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    Summary
    EudraCT Number:2014-001365-26
    Sponsor's Protocol Code Number:AN-IGN3321
    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:2015-03-27
    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 number2014-001365-26
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy
    Estudio de fase II/III, aleatorizado, doble ciego y controlado con placebo, para evaluar la eficacia y seguridad de la administración de blisibimod en pacientes con nefropatía IgA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy
    Estudio para evaluar la eficacia y la seguridad de Blisibimod en Nefropatía IgA
    A.3.2Name or abbreviated title of the trial where available
    BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration
    BRIGHT-SC: Respuesta de la IgA después del trat. domiciliario con blisibimob admin. por vía subcut.
    A.4.1Sponsor's protocol code numberAN-IGN3321
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02062684
    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 SponsorAnthera pharmaceuticals, Inc
    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 supportAnthera Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAnthera pharmaceuticals, Inc
    B.5.2Functional name of contact pointColin Hislop, MD
    B.5.3 Address:
    B.5.3.1Street Address25801 Industrial Blvd., Suite B
    B.5.3.2Town/ cityHayward
    B.5.3.3Post codeCA 94545
    B.5.3.4CountryUnited States
    B.5.4Telephone number34911459110
    B.5.5Fax number34914342773
    B.5.6E-mailregulatory.spain@pharm-olam.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 nameBlisibimod Injection
    D.3.2Product code A-623 or AMG 623
    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 INNblisibimod
    D.3.9.1CAS number 1236126-45-6
    D.3.9.2Current sponsor codeA-623 or AMG-623
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Yes
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    IgA Nephropathy
    Nefropatía IgA
    E.1.1.1Medical condition in easily understood language
    Immunoglobulin A Nephropathy (IgAN)
    Nefropatía por inmunoglobulina A (IgA)
    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 10021263
    E.1.2Term IgA nephropathy
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study is divided into 2 parts (A and B). All subjects will be on stable, optimized therapy with angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB), and the analyses will compare the effects of blisibimod plus ACEI/ARB therapy with placebo plus ACEI/ARB therapy.

    The objective of Part A (from randomization through Week 24) is to assess the effect of blisibimod treatment on proteinuria.

    The objective of Part B is to follow subjects for the occurrence of end-stage renal disease (ESRD) clinical events. The analysis for ESRD clinical events will include events accrued in this study (during Parts A and B) as well as in other concurrent placebo-controlled trials with blisibimod in patients with IgA nephropathy (e.g. Study AN-IGN3331).
    El presente estudio se divide en 2 partes. Todos los sujetos deberán estar recibiendo un tratamiento estable, optimizado, con inhibidores de la enzima convertidora de angiotensina (IECA) o con antagonistas de los receptores de angiotensina (ARA). En los análisis se compararán los efectos de blisibimod más el tratamiento con IECA/ARA con los del placebo más el tratamiento con IECA/ARA.

    El objetivo de la Parte A (desde la aleatorización hasta la semana 24) es evaluar el efecto del tratamiento con blisibimod en la proteinuria.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to evaluate changes in proteinuria, immunoglobulins IgA, IgG, IgM, plasma cells, renal function, safety profile, requirement for steroid therapy and biomarker changes in subjects treated with blisibimod compared to placebo.
    Los objetivos secundarios comprenden la evaluación de cambios en la proteinuria, inmunoglobulinas IgA, IgG, IgM, células plasmáticas, función renal, perfil de seguridad, necesidad de tratamiento con esteroides y cambios en biomarcadores en los sujetos tratados con blisibimod en comparación con placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects are eligible for enrollment if they meet the following inclusion criteria:
    1.Male or female age 18 ? 65 years of age, inclusive.
    2.Historical documentation of biopsy-proven IgA nephropathy according to definitions specified in the Oxford classification of IgA nephropathy (Appendix B). Histology should include evidence of staining of IgA in glomeruli by immunofluorescence of immunoperoxidase. Evidence of mesangial hypercellularity, segmental glomerulosclerosis, or endocapilllary hypercellularity must also be present.
    3.Treatment with a stable clinically-optimized dose of ACEI and/or ARB for at least 90 days prior to screening.
