo del anifrolumab por vía intravenosa
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects who have qualified for and received investigational product (anifrolumab or placebo) and completed the treatment period in Studies D3461C00004 or D3461C00005 (through Week 52)
    2. Adequate peripheral venous access
    3. Females with an intact cervix should have documentation of a Pap smear with no documented malignancy within 90 days before Day 1/Visit 1. Since access to a Pap smear may vary by country, the Sponsor recommends that local guidelines for obtaining Pap smears in subjects who have received immunomodulators or immunosuppressive treatment be followed.
    4. Meets the following TB criteria:
    (a) Negative QuantiFERON®-TB Gold [QFT-G] test result for TB obtained from the study central laboratory at Week 52 of Studies D3461C00004 or D3461C00005; OR
    (b) Newly positive QFT-G test result for TB obtained at Week 52 of Studies D3461C00004 or D3461C00005 from the study central laboratory. A chest x-ray must be performed. If the chest x-ray shows no evidence of active TB, and the subject has no symptoms or medical history consistent with active TB, the subject must have a retest. If the retest is positive, the subject must initiate treatment for latent TB within 30 days of randomisation, but prior to the second dose of investigational product administration (Visit 2/Week 4); OR
    (c) Positive but not newly positive QFT-G test at Week 52 of Studies D3461C00004 or D3461C00005 from the study central laboratory. The subject must have been diagnosed with latent TB and must have documentation confirming completion of appropriate treatment OR initiate treatment for latent TB within 30 days of randomization, but prior to the second dose of investigational product administration (Visit 2/Week 4)
    (d) Newly indeterminate (confirmed on retest) or indeterminate but not newly indeterminate QFT-G test result at Week 52 of Studies D3461C00004 or D3461C00005 from the study central laboratory with ongoing QFT-G testing for TB according to the Study Plan
    5. In the opinion of the Investigator, subject must be able to comprehend the ICF and all protocol related assessments
    1.Pacientes aptos que hayan recibido el producto en investigación (anifrolumab o placebo) y que hayan terminado el periodo de tratamiento en los estudios D3461C00004 o D3461C00005 (hasta la semana 52)
    2.Acceso venoso periférico adecuado
    3.Las mujeres con cuello uterino intacto deben documentar que carecen de neoplasias malignas mediante una prueba de Papanicoláu realizada dentro de los 90 días anteriores al día 1/visita 1. Dado que el acceso a la prueba de Papanicoláu puede variar de un país a otro, el promotor recomienda seguir las directrices locales para su realización en pacientes receptoras de inmunomoduladores o de tratamiento inmunodepresor.
    4.Cumplimiento de los criterios de TB (tuberculosis) siguientes:
    a)Resultado negativo en la prueba QuantiFERON®-TB Gold (QFT-G) de la TB obtenido del laboratorio central del estudio en la semana 52 de los estudios D3461C00004 o D3461C00005
    O
    b)Resultado positivo de nueva aparición en la prueba QFT-G de la TB obtenido del laboratorio central del estudio en la semana 52 de los estudios D3461C00004 o D3461C00005. Debe realizarse una radiografía de tórax. Si la radiografía de tórax no muestra indicios de TB activa y el paciente carece de síntomas o de antecedentes médicos compatibles con TB activa, se deberá repetir la prueba al paciente. Si la repetición da
    positivo, el paciente debe comenzar un tratamiento para la TB latente en los 30 días siguientes a la aleatorización, pero antes de administrar la segunda dosis del producto en investigación (visita 2/semana 4).
