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    Summary
    EudraCT Number:2013-002758-62
    Sponsor's Protocol Code Number:EMR700461-024
    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:2014-03-31
    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 number2013-002758-62
    A.3Full title of the trial
    A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II)
    Sperimentazione di estensione a lungo termine di Fase IIb, multicentrica per valutare la sicurezza e la tollerabilità di Atacicept in soggetti affetti da lupus eritematoso sistemico (LES) che hanno completato il protocollo EMR-700461-023 (ADDRESS II)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term safety and tolerability study of atacicept in patients with Systemic Lupus Erythematosus who completed protocol EMR-700461-023 (ADDRESS II)
    Studio a lungo termine per la valutazione della sicurezza e tollerabilità di Atacicept in pazienti con Lupus Eritematoso Sistemico che hanno completato il protocollo EMR-700461-023
    A.4.1Sponsor's protocol code numberEMR700461-024
    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 SponsorMerck KGaA
    B.1.3.4CountryGermany
    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 supportMerck KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Center
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Strasse 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number496151725200
    B.5.6E-mailservice@merckgroup.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 nameAtacicept
    D.3.4Pharmaceutical form Solution for infusion in pre-filled syringe
    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.3.8INN - Proposed INNAtacicept
    D.3.9.3Other descriptive nameATACICEPT
    D.3.9.4EV Substance CodeSUB30888
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 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 nameAtacicept
    D.3.4Pharmaceutical form Solution for infusion in pre-filled syringe
    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.3.8INN - Proposed INNAtacicept
    D.3.9.3Other descriptive nameATACICEPT
    D.3.9.4EV Substance CodeSUB30888
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 (SLE)
    Lupus Eritemetoso Sistemico (SLE)
    E.1.1.1Medical condition in easily understood language
    Systemic Lupus Erythematosus (SLE)
    Lupus Eritemetoso Sistemico (SLE)
    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 16.1
    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
    Determine the long-term safety and tolerability of atacicept in SLE subjects.
    determinare la sicurezza e la tollerabilità a lungo termine di atacicept nei soggetti affetti da LES
    E.2.2Secondary objectives of the trial
    1. Evaluate the effect of atacicept on changes in disease activity over time.
    2. Evaluate the effect of atacicept in reducing corticosteroid (CS) usage.
    3. Evaluate the immunogenicity, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of atacicept.
    4. Evaluate the effect of atacicept on patient-reported outcomes (PROs).
    5. Identify potential associations of genetic variations and gene.
    Valutare l’effetto di atacicept sulle modifiche dell’attività della malattia nel tempo,
    2. Valutare l’effetto di atacicept riducendo l’uso di corticosteroidi (CS),
    3. Valutare i profili di immunogenicità, farmacocinetica (PK) e farmacodinamica (PD) di atacicept,
    4) Valutare l’effetto di atacicept sugli esiti riportati dal paziente (Patient-Reported Outcomes, PRO), e
    5. Identificare le potenziali associazioni di variazioni genetiche ed espressione genica con la risposta, l’efficacia e la sicurezza di atacicept.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic study; Objective see E.2.2
    Studio di farmacocinetica; Obiettivi: vedere E 2.2
    E.3Principal inclusion criteria
    - Subjects who have completed the 24-week treatment period of trial EMR-700461-023 (ADDRESS II core trial).
    - Women of childbearing potential (WOCBP) who have a negative pregnancy test
    - Other protocol defined inclusion criteria may apply
    - I soggetti che avranno completato il periodo di trattamento di EMR-700461-023 (ADDRESS II Sperimentazione Principale).
    - Donne in età fertile [Women of childbearing potential (WOCBP)] che mostrano un risultato negativo al test di gravidanza
    - Possono essere applicati altri criteri di inclusione definiti da protocollo
    E.4Principal exclusion criteria
    - Active neurological symptoms of SLE that are deemed severe or progressive
    - Diagnosis of any demyelinating disease, such as, but not restricted to, MS or optic neuritis
    - Pregnancy
    - Other protocol defined exclusion criteria may apply
    - Sintomi neurologici di SLE gravi o progressivi;
    - Diagnosi di qualsiasi malattia demielinizzante come, ma non limitato a, sclerosi multipla, neuromielite ottica
    - Gravidanza
    E.5 End points
    E.5.1Primary end point(s)
    - Number of subjects reporting at least one SAE during the treatment period.
    - Number of subjects prematurely discontinuing the treatment due to AE.
