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    Summary
    EudraCT Number:2010-020859-30
    Sponsor's Protocol Code Number:SL0012
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-06
    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 number2010-020859-30
    A.3Full title of the trial
    A phase 3, multicenter, open-label, extension study to asssess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4)
    STUDIO DI ESTENSIONE DI FASE 3 MULTICENTRICO, IN APERTO, TESO A VALUTARE LA SICUREZZA E LA TOLLERABILITA' DEL TRATTAMENTO CON EPRATUZUMAB IN SOGGETTI AFFETTI DA LUPUS ERITEMATOSO SISTEMICO (EMBODY 4)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label study of long-term Epratuzumab treatment in subjects with
    Systemic Lupus Erythematosus (SLE)
    Studio in aperto di lungo periodo con Epratuzumab in pazienti affetti da
    lupus eritematoso sistemico (LES)
    A.3.2Name or abbreviated title of the trial where available
    EMBODY 4
    EMBODY 4
    A.4.1Sponsor's protocol code numberSL0012
    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 SponsorUCB 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 supportUCB Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB Biosciences GmbH
    B.5.2Functional name of contact pointClinical Program Director
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 2173 48 2075
    B.5.5Fax number+49 2173 48 1572
    B.5.6E-mailsabine.bongardt@ucb.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 nameEpratuzumab
    D.3.2Product code CDP3194
    D.3.4Pharmaceutical form 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 INNEPRATUZUMAB
    D.3.9.1CAS number 205923-57-5
    D.3.9.2Current sponsor codeCDP3194
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systemic lupus erythematosus
    Lupus Eritematoso Sistemico
    E.1.1.1Medical condition in easily understood language
    Lupus
    Lupus
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    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 the study is to assess the safety and tolerability of long-term epratuzumab treatment in subjects with SLE
    L’obiettivo primario dello studio e` valutare la sicurezza e la tollerabilita` di un trattamento a lungo termine con epratuzumab in soggetti affetti da LES
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to assess the efficacy and immunogenicity of long-term epratuzumab treatment in subjects with SLE
    Come obiettivi secondari lo studio si propone di valutare l’efficacia e l’immunogenicita` del trattamento a lungo termine con epratuzumab in soggetti affetti da LES
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - The subject has completed double-blind study SL0009 or SL0010, or the subject has terminated prematurely at Week 16 or later in SL0009 or SL0010 due to lack of efficacy, as described in the respective protocols and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment in SL0012. The subject has completed open-label study SL0006 or SL0008, and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment in SL0012. - The subject has maintained the eligibility requirements (including concomitant medication restrictions) throughout their participation in the prior study. - Woman of childbearing potential using an acceptable method of birth control. - Male subjects must agree to ensure they or their female partner(s) use adequate contraception during the study and for a period of 3 months after their final dose of study drug
    1. Il soggetto ha completato lo studio in doppio cieco SL0009 o SL0010, oppure lo ha interrotto anticipatamente alla Settimana 16 o in un momento successivo per mancanza di efficacia, come descritto nei rispettivi protocolli, e nell’opinione dello sperimentatore, continuerebbe a beneficiare del trattamento continuativo con epratuzumab nell’ambito dello studio SL0012. Il soggetto ha completato lo studio in aperto SL0006 o SL0008 e, nell’opinione dello sperimentatore, continuerebbe a beneficiare del trattamento continuativo con epratuzumab nell’ambito dello studio SL0012. 2. Il soggetto ha rispettato i criteri di idoneità (comprese le limitazioni inerenti ai trattamenti concomitanti) per l’intero periodo di partecipazione allo studio precedente. 3. Le donne in età fertile devono acconsentire all’uso di un metodo contraccettivo accettabile durante lo studio. 4. I soggetti di sesso maschile devono accettare di utilizzare e far utilizzare alla/e loro partner/s un metodo contraccettivo adeguato per l’intera durata dello studio e per i 3 mesi successivi all’ultima somministrazione di farmaco in studio.
    E.4Principal exclusion criteria
    - Subject has active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease. - Subject has active, severe, SLE disease activity which involves the renal system defined by BILAG renal level A activity. - Evidence of an immunosuppressive state. - Subjects with a history of chronic infections, including but not limited to subjects with concurrent acute or chronic viral hepatitis B or C. - Subjects with substance abuse/dependence or other concurrent medical conditions. - Subjects with significant hematologic abnormalities. - History of malignant cancer. - Subject has used the prohibited medications
    - Il soggetto e` affetto da forma attiva e grave di LES neuropsichiatrico, definito da punteggio BILAG di grado A; - Il soggetto e` affetto da LES in forma attiva e grave che coinvolge l’apparato renale (attivita` renale di livello A secondo l’indice BILAG); - Evidenza di stato immunosoppressivo; - Soggetti con una storia di infezioni croniche, compresi, a titolo puramente esemplificativo, i soggetti con epatite virale B o C concomitante acuta o cronica; - Soggetti in condizione di abuso/dipendenza da sostanze o affetti da altri disturbi medici concomitanti; - Soggetti con anomalie ematologiche significative; - Storia di neoplasie maligne; - il soggetto ha fatto uso di farmaci non consentiti.
    E.5 End points
    E.5.1Primary end point(s)
    The percent of subjects meeting treatment response criteria at Week 48 and Week 96 according to a combined response index
    La variabile di efficacia primaria corrisponde alla percentuale di soggetti responder alla Settimana 48 e alla Settimana 96 secondo un indice di risposta combinata.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 and 96 weeks
    Settimana 48 e 96
    E.5.2Secondary end point(s)
    The percent of subjects meeting treatment response criteria at time points other than Week 48 and Week 96, according to the combined index
    La percentuale di soggetti responder ad ulteriori tempi di rivelazione dell'endpoint rispetto alla Settimana 48 e alla Settimana 96, secondo un indice di risposta combinata.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline - 96 weeks
    Basale - 96 settimane
    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 No
    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) 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 trial1
    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 concerned10
    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
    Australia
    Brazil
    Canada
    Hong Kong
    India
    Israel
    Korea, Republic of
    Mexico
    Russian Federation
    South Africa
    Taiwan
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee No
    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
    The end of study is defined as the date of the last visit of the last subject in the study
    Conclusione sperimentazione: ultima visita ultimo paziente dello studio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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: 1218
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 540
    F.4.2.2In the whole clinical trial 1400
    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)
    ---
    ---
    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 Decision2012-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-19
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