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    Summary
    EudraCT Number:2010-022101-18
    Sponsor's Protocol Code Number:H9B-MC-BCDX
    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:2012-09-03
    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 number2010-022101-18
    A.3Full title of the trial
    A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X)
    Studio di fase 3b, multicentrico, in aperto per la valutazione della sicurezza e dell'efficacia a lungo termine di LY2127399 sottocute in pazienti con lupus eritematoso sistemico (LES) (ILLUMINATE-X)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Non disponibile
    Non disponibile
    A.3.2Name or abbreviated title of the trial where available
    ILLUMINATE-X
    ILLUMINATE-X
    A.4.1Sponsor's protocol code numberH9B-MC-BCDX
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01488708
    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 SponsorELI LILLY AND COMPANY
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address---
    B.5.3.2Town/ city---
    B.5.3.3Post code---
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number---
    B.5.5Fax number---
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 nameLY2127399
    D.3.2Product code LY2127399
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeLY2127399
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 Yes
    D.3.11.13.1Other medicinal product typeanticorpo monoclonale
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systemic Lupus Erythematosus (SLE)
    Lupus eritematoso sistemico (LES)
    E.1.1.1Medical condition in easily understood language
    Systemic Lupus Erythematosus (SLE)
    Lupus eritematoso sistemico (LES)
    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 LLT
    E.1.2Classification code 10025139
    E.1.2Term Lupus erythematosus systemic
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue 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 this study is to evaluate the safety and tolerability of LY2127399 (120 mg every 4 weeks [Q4W] + SoC or 120 mg every 2 weeks [Q2W] + SoC) in patients with SLE who have completed 52 weeks of treatment in either Study BCDS or Study BCDT. Safety and tolerability assessments for Study BCDX include the following: - Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) - Laboratory evaluations (including chemistry, immunoglobulins, hematology, B cell counts, and urinalysis) - Immunogenicity (anti-LY2127399 antibodies)
    L’obiettivo primario di questo studio e' valutare la sicurezza e la tollerabilita' di LY2127399 (120 mg ogni 4 settimane [Q4W] + SoC o 120 mg ogni 2 settimane [Q2W] + SoC) in pazienti con LES che hanno completato 52 settimane di trattamento in uno dei due studi BCDS o BCDT. Le valutazioni di sicurezza e tollerabilita' per lo studio BCDX comprendono i seguenti accertamenti:  eventi avversi insorti durante il trattamento (TEAE), eventi avversi di particolare interesse (AESI) ed eventi avversi seri (SAE);  parametri di laboratorio (inclusi i parametri ematochimici ed ematologici, i livelli di immunoglobuline, le conte delle cellule B e le analisi delle urine);  immunogenicita' (anticorpi anti-LY2127399).
    E.2.2Secondary objectives of the trial
    The following secondary objectives of this study will examine the effect over time during long-term administration of LY2127399 on the following outcomes:- Proportion of patients who achieve a response over time as defined by the SLE responder index-5 (SRI-5). - Proportion of patients who achieve a response as defined by each subcomponent of SRI-5. - Proportion of patients who achieve a response as defined by the SRI-4, the SRI-6, and the SRI-7. - Proportion of patients able to decrease dose to 7.5 mg/day or less of prednisone or equivalent, with quiescent disease (BILAG C score or better in all 9 systems) and no flares (BILAG A or B) for at least 3 consecutive months. - Change in anti-double-stranded deoxyribonucleic acid (anti-dsDNA) level. - Change in SLE Disease Activity Index-2000 (SLEDAI-2K) score. - Proportion of patients with new severe SLE flares (modified SELE...
    I seguenti obiettivi secondari di questo studio valuteranno l’effetto della somministrazione a lungo termine di LY2127399 sui seguenti esiti:  percentuale di pazienti che ottengono una risposta nel tempo,come risulta dall’indice di risposta SRI-5 (SLE responder index-5).La risposta SRI-5 e' definita come: o riduzione &gt;=5 punti nel punteggio SELENA-SLEDAI rispetto al basale; o assenza di nuovi punteggi BILAG A o non piu' di 1 nuovo punteggio BILAG B relativo all’attivita' della malattia; e o assenza di peggioramento (definito come aumento &gt;=0,3 punti rispetto al basale) alla scala PGA;  percentuale di pazienti che ottengono una risposta,come definito da ciascun subcomponente dell’indice SRI-5 menzionato sopra;  percentuale di pazienti che ottengono una risposta come definito dagli indici SRI-4,SRI-6 e SRI-7;  percentuale di pazienti in grado di ridurre la dose a &lt;=7,5 mg/die
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are eligible to be included in the study only if they meet all of the following criteria: - Have completed 52 weeks of treatment in Study BCDS or Study BCDT. - For female patients of childbearing potential, must test negative for pregnancy at the time of enrollment and agree to use a reliable method of birth control or remain abstinent during the study or for at least 8 weeks following the last dose of study drug, whichever is longer, or - For female patients of non-childbearing potential, defined as: • Women who have had surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) • Women ≥60 years of age • Women ≥40 and <60 years of age who have had a cessation of menses for at least 12 months and a follicle-stimulating hormone (FSH) test confirming non-childbearing potential (FSH ≥40 mIU/mL). - Have given written informed consent approved by Lilly or its designee and the Investigational Review Board/Ethical Review Board (IRB/ERB) governing the site.
