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    Summary
    EudraCT Number:2011-002159-32
    Sponsor's Protocol Code Number:211LE201
    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:2012-01-27
    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 number2011-002159-32
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BIIB023 in Subjects With Lupus Nephritis
    Estudio multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia, seguridad y tolerabilidad de BIIB023 en
    sujetos con nefritis lúpica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Anti-TWEAK in lupus nephritis study
    Estudio de anti-TWEAK en Nefritis lúpica
    A.3.2Name or abbreviated title of the trial where available
    ATLAS
    A.4.1Sponsor's protocol code number211LE201
    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 SponsorBiogen Idec Research Limited
    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 supportBiogen Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact pointATLAS Clinical Trials Team
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailimmunologyclinicaltrials@biogenidec.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 nameBIIB023
    D.3.4Pharmaceutical form Solution for injection/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.3.9.2Current sponsor codeBIIB023
    D.3.9.3Other descriptive nameAnti-TWEAK monoclonal antibody BIIB023
    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) 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.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 CellCept (mycophenolate mofetil)
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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.3.9.1CAS number 115007-34-6
    D.3.9.3Other descriptive nameMYCOPHENOLATE MOFETIL
    D.3.9.4EV Substance CodeSUB03360MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 placeboSolution 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
    Lupus Nephritis
    Nefritis lúpica
    E.1.1.1Medical condition in easily understood language
    Lupus Nephritis
    Nefritis Lúpica
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10025140
    E.1.2Term Lupus nephritis
    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
    The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of subjects with active, biopsy-proven LN.
    El objetivo principal del estudio es evaluar la eficacia de BIIB023 como tratamiento complementario del tratamiento de base frente a placebo en combinación con el tratamiento de base en el tratamiento de sujetos con NL activa demostrada por biopsia.
    E.2.2Secondary objectives of the trial
    Secondary objectives of this study are to assess the safety and tolerability of BIIB023 compared with placebo in this study population.
    Los objetivos secundarios de este estudio son evaluar la seguridad y tolerabilidad de BIIB023 comparado con placebo en esta población de estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ?Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.

    ?Aged 18 to 75 years old, inclusive, at the time of informed consent.

    ?Must have a documented diagnosis of SLE according to current ACR criteria. At least 4 ACR criteria must be documented, 1 of which must be a positive antinuclear antibody (ANA), anti-Sm, or anti-dsDNA antibody.

    ?Must have a diagnosis of ISN/RPS 2003 Class III or IV LN with either active or active/chronic disease, confirmed by biopsy within 3 months prior to Screening. Subjects are permitted to have co-existing Class V LN. The local histological diagnosis must be confirmed by the central study pathologist.

    ?Must have proteinuria at Screening (from a 24-hour urine sample collection) defined as: uPCR >1.0 in subjects with biopsy Class III or IV LN uPCR >2.0 in subjects with co-existing Class V LN

    ?Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment.
    1. Capacidad para comprender el propósito y los riesgos del estudio y proporcionar un consentimiento informado firmado y fechado y una autorización para usar información de salud protegida (protected health information, PHI) de acuerdo con las reglamentaciones nacionales y locales sobre la privacidad de los sujetos.

    2. Tener entre 18 y 75 años de edad, inclusive, en el momento del consentimiento informado.

    3. Tener un diagnóstico documentado de LES según los criterios actuales del ACR. Al menos 4 criterios del ACR deben estar documentados, 1 de los cuales debe ser anticuerpo antinuclear (ANA) positivo, anticuerpo antiSm o anticuerpo antidsADN.

    4. Debe tener un diagnóstico de NL clase III o IV de ISN/RPS 2003 con enfermedad activa o activa/crónica confirmada por biopsia en los 3 meses previos a la selección. Los sujetos pueden tener NL coexistente de clase V. El diagnóstico histológico local debe ser
    confirmado por el patólogo central del estudio.

