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    Summary
    EudraCT Number:2013-002773-21
    Sponsor's Protocol Code Number:EMR700461-023
    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:2014-02-03
    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 number2013-002773-21
    A.3Full title of the trial
    A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)
    Studio multicentrico di fase IIb, randomizzato, in doppio cieco, controllato con placebo, multidose, della durata di 24 settimane per valutare l'efficacia e la sicurezza di Atacicept in soggetti affetti da lupus eritematoso sistemico (LES)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)
    Studio per la valutazione dell’efficacia e della sicurezza di Atacicept in pazienti con Lupus Eritematoso Sistemico (ADDRESS II)
    A.3.2Name or abbreviated title of the trial where available
    ADDRESS II
    ADDRESS II
    A.4.1Sponsor's protocol code numberEMR700461-023
    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 number+496151725200
    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 injection 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 injection 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    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
    Primary:
    1. Evaluate the efficacy of atacicept compared to placebo in reducing SLE disease activity in subjects treated with standard of care (SoC) therapy and to investigate the dose-response relationship.
    Obiettivo principale:
    1. Valutare l'efficacia di atacicept rispetto a placebo nel ridurre l'attività della malattia LES nei soggetti sottoposti a terapia standard (TS) ed esaminare il rapporto dose-risposta.
    E.2.2Secondary objectives of the trial
    Secondary:
    1. Evaluate the effect of atacicept in reducing corticosteroid (CS) usage.
    2. Evaluation of changes in disease activity over time.
    3. Evaluate the safety, tolerability and immunogenicity profile of atacicept.
    4. Evaluate the pharmacokinetics (PK) and pharmacodynamic (PD) profiles of atacicept.
    5. Evaluate the effect of atacicept on patient-reported outcomes (PROs).
    Other:
    1. Identify potential associations of genetic variations with drug response, efficacy and safety.
    2. Identify potential associations of gene expression profiles before and after atacicept treatment with drug response, efficacy and safety.
    3. Identify potential associations of the profiles of circulating proteins before and after atacicept treatment with drug response, efficacy and safety.
    4. Evaluate the effect of atacicept in reducing damage accrual from SLE (Systemic Lupus International Collaborating Clinics [SLICC]/American College of Rheumatology [ACR] damage index).
    - Valutare l’effetto di atacicept nel ridurre l'utilizzo di corticosteroidi (CS);
    - Valutare l'effetto di atacicept sulle variazioni dell'attività della malattia nel tempo;
    - Valutare i profili di sicurezza, tollerabilità e immunogenicità di atacicept nei soggetti affetti da LES;
    - Valutare il profilo farmacocinetico (PK) e farmacodinamico (PD) di atacicept nei soggetti affetti da LES;
    - Valutare l'effetto di atacicept sugli esiti riferiti dai pazienti;
    Altro:
    - Identificare eventuali associazioni tra variazioni genetiche ed espressione genica e risposta, efficacia e sicurezza di atacicept.
    - Identificare eventuali associazioni tra i profili di espressione genica prima e dopo il trattamento con atacicept con risposta, efficacia e sicurezza di atacicept.
    - Valutare l'effetto di atacicept nel ridurre l'impatto dei danni derivanti da LES (in base al Systemic Lupus International Collaborating Clinics [SLICC]/American College of Rheumatology [ACR] Damage Index)

    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
    - Male or female of ≥18 years of age, who provide written informed consent at the screening visit
    - SLEDAI-2K score ≥6 at screening visit
    - Diagnosis of SLE satisfying at least 4 out of the 11 ACR classification criteria for SLE during the course of their illness at the screening visit
    - Disease duration of at least 6 months from the time of diagnosis (when the subject met at least 4 of the ACR criteria) at the screening visit
    - Positive test results for ANA (human epithelial cell [Hep]-2 ANA = or >1:80) and/or anti-dsDNA antibody (≥30 IU/mL) at screening visit
    - Other protocol defined inclusion criteria may apply
    - I soggetti maschi e femmine idonei maggiorenni che firmano il consenso informato alla visita di screening;
    - Indice SLEDAI-2K ≥6 alla visita di screening;
    - Diagnosi SLE cbe soddisfi almeno 4 degli 11 criteri ACR per LES durante la visita di screening;
    - Durata della malattia di almeno 6 mesi dal momento della diagnosi (da quando il soggetto ha soddifsatto almeno 4 criteri ACR) alla visita di screening;
    - Risultato positivo al test degli anticorpi antinucleo (ANA) (human epithelial cell [Hep]-2 ANA = o > 1:80) e/o agli anticorpi anti-acido deossiribonucleico a doppia elica (anti-dsDNA) (≥30 IU/mL) alla visita di screening;
    - Possono essere applicati altri criteri di inclusione come definito dal protocollo