    Sono idonei all’inclusione nello studio i pazienti che soddisfano tutti i criteri seguenti. [1] Completamento delle 52 settimane di trattamento nello Studio BCDS o BCDT. [2a] Per le donne in eta' fertile: risultato negativo al test di gravidanza effettuato all’arruolamento e consenso a utilizzare un metodo contraccettivo affidabile o a praticare l’astinenza per la durata dello studio o per almeno 8 settimane dall’ultima dose di farmaco in studio, a seconda di quale periodo sia piu' lungo; oppure [2b] donne non in eta' fertile, definite come: • donne sottoposte a sterilizzazione chirurgica (isterectomia, ovariectomia bilaterale o legatura delle tube); • donne di eta' ≥60 anni; • donne di eta' compresa tra 40 e 60 anni in post-menopausa da almeno 12 mesi e che presentano valori di ormone follicolo stimolante (FSH) ≥40 mIU/mL a conferma dell’impossibilita' di sviluppare una gravidanza. [3] Firma del consenso informato scritto approvato da Lilly o da un suo incaricato e dal Comitato di revisione istituzionale/Comitato di revisione etica (IRB/ERB) competente per il centro.
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they meet any of the following criteria: - Presence of significant uncontrolled cerebrocardiovascular (for example: myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic or neuropsychiatric disorders, or abnormal laboratory values at baseline that in the opinion of the Investigator pose an unacceptable risk to the patient if study drug would be administered. - Have any other condition that renders the patient unable to understand the nature, scope, and possible consequences of the study or precludes the patient from following and completing the protocol, in the opinion of the Investigator. - Are unwilling or unable to comply with study procedures. - Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. - Are Lilly employees or representatives of a third party organization (TPO) involved in the study who require exclusion of their employees.
    Saranno esclusi dallo studio i pazienti che soddisfano uno qualsiasi dei criteri seguenti. [4] Significativi disturbi cerebro-cardiovascolari (p. es. infarto del miocardio [MI], angina instabile, ipertensione arteriosa instabile, grave insufficienza cardiaca o accidente cerebrovascolare), respiratori, epatici, renali, gastrointestinali, endocrini, ematologici o neuropsichiatrici non controllati o anomalie nei parametri di laboratorio al basale che nell’opinione dello Sperimentatore rappresenterebbero un rischio inaccettabile per il/la paziente qualora gli/le fosse somministrato il farmaco in studio. [5] Qualsiasi altra patologia che, nell’opinione dello Sperimentatore, impedisce al/la paziente di comprendere la natura, le finalita' e le possibili conseguenze dello studio o di rispettare e completare il protocollo. [6] Impossibilita' o rifiuto di aderire alle procedure dello studio. [7] Il/La paziente e' un membro del personale del centro di sperimentazione direttamente coinvolto in questo studio e/o un parente stretto di un membro del personale di studio. Per parente stretto si intendono coniugi, genitori, figli/e o fratelli/sorelle, sia per legame biologico che per adozione legale. [8] Il/La paziente e' un dipendente di Lilly o un rappresentante di un’organizzazione terza coinvolta nello studio che prevede l’esclusione dei propri dipendenti.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of Study BCDX is to evaluate the safety and tolerability of LY2127399 in patients with SLE who have completed 52 weeks of treatment in either Study BCDS or Study BCDT. Safety and tolerability assessments will include frequency of TEAEs and SAEs and laboratory evaluations.
    L’end point primario dello studio BCDX e' valutare la sicurezza e la tollerabilita' di LY2127399 in pazienti con LES che hanno completato 52 settimane di trattamento in uno dei due studi BCDS o BCDT. Le valutazioni di sicurezza e tollerabilita' per lo studio BCDX includeranno la frequenza dei TEAE dei SAE e degli esami di laboratorio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study.
    Conclusione dello studio.
    E.5.2Secondary end point(s)
    None
    Nessuno
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    Non applicabile
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Dosing intervals of 120 mg every 2 weeks versus every 4 weeks
    Intervalli di dosaggio da 120 mg ogni 4 settimane in confronto a 120 mg ogni 2 settimane
    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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    2 bracci di studio per investigare gli intervalli di dosaggio ( 2 settimane verso 4 settimane)
    2 arm study to investigate dosing intervals (2 weeks versus 4 weeks)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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
    Belarus
    Brazil
    Canada
    Chile
    Colombia
    Croatia
    Ecuador
    Egypt
    Guatemala
    India
    Israel
    Japan
    Korea, Republic of
    Macedonia, the former Yugoslav Republic of
    Malaysia
    Mexico
    New Zealand
    Peru
    Philippines
    Russian Federation
    Singapore
    South Africa
    Taiwan
    Thailand
    Tunisia
    Turkey
    Ukraine
    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
    End of study (trial) is the date of the last visit or last scheduled procedure shown in the Study Schedule for the last active patient in the study.
    La conclusione dello studio (sperimentazione) e' la data dell'ultima visita o dell'ultima procedura programmata dimostrata nel programma di studio dell'ultimo paziente attivo nello studio.
    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 months67
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 1148
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 128
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 412
    F.4.2.2In the whole clinical trial 1276
    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)
    Participation in Study BCDX will last for at least 4 years or until market availability or development of LY2127399for SLE is discontinued. All patients (including those who discontinue study treatment) will be followed for safety for at least an additional 24 weeks after their final injection of studydrug. If a patient’s B cell counts have not recovered, additional visits may be scheduled to continue monitoring the status of B cell counts
    La partecipazione allo studio BCDX durera' almeno 4 anni o fino alla commercializzazione di LY2127399 o all’interruzione del suo sviluppo per il LES. La sicurezza di tutti i pazienti(inclusi coloro che sospenderanno il trattamento)sara' monitorata per almeno altre 24 settimane dopo l’ultima iniezione di farmaco in studio.Se il livello di cellule B di un paziente non si sia normalizzato,potranno essere programmatealtre visite per continuare il monitoraggio delle conte dellecelluleB
    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 Decision2013-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-01-12
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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