    4.Proteinuria > or = 1g/24hr but < or = 6g/24hr or equivalent as measured by random urine protein:creatinine ratio at 2 consecutive time points measured 2-6 weeks apart prior to randomization. At least one of these measures must be collected during screening.
    Los sujetos serán aptos para ser incluidos si cumplen los criterios de inclusión siguientes:
    1. Hombre o mujer de entre 18 y 65 años de edad, inclusive.
    2. Historia documentada de nefropatía IgA confirmada mediante biopsia, de acuerdo con las definiciones que se especifican en la clasificación de Oxford de la nefropatía IgA (Apéndice B). La histología debe presentar tinción de IgA en los glomérulos mediante inmunofluorescencia o inmunoperoxidasa. Asimismo, deben existir signos de hipercelularidad mesangial, glomeruloesclerosis segmentaria o hipercelularidad endocapilar.
    3. Tratamiento con IECA y/o ARA, a una dosis estable, clínicamente óptima, durante un mínimo de 90 días antes de la selección.
    4. Proteinuria > 0 = 1g/24h pero < o = 6g/24h o equivalente, según el cociente proteína:creatinina en orina determinado en 2 evaluaciones consecutivas realizadas con un intervalo de 2 6 semanas antes de la aleatorización. Al menos una de las muestras para estas determinaciones debe obtenerse durante la selección.
    E.4Principal exclusion criteria
    Subjects must NOT meet any of the following exclusion criteria:
    1.Clinical or histologic evidence of lupus nephritis or membranoproliferative glomerulonephritis, or non-IgA-related glomerulonephritis.
    2.Greater than 50% glomerulosclerosis or cortical scarring on renal biopsy or an Oxford Classification Score that includes T2.
    3.Crescentic IgA nephropathy (> or =30%) or clinical evidence of rapidly progressive glomerulonephritis.
    4.Henoch-Schonlein purpura resulting in nephropathy.
    5.eGFR < or = 30 mL/min per 1.73 m2 in subjects with a qualifying biopsy within 1 year of screening, or eGFR < or = 40 mL/min per 1.73 m2 in subjects with a qualifying biopsy conducted more than 1 year before screening.
    6.Blood uric acid > 1.5 times the upper limit of normal upon repeat testing at screening.
    7.History or clinical evidence of cirrhosis, or liver disease with serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x upper limit of normal upon repeat testing.
    8.Poorly controlled hypertension (> or = 150/90 mmHg).
    9.History of diabetes mellitus.
    10.Known to be positive for human immunodeficiency virus (HIV) and/or positive at the screening visit for hepatitis B surface antigen, or hepatitis C virus.
    11.History of Crohn?s disease or celiac sprue.
    12.Anemia (hemoglobin <8 g/dL), neutropenia (< or = 1500 cells/?L), or thrombocytopenia (<75,000 cells/?L).
    13.Malignancy within the past 5 years (other than a squamous or basal cell carcinoma of the skin which has been excised and considered cured). Those with history of malignancy greater than 5 years ago should provide evidence of remission or cure. Subjects with a history of cervical cancer may be included in the study with documented evidence of conization or cure within the last 3 years.
    14.Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days, or history of repeated herpetic viral infections (defined as more than 2 episodes in the year prior to screening). Other chronic infectious history should be discussed with the Medical Monitor.
    15.History of active tuberculosis (TB). History of latent TB infection is also excluded unless there is documentation of appropriate anti TB therapy per Centers for Disease Control (CDC) guidelines or local regulations. In addition, the subject must not have any clinical signs/symptoms of active TB.
    16.History of treatment with oral or parenteral corticosteroids for the treatment of IgA nephropathy within 3 months of screening or immunosuppressants within 6 months prior to screening. Treatment with oral or parenteral corticosteroids for non-IgAN related disease may be permitted at any time prior to or during the trial (please refer to protocol section 5.3 for specific requirements).
    17.History of treatment with a molecule that targets the B-cell pathway within the last 12 months (e.g. rituximab, belimumab).