    E.4Principal exclusion criteria
    - History or current diagnosis of any demyelinating disease
    - Active central nervous system SLE deemed to be severe or progressive
    - Use of cyclophosphamide within 3 months before or during SV
    - Active, moderate to severe glomerulonephritis and/or severe renal impairment (spot urine protein:creatinine ratio [UPCr] ≥2 mg/mg
    -Other protocol defined exclusion criteria may apply
    - Non possono partecipare i soggetti affetti da malattia demielinizzante;
    - LES severo del sistema nervoso centrale, considerata grave o progressiva;
    - soggetti che hanno utilizzato ciclofosfamide entro 3 mesi dalla visita di screening o durante la visita di screening;
    - Glomerulonefrite attiva, da moderata a grave e/o grave insufficienza renale [rapporto proteine-creatinina nelle urine (UPCr) ≥2 mg/mg/die];
    - Possono essere applicati altri criteri di esclusione come definito dal protocollo
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects with SRI response at Week 24 compared to the screening visit
    La percentuale di soggetti con risposta alla Settimana 24 rispetto alla visita di screening.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at week 24
    24 settimane
    E.5.2Secondary end point(s)
    - Proportion of subjects at Week 24 whose prednisone-equivalent CS dose has been reduced from screening visit (SV) by ≥25% and to a dose of ≤7.5mg/day, and have no BILAG A or 2B flare in disease activity during Weeks 16 through 24
    - Proportion of subjects in the patient global impression of change (PGIC) categories at Week 24
    - Change from screening visit to Week 24 in prednisone-equivalent CS daily dose
    - Time to first SRI response during treatment period
    - Proportion of subjects responding to treatment according to the BILAG-based Combined Lupus Assessment (BICLA), at week 24
    - Change from Day 1 in SF-36 PCS, MCS and total score at each time point
    - Nature, incidence, severity, and outcome of AEs
    - Percentuale di soggetti che alla Settimana 24 hanno avuto una riduzione ≥25% della dose di CS prednisone-equivalente dalla visita di screening, fino ad arrivare a una dose ≤7,5 mg/die e che non hanno mostrato nessun BILAG A o flare 2B nell'attività della malattia dalla Settimana 16 alla 24;
    - Percentuale di soggetti nelle categorie 1 o 2, 3 o 4 o 5, 6 o 7 del Patient Global Impression of Change (PGIC) alla Settimana 24;
    - Cambiamento della dose giornaliera di CS prednisone-equivalente dalla visita di screening alla Settimana 24;
    - Tasso di risposta SRI durante il priodo di trattamento;
    - Percentuale di soggetti responsivi al trattamento secondo il BICLA (BILAG-based Combined Lupus Assessment), alla settimana 24;
    - Variazione dal Giorno 1 nell'SF-36 PCS (Medical Outcomes Study 36-item Short Form Health Survey (SF-36) Physical Component Summary), nel Mental Component Summary (MCS) e nel punteggio totale a ogni punto temporale.
    - Natura, incidenza, la gravità, e l'esito di eventi avversi
    E.5.2.1Timepoint(s) of evaluation of this end point
    See E.5.2
    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 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.8.5The 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
    Argentina
    Brazil
    Bulgaria
    Chile
    Czech Republic
    Germany
    Italy
    Korea, Republic of
    Mexico
    Peru
    Philippines
    Poland
    Russian Federation
    South Africa
    Spain
    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)
    quando verrà effettuato il database lock, in accordo al 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 years2
    E.8.9.2In all countries concerned by the trial months10
    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.1.1.1In 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: 265
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 86
    F.4.2.2In the whole clinical trial 279
    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 subject has completed the trial through the safety FU period or has withdrawn early, standard treatment should be administered. Subjects who complete 24-week treatment period will be offered participation in a Long-Term Extension trial, which will be conducted under a separate CTP. The placebo arm of this trial will be switched over to the 150 mg dose of atacicept while the subjects in the treatment arms will remain on their original respective doses of atacicept when enrolled in the LTE.
    Sarà somministrato un trattamento standard per quei soggetti che terminano il follow-up di sicurezza o si ritirano precocemente dallo studio. I che completano periodo di trattamento di 24 settimane potranno partecipare ad uno studio di estensione a lungo termine. Il braccio placebo assumerà 150 mg di atacicept, i soggetti del braccio di trattamento continueranno ad assumere le dosi originali rispettive di Atacicept.
    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 Decision2014-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-25
    P. End of Trial
    P.End of Trial StatusCompleted
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