    O
    c)Resultado positivo, pero no de nueva aparición en la prueba QFT-G obtenido del laboratorio central del estudio en la semana 52 de los estudios D3461C00004 o D3461C00005. Se debe haber diagnosticado al paciente TB latente y debe tener documentación que confirme la realización completa del tratamiento correspondiente O comenzar un tratamiento para la TB latente en los 30 días siguientes a la aleatorización, pero antes de administrar la segunda dosis del producto en investigación (visita 2/semana 4)Resultado indeterminado de nueva aparición (confirmado al repetir la prueba) o no en la prueba QFT-G obtenido del laboratorio central del estudio en la semana 52 de los estudios D3461C00004 o D3461C00005 con pruebas continuas de QFT-G para la TB según el plan del estudio
    5.En opinión del investigador, el paciente debe ser capaz de comprender el FCI y todas las evaluaciones relacionadas con el protocolo
    E.4Principal exclusion criteria
    1. Receipt of any of the following within the last 60 days:
    (a) Azathioprine >200 mg/day
    (b) Mycophenolate mofetil/mycophenolic acid >2.0 g/day
    (c) Oral, subcutaneous, or intramuscular methotrexate >25 mg/week
    (d) Mizoribine >150 mg/day
    2. Receipt of any investigational product (small molecule or biologic agent other than anifrolumab) within 4 weeks or 5 half-lives prior to Day 1/Visit 1, whichever is greater
    3. Receipt of any of the following:
    (a) Any live or attenuated vaccine within 8 weeks prior to Day 1/Visit 1 (administration of killed vaccines is acceptable, the Sponsor recommends Investigators ensure all subjects are up to date on required
    vaccinations, including influenza [inactivated/recombinant] vaccine prior to study entry)
    (b) Bacillus Calmette-Guerin (BCG) vaccine between the end of Studies D3461C00004 or D3461C00005 and Day 1/Visit 1
    4. Active severe SLE-driven renal or neuropsychiatric disease
    5. Any underlying condition that predisposes the subject to infection, including history of/current human immunodeficiency virus (HIV) infection
    6. Subjects with Hepatitis B core antibody (HBcAb) positivity at enrolment of Studies D3461C00004 or D3461C00005 will be tested every 3 months for Hepatitis B virus (HBV) DNA. To remain eligible in the LTE study, subject HBV DNA levels must remain below the lower limit of quantitation as per the central laboratory.
    7. Opportunistic infection requiring hospitalisation or parenteral antimicrobial treatment within 3 years of Day 1/Visit 1
    Recepción de cualquiera de los medicamentos siguientes durante los 60 días previos al día 1/visita 1:
    (a)Azatioprina >200 mg/día
    (b)Micofenolato mofetilo/ácido micofenólico >2,0 g/día
    (c)Metotrexato por vía oral, subcutánea o intramuscular >25
    mg/semana
    (d)Mizoribina >150 mg/día
    2.Recepción de cualquier producto en investigación (agente tradicional o biológico distinto del anifrolumab) durante las 4 semanas o las 5 semividas previas al día 1/visita 1, aplicando el plazo que sea más largo
    3.Recepcion de cualquiera de los siguientes:
    a)Cualquier vacuna de microorganismos vivos o atenuados dentro de las 8 semanas anteriores al día 1/visita 1 (se permite la administración de vacunas muertas; el promotor recomienda a los investigadores que se aseguren de que todos los pacientes hayan recibido todas las vacunas necesarias, incluida la de la gripe [inactivada/recombinante] antes de ingresar en el estudio)
    b)Vacuna contra el bacilo de Calmette-Guérin (BCG) entre el final de los estudios D3461C00004 o D3461C00005 y el día 1/visita 1
    4.Enfermedad renal o neuropsiquiátrica grave activa causada por el LES
    5.Cualquier afección subyacente que predisponga al paciente a infecciones, como infección previa o en curso por el virus de la inmunodeficiencia humana (VIH)
    6.A los pacientes que den positivo para anticuerpos contra el antígeno central del virus de la hepatitis B (HBcAb) en el momento de la inclusión en los estudios D3461C00004 o D3461C00005 se les realizará cada 3 meses la prueba de ADN del virus de la hepatitis B (VHB). Para seguir siendo apto para el estudio de ELP, los niveles de ADN del VHB del
    paciente deben permanecer por debajo del límite mínimo de cuantificación (LMC) según el laboratorio central
    7.Infección oportunista que haya requerido hospitalización o tratamiento antimicrobiano parenteral durante los 3 años anteriores al día 1/visita 1
    E.5 End points
    E.5.1Primary end point(s)
    Rates of adverse events of special interest and serious adverse events from baseline of the Phase 3 pivotal Studies D3461C00004 or D3461C00005
    Indice de efectos adversos de especial interés y efectos adversos graves tomando como referencia los estudios pivotales D3461C00004 o D3461C00005
    E.5.1.1Timepoint(s) of evaluation of this end point
    164 weeks
    164 semanas
    E.5.2Secondary end point(s)
    Not applicable
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplica
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic 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 No
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA71
    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
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Lithuania
    Mexico
    New Zealand
    Peru
    Poland
    Romania
    Russian Federation
    Singapore
    South Africa
    Spain
    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
    LVLS
    Ultima visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months3
    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: 383
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 192
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 177
    F.4.2.2In the whole clinical trial 575
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-19
    P. End of Trial
    P.End of Trial StatusOngoing
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