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    Summary
    EudraCT Number:2011-004569-33
    Sponsor's Protocol Code Number:HGS1006-C1100
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-01-14
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio di fase 3, multicentrico, multinazionale, randomizzato, in doppio cieco, condotto per valutare l'efficacia e la sicurezza di belimumab (HGS1006) in combinazione con azatioprina per il mantenimento della remissione nella granulomatosi di Wegener e nella poliangioite microscopica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Belimumab in Remission of Vasculitis
    Belimumab nella Remissione della Vasculite
    A.3.2Name or abbreviated title of the trial where available
    BREVAS
    BREVAS
    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
    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 number0044 208 990 4466
    B.5.5Fax number0044 208 990 4466
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 400mg polvere per concentrato per soluzione per infusione
    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 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 Powder 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.3.9.4EV 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 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) Vasculitis
    granulomatosi di Wegener (WG) poliangioite microscopica (MPA) Vasculite
    E.1.1.1Medical condition in easily understood language
    Wegener's granulomatosis (WG) Microscopic polyangiitis (MPA) Vasculitis
    Granulomatosi di Wegener (WG) Poliangioite microscopica (MPA) Vasculite
    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 15.1
    E.1.2Level LLT
    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 15.1
    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.
    Valutare l'efficacia di belimumab nel mantenimento della remissione in seguito a un regime di induzione standard in soggetti affetti da granulomatosi di Wegener (Wegener’s granulomatosis, WG) o poliangioite microscopica (microscopic polyangiitis, MPA). Valutare la sicurezza di belimumab in soggetti affetti da WG o MPA.
    E.2.2Secondary objectives of the trial
    Non applicabile
    Non Applicabile
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENETIC:
    Vers:
    Date:2012/06/22
    Title:Pharmacogenetic Research
    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.
    FARMACOGENETICA:
    Vers:
    Data:2012/06/22
    Titolo:Ricerca Farmacogenetica
    Obiettivi:- relazione tra le varianti genetiche e la farmacocinetica di belimumab -- relazione tra le varianti genetiche e la sicurezza e/o tollerabilità dei belimumab - relazione tra le varinati genetiche e l'efficacia di 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.
    - Diagnosi di granulomatosi di Wegener (WG) o una diagnosi di poliangioite microscopica (MPA) secondo i criteri diagnostici della Chapel Hill. - Riacutizzazione della patologia nelle 26 settimane precedenti la randomizziazione che abbia richiesto un trattamento con corticosteroidi a dosi elevate ed uno dei seguenti regimi: rituximamb, ciclofosfamide orale o per via endovenosa. -Evidenza documentata di anti-proteinasi 3 (anti-PR3) o anti-mieloperossidasi (anti-MPO) prima dell'arruolamento. - Raggiungimento della remissione non oltre le 26 settimane successive alla prima dose del trattamento d'induzione. La remissione è definita con un punteggio sulla scala di valutazione dell'attività della vasculite di Birmingham (Birmingham Vasculitis Activity Score, BVAS) pari a 0 e attuale assunzione di &lt; 10 mg/die di prednisone (o equivalente) per via orale in occasione di 2 misurazioni consecutive a distanza di 21-35 giorni l'una dall'altra. - La terapia di mantenimento deve iniziare non oltre 2 settimane dopo la conferma della remissione.
    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.
    -Gravidanza o allattamento -Precedente trattamento a base di una terapia mirata alle cellule B (diversa da rituximab) -Precedente trattamento a base di un agente biologico sperimentale nei 60 giorni che precedono la randomizzazione; Attuale abuso o dipendenza da droghe o alcool; Precedente o attuale positività al test per HIV, epatite B o epatite C; - Storie di reazione allergica severa ad agenti di contrasto o biologici.
    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.
    L'endpoint di efficacia primario è rappresentato dal tempo intercorso tra il Giorno 0 e il primo episodio di recidiva, definito come segue: • almeno 1 voce BVAS significativa; OPPURE • un punteggio totale minimo BVAS di 6; OPPURE • prescrizione di farmaci non consentiti.
    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.
    L'analisi primaria di efficacia sarà condotta dopo che almeno 66 soggetti abbiano subito un episodio di recidiva e siano trascorsi almeno 12 mesi dalla randomizzazione dell'ultimo soggetto.
    E.5.2Secondary end point(s)
    Time from Day 0 to the first major relapse (defined as experiencing at least 1 major BVAS item)
    Tempo intercorso tra il Giorno 0 e il primo episodio di recidiva significativo (definito come il verificarsi di almeno 1 voce BVAS significativa)
    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
    L'analisi secondaria di efficacia sarà condotta dopo che almeno 66 soggetti abbiano subito un episodio di recidiva e siano trascorsi almeno 12 mesi dalla randomizzazione dell'ultimo soggetto
    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 concerned6
    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
    European Union
    Australia
    Canada
    India
    Mexico
    Peru
    Russian Federation
    Switzerland
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months45
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months45
    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.1.1Number of subjects for this age range: 0
    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 state50
    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.
    Ai soggetti che completano il periodo in doppio cieco dello studio e che non hanno manifestato episodi di recidiva, sarà offerta la possibilità di ricevere il trattamento a base di belimumab nella fase di estensione per sei mesi.
    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 Decision2013-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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