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    Summary
    EudraCT Number:2018-000746-19
    Sponsor's Protocol Code Number:LP0162-1337
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-08-22
    Trial 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 number2018-000746-19
    A.3Full title of the trial
    An open-label, single-arm, multi-centre, long-term extension trial to evaluate the safety and efficacy of tralokinumab in subjects with atopic dermatitis who participated in previous tralokinumab clinical trials
    Ensayo de extensión a largo plazo, multicéntrico, abierto y de un solo brazo, para evaluar la seguridad y eficacia de tralokinumab en pacientes con dermatitis atópica que participaron previamente en ensayos clínicos con tralokinumab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term extension trial in subjects with atopic dermatitis who participated in previous tralokinumab trials – ECZTEND
    Ensayo de extensión a largo plazo en pacientes con dermatitis atópica que participaron en ensayos previos de tralokinumab: ECZTEND
    A.3.2Name or abbreviated title of the trial where available
    ECZTEND
    ECZTEND
    A.4.1Sponsor's protocol code numberLP0162-1337
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03587805
    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 pointGlobal Clinical Operations / MedSci
    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.5.4Telephone number+4544945888
    B.5.6E-mailhgddk@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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atopic Dermatitis
    Dermatitis atopica
    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 evaluate the long-term safety of tralokinumab
    Evaluar la seguridad a largo plazo de tralokinumab
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of tralokinumab given as continuous treatment, re-treatment, or introduced for the first time in tralokinumab naïve subjects
    Evaluar la eficacia de tralokinumab administrado como tratamiento continuo, como retratamiento o utilizado por primera vez en pacientes sin tratamiento previo con tralokinumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Completed the treatment period(s) of one of the parent trials: LP0162-1325, -1326, -1339, -1341 or -1342.
    -Complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.
    -Able and willing to self-administer tralokinumab treatment (or have it administered by a caregiver) at home after the initial 3 injection visits at the trial site (in this trial).
    -Stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline.
    • Haber completado los períodos de tratamiento de uno de los ensayos principales: LP0162-1325, -1326, -1339, -1341 o -1342.
    • Haber cumplido con el protocolo del ensayo clínico principal a criterio del investigador.
    • Ser capaz de autoadministrarse el tratamiento con tralokinumab en casa y estar dispuesto a hacerlo (o que lo haga un cuidador) después de las 3 visitas de inyección iniciales en el centro del ensayo (en este ensayo).
    • Haber recibido una dosis estable de emolientes dos veces al día (o más, si es necesario) durante al menos 14 días antes del inicio del ensayo.
    E.4Principal exclusion criteria
    -Any condition that required permanent discontinuation of trial treatment in the parent trial.
    -More than 20 weeks have elapsed since the subject received the last injection of investigational medicinal product (IMP) in the parent trial
    (to be assessed at baseline).
    -Subjects who, during their participation in the parent trial, developed a serious adverse event (SAE) deemed related to tralokinumab by the
    investigator, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable
    safety risk for the subject.
    -Subjects who, during their participation in the parent trial, developed an AE that was deemed related to tralokinumab by the investigator and
    led to temporary discontinuation of trial treatment, which in the opinion of the investigator could indicate that continued treatment with
    tralokinumab may present an unreasonable safety risk for the subject.
    -Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to baseline.
    -Treatment with topical phosphodiesterase 4 inhibitors within 2 weeks prior to baseline.
    -Receipt of any marketed biological therapy (that is, immunoglobulin or anti-immunoglobulin E) including dupilumab or investigational
    biologic agents:
    o Any cell-depleting agents, including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer.
    o Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline.
    -Clinically significant infection within 4 weeks prior to baseline.
    -A helminth parasitic infection within 6 months prior to the date when informed consent is obtained.
    -Tuberculosis requiring treatment within 12 months prior to screening.
    - Known primary immunodeficiency disorder.
    • Cualquier condición que haya requerido la interrupción permanente del tratamiento del ensayo en el ensayo principal.
    • Que hayan transcurrido más de 20 semanas desde que el paciente recibió la última inyección del medicamento en investigación (PEI) en el ensayo principal (se evaluará al inicio del ensayo).
    • Que el paciente, durante su participación en el ensayo principal, haya desarrollado un acontecimiento adverso grave (AAG) que el investigador considere relacionado con tralokinumab y posible indicativo de que el tratamiento continuado con tralokinumab puede suponer un riesgo de seguridad no razonable para el paciente.
    • Que el paciente, durante su participación en el ensayo principal, haya desarrollado un AA por el que se haya interrumpido temporalmente el tratamiento del ensayo que el investigador considere relacionado con tralokinumab y posible indicativo de que el tratamiento continuado con tralokinumab puede suponer un riesgo de seguridad no razonable para el paciente.
    • Tratamiento con fármacos inmunodepresores/inmunomoduladores sistémicos o con corticoides sistémicos en las 4 semanas previas al inicio del ensayo.
    • Tratamiento con inhibidores de la fosfodiesterasa 4 por vía tópica en las 2 semanas previas al inicio del ensayo.
    • Recepción de cualquier tratamiento biológico comercializado (es decir, inmunoglobulina o antinmunoglobulina E), incluidos dupilumab o biofármacos en fase de investigación.
    o Cualquier fármaco reductor del número de células, como rituximab, en los 6 meses anteriores al inicio del ensayo o hasta que el número de linfocitos vuelva a la normalidad, lo que implique más tiempo.
    o Otros tratamientos biológicos en los 3 meses o 5 semividas anteriores al inicio del ensayo, lo que implique más tiempo.
    • Infección clínicamente significativa en las 4 semanas previas al inicio del ensayo.
    • 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)
    Number of adverse events (AEs) from baseline through the last treatment visit (up to Week 142)
    Número de acontecimientos adversos (AA) desde el inicio del ensayo hasta la última visita de tratamiento (hasta la semana 142)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 142
    Semana 142
    E.5.2Secondary end point(s)
    1) IGA score of 0 (clear) or 1 (almost clear) at Weeks 16, 56, 80, 104, 128 and 142.
    2) EASI75 at Weeks 16, 56, 80, 104, and 128
    1) Evaluación global del investigador (IGA)1 con puntuación de 0 (ausente) o 1 (casi ausente) en las semanas 16, 56, 80, 104 y 128
    2) Al menos un 75 % de reducción del Índice de gravedad y área del eczema (EASI75) respecto al inicio del ensayo principal en las semanas 16, 56, 80, 104 y 128
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Weeks 16, 56, 80, 104, and 128.
    2) Weeks 16, 56, 80, 104, and 128.
    1) Semanas 16, 56, 80, 104 y 128.
    2) Semanas 16, 56, 80, 104 y 128.
    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 No
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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.8.3 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 concerned19
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA95
    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
    France
    Germany
    Italy
    Japan
    Spain
    United Kingdom
    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
    LVLS
    Ultima visita del ultimo paciente (LSLV)
    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 months11
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days15
    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: 1105
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state107
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 654
    F.4.2.2In the whole clinical trial 1125
    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 Decision2018-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-18
    P. End of Trial
    P.End of Trial StatusOngoing
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