    5. Debe tener proteinuria en la selección (de una muestra de orina de 24 horas), definida como:
    ? uPCR >1,0 en sujetos con NL clase III o IV por biopsia
    ? uPCR >2,0 en sujetos con NL clase V coexistente

    6. Las participantes con capacidad de concebir deben utilizar un método anticonceptivo efectivo durante el estudio y estar dispuestas a continuar utilizándolo durante 3 meses después de recibir la última dosis del tratamiento del estudio, y ser capaces de hacerlo.
    E.4Principal exclusion criteria
    ?Retinitis, poorly-controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE at Screening

    ?Estimated GFR <30 mL/min per 1.73 m2 (calculated using the abbreviated MDRD equation) or the presence of oliguria or ESRD requiring dialysis or transplantation

    ?Subjects requiring dialysis within 12 months prior to Screening

    ?History of renal transplant

    ?History of opportunistic infection within 3 years of Screening.

    ?Subjects with the following abnormal laboratory test result at Screening considered clinically significant (as determined by the Investigator) or: AST/SGOT or ALT/SGPT >2 x upper limit of normal established by the central laboratory; platelet count <20,000/?L; subjects with platelet count >20,000/?L and <150,000 who are experiencing, or at high risk for developing, clinically significant bleeding or organ dysfunction requiring therapy (as determined by the Investigator) should be excluded from the study; hemoglobin <8.5 g/dL; neutrophils <1.5 x 103/?L

    ?Receipt of >1.5 g IV methylprednisolone (cumulative dose) within 28 days prior to Screening

    ?Use of >30 mg/day oral prednisone or equivalent for >14 consecutive days within 4 weeks prior to Screening

    ?Treatment with any biologic B-cell-depleting therapy (e.g., anti-CD20 [rituximab], anti-CD22 [epratuzumab], anti-BLyS/BAFF [e.g., briobacept, belimumab] therapy), or TACI-Ig within 12 months prior to Run-in Day 1.
    1. Retinitis, trastorno convulsivo mal controlado, estado de confusión agudo, mielitis, accidente cerebrovascular o síndrome de accidente cerebrovascular, ataxia cerebelosa o demencia que esté activa actualmente y sea consecuencia del LES en la selección.

    2. TFG estimada <30 ml/min por 1,73 m2 (calculada utilizando la ecuación abreviada de MDER) o la presencia de oliguria o ERT que requiere diálisis o trasplante.

    3. Antecedentes de infección oportunista dentro de los 3 años de la selección. Nota: los sujetos con antecedentes de candidiasis bucal o erupción cutánea debido a varicela zóster no quedan excluidos de la participación en el estudio.

    4. Sujetos que requirieron diálisis en los 12 meses previos a la selección.

    5. Antecedentes de trasplante renal.

    6.Sujetos con los siguientes resultados anómalos en los análisis de laboratorio en la selección que se consideren clínicamente significativos (según lo determine el investigador) o:
    ? aspartato aminotransferasa/transaminasa glutámico oxalacética sérica (AST/SGOT) o alanina aminotransferasa/transaminasa glutámico pirúvica sérica (ALT/SGPT) >2 veces el límite superior de lo normal establecido por el laboratorio central
    cifra de plaquetas <20.000/?l; los sujetos con una cifra de
    ? plaquetas >20.000/?l y <150.000 que experimenten o corran un alto riesgo de presentar sangrado o disfunción orgánica clínicamente significativos que requiera tratamiento (según lo determine el investigador) deben ser excluidos del estudio
    ? hemoglobina <8,5 g/dl
    ? neutrófilos <1,5 x 103/?l

    7.Recepción de >1,5 g de metilprednisolona i.v. (dosis acumulada) en los 28 días previos a la selección.

    8.Uso de >30 mg/día de prednisona oral o su equivalente durante >14 días consecutivos en las 4 semanas previas a la selección.

