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    Summary
    EudraCT Number:2018-002401-56
    Sponsor's Protocol Code Number:I9N-MC-FCAB
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-06-11
    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 number2018-002401-56
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3375880 in Adult Subjects with Moderate-to-Severe Atopic Dermatitis
    Estudio de fase 2, multicéntrico, aleatorizado, con enmascaramiento doble y comparativo con un placebo, para evaluar la eficacia y la seguridad de LY3375880 en pacientes adultos con dermatitis atópica de moderada a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to determine the safety and efficacy of LY3375880 in Adult Patients with Atopic Dermatitis
    Un estudio para determinar la seguridad y la eficacia de LY3375880 en pacientes adultos con dermatitis atópica
    A.4.1Sponsor's protocol code numberI9N-MC-FCAB
    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 SponsorLilly S.A.
    B.1.3.4CountrySpain
    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 supportEli Lilly & Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly & Company
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressIsland House , Eastgate Road, Eastgate Business Park
    B.5.3.2Town/ citylittle Island
    B.5.3.3Post codeNA
    B.5.3.4CountryIreland
    B.5.6E-mailensayosclinicos@lilly.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 nameLY3375880 200mg/2ml
    D.3.2Product code LY3375880
    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 INNLY3375880
    D.3.9.3Other descriptive nameLY3375880
    D.3.9.4EV Substance CodeSUB194903
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 placeboInjection
    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
    Atopic Dermatitis
    Dermatitis atópica
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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 compare the efficacy of LY3375880 to placebo as measured by IGA at Week 16 in the treatment of subjects with moderate-to-severe AD
    Comparar la eficacia de LY3375880 con la del placebo en el tratamiento de pacientes con DA de moderada a grave, de acuerdo con la EGI en la semana 16.
    E.2.2Secondary objectives of the trial
    • To compare the efficacy of LY3375880 to placebo as measured by improvement in signs and symptoms at Week 16 and 52 in the treatment of subjects with moderate-to-severe AD

    • To characterize the PK of LY3375880 in subjects with moderate-to-severe AD
    • Comparar la eficacia de LY3375880 con la del placebo en el tratamiento de pacientes con DA de moderada a grave, de acuerdo con la EGI en la semana 16.

    • Caracterizar la FC de LY3375880 en pacientes con DA de moderada a grave.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    --At least 18 years of age at the time of informed consent
    --Diagnosis of AD >= 12 months according to AAD criteria (Eichenfeld, 2014)
    --Moderate to severe AD at screening and randomization
    --Inadequate response to topical medications within 6 months of screening (or history of intolerance)
    -- Al menos 18 años de edad en el momento de la firma del consentimiento informado.
    -- Diagnóstico de DA al menos desde hace 12 meses, de acuerdo con los criterios de la AAD (Eichenfeld, 2014).
    -- DA de moderada a grave durante la selección y la aleatorización.
    -- Respuesta insuficiente a medicamentos tópicos en el transcurso de los 6 meses anteriores a la selección (o antecedentes de intolerancia a estos medicamentos).
    E.4Principal exclusion criteria
    --Have received any prior treatment with dupilumab or any agent directly targeting Il-33 or IL-13
    --Concurrent treatment with topical or systemic treatments for AD
    -- Haber recibido anteriormente cualquier tratamiento con dupilumab o con otro medicamento que actúe directamente sobre la IL-33 o la IL-13.
    -- Administración concomitante de tratamientos tópicos o sistémicos para la DA.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects achieving IGA of 0 or 1 with a ≥2 point improvement
    Porcentaje de pacientes que alcancen una puntuación de 0 o 1 en la EGI, con una mejoría ≥2 puntos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Semana 16
    E.5.2Secondary end point(s)
    Proportion of subjects achieving at Week 16
    o EASI-50
    o EASI-75
    o EASI-90
    o SCORAD-75
    o SCORAD-90
    o IGA of 0

    Mean change from baseline to Week 16 in
    o EASI
    o SCORAD

    Proportion of subjects achieving IGA of 0 or 1 at Week 52

    Serum PK Data
    Porcentaje de pacientes que en la semana 16 alcancen:
    o una respuesta EASI-50
    o una respuesta EASI-75
    o una respuesta EASI-90
    o una respuesta SCORAD-75
    o una respuesta SCORAD-90
    o una puntuación de 0 en la EGI
    Media de la variación entre el período inicial y la semana 16 en:
    o el índice EASI
    o el índice SCORAD
    Porcentaje de pacientes que en la semana 52 alcancen una puntuación de 0 o 1 en la EGI.
    Datos relativos a la FC sérica.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16 and Week 52
    Semana 16 y semana 52
    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 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) 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 trial4
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Austria
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Japan
    Spain
    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
    The date of the last visit or last scheduled procedure shown for the last active patient in the study
    Fecha de la última vista o del último procedimiento programado para el último paciente activo del estudio
    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 months
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial days7
    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: 185
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 47
    F.4.2.2In the whole clinical trial 200
    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)
    Study drug is experimental and will be provided to study subjects only according to the protocol; it will not be made available to subjects after they have completed or discontinued from the study unless the subject qualifies to continue study drug in another protocol.
    El fármaco del estudio es experimental y se proporcionará a los pacientes del estudio únicamente de conformidad con el protocolo; los pacientes no podrán continuar recibiéndolo una vez que hayan completado o interrumpido su participación en el estudio, a menos que el paciente se considere idóneo para seguir recibiendo el fármaco del estudio en otro protocolo.
    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 Decision2019-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-12-06
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