    18.Received transfusion, plasmapheresis or plasma exchange, IV immunoglobulin (IVIg), or live vaccines according to listed wash-out periods:
    ?Transfusion, IVIg, plasmapheresis or plasma exchange ? 90 days prior to screening
    ?Live vaccines ? 30 days prior to randomization
    19.Females who are nursing, pregnant, intending to become pregnant or intending to nurse during the time of the study, or who have a positive pregnancy test at baseline. All sexually-active subjects of reproductive potential are required to use a reliable method of birth control. Females and males are required to use or start using a reliable method of birth control at least 2 weeks prior to randomization, throughout the study, and for at least 3 months following completion of study therapy. A reliable method of birth control is defined as one of the following: oral or injectable contraceptives, intrauterine device, contraceptive implants, tubal ligation, hysterectomy, or a double-barrier method (diaphragm with spermicidal foam or jelly, or a condom), abstinence or vasectomy.
    20.General Exposure to an investigational drug or device within the prior 90 days or 5 half-lives, whichever is longer.
    ?Exposure to any B cell modulating therapy within the preceding 12 months.
    ?Known sensitivity to any of the products to be administered during dosing.
    ?Subject will not be available for follow-up assessment.
    ?History of congenital immunodeficiency.
    ?Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
    Los suj. NO deben cumplir ninguno de los ss criterios de excl.:
    1.Signos clínicos o histológicos de nefritis lúpica o de glomerulonefritis membranoproliferativa o de glomerulonefritis no rel. con IgA.
    2.Glomeruloesclerosis sup. al 50% o cicatrices corticales en la biopsia renal o punt. en la Clasif. de Oxford que incluya T2.
    3.Nefrop. IgA con semilunas (>o= 30%) o signos clínicos de glomerulonefritis rápidamente progresiva.
    4.Púrpura de Henoch-Schonlein que conduce a nefrop.
    5.TFGe <o=30ml/min x 1,73m2 en suj. con una biopsia que cumpla los req. especificados realizada en el año previo a la selec. o, TFGe <o= 40 ml/min x 1,73 m2 en suj. con una biopsia que cumpla los req. especificados realizada + de 1 año antes de la selec.
    6.Ácido úrico en sangre >1,5 veces el límite superior de normalidad al repetir la prueba durante la selec.
    7.Antec. o signos clínicos de cirrosis o, hepatopatía con alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) séricas > 3 veces el límite superior de normalidad al repetir la prueba.
    8.Hipertensión mal controlada (>o=150/90 mmHg).
    9.Antec. de diabetes mellitus.
    10.Resultado positivo conocido para el virus de la inmunodeficiencia humana (VIH) y/o resultado positivo en la visita de selec. para el antígeno de superficie del virus de la hepatitis B o para el virus de la hepatitis C.
    11.Antec. de enfermedad de Crohn o enfermedad celíaca.
    12.Anemia (hemoglobina <8 g/dl), neutropenia (<o=1500 células/?l) o trombocitopenia (<75.000 células/?l).
    13.Neoplasia maligna en los últimos 5 años (excepto carcinoma cutáneo escamoso o basocelular que haya sido extirpado y se considere curado). Aquellos suj. con antec. de haber tenido una neoplasia maligna hace más de 5 años deberán proporcionar pruebas de remisión o curación. Las pac. con anteced. de cáncer de cuello uterino podrán ser incluidas en el estudio siempre que proporcionen pruebas de conización o curación en los últimos 3 años.
    14.Infección activa que haya requerido hospitalización o trat. con antibióticos x vía parenteral en los 60d anteriores o, anteced. de infecciones víricas herpéticas repetidas (definidas como más de 2 episodios durante el año previo a la selec.). Otros anteced. de infecciones crónicas deberán comentarse con el monitor médico.
    15.Anteced. de tuberculosis (TB) activa. También constituyen un criterio de exclusión anteced. de infección TB latente a menos que esté documentado un trat. anti-TB adecuado conforme a las directrices de los Centros para el Control de Enfermedades de los EE.UU. (CDC) o a la normativa local. Además, el suj. no debe presentar síntomas/signos clínicos de TB activa.
