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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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:2011-004350-26
    Sponsor's Protocol Code Number:I1F-MC-RHBA
    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:2012-02-28
    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 number2011-004350-26
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients with Moderate-to-Severe Plaque Psoriasis
    Estudio multicéntrico, aleatorizado, en doble ciego y controlado con placebo, para comparar la eficacia y la seguridad de LY2439821 frente a etanercept y placebo en pacientes con psoriasis en placas de grado moderado a severo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Study in Moderate to Severe Psoriasis Patients
    Estudio Fase 3 en pacientes con psoriasis de grado moderado a severo
    A.3.2Name or abbreviated title of the trial where available
    The UNCOVER Study-2
    A.4.1Sponsor's protocol code numberI1F-MC-RHBA
    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 SponsorEli Lilly and Company
    B.1.3.4CountryUnited States
    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 and 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 and Company
    B.5.2Functional name of contact pointClinical trial information
    B.5.3 Address:
    B.5.3.1Street AddressN.A
    B.5.3.2Town/ cityN.A
    B.5.3.3Post codeN.A
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_Clinical_Trials@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.3.2Product code LY2439821
    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 INNLY2439821
    D.3.9.1CAS number 1143503-69-8
    D.3.9.2Current sponsor codeLY2439821
    D.3.9.3Other descriptive nameAnti-IL-17Monoclonal Antibody(MAb)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name Enbrel
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameENBREL
    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 INNETANERCEPT
    D.3.9.1CAS number 185243-69-0
    D.3.9.4EV Substance CodeSUB01984MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 2
    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
    Moderate to severe plaque psoriasis
    Psoriasis en placas de grado moderado a severo
    E.1.1.1Medical condition in easily understood language
    Psoriasis is a skin condition that causes red, raised scaly patches on the skin
    La Soriaris es una afección cutanéa que provoca placas escamosas rojas y abultadas en la piel.
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10071117
    E.1.2Term Plaque psoriasis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous 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
    Efficacy of Anti-IL-17 MAb vs. etanercept in subjects with moderate to severe chronic plaque psoriasis based on sPGA and PASI at 12 weeks.
    Eficacia del anticuerpo monoclonal (Anti-IL-17A) versus etanercept
    en sujetos con placas de grado moderado a severo basado en sPGA y PASI a las 12 semanas.
    E.2.2Secondary objectives of the trial
    -Efficacy of anti-IL-17 MAb in subjects with moderate to severe chronic plaque psoriasis based on sPGA and PASI over 12 and 60 weeks
    -Efficacy of anti-IL-17 MAb vs. etanercept over 12 weeks
    -Quality of life assessments based on patient reported outcomes over 12 and 60 weeks
    -Eficacia del anticuerpo monoclonal IL-17 en pacientes con psoriasis en placas de grado severo a crónico basado en sPGA (Evaluación global estática por el médico)y PASI (Índice de áreas y severidad de la psoriasis) entre la semana 12 y 60.
    -Eficacia del anticuerpo monoclonal IL-17 frente a etanercept pasada la semana 12.
    - Evaluaciones de la calidad de vida basada en resultados obtenidos de los pacientes entre la semana 12 y la 60
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization
    -At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization
    -Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at randomization
    -Candidate for phototherapy and/or systemic therapy
    -Men must agree to use a reliable method of birth control during the study
    -Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
    -Presentar psoriasis en placas crónica, según un diagnóstico confirmado de psoriasis en placas crónica durante al menos 6 meses antes del momento basal
    -Presentar afectación de ?10% de la BSA en la selección (visita 1) y en el momento basal (semana 0; visita 2).
    -Presentar una puntuación sPGA de?3 y una puntuación PASI?12 en la selección (visita 1) y en el momento basal (semana 0; visita 2).
    -Ser candidato a la fototerapia o al tratamiento sistémico.
    -Los pacientes varones deberán comprometerse a utilizar un método anticonceptivo fiable durante el estudio.
    -Los pacientes mujeres deberán comprometerse a utilizar un método anticonceptivo fiable durante el estudio o a abstenerse de mantener relaciones sexuales durante el estudio y hasta 12 semanas después de recibir la última dosis
    E.4Principal exclusion criteria
    -Pustular, erythrodermic, and/or guttate forms of psoriasis
    -History of drug-induced psoriasis
    -Prior use of etanercept
    -Clinically significant flare of psoriasis during the 12 weeks prior to randomization
    -Concurrent or recent use of any biologic agent
    -Received non-biologic systemic psoriasis therapy or phototherapy (including psoralens and ultraviolet A [PUVA], ultraviolet B [UVB]) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization
    -Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study
    -Have participated in any study with IL-17 antagonists, including LY2439821
    -Serious disorder or illness other than plaque psoriasis
    -Serious infection within the last 3 months
    -Breastfeeding or nursing (lactating) women
    -Presentar psoriasis pustulosa, eritrodérmica o en gotas.
    -Presentar antecedentes de psoriasis inducida por fármacos.
    -Uso previo de etanercept.
    -Haber presentado un exacerbación de la psoriasis clínicamente significativa en las 12 semanas previas al momento basal (semana 0; visita 2).
    -Haber recibido tratamiento no biológico sistémico para la psoriasis
    -Haber recibido tratamiento no biológico sistémico para la psoriasis (incluidos los psoralenos y las luces ultravioleta A [PUVA] y B [UVB] en las 4 semanas previas al momento basal o el autotratamiento con camas de bronceado o exposición al sol terapéutica dentro de las 2 semanas previas a la randomización.
    -Imposibilidad de evitar la exposición al sol o el uso de cabinas de bronceado en al menos las 4 semanas previas al momento basal.
    -Haber participado en otro estudio con antagonistas de la IL-17 incluyendo LY2439821
    -Haber padecido una enfermedad grave aparte de soriasis en placas.
    -Haber padecido una infección grave en los últimos 3 meses
    -Encontrarse en periodo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Static Physician Global Assessment (sPGA) and Psoriasis Area and Severity Index (PASI)
    (sPGA)Evaluación global estática por el médico(PASI)Índice de áreas y severidad de la psoriasis
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 semanas
    E.5.2Secondary end point(s)
    PASI and sPGA
    Quality of life assessments
    PASI y sPGA
    Evaluaciones de la calidad de vida
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 12 and Week 60
    En la semana 12 y semana 60
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Pharmacokinetic may be done for immunogenicity purposes only.
    El estudio farmacocinético será realizdo sólamente por motivos inmunogenéticos.
    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) Yes
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Australia
    Austria
    Canada
    Czech Republic
    France
    Germany
    Netherlands
    Poland
    Romania
    Spain
    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
    End of study is the date of the last visit or last scheduled procedure for the last active subject in the study.
    El final del estudio es la fecha de de la última visita o el último procedimiento programado para el último paciente activo en el estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months9
    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: 1175
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 1225
    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)
    Subject will return to their normal standard of care therapy as determined by their physician
    Los pacientes regresarán a su tratamiento habitual como determinado por su médico.
    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 Decision2012-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-18
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