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    Summary
    EudraCT Number:2015-002022-39
    Sponsor's Protocol Code Number:WA29748
    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:2015-09-11
    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 number2015-002022-39
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety and efficacy of Obinutuzumab in patients with ISN/RPS 2003 class III or IV Lupus Nephritis
    ESTUDIO MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE OBINUTUZUMAB EN PACIENTES CON NEFRITIS LÚPICA DE CLASE III O IV DE LA ISN/RPS DE 2003
    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 Obinutuzumab, an antibody targeting certain types of immune cells, in Patients with Lupus Nephritis
    Estudio para evaluar la seguridad y eficacia de obinituzumab, un anticuerpo dirigido a determinado tipo de células inmunes, en pacientes son nefritis lúpica.
    A.4.1Sponsor's protocol code numberWA29748
    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 SponsorRoche Farma, S.A., que representa en España a F. Hoffmann-La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 Gazyvaro
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited, UK
    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 nameObinutuzumab
    D.3.2Product code RO5072759/F06-01
    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 INNObinutuzumab
    D.3.9.1CAS number 949142-50-1
    D.3.9.2Current sponsor codeRO5072759/F06
    D.3.9.3Other descriptive nameOBINUTUZUMAB/GA101
    D.3.9.4EV Substance CodeSUB32751
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 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 is an inflammation of the kidney caused by systemic lupus erythematosus (SLE), a disease of the immune system
    Nefritis lúpica es una inflamación del riñón causada por lupus eritematoso sistemico (LES), una enfermedad del sistema inmunitario
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    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 obinutuzumab compared with placebo in patients with International Society of Nephrology (ISN)/Renal Pathology Society (RPS) Class III or IV Lupus Nephritis (LN) as measured by complete renal response (CRR) at 52 weeks
    - Evaluar la eficacia de obinutuzumab comparado con placebo en pacientes con nefritis lúpica (NL) de clase III o IV de la International Society of Nephrology (ISN)/Renal Pathology Society (RPS) medida por la respuesta renal completa (RRC) a las 52 semanas
    E.2.2Secondary objectives of the trial
    ? To assess the ability of obinutuzumab to induce overall renal response and to improve time-to-response over the course of 52 weeks
    ? To evaluate the safety of obinutuzumab compared with placebo in patients with Class III or IV LN
    ? To characterize the immunogenic potential of obinutuzumab by measuring human anti-drug antibodies and assessing their relationship with other outcome measures
    ? To fully characterize adverse events of special interest, including infusion reactions, infections, thrombocytopenia, and neutropenia
    ? To compare changes in CD19+ B cells in the peripheral blood following treatment with obinutuzumab versus placebo
    ? To characterize the pharmacokinetics of obinutuzumab in the LN population and assess potential PK interactions between obinutuzumab and concomitant medications
    ? To assess the change from baseline of the patient?s general health over the course of the study by use of the Patient?s Global Assessment
    -Evaluar la capacidad de obinutuzumab de inducir respuesta renal global y de mejorar el tiempo hasta la respuesta a lo largo de 52 semanas. -Evaluar la seguridad de obinutuzumab comparado con placebo en pacientes con NL de clase III o IV. -Caracterizar la capacidad inmunógena de obinutuzumab midiendo anticuerpos antifármaco humanos y examinando su relación con otros criterios de valoración. -Caracterizar por completo los AA de interés especial, como las reacciones a la infusión, las infecciones, la trombocitopenia y la neutropenia. -Comparar las variaciones de los linfocitos B CD19+ en la sangre periférica después del tratamiento con obinutuzumab en comparación con placebo. -Caracterizar la FC de obinutuzumab en la población con NL y evaluar las posibles interacciones FC entre obinutuzumab y fármacos concomitantes.
    - Evaluar la variación de la salud general del paciente durante el estudio con respecto al momento basal empleando la Evaluación global por el paciente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Age 18?75 years
    ? Diagnosis of SLE, according to current American College of Rheumatology criteria
    ? Diagnosis of ISN/RPS 2003 Class III or IV LN as evidenced by renal biopsy performed within 6 months prior to screening. Patients may co-exhibit Class V disease in addition to either Class III or Class IV disease.
    ? Patients must demonstrate active urinary sediment as evidenced by >=10 red blood cells/high power field or the presence of red cell casts.