    16.Anteced. de trat. con corticosteroides x vía oral o parenteral para el trat. de la nefrop. IgA en los 3 meses previos a la selec. o con inmunosupresores en los 6 meses previos a la selec. Se podrá permitir, en cualq. momento antes o durante el ensayo, el trat. con corticosteroides x vía oral o parenteral de patologías no rel. con la nefrop. IgA (véase la Sección 5.3 del protocolo en relación a los req. específicos).
    17.Anteced. de trat. con una molécula dirigida a la vía de los linfocitos B en los últimos 12 meses (p.ej rituximab, belimumab)
    18.Transfusión, plasmaféresis o recambio plasmático, inmunoglobulina i.v. (Ig i.v.) o vacunas con org. vivos de acuerdo con los periodos de lavado indicados:
    .Transfusión, Ig i.v., plasmaféresis o recambio plasmático: 90d antes de la selec.
    .Vacunas con org. vivos: 30d antes de la aleatorización
    19.Mujeres que estén dando el pecho, estén embarazadas o tengan la intención de quedarse embarazadas o de dar el pecho durante el periodo del estudio o, que tengan un resultado positivo en la prueba de embarazo en la eval. basal. Todos los suj. con capacidad de engendrar descendencia y sexualmente activos deben utilizar un método anticoncep. fiable. Las mujeres y los hombres deben utilizar o empezar a utilizar un método anticoncep. fiable al menos 2 semanas antes de la aleatorización, en el transcurso del estudio y durante al menos 3 meses después de la finalización del trat. del estudio. Un método anticoncep. fiable se define como uno de los siguientes métodos: anticoncep. orales o inyectables, dispositivo intrauterino, implantes anticoncep., ligadura de trompas, histerectomía o un método de barrera doble (diafragma con espuma o gel espermicida o preservativo), abstinencia o vasectomía.
    20.General
    .Exposición a un fármaco o dispositivo en fase de invest. en los 90d anteriores, o el tiempo equivalente a 5 semividas, el periodo que sea el más largo.
    .Exposición a algún trat. modulador de linfocitos B en los 12 meses anteriores.
    .Sensibilidad conocida a cualquiera de los productos que se vayan a administrar.
    .El suj. no estará disponible para la eval. de seguimiento.
    .Anteced. de inmunodeficiencia congénita.
    .El suj. presenta cualquier tipo de trastorno que compromete su capacidad para dar su CI x escrito y/o para cumplir los proced. del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    All efficacy analyses in this study will compare the effects of blisibimod plus ACEI/ARB therapy with placebo plus ACEI/ARB therapy. All analyses will seek to evaluate superiority of blisibimod over placebo.

    Primary Endpoint in Part A
    In Part A, the Proteinuria Efficacy Endpoint will compare the proportion of subjects with baseline proteinuria > or = 1 g/24hr achieving proteinuria ? 0.5g/24hr at 24 weeks.
    For this analysis, proteinuria will be inferred from urinary protein:creatinine ratio determined at 2 consecutive time points including Week 24.
    En el presente estudio, todos los análisis de eficacia compararán los efectos de blisibimod más el tratamiento con IECA/ARA con los del placebo más el tratamiento con IECA/ARA. Todos los análisis procurarán evaluar la superioridad de blisibimod sobre placebo.

    Criterio de valoración principal de la Parte A
    En la Parte A, el criterio de valoración de eficacia en la proteinuria comparará la proporción de sujetos con proteinuria basal >o =1g/24h que logran un valor de proteinuria <o=0,5g/24h a las 24 semanas.
    Para este análisis, la proteinuria se deducirá a partir del cociente proteína:creatinina en orina determinado en 2 evaluaciones consecutivas que incluyan la evaluación de la semana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Semana 24
    E.5.2Secondary end point(s)
    Secondary endpoints to be evaluated at the end of Part A include:
    .The proportion of subjects achieving proteinuria < or = 1g/24hr at Week 24.
    .Percent change in proteinuria from baseline to Week 24.
    .The proportion of subjects with baseline proteinuria > or = 1 g/24hr who
    achieve proteinuria < or = 0.5g/24hr at Week 36 amongst subjects who
    electively discontinue study drug therapy at Week 24.
