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    EudraCT Number:2011-004569-33
    Sponsor's Protocol Code Number:HGS1006-C1100
    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:2012-11-26
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2011-004569-33
    A.3Full title of the trial
    A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener's Granulomatosis and Microscopic Polyangiitis.
    Estudio en fase 3, multicéntrico, multinacional, aleatorizado y doble ciego para evaluar la eficacia y la seguridad de belimumab (HGS1006) en combinación con azatioprina para el mantenimiento de la remisión en la granulomatosis de Wegener y la poliangeitis microscópica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Belimumab in Remission of Vasculitis
    Belimumab en la remisión de vasculitis.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberHGS1006-C1100
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01663623
    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. (a wholly owned subsidiary of GlaxoSmithKline PLC)
    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 organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 - 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number44208990 4466
    B.5.5Fax number44208990 4466
    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. name Benlysta 400 mg powder for concentrate for solution for infusion
    D. 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Wegener's granulomatosis (WG)
    Microscopic polyangiitis (MPA)
    Granulomatosis de Wegener (GW)
    poliangeítis microscópica (PAM)
    E.1.1.1Medical condition in easily understood language
    Wegener's granulomatosis (WG)
    Microscopic polyangiitis (MPA)
    Granulomatosis de Wegener (GW)
    poliangeítis microscópica (PAM)
    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 10047888
    E.1.2Term Wegener's granulomatosis
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10063344
    E.1.2Term Microscopic polyangiitis
    E.1.2System Organ Class 10047065 - Vascular 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 evaluate the efficacy of belimumab in the maintenance of remission following a standard induction regimen in subjects with Wegener's granulomatosis (WG) or microscopic polyangiitis (MPA).
    -To evaluate the safety of belimumab in subjects with WG or MPA.
    -Evaluar la eficacia de belimumab en el mantenimiento de la remisión luego de un régimen de inducción estándar en sujetos con granulomatosis de Wegener (GW) o poliangeítis microscópica (PAM).

    -Evaluar la seguridad de belimumab en sujetos con GW o PAM.
    E.2.2Secondary objectives of the trial
    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: 22 June 2012
    -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: 22 Junio 2012
    -Relación entre las variantes genéticas y la farmacocinética de belimumab.
    -Relación entre las variantes genéticas y la seguridad y/o tolerabilidad de belimumab.
    -Relación entre las variantes genéticas y la eficacia de belimumab.
    E.3Principal inclusion criteria
    -Clinical diagnosis Wegener's granulomatosis or microscopic polyangiitis by Chapel Hill criteria.
    -Disease flare in the past 26 weeks requiring treatment with high dose corticosteroids and 1 of the following medications: rituximab, oral cyclophosphamide OR IV cyclophosphamide.
    -Tested positive for anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase (anti-MPO) antibodies at any time prior to enrollment.
    -Achieve remission no more than 26 weeks after first dose of induction treatment. Remission is defined as a Birmingham Vasculitis Activity (BVAS) score of 0 and receiving less than 10 mg/day of oral prednisone (or equivalent) on 2 consecutive visits 21 to 35 days apart.
    -Maintenance therapy on this study must start no more than 2 weeks after confirmation of remission.
    - Presentar un diagnóstico clínico de granulomatosis de Wegener (GW) o un diagnóstico de poliangeítis microscópica (PAM) según los criterios de Chapel Hill
    -Haber presentado en las 26 semanas previas a la randomización (Día 0) un episodio de GW o PAM moderada a severamente activa que requirió tratamiento con alguno de los siguientes regímenes de inducción: Un curso único de rituximab, Ciclofosfamida oral o IV
    - Presentar un Puntaje de Actividad de la Vasculitis de Birmingham (BVAS) de 0 y estar recibiendo <10 mg/día de prednisona oral (o equivalente) en 2 mediciones consecutivas con 21 a 35 días de diferencia, dentro de las 26 semanas luego de la primera dosis del tratamiento de inducción.
    - Presentar evidencia documentada de anti-proteinasa 3 (anti-PR3) o anti-mieloperoxidasa (anti-MPO) antes del Día 0.
    - Alcanzar remisión no antes de la semana 26 antes de la primera dosis del tratamiento de inducción. La remisión se define como presentar un Puntaje de Actividad de la Vasculitis de Birmingham (BVAS) de 0 y estar recibiendo <10 mg/día de prednisona oral (o equivalente) en 2 mediciones consecutivas con 21 a 35 días de diferencia.
    - La terapia de mantenimiento de este estudio debe empezar no más de dos semanas después de la confirmación de la remisión.
    E.4Principal exclusion criteria
    -Pregnant or nursing.
    -Receipt of a B cell targeted therapy (other than rituximab) at anytime
    -Receipt of an investigational biological agent within the 60 days.
    -Required management of acute or chronic infections within the past 60 days.
    -Current drug or alcohol abuse or dependence.
    -Current or past positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
    -History of severe allergic reaction to contrast agents or biological medicines.
    - Embarazo o lactancia
    - Haber recibido tratamiento dirigido a las células B (diferente del rituximab) en cualquier momento
    - Haber recibido un agente en investigación biológico o no biológico dentro de los 60 días
    - Haber requerido un manejo de infecciones agudas o crónicas en los últimos 60 days.
    - Abuso o dependencia actual de alcohol o drogas.
    - Presentar una prueba históricamente positiva o una prueba positiva en la selección para el antígeno de superficie de la hepatitis B, o anticuerpos de la hepatitis C o ser VIH-1 positivo confirmado
    - Presentar antecedentes de una reacción anafiláctica a la administración parenteral de sustancias de contraste, proteínas humanas o murinas o anticuerpos monoclonales.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is time from Day 0 to the first relapse, defined as:
    -At least 1 major BVAS item OR
    -A minimum total BVAS score of 6 OR
    -Receipt of protocol prohibited medications.
    El objetivo primario de eficacia se considera desde el día 0 hasta la recaída, definida como.
    -Por lo menos 1 ítem mayor del BVAS (Apéndice 4), O BIEN
    -Un puntaje total mínimo del BVAS de 6 (Apéndice 4), O BIEN
    -Uso de medicamentos prohibidos (que se definen en la Sección 5.5.1).
    E.5.1.1Timepoint(s) of evaluation of this end point
    - At least 66 subjects have experienced a relapse and at least 12 months have elapsed after the last subject is randomised
    El análisis primario se realizará luego de que al menos 66 sujetos hayan presentado una recidiva y hayan transcurrido por lo menos 12 meses después de que el último sujeto haya sido aleatorizado.
    E.5.2Secondary end point(s)
    Time from Day 0 to the first major relapse (defined as experiencing at least 1 major BVAS item)
    Tiempo transcurrido desde el Día 0 hasta la primera recidiva mayor (definida como al menos un ítem mayor del BVAS que presenta el sujeto).
    E.5.2.1Timepoint(s) of evaluation of this end point
    - At least 66 subjects have experienced a relapse and at least 12 months have elapsed after the last subject is randomised
    Al menos 66 sujetos hayan presentado una recidiva y hayan transcurrido por lo menos 12 meses después de que el último sujeto haya sido aleatorizado
    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. 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 EEA70
    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
    Czech Republic
    Russian Federation
    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
    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 months9
    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 months9
    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: 320
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 400
    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 of the trial and who have not relapsed will be given the option to receive treatment with belimumab in the open-label extension phase for up to 6 months.
    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 Decision2013-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-06
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