    - Il numero di soggetti che riportano almeno 1 evento avverso serio (SAE) durante il periodo di trattamento.
    - Il numero di soggetti che interrompono prematuramente il trattamento a causa di un evento avverso (EA).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continuous throughout treatment period up to week 96
    Tutto il periodo di trattamento fino alla settimana 96
    E.5.2Secondary end point(s)
    - Change from Baseline in SLICC/ACR Damage Index organ damage scores at Week 96
    - Change from Baseline in disease activity as measured by BILAG at Week 96
    - Change from Baseline in disease activity as measured by SLEDAI-2K at Week 96
    - Change from Baseline in disease activity as measured by SRI-50 at Week 96
    - Change from Baseline in disease activity as measured by PGA at Week 96
    - Change from Baseline in SRI (a disease activity composite index) response at Week 96
    - Change from Baseline in BICLA (a disease activity composite index) response at Week 96
    - Change from Baseline in prednisone-equivalent CS dose at Week 96
    - Change from Baseline in SF-36 at Week 96
    - Change from Baseline in LupusQoL at Week 96
    - Change from Baseline in PGIC at Week 96
    - Change from Baseline in EQ-5D at Week 96
    - Change from Baseline in FACIT-Fatigue at Week 96
    - Number of subjects with AEs
    - C-SSRS score
    - Variazione rispetto al basale dei punteggi relativi al danno d’organo secondo il Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR [SLICC/ACR Damage Index]) alla settimana 96;
    - Variazione rispetto al basale dell’attività della malattia misurata secondo l’indice BILAG (British Isles Lupus Assesment Group, BILAG) alla settimana 96;
    - Variazione rispetto al basale dell’attività della malattia misurata secondo SLEDAI (Systemic Lupus Erythematosus Disease Activity Index 2000, SLEDAI-2K) alla settimana 96;
    - Variazione rispetto al basale dell’attività della malattia misurata secondo SRI-50 (SLEDAI-2K Responder Index-50, SRI-50) alla settimana 96;
    - Variazione rispetto al basale dell’attività della malattia misurata secondo la Valutazione globale del medico (PGA) (Physician’s Global Assessment, PGA) alla settimana 96;
    - Variazione rispetto al basale dell’attività della malattia misurata secondo SRI (SLE Responder Index, SRI) alla settimana 96;
    - Variazione rispetto al basale dell’attività della malattia misurata secondo BICLA (BILAG-based Combined Lupus Assessment, BICLA) alla settimana 96;
    - Variazione rispetto al basale dell’attività della malattia misurata secondo la dose di CS equivalente al prednisone alla settimana 96;
    - Variazione rispetto al basale dei punteggi delle scale di valutazione: SF-36 (Health Status Inventory, SF-36), LupusQoL, Impressione globale di cambiamento del paziente (Patients’ Global Impression of Change, PGIC), Valutazione funzionale della terapia delle malattie croniche-affaticamento (Functional Assessment of Chronic Illness Therapy-Fatigue, FACIT-F), e Strumento EuroQoL 5-D (EuroQoL 5 Dimension Instrument, EQ-5D) e del numero di aventi avversi alla settimana 96;
    -Punteggio C-SSRS
    E.5.2.1Timepoint(s) of evaluation of this end point
    96 weeks (See E.5.2)
    96 settimane (Vedere E.5.2)
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker and Health resource utilization
    Biomarker e utilizzo dei servizi di cura
    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 No
    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 No
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    Bulgaria
    Italy
    Argentina
    Brazil
    Chile
    Czech Republic
    Germany
    Korea, Republic of
    Spain
    Mexico
    Peru
    Philippines
    Poland
    Russian Federation
    South Africa
    Ukraine
    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
    When final database lock occurs (according to protocol)
    Al verificarsi della chiusura del database (secondo il protocollo)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months7
    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: 202
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 213
    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)
    After a subject has completed the trial through the safety FU period, or has withdrawn early, standard treatment should be administered, if required, in accordance with the trial site’s SoC and generally accepted medical practice, and depending on the subject’s individual medical needs.
    Dopo che un soggetto ha completato la sperimentazione attraverso il periodo di FU di sicurezza, o ha ritirato precocemente il proprio consenso, dovrà essere somminitrato il trattamento standard, se richiesto, in conformità con le SoC [standard of care] del centro di sperimentazione e generalmente accettato nella pratica clinica, e dipendentemente dal bisogno medico individuale.
    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 Decision2014-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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