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    Summary
    EudraCT Number:2013-002773-21
    Sponsor's Protocol Code Number:EMR700461-023
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-01-22
    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 ConcernedSpain - AEMPS
    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)
    Estudio de fase IIb, multicéntrico, aleatorizado, doble ciego, controlado por placebo, de varias dosis, de 24 semanas de duración, para evaluar la eficacia y seguridad de atacicept en pacientes con lupus eritematoso sistémico (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)
    Eficacia y seguridad de atacicept en pacientes con lupus eritematoso sistémico (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 organisationQuintiles S.L.
    B.5.2Functional name of contact pointRegulatory and Start Up Group
    B.5.3 Address:
    B.5.3.1Street AddressCalle Vía de los Poblados 3, Edificio 7/8, Planta 5
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number0034918062000
    B.5.5Fax number0034918066459
    B.5.6E-mailensayosclinicos@quintiles.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 eritematoso sistémico (LES)
    E.1.1.1Medical condition in easily understood language
    Systemic Lupus Erythematosus (SLE)
    Lupus eritematoso sistémico (LES)
    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.
    El objetivo principal de este ensayo es evaluar la eficacia de atacicept en comparación con el placebo en la reducción de la actividad de la enfermedad LES en pacientes tratados con el tratamiento de referencia e investigar la relación entre la dosis y la respuesta.
    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).
    Secundarios
    1.El efecto de atacicept en la reducción del uso de corticoesteroides.
    2.El efecto de atacicept en los cambios en la actividad de la enfermedad con el tiempo.
    3.Los perfiles de seguridad, tolerabilidad e inmunogenia de atacicept en los pacientes de LES.
    4.Los perfiles farmacocinético y FD de atacicept en pacientes de LES.
    5.El efecto de atacicept en los resultados comunicados por el paciente (PRO).
    Otros
    Objetivos exploratorios
    1.Identificar posibles asociaciones entre las variaciones genéticas y la expresión génica con la respuesta a atacicept, su eficacia y seguridad.
    2.Identificar posibles asociaciones de los perfiles de proteínas en circulación con la respuesta a atacicept, su eficacia y seguridad.
    3.Evaluar el efecto de atacicept en la reducción de la acumulación de daños por LES (Índice de daños de SLICC [Clínicas colaboradoras a nivel internacional en el lupus sistémico]/ACR [Sociedad Estadounidense de Reumatología]).
    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
    Estudio farmacocinético; Objetivo, por favor, refiérase al apartado 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
    -Varones y mujeres de ? 18 años de edad que den su consentimiento informado por escrito en la visita de selección.
    -Puntuación ? 6 en el índice SLEDAI-2K en la visita de selección.
    -Diagnóstico de LES que satisfaga al menos 4 de los 11 criterios de clasificación del ACR para LES durante el transcurso de su enfermedad en la visita de selección
    -Duración de la enfermedad de al menos 6 meses desde el momento del diagnóstico (cuando el paciente cumplía al menos 4 de los criterios del ACR) en la visita de selección
    -Resultados positivos en la prueba de detección de ANA (ANA en células epiteliales humanas [Hep]-2 = o > 1:80) y/o anticuerpos anti ADNdh (? 30 UI/ml) en la visita de selección
    -Otros criterios de inclusión definidos en el protocolo pueden aplicar
    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
    -Antecedentes o diagnóstico actual de alguna enfermedad desmielinizante
    -LES del sistema nervioso central activo que se considere grave o progresivo
    -Glomerulonefritis activa de moderada a grave y/o insuficiencia renal grave (cociente de proteína: creatinina en la orina al azar [UPCr] ? 2 mg/mg
    -Otros criterios de exclusión descritos en el protocolo pueden aplicar
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects with SRI response at Week 24 compared to the screening visit
    Proporción de pacientes con respuesta SRI en la semana 24 en comparación con la visita de selección
    E.5.1.1Timepoint(s) of evaluation of this end point
    at week 24
    En la semana 24
    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
    - Proporción de pacientes en la semana 24 cuya dosis de corticoesteroides equivalente a prednisona se haya reducido en relación con la visita de selección en ?25 % y a una dosis ?7,5 mg/día, y que no presenten ninguna reagudización BILAG A ni 2B en la actividad de la enfermedad durante las semanas 16 a 24
    -Proporción de pacientes en las categorías de PGIC en la semana 24
    -Cambio desde la visita de selección hasta la semana 24 en dosis diaria de corticoesteroides equivalentes a prednisona
    -Tiempo transcurrido hasta la primera respuesta SRI confirmada durante el periodo de tratamiento
    -Proporción de pacientes que responden al tratamiento conforme a la evaluación BICLA (evaluación del lupus combinada basada en BILAG), en la semana 24
    -Cambio desde el día 1 en SF-36 RCF, RCM y puntuación total en cada momento
    -Naturaleza, incidencia, intensidad y desenlace clínicos de los acontecimientos adversos (AA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    See E.5.2
    Por favor refiérase al apartado 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
    Utilización de biomarcadores y de recursos de la salud
    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 concerned5
    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)
    Cuando tenga lugar el cierre de la base de datos (de acuerdo con el protocolo)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    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 state5
    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.
    Cuando paciente complete estudio después de periodo de seguimiento de seguridad o discontinue prematuramente, tratamiento estandard debería ser administrado. Paciente complete 24 semanas de tratamiento le será ofrecido ensayo de extensión, llevado a cabo por protocolo diferente. El brazo de placebo será cambiado a 150mg de atacicept mientras que los pacientes en brazos de tratamiento recibirán misma dosis original cuando sean incluidos en la fase de extensión.
    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 Decision2014-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-08
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