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    Summary
    EudraCT Number:2014-000049-56
    Sponsor's Protocol Code Number:GS29250
    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:2015-03-27
    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 number2014-000049-56
    A.3Full title of the trial
    A phase II, randomised, double-blind, placebo-controlled study to evaluate the safety and efficacy of lebrikizumab in patients with persistent moderate to severe atopic dermatitis that is inadequately controlled by topical corticosteroids
    ESTUDIO DE FASE II ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE LEBRIKIZUMAB EN PACIENTES CON DERMATITIS ATÓPICA PERSISTENTE, MODERADA A GRAVE, NO CONTROLADA ADECUADAMENTE CON CORTICOSTEROIDES TÓPICOS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Lebrikizumab in Patients with Persistent Moderate to Severe Atopic Dermatitis
    Estudio de Lebrikizumab en pacientes con dermatitis atópica persistente, moderada a grave.
    A.4.1Sponsor's protocol code numberGS29250
    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 SponsorRoche Farma, S.A. , en nombre de F. Hoffmann- La Roche
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34 91 325 73 00
    B.5.6E-mailglobal.roche.genentechtrials@roche.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 namelebrikizumab
    D.3.2Product code RO5490255/F01-02
    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 INNLEBRIKIZUMAB
    D.3.9.2Current sponsor codeRO5490255
    D.3.9.3Other descriptive nameTNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A
    D.3.9.4EV Substance CodeSUB31913
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 Yes
    D.3.11.13.1Other medicinal product typeLebrikizumab is a humanized monoclonal IgG4 antibody with an Fc region modification for increased stability, that binds specifically to soluble interleukine-13 (IL-13)
    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 Yes
    D.2.1.1.1Trade name Hydrocortisone cream USP, 2.5%
    D.2.1.1.2Name of the Marketing Authorisation holderPERRIGO
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHYDROCORTISONE
    D.3.9.2Current sponsor codeRO0079351
    D.3.9.4EV Substance CodeSUB08065MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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.IMP: 3
    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 Yes
    D.2.1.1.1Trade name triamcinolone Acetonide cream USP, 0.1%
    D.2.1.1.2Name of the Marketing Authorisation holderPERRIGO
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRIAMCINOLONE ACETONIDE
    D.3.9.2Current sponsor codeRO0058382
    D.3.9.4EV Substance CodeSUB04936MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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 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
    Atopic Dermatitis
    Dermatitis atópica.
    E.1.1.1Medical condition in easily understood language
    Atopic dermatitis (AD) or eczema is a common inflammatory skin disease characterized by dry skin, red and crusting rash and intense pruritus that may affect people of all age.
    Dermatitis atópica o eczema es un trastorno inflamatorio crónico común de la piel,se caracteriza por xerosis, erupción eritematosa con costras y prurito intenso, afecta a personas de todas las edades.
    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 17.1
    E.1.2Level PT
    E.1.2Classification code 10012438
    E.1.2Term Dermatitis atopic
    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
    The primary objective of this study is to evaluate the efficacy and safety of lebrikizumab used as adjunctive therapy with topical corticosteroid (TCS) compared with TCS alone in patients with persistent moderate to severe atopic dermatitis.
    El objetivo principal de este estudio es evaluar la eficacia y seguridad de lebrikizumab cuando se utiliza como tratamiento adyuvante en combinación con corticosteroides tópicos (CST), comparado con CST solo, en pacientes con DA persistente moderada a grave.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of lebrikizumab adjunctive therapy with TCS compared with TCS alone, as measured by AD symptoms, including pruritis, and AD-specific health-related quality of life.
    ? To evaluate the pharmacokinetics and immunogenicity of lebrikizumab administered by subcutaneous (SC) injection
    ? To evaluate AD-related biomarkers and the effect on their expression from lebrikizumab used as adjunctive therapy with TCS compared with TCS
    Evaluar la eficacia de lebrikizumab cuando se utiliza como tratamiento adyuvante en combinación con CST, comparado con CST solo, que se determinará basándose en los síntomas de la DA, incluyendo prurito, y la calidad de vida (CV) relacionada.
