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    Summary
    EudraCT Number:2011-004570-28
    Sponsor's Protocol Code Number:HGS1006-C1121
    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:2012-10-01
    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 number2011-004570-28
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Belimumab plus Standard of Care versus Placebo plus Standard of Care in Adult Subjects with Active Lupus Nephritis
    Estudio en fase 3, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de belimumab más el tratamiento de referencia en comparación con placebo más el tratamiento de referencia en sujetos adultos con nefritis lúpica activa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis
    Eficacia y seguridad del Belimumab en pacientes con nefritis lúpica activa.
    A.3.2Name or abbreviated title of the trial where available
    BLISS-LN
    A.4.1Sponsor's protocol code numberHGS1006-C1121
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01639339
    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 SponsorHuman Genome Sciences, 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 supportHuman Genome Sciences, Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportGlaxoSmithKline Research & Development Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHuman Genome Sciences, Inc.
    B.5.2Functional name of contact pointClinical Trials Information Center
    B.5.3 Address:
    B.5.3.1Street Address14200 Shady Grove Road
    B.5.3.2Town/ cityRockville, Maryland
    B.5.3.3Post code20850
    B.5.3.4CountryUnited States
    B.5.4Telephone number12403144430
    B.5.6E-mailclinicaltrialsinfo@hgsi.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 Benlysta 400 mg powder for concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom
    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 nameBelimumab
    D.3.4Pharmaceutical form Powder for 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 INNBelimumab
    D.3.9.1CAS number 356547-88-1
    D.3.9.3Other descriptive nameBenlysta
    D.3.9.4EV Substance CodeSUB25607
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 placeboPowder for concentrate 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
    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 15.0
    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 purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.
    El objetivo de este estudio es evaluar la eficacia, seguridad y tolerabilidad de belimumab en pacientes adultos con nefritis lúpica activa
    E.2.2Secondary objectives of the trial
    not applicable
    No aplicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Pharmacogenetic Research
    Date: 08 March 2012
    Objectives:
    -Relationship between genetic variants and the pharmacokinetics of belimumab.
    - Relationship between genetic variants and safety and/or tolerability of belimumab.
    - Relationship between genetic variants and efficacy of belimumab.
    Título: Estudio farmacogenético
    Fecha 8 de marzo de 2012
    Objetivos:
    - Relación entre las diferentes variantes genéticas y la farmacocinética del belimumab
    - Relación entre las diferentes variantes genéticas y la seguridad y/o tolarabilidad del belimumab
    - Relación entre las diferentes variantes genéticas y la eficacia del belimumab.
    E.3Principal inclusion criteria
    -Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
    -Biopsy confirmed active lupus nephritis.
    -Autoantibody-positive.
    - Tener un diagnóstico clínico de lupus eritematoso sistémico (LES) con arreglo a los criterios del American College of Rheumatology (ACR)
    - Presentar una nefritis lúpica proliferativa, confirmada mediante biopsia
    - Tener unos resultados inequívocamente positivos en los análisis de anticuerpos antinucleares
    E.4Principal exclusion criteria
    -Pregnant or nursing.
    -On dialysis within the past year.
    -Prior treatment with belimumab.
    -Receipt of any induction therapy within the past 6 months.
    -Receipt of any B cell targeted therapy (for example, rituximab), investigational biological agent within the past year.
    -Severe active central nervous system (CNS) lupus.
    -Required management of acute or chronic infections within the past 60 days.
    -Current drug or alcohol abuse or dependence.
    -Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
    -History of severe allergic reaction to contrast agents or biological medicines.
    - Mujer embarazada o en período de lactancia
    - En diálisis durante el pasado año
    - Haber recibido un tratamiento previo con belimumab
    - Haber recibido una terapia de inducción durante los últimos 6 meses
    - Haber recibido una terapia dirigido contra células B (por ejemplo, rituximab) durante el último año.
    - Presentar un lupus activo grave con afectación del sistema nervioso central (SNC)
    - Haber requerido tratamiento por infecciones agudas o crónicas en los últimos 60 días
    - Presencia o antecedentes de abuso o dependencia de drogas o alcohol
    - Tener una prueba positiva en el pasado o en la selección para anticuerpos contra el VIH, antígeno de superficie del virus de la hepatitis B o anticuerpos contra el virus de la hepatitis C.
    - Tener antecedentes de una reacción anafiláctica a la administración parenteral de medios de contraste, proteínas humanas o murinas o anticuerpos monoclonales.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Outcome Measure:
    -Number of participants with a renal response at Week 104
    Criterio de valoración primario:
    - Número de sujetos con respuesta renal a la semana 104
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to point E.5.1
    Por favor, referirse al punto E.5.1
    E.5.2Secondary end point(s)
    Secondary Outcome Measures:
    - Number of participants with a complete renal response at Week 104
    - Number of participants with a renal response at Week 52
    - Number of participants who experienced adverse events up to 136 weeks
    Criterios de valoración secundarios:
    - Número de sujetos con respuesta renal completa a la semana 104
    -Número de sujetos con respuesta renal a la semana 52
    -Número de sujetos que experimentaron acontecimientos adversos en las 136 semanas
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to point E.5.2
    Por favor, referirse al punto E.5.2
    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 Yes
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Belgium
    Brazil
    Canada
    Colombia
    France
    Germany
    Hungary
    India
    Korea, Republic of
    Mexico
    Philippines
    Russian Federation
    Spain
    Taiwan
    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 patient last visit
    Última visita, último 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 months1
    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 months1
    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: 455
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 86
    F.4.2.2In the whole clinical trial 464
    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 the double-blind period through Week 104 will be given the option to receive belimumab in the 6-month open-label extension
    A los sujetos que completen el periodo de doble ciego hasta la semana 104 se les dará la opcíón de recibir belimumab en el periodo de extensión de 6 meses en abierto.
    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 Decision2012-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-15
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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