    ? Proteinuria (urine protein to creatinine ratio) >1.0
    ? For women who are not postmenopausal (>=12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of <1% per year, during the treatment period and for at least 18 months after the last dose of study drug
    ? For men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the treatment period and for at least 12 months after the last dose of study drug and agreement to refrain from donating sperm during this same period
    - 18-75 años de edad
    - Diagnóstico de lupus eritematoso sistémico (LES), según los criterios vigentes del ACR
    - Diagnóstico de NL de clase III o IV de la ISN/RPS 2003 demostrado por la biopsia renal realizada en los 6 meses previos a la selección. Los pacientes pueden presentar también enfermedad de clase V además de la enfermedad de clase III o clase IV.
    - Los pacientes deben presentar un sedimento urinario activo, demostrado por la existencia de >= 10 eritrocitos/CGA o cilindros de eritrocitos.
    - Proteinuria (cociente proteínas/creatinina en orina) > 1,0
    - Las mujeres que no sean posmenopáusicas ( >=12 meses de amenorrea no inducida por fármacos) ni quirúrgicamente estériles (ausencia de los ovarios o el útero): deberán comprometerse a no mantener relaciones sexuales o a usar dos métodos anticonceptivos adecuados, incluyendo al menos uno con una tasa de fallos anual < 1% al año, durante el período de tratamiento y durante al menos 18 meses después de la última dosis del fármaco del estudio.
    -Los varones deben comprometerse a no mantener relaciones sexuales o a utilizar un preservativo y otro método anticonceptivo que en conjunto tengan una tasa de fallos< 1% al año durante el periodo de tratamiento y durante al menos 12 meses después de la última dosis del fármaco del estudio, y deben comprometerse también a no donar semen durante ese mismo periodo.
    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
    ? Presence of rapidly progressive glomerulonephritis
    ? Severe renal impairment as defined by estimated GFR <30 milliliter per minute or the need for dialysis or renal transplant
    ? Greater than 50% of glomeruli with sclerosis on renal biopsy
    ? Treatment with cyclophosphamide or calcineurin inhibitors within the 3 months prior to randomization
    ? Unstable disease with thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions
    ? History of severe allergic or anaphylactic reactions to monoclonal antibodies or known hypersensitivity to any component of the obinutuzumab infusion
    ? Significant or uncontrolled medical disease in any organ system not related to SLE or LN, which, in the investigator?s opinion, would preclude patient participation
    ? Concomitant chronic conditions, excluding SLE, (e.g., asthma, Crohn?s disease) that required oral or systemic steroid use in the 52 weeks prior to screening
    ? History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ (except basal cell carcinomas of the skin that have been treated or excised and have resolved)
    - Retinitis, trastorno convulsivo mal controlado, estado de confusión agudo, mielitis, ictus o síndrome ictal, ataxia cerebelosa o demencia activa en la actualidad y secundaria al LES.
    - Presencia de glomerulonefritis rápidamente progresiva.
    - Insuficiencia renal grave, definida como una FG estimada < 30 ml/min o la necesidad de diálisis o trasplante renal.
    - Presencia de esclerosis en más del 50% de los glomérulos en la biopsia renal
    - Tratamiento con ciclofosfamida o inhibidores de la calcineurina en los 3 meses previos a la aleatorización.
    - Enfermedad inestable con trombocitopenia o con alto riesgo de sufrir una hemorragia o una disfunción orgánica clínicamente importantes que precisen tratamientos como plasmaféresis o transfusiones inmediatas de sangre o plaquetas.
    - Antecedentes de reacciones alérgicas o anafilácticas graves a anticuerpos monoclonales o hipersensibilidad conocida a cualquier componente de la infusión de obinutuzumab.
    - Enfermedad física significativa o no controlada en algún órgano o sistema no relacionada con LES o NL que, en opinión del investigador, impida la participación del paciente
    -Enfermedades crónicas concomitantes, excluido el LES (p. ej., asma, enfermedad de Crohn), que requieran el uso de esteroides orales o sistémicos en las 52 semanas previas a la selección.
    - Antecedente de cáncer, incluidos tumores sólidos, neoplasias malignas hematológicas y carcinoma in situ (excepto carcinomas basocelulares de la piel tratados o extirpados y que se hayan resuelto).