    - Evaluar la farmacocinética e inmunogenicidad de lebrikizumab administrado en inyección subcutánea (SC).
    - Evaluar biomarcadores relacionados con la DA y el efecto de lebrikizumab cuando se utiliza como tratamiento adyuvante en combinación con CST, comparado con CST solo, sobre la expresión de estos biomarcadores.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18 to 75 years, inclusive, at the start of the run-in period
    - AD diagnosed by the Hanifin/Rajka criteria and that has been present for at least 1 year at screening
    - Moderate to severe AD as graded by the Rajka/Langeland criteria at screening
    - History of inadequate response to a >/= 1 month (within the 3 months prior to the screening visit) treatment regimen of at least daily TCS and regular emollient for treatment of AD
    - EASI score >/= 14 at screening
    - IGA score >/= 3
    - AD involvement of >/= 10% body surface area
    - Pruritus Visual Analog Scale score >/= 3
    - Tener entre 18 y 75 años de edad, al inicio del período de introducción.
    - Presentar DA, diagnosticada de acuerdo con los criterios de Hanifin/Rajka, desde hace al menos 1 año en el momento de la visita de selección.
    - Presentar DA moderada a grave, clasificada de acuerdo con los criterios de Rajka/Langeland, en el momento de la visita de selección.
    - Respuesta inadecuada a un tratamiento previo para la DA administrado durante >/=1 mes (en los 3 meses anteriores a la visita de selección) con un CST y un emoliente de uso habitual, aplicados como mínimo una vez al día.
    - Puntuación EASI >/= 14 en la visita de selección.
    - Puntuación IGA >/= 3.
    - DA que afecta a >/= 10% del área de superficie corporal.
    - Puntuación >/= 3 en la EVA de prurito.
    E.4Principal exclusion criteria
    - Past and/or current use of any anti-IL-13 or anti-IL-4/IL-13 therapy, including lebrikizumab
    - Use of an investigational agent within 4 weeks prior to screening or within 5 half-lives of the investigational agent, whichever is longer
    - Evidence of other skin conditions, including, but not limited to, T-cell lymphoma or allergic contact dermatitis
    - History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
    - Use of any complementary, alternative, or homeopathic medicines including, but not limited to, phytotherapies, traditional or non-traditional herbal medications, essential fatty acids, or acupuncture within 7 days prior to the run-in period or need for such medications during the study
    - Evidence of other skin conditions; including, but not limited to, T-cell lymphoma or allergic contact dermatitis
    - Evidence of, or ongoing treatment (including topical antibiotics) for active skin infection at screening
    - Other recent infections meeting protocol criteria
    - Active tuberculosis requiring treatment within the 12 months prior to Visit 1
    - Evidence of acute or chronic hepatitis or known liver cirrhosis
    - Known immunodeficiency, including HIV infection
    - Use of a topical calcineurin inhibitor (TCI) at the time of screening, unless the patient is willing to stop TCI use during the study (including the run-in period) and, in the investigators opinion, it is safe to do so
    - Clinically significant abnormality on screening ECG or laboratory tests
    - Known current malignancy or current evaluation for a potential malignancy, including basal or squamous cell carcinoma of the skin or carcinoma in situ
    - History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer
    - Uso previo y/o actual de cualquier tratamiento anti-IL-13 o anti-IL-4/IL-13, incluyendo lebrikizumab.
    - Uso de un agente en investigación en las 4 semanas previas a la visita de selección o durante 5 vidas medias del agente, dependiendo de lo que sea más prolongado.
    - Antecedentes de reacciones alérgicas graves o anafilácticas a un agente biológico o hipersensibilidad conocida a cualquiera de los excipientes de la inyección de lebrikizumab.