    .Percent change in proteinuria from baseline to Week 36 amongst
    subjects who electively discontinue study drug therapy at Week 24.
    .The proportion of subjects with baseline proteinuria > or = 2g/24hr
    achieving proteinuria < or = 1g/24hr at Week 24.
    .Change in serum IgG from baseline to Week 24.
    .Change in serum IgA from baseline to Week 24.
    . Change in plasma cell counts from baseline to Week 24.
    . Change from baseline in serum immunoglobulin IgM.
    . Percent reduction from baseline in plasma cells and B-cell subsets.
    . Percent reduction from baseline in complement C3 and C4.
    . Proportion of subjects achieving proteinuria < or = 1g/24hr or a reduction in proteinuria of ?50% from baseline.
    . Proportion of subjects with baseline proteinuria > or = 3g/24hr achieving proteinuria < or = 1g/24hr.
    . Change in hematuria from baseline to Week 24.
    . Population PK evaluation of the effects of covariate factors, including demographic and health factors, on blisibimod PK parameters.
    Los criterios de valoración secundarios que se evaluarán al final de la Parte A comprenden:
    . Proporción de sujetos que logran valores de proteinuria <o=1g/24h en la semana 24.
    . Porcentaje de cambio en la proteinuria entre la evaluación basal y la semana 24.
    . Proporción de sujetos con proteinuria basal >o=1 g/24h que logran un valor de proteinuria >o=0,5g/24h en la semana 36, entre los sujetos que interrumpen de forma voluntaria el tratamiento con el fármaco del estudio en la semana 24.
    . Porcentaje de cambio en la proteinuria entre la evaluación basal y la semana 36, entre los sujetos que interrumpen de forma voluntaria el tratamiento con el fármaco del estudio en la semana 24.
    . Proporción de sujetos con proteinuria basal >o=2g/24h que logran valores de proteinuria <o=1g/24h en la semana 24.
    . Cambio en la IgG sérica entre la evaluación basal y la semana 24.
    . Cambio en la IgA sérica entre la evaluación basal y la semana 24.
    . Cambio en los recuentos de células plasmáticas entre la evaluación basal y la semana 24.
    . Cambio en la inmunoglobulina IgM sérica respecto a la evaluación basal.
    . Porcentaje de disminución de células plasmáticas y de subpoblaciones de linfocitos B respecto a la evaluación basal.
    . Porcentaje de disminución de las fracciones C3 y C4 del complemento respecto a la evaluación basal.
    . Proporción de sujetos que logran valores de proteinuria <o=1g/24h o una reducción de la proteinuria ?50%, respecto a la evaluación basal.
    . Proporción de sujetos con proteinuria basal >o=3g/24h que logran valores de proteinuria <o=1g/24h.
    . Cambio en la hematuria entre la evaluación basal y la semana 24.
    . Evaluación de FC poblacional de los efectos de factores covariables, incluidos factores demográficos y de salud, sobre los parámetros FC de blisibimod.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints to be evaluated at the end of Part A
    Los criterios de valoración secondarios serán evaluados al final de la Parte A
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Belarus
    Belgium
    Brazil
    Bulgaria
    Canada
    Czech Republic
    France
    Georgia
    Germany
    Hong Kong
    Hungary
    Italy
    Japan
    Korea, Republic of
    Lithuania
    Malaysia
    Netherlands
    Philippines
    Poland
    Portugal
    Romania
    Russian Federation
    Singapore
    Spain
    Sweden
    Taiwan
    Thailand
    Turkey
    Ukraine
    United Kingdom
    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
    Each Subject may be treated for a maximum of 104 weeks. Subjects will contuinue to be followed in their routine quarterly clinic visits until the required number of ESRD clinical events is attained over an estimated 5 year period.
    Cada sujeto puede ser tratado por un máximo de 104 semanas. Los sujetos continuarán con sus visitas clínicas de rutina trimestrales hasta que se hayan alcanzado los acontecimientos clínicos de ERT durante un perido estimado de 5 años.
    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 months0
    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 months0
    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: 190
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 100
    F.4.2.2In the whole clinical trial 200
    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 Decision2015-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-26
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