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    The EU Clinical Trials Register currently displays   44242   clinical trials with a EudraCT protocol, of which   7339   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-002065-21
    Sponsor's Protocol Code Number:LP0162-1339
    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:2018-01-30
    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 number2017-002065-21
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroid in subjects with moderate-to-severe atopic dermatitis who are candidates for systemic therapy
    Ensayo fase III, aleatorizado, doble ciego y controlado con placebo, para evaluar la eficacia y seguridad de tralokinumab en combinación con corticosteroides tópicos en pacientes con dermatitis atópica de moderada a grave que sean candidatos para un tratamiento sistémico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 3 trial to evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroid in adults with moderate to severe atopic dermatitis. ECZTRA 3 (ECZema TRAlokinumab trial no. 3)
    Ensayo fase 3 para evaluar la eficacia y seguridad de tralokinumab en combinación con corticoides tópicos para la dermatitis atópica moderada a grave en adultos. ECZTRA 3 (Ensayo ECZema TRAlokinumab nº 3)
    A.3.2Name or abbreviated title of the trial where available
    ECZTRA 3
    ECZTRA 3
    A.4.1Sponsor's protocol code numberLP0162-1339
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03363854
    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 SponsorLEO Pharma A/S
    B.1.3.4CountryDenmark
    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 supportLEO Pharma A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLEO Pharma A/S
    B.5.2Functional name of contact pointThomas Coquelle
    B.5.3 Address:
    B.5.3.1Street AddressIndustriparken 55
    B.5.3.2Town/ cityBallerup
    B.5.3.3Post code2750
    B.5.3.4CountryDenmark
    B.5.6E-mailtaqdk@leo-pharma.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 nameTralokinumab
    D.3.2Product code CAT-354
    D.3.4Pharmaceutical form Solution for injection
    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 INNTralokinumab
    D.3.9.1CAS number 1044515-88-9
    D.3.9.3Other descriptive nameCAT-354
    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
    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
    Atopic Dermatitis
    Dermatitis atópica
    E.1.1.1Medical condition in easily understood language
    Eczema
    Eccema
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that tralokinumab in combination with TCS is superior to placebo in combination with TCS in treating moderate-to-severe AD.
    Demostrar que tralokinumab en combinación con corticoides tópicos en superior a placebo en combinación con corticoides tópicos en el tratamiento de la dermatitis atópica moderada-grave.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, and health-related quality of life compared with placebo in combination with TCS.

    To assess safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 32 weeks.
    Evaluar la eficacia de tralokinumab en combinación con CST en la gravedad y extensión de la DA, el prurito y la calidad de vida, en comparación con placebo combinado con CST.

    Evaluar la seguridad de tralokinumab en combinación con CST para el tratamiento de la DA de moderada a grave durante 32 semanas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 18 and above.
    Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
    History of AD for ≥1 year.
    Subjects who have a recent history of inadequate response to treatment with topical medications.
    AD involvement of ≥10% body surface area at screening and baseline.
    An EASI score of ≥12 at screening and 16 at baseline.
    An IGA score of ≥3 at screening and at baseline.
    A Worst Daily Pruritus NRS average score of ≥4 during the week prior to baseline.
    Stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.
    - Edad mínima de 18 años.
    - Diagnóstico de DA definido por los criterios de Hanifin y Rajka (1980) para la DA.
    - Antecedentes de DA durante ≥ 1 año.
    - Antecedentes recientes de respuesta inadecuada a un tratamiento con fármacos tópicos.
    - DA que afecte a ≥ 10 % de la superficie corporal en la selección y en el inicio.
    - Puntuación EASI ≥ 12 en la selección y de 16 en el inicio.
    - Puntuación IGA ≥ 3 en la selección y en el inicio.
    - Puntuación media de NRS del peor prurito diario ≥ 4 durante la semana previa al inicio.
    - Dosis estable de emolientes dos veces al día (o más, si es necesario) durante al menos 14 días antes de la aleatorización.
    E.4Principal exclusion criteria
    Subjects for whom TCSs are medically inadvisable e.g., due to important side effects or safety risks in the opinion of the investigator.
    Active dermatologic conditions that may confound the diagnosis of AD.
    Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
    Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation.
    Treatment with TCS, TCI, or topical phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomisation.
    Receipt of any marketed biological therapy (i.e. immunoglobulin, anti- immunoglobulin E) including dupilumab or investigational biologic agents.
    Active skin infection within 1 week prior to randomisation.
    Clinically significant infection within 4 weeks prior to randomisation.
    A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
    Tuberculosis requiring treatment within the 12 months prior to screening.
    Known primary immunodeficiency disorder.
    - Pacientes para quienes los tratamientos tópicos resulten desaconsejables por razones médicas, como efectos secundarios importantes o riesgos para la seguridad en opinión del investigador.
    - Trastornos dermatológicos activos que puedan confundir el diagnóstico de DA.
    - Uso de camas bronceadoras o fototerapia en las 6 semanas previas a la aleatorización.
    - Tratamiento con fármacos inmunosupresores/inmunomoduladores sistémicos o corticoides sistémicos en las 4 semanas previas a la aleatorización.
    - Tratamiento con corticosteroides, inhibidores de calcineurina, o inhibidores de fosfodiesterasa 4 (FDE-4) tópicos en las 2 semanas previas a la aleatorización.
    - Cualquier tratamiento biológico comercializado (p. ej., inmunoglobulina, anti-inmunoglobulina E), incluidos dupilumab o biofármacos en fase de investigación.
    - Infección cutánea activa en la semana previa a la aleatorización.
    - Infección clínicamente significativa en las 4 semanas previas a la aleatorización.
    - Infección por parásito helminto en los 6 meses previos a la fecha de obtención del consentimiento informado.
    - Tuberculosis que haya requerido tratamiento en los 12 meses previos a la selección.
    - Inmunodeficiencia primaria conocida.
    E.5 End points
    E.5.1Primary end point(s)
    Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Week 16.
    At least 75% reduction in Eczema Area and Severity Index (EASI) score from baseline (EASI75) at Week 16.
    - Puntuación IGA (evaluación global del investigador) de 0 (ausente) o 1 (casi ausente) en la semana 16.
    - Reducción del 75 %, como mínimo, en la puntuación del Índice de gravedad y área del eccema (EASI) con respecto al inicio [EASI75]) en la semana 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Semana 16
    E.5.2Secondary end point(s)
    Change in Scoring Atopic Dermatitis (SCORAD) from baseline to Week 16.
    Reduction of Worst Daily Pruritus numeric rating scale (NRS) (weekly average) of at least 4 from baseline to Week 16.
    Change in Dermatology Life Quality Index (DLQI) from baseline to Week 16.
    - Cambio en el Índice de gravedad de la dermatitis atópica (SCORAD) desde el inicio hasta la semana 16.
    - Reducción en la escala numérica de calificación (NRS) del peor prurito diario (promedio semanal) de 4, como mínimo, desde el inicio hasta la semana 16.
    - Cambio en el Índice de calidad de vida en dermatología (DLQI) desde el inicio hasta la semana 16.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16
    Semana 16
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 trial5
    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 EEA32
    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
    Canada
    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
    LSLV (Last visit of the last subject undergoing the trial)
    UVUP (Última visita del último paciente)
    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 months8
    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 months8
    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: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 19
    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 state43
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 308
    F.4.2.2In the whole clinical trial 492
    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)
    None
    Ninguno
    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 Decision2018-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-09-26
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