    E.5 End points
    E.5.1Primary end point(s)
    1. Number of patients who achieve complete renal response (CRR) at Week 52
    1. Número de pacientes que consigan una RRC en Semana 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Week 52
    1. Semana 52
    E.5.2Secondary end point(s)
    1. Number of patients who achieve overall response at Week 52
    2. Number of patients who achieve partial renal response (PRR) at Week 52
    3. Time to first overall response over the course of 52 weeks
    4. Number of patients who achieve CRR at Week 24
    5. Percent change from baseline in biomarkers of LN disease activity
    6. Time to CRR over the course of 52 weeks
    7. Number of patients who achieve a modified CRR (mCRR1) at Week 52
    8. Number of patients who achieve a second mCRR (mCRR2) at Week 52
    9. Change in Patient's Global Assessment from baseline to Week 52
    1. Número de pacientes que consigan una respuesta global en la semana 52.
    2. Número de pacientes que logren una respuesta renal parcial (RRP) en semana 52.
    3. Tiempo transcurrido hasta la RRC a lo largo de 52 semanas.
    4. Número de pacientes que logren una RRC en la semana 24.
    5. Cambio en porcentage con respecto al momento basal de biomarcadores de la actividad de la NL.
    6. Tiempo transcurrido hasta la RRC a lo largo de 52 semanas.
    7. Número de pacientes que logren una RRC modificada (RRCm1) en la semana 52.
    8. Número de pacientes que logren una segunda RRCm (RRCm2) en la semana 52.
    9. Cambios en la Evaluación Global de la actividad de la enfermedad por el paciente desde basal a semana 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 52
    2. Week 52
    3. Baseline (Day 1) to Week 52
    4. Week 24
    5. At screening (Day -28 to -1), Week 1 (before infusion), Week 2, Week 4, Week 12, Week 24 (before infusion), Week 36, Week 52, Week 76, and Week 104
    6. Baseline (Day 1) to Week 52
    7. Week 52
    8. Week 52
    9. Baseline (Day 1), Week 4, Week 12, Week 24, Week 36, Week 52
    1. Semana 52
    2. Semana 52
    3. Basal (Día 1) a Semana 52.
    4. Semana 24.
    5. En selección (Día -28 a -2), Semana 1 (antes de infusión), Semana 2, Semana 4, Semana 12, Semana 24 (antes de infusión), Semana 36, Semana 52, Semana 76 y Semana 104.
    6. Basal (día 1) a Semana 52.
    7. Semana 52
    8. Semana 52
    9. Basal (Día 1), Semana 4, Semana 12, Semana 24, Semana 36, Semana 52.
    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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Brazil
    Colombia
    France
    Germany
    Israel
    Italy
    Mexico
    Spain
    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
    The end of this study is defined as LPLV at Week 104. This has been selected to enable 76 weeks of safety follow-up for obinutuzumab to assess the occurrence of AEs and to enable an assessment of peripheral blood CD19+ B cell return. Additional B-cell follow-up (BCFU) visits will occur in relevent patients until they have achieved their baseline CD19 level or LLN of CD19+ B cells for this lupus population, whichever occurs first.
    El final del estudio se define como la UVUP en la semana 104. Se ha determinado así para hacer un seguimiento de la seguridad de obinutuzumab durante 76 semanas a fin de evaluar la incidencia de AA y la recuperación de linfocitos B CD19 en sangre periférica. Se realizarán más visitas de seguimiento de los linfocitos B hasta que los pacientes alcancen su concentración basal de CD19 o el límite inferior de la normalidad de los linfocitos B CD19 en esta población con lupus, lo que ocurra primero.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    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: 108
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 69
    F.4.2.2In the whole clinical trial 120
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The Sponsor will offer post-study access to the study drug, obinutuzumab, free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product.

    Please see section 4.3.5 of the protocol for more details.
    El promotor ofrecerá acceso gratuito al fármaco del estudio (obinutuzumab) después del estudio a los pacientes que reúnan los requisitos de conformidad con la política internacional de Roche sobre el acceso continuo a productos en investigación.

    Por favor, ver sección 4.3.5 del protocolo para más detalle.
    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 Decision2015-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-10
    P. End of Trial
    P.End of Trial StatusOngoing
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