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    Summary
    EudraCT Number:2011-002159-32
    Sponsor's Protocol Code Number:211LE201
    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:2012-06-14
    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 number2011-002159-32
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BIIB023 in Subjects With Lupus Nephritis
    Studio multicentrico, randomizzato, in doppio-cieco, controllato con placebo per valutare l'efficacia, la sicurezza e la tollerabilitï ½ di BIIB023 in soggetti affetti da nefrite lupica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Anti-TWEAK in lupus nephritis study
    Anti-TWEAK in uno studio sulla nefrite lupica
    A.3.2Name or abbreviated title of the trial where available
    ATLAS
    ATLAS
    A.4.1Sponsor's protocol code number211LE201
    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 SponsorBIOGEN IDEC LTD
    B.1.3.4CountryUnited Kingdom
    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 supportBiogen Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact pointATLAS Clinical Trials Team
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone numbernd
    B.5.5Fax numbernd
    B.5.6E-mailimmunologyclinicaltrials@biogenidec.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 nameBIIB023
    D.3.2Product code NA
    D.3.4Pharmaceutical form Solution for injection
    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.3.9.2Current sponsor codeBIIB023
    D.3.9.3Other descriptive nameAnti-TWEAK monoclonal antibody BIIB023
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 2
    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 CellCept (mycophenolate mofetil)
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMYCOPHENOLATE MOFETIL
    D.3.9.1CAS number 115007-34-6
    D.3.9.4EV Substance CodeSUB03360MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    Nefrite Lupica
    E.1.1.1Medical condition in easily understood language
    Lupus Nephritis
    Nefrite Lupica
    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 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 primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of subjects with active, biopsy-proven LN.
    L’obiettivo primario dello studio è valutare l’efficacia di BIIB023 come trattamento aggiuntivo alla terapia di base, rispetto al placebo associato alla terapia di base, nel trattamento di soggetti affetti da NL attiva, comprovata da biopsia.
    E.2.2Secondary objectives of the trial
    Secondary objectives of this study are to assess the safety and tolerability of BIIB023 compared with placebo in this study population.
    Gli obiettivi secondari di questo studio sono quelli di valutare la sicurezza e la tollerabilità di BIIB023 rispetto al placebo in questa popolazione dello studio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
    •Aged 18 to 75 years old, inclusive, at the time of informed consent.
    •Must have a documented diagnosis of SLE according to current ACR criteria. At least 4 ACR criteria must be documented, 1 of which must be a positive antinuclear antibody (ANA), anti-Sm, or anti-dsDNA antibody.
    •Must have a diagnosis of ISN/RPS 2003 Class III or IV LN with either active or active/chronic disease, confirmed by biopsy within 3 months prior to Screening. Subjects are permitted to have co-existing Class V LN. The local histological diagnosis must be confirmed by the central study pathologist.
    •Must have proteinuria at Screening (from a 24-hour urine sample collection) defined as: uPCR >1.0 in subjects with biopsy Class III or IV LN uPCR >2.0 in subjects with co-existing Class V LN
    •Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment.
    • Capacità di comprendere lo scopo e i rischi dello studio e fornire consenso informato firmato e datato e l'autorizzazione per utilizzare le informazioni mediche private nel rispetto delle norme nazionali e regolamenti locali in materia di privacy del soggetto. • età compresa tra 18 e 75 anni, compreso, al momento del consenso informato. • Deve avere una diagnosi di LES documentata secondo i vigenti criteri ACR. Almeno 4 criteri ACR devono essere documentati, uno dei quali deve essere un anticorpo antinucleo positivo (ANA), anti-Sm, o un anticorpo anti-dsDNA. • Deve avere una diagnosi di ISN / RPS 2003 Classe III o IV LN con la malattia sia attiva che attiva/cronica, confermata da biopsia nei 3 mesi precedenti allo screening. I soggetti possono avere una co-esistente LN di Classe V. La diagnosi istologica locale deve essere confermata dal patologo del laboratorio centrale. • Deve avere proteinuria allo screening (dalla raccolta delle urine a 24 ore) definito come: uPCR&gt; 1,0 nei soggetti con LN comprovata da biopsia di classe III o IV o uPCR&gt; 2.0 in soggetti con LN co-esistente di Classe V • Soggetti in età fertile devono usare un efficace metodo contraccettivo durante lo studio ed essere disposti e in grado di continuare la contraccezione per 3 mesi dopo la loro ultima dose del trattamento in studio.
    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 at Screening
    •Estimated GFR <30 mL/min per 1.73 m2 (calculated using the abbreviated MDRD equation) or the presence of oliguria or ESRD requiring dialysis or transplantation
    •Subjects requiring dialysis within 12 months prior to Screening
    •History of renal transplant
    •History of opportunistic infection within 3 years of Screening.
    •Subjects with the following abnormal laboratory test result at Screening considered clinically significant (as determined by the Investigator) or: AST/SGOT or ALT/SGPT >2 x upper limit of normal established by the central laboratory; platelet count <20,000/μL; subjects with platelet count >20,000/μL and <150,000 who are experiencing, or at high risk for developing, clinically significant bleeding or organ dysfunction requiring therapy (as determined by the Investigator) should be excluded from the study; hemoglobin <8.5 g/dL; neutrophils <1.5 x 103/μL
    •Receipt of >1.5 g IV methylprednisolone (cumulative dose) within 28 days prior to Screening
    •Use of >30 mg/day oral prednisone or equivalent for >14 consecutive days within 4 weeks prior to Screening
    •Treatment with any biologic B-cell-depleting therapy (e.g., anti-CD20 [rituximab], anti-CD22 [epratuzumab], anti-BLyS/BAFF [e.g., briobacept, belimumab] therapy), or TACI-Ig within 12 months prior to Run-in Day 1.