    9.Cualquier tratamiento biológico para disminuir los linfocitos B (p. ej., terapia antiCD20 [rituximab], antiCD22 [epratuzumab], antiBLyS/BAFF [p. ej., briobacept, belimumab]) o TACIIg en los 12 meses previos al día 1 de preinclusión. Los sujetos tratados con un fármaco que disminuye los linfocitos B >12 meses antes del día 1 de preinclusión quedan excluidos de la participación en el estudio si el total de linfocitos B CD19 es <25 células/?l.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects who achieve a renal response (complete or partial renal response) at Week 52.
    Proporción de sujetos que alcanzan una respuesta renal (completa o parcial) en la semana 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    Semana 52
    E.5.2Secondary end point(s)
    1. Proportion of subjects who achieve complete renal response at Week 52.

    2. Duration of response in subjects who achieve complete renal response at Week 52.

    3. Proportion of subjects with uPCR >3.0 at Day 1 (Baseline) who achieve uPCR <1.0 at Week 52.

    4. Time to partial or complete renal response in subjects who achieve renal response at Week 52.

    5. Proportion of subjects with active urinary sediment at Day 1 (Baseline) who have inactive urinary sediment at Week 52.

    Active urinary sediment is defined by 1 of the following (in the absence of a urinary tract infection or menses):
    ->5 red blood cell/high power field (RBC/HPF) or above the reference range for the laboratory, and >5 white blood cell/high power field (WBC/HPF) or above the reference range for the laboratory
    -Presence of cellular casts (RBC or WBC)

    Inactive urinary sediment defined as:
    -<5 RBC/HPF and <5 WBC/HPF, or within the laboratory reference range, and
    -no cellular casts (no RBC or WBC casts).

    6. Incidence of AEs, SAEs, and AEs leading to study discontinuation.

    7. Duration of renal response.
    1. Proporción de sujetos que logran una respuesta renal
    completa en la semana 52.

    2.Duración de la respuesta en los sujetos que logran una
    respuesta renal completa en la semana 52.

    3.Proporción de sujetos con uPCR >3,0 el día 1 (inicio) que llegan a uPCR <1,0 en la semana 52.

    4.Tiempo hasta la respuesta renal parcial o completa en sujetos que logran una respuesta renal en la semana 52.

    5. Proporción de sujetos con sedimento urinario activo el primer día (inicio) que llegan a sedimento urinario inactivo en la semana 52.

    El sedimento urinario activo se define por una de las siguientes situaciones (en ausencia de infección de las vías urinarias o de período menstrual):
    ? >5 glóbulos rojos por campo de alta resolución (RBC/HPF) o por encima de los valores de referencia para el laboratorio, y >5 glóbulos blancos por campo de alta resolución (WBC/HPF) o por encima de los valores de referencia para el laboratorio.
    ? Presencia de cilindros celulares (RBC o WBC)

    El sedimento urinario inactivo se define como:
    ? <5 RBC/HPF y <5 WBC/HPF o dentro de los valores de referencia del laboratorio y
    ? ausencia de cilindros celulares (sin cilindros deRBC o WBC)

    6. Incidencia de acontecimientos adversos (AA), acontecimientos adversos graves (AAG) y AA que provocan la interrupción de la participación en el estudio.

    7. Duración de la respuesta renal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 52 or throughout the duration of the study
    En la semana 52 o durante la duración del estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy 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) 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    China
    Colombia
    Czech Republic
    France
    Germany
    Hong Kong
    Hungary
    Israel
    Korea, Republic of
    Malaysia
    Mexico
    Peru
    Philippines
    Poland
    Portugal
    Russian Federation
    South Africa
    Spain
    Thailand
    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
    Last subject, last visit
    Último paciente, última visita
    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 months11
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    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: 285
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 92
    F.4.2.2In the whole clinical trial 300
    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)
    Subjects who complete this study through Week 52 will be offered the option to enter an Open Label Extension (OLE) study under a separate protocol.
    A los sujetos que completen el estudio hasta la semana 52 se les ofrecerá la opción de participar en un estudio de Extensión en abierto con un protocolo por separado.
    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 Decision2012-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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