    - Uso de medicinas complementarias, alternativas u homeopáticas, incluyendo, aunque no exclusivamente, fitoterapia, medicinas herbales tradicionales o no tradicionales, ácidos grasos esenciales o acupuntura, en los 7 días previos al período de introducción o
    necesidad de utilizar estas medicaciones durante el estudio.
    - Evidencia de otras patologías cutáneas, incluyendo, aunque no exclusivamente, linfoma de células T o dermatitis alérgica por contacto.
    -Tratamiento en curso (incluyendo antibióticos tópicos) para una infección cutánea activa, confirmado en la visita de selección.
    - Otras infecciones que cumplan criterios del protocol.
    - Tuberculosis activa que haya requerido tratamiento en los 12 meses previos a la visita 1.
    - Evidencia de hepatitis aguda o crónica o cirrosis hepática documentada.
    - Inmunodeficiencia documentada, incluyendo infección por VIH.
    - Uso de ICT en el momento de la visita de selección, a menos que el paciente esté dispuesto a interrumpir su aplicación durante el estudio (incluyendo el período de introducción) y el investigador considere que es seguro hacerlo.
    - Anomalías clínicamente significativas en el ECG o las pruebas de laboratorio realizadas en la visita de selección.
    - Pacientes que en la actualidad presenten algún tipo de neoplasia maligna documentada, incluyendo carcinoma de piel basocelular o de células escamosas o carcinoma in situ.
    - Antecedentes de cáncer en los 5 años previos a la visita de selección, exceptuando carcinoma in situ de cérvix, carcinoma de piel no melanomatoso o cáncer de útero en estadio I.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients achieving a 50% reduction in Eczema Area and Severity Index (EASI) score (EASI-50) from baseline to Week 12
    Porcentaje de pacientes que alcanzan EASI-50 (reducción del 50% de la puntuación EASI respecto al valor basal) en la semana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline to Week 12
    Desde basal a semana 12.
    E.5.2Secondary end point(s)
    1. Outcome Measure: Efficacy (composite outcome measure): Percent and absolute change from baseline in EASI score at Week 12
    2. Outcome Measure: Percent of patients achieving an Investigators Global Assessment (IGA) score of 0 or 1 at Week 12
    3. Outcome Measure: Efficacy (composite outcome measure): Percent and absolute change from baseline in Severity Scoring of Atopic Dermatitis (SCORAD) at Week 12
    4. Outcome Measure: Frequency and severity of treatment-emergent adverse events
    1. Variable valoración: Eficacia (variable valoración compuesta):
    Cambio porcentual y absoluto, respecto al valor basal, en la puntuación EASI en la semana 12.
    2. Variable valoración: Porcentaje de pacientes que alcanzan una puntuación IGA de 0 o 1 en la semana 12.
    3. Variable valoración: eficacia (variable valoración compuesta):
    Cambio absoluto y porcentual, respecto al valor basal, en el SCORAD en la semana 12.
    4. Variable valoración: Frecuencia y severidad de los acontecimientos adversos originados por el tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 to 3. From Baseline to Week 12
    4. Up to Week 20
    1 a 3. Desde basal a semana 12.
    4. Hasta semana 20.
    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 Yes
    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) 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 Yes
    E.8.1.7.1Other trial design description
    Periodo de introducción
    Run-in period
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Canada
    Czech Republic
    Finland
    France
    Germany
    Korea, Republic of
    Netherlands
    Poland
    Spain
    Switzerland
    Taiwan
    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
    Última visita del útimo paciente (UVUP).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months15
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial months16
    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: 198
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-03-27. Yes
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    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)
    The Sponsor will offer post-trial access to the study drug (lebrikizumab) free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product.
    El promotor ofrecerá a los pacientes elegibles acceso gratuito al fármaco del estudio (lebrikizumab) después del estudio, de acuerdo con la Política Global de Roche sobre el
    Acceso Continuado al Medicamento en Investigación.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-18
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