    • Retinite, disturbi convulsivi mal controllato, stato confusionale acuto, mielite, ictus o sindrome tipo ictus, atassia cerebellare, o demenza che è attualmente attiva e derivanti da SLE allo screening • stimato GFR &lt;30 mL / min per 1,73 m2 (calcolato con la equazione MDRD abbreviata) o la presenza di oliguria o ESRD che necessita di dialisi o di trapianto • soggetti che necessitano di dialisi nei 12 mesi precedenti allo screening • Storia del trapianto renale • storia di infezione opportunistica nei 3 anni precedenti lo screening. • Soggetti con il seguente risultato anomalo del test di laboratorio al momento dello screening considerati clinicamente significativi (come determinato dallo sperimentatore) oppure: AST / ALT o SGOT / SGPT&gt; 2 x limite superiore del valore normale stabilito dal laboratorio centrale, conta piastrinica &lt;20.000 / ul; soggetti con conta piastrinica&gt; 20.000 / ul e &lt;150.000 che stanno vivendo, o ad alto rischio di sviluppare, sanguinamento clinicamente significativo o disfunzione d'organo che richiedono una terapia (come stabilito dallo sperimentatore) dovrebbero essere esclusi dallo studio; emoglobina &lt;8,5 g / dL ; neutrofili &lt;1,5 x 103/μL • Ricevimento di&gt; 1,5 g IV metilprednisolone (dose cumulativa) entro 28 giorni prima screening • Utilizzo di&gt; 30 mg / die di prednisone o equivalente per&gt; 14 giorni consecutivi entro 4 settimane prima dello screening • Il trattamento con qualsiasi terapia biologica di riduzione delle cellule B(ad esempio, anti-CD20 [rituximab], anti-CD22 [epratuzumab], anti-BLyS/BAFF [ad esempio, briobacept, belimumab] terapia), o TACI-Ig nei 12 mesi precedenti al Run-in Giorno 1.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects who achieve a renal response (complete or partial renal response) at Week 52.
    Percentuale di soggetti che raggiungono una risposta renale (completa o parziale) alla settimana 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    settimana 52
    E.5.2Secondary end point(s)
    1. Proportion of subjects who achieve complete renal response at Week 52. 2. Duration of response in subjects who achieve complete renal response at Week 52.
    3. Proportion of subjects with uPCR >3.0 at Day 1 (Baseline) who achieve uPCR <1.0 at Week 52.
    4. Time to partial or complete renal response in subjects who achieve renal response at Week 52.
    5. Proportion of subjects with active urinary sediment at Day 1 (Baseline) who have inactive urinary sediment at Week 52. Active urinary sediment is defined by 1 of the following (in the absence of a urinary tract infection or menses): ->5 red blood cell/high power field (RBC/HPF) or above the reference range for the laboratory, and >5 white blood cell/high power field (WBC/HPF) or above the reference range for the laboratory -Presence of cellular casts (RBC or WBC) Inactive urinary sediment defined as: -<5 RBC/HPF and <5 WBC/HPF, or within the laboratory reference range, and -no cellular casts (no RBC or WBC casts). 6. Incidence of AEs, SAEs, and AEs leading to study discontinuation.
    7. Duration of renal response.
    1. Percentuale di soggetti che ottengono una risposta renale completa alla 52^ Settimana.
    2. Durata della risposta nei soggetti che ottengono una risposta renale completa alla 52^ Settimana .
    3. Percentuale di soggetti con uPCR >3,0 al Giorno 1 (Basale) che ottengano un uPCR <1,0 alla 52^ Settimana .
    4. Tempo alla risposta renale parziale o completa nei soggetti che ottengono una risposta renale alla 52^ Settimana .
    5. Percentuale di soggetti con sedimento urinario attivo al Giorno 1 (Basale), che hanno un sedimento urinario inattivo alla 52^ Settimana . Il sedimento urinario attivo è definito dalla presenza di 1 delle seguenti condizioni (in assenza di un’infezione del tratto urinario o mestruazioni): - globuli rossi/campo ad alto ingrandimento (RBC/HPF) >5 o sopra l’intervallo di riferimento del laboratorio, e globuli bianchi/campo ad alto ingrandimento (WBC/HPF) >5 o sopra l’intervallo di riferimento del laboratorio. - Presenza di cilindri cellulari (RBC o WBC)
    Sedimento urinario inattivo definito come: - RBC/HPF <5 e WBC/HPF <5, o entro l’intervallo di riferimento del laboratorio, e - assenza di cilindri cellulari (assenza di cilindri di RBC o WBC)
    6. Incidenza di eventi avversi (adverse event, AE), eventi avversi seri (serious adverse event, SAE) ed AE che portano all’interruzione dello studio. 7. Durata della risposta renale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 52 or throughout the duration of the study
    Alla settimana 52 o per tutta la durata dello studio
    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 trial3
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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
    Brazil
    Canada
    China
    Colombia
    Hong Kong
    Israel
    Korea, Republic of
    Malaysia
    Mexico
    Peru
    Philippines
    South Africa
    Taiwan
    Thailand
    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
    LSLV
    LSLV
    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 months27
    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 months41
    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: 285
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 78
    F.4.2.2In the whole clinical trial 300
    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 this study through Week 52 will be offered the option to enter an Open Label Extension study under a separate protocol.
    Ai pazienti che completano lo studio fino alla 52a settimana sarà offerta l'opzione di partecipare in uno studio di estensione in aperto con un protocollo separato
    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 Decision2012-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-10-08
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