Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-004218-41
    Sponsor's Protocol Code Number:GB27862
    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:2012-05-10
    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 number2011-004218-41
    A.3Full title of the trial
    A Phase III, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of LEBRIKIZUMAB in patients with uncontrolled asthma who are on inhaled corticosteroids and second controller medication.
    Estudio de fase III aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y seguridad de lebrikizumab en pacientes con asma no controlada que reciben corticoesteroides inhalados y una segunda medicación para control
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of LEBRIKIZUMAB in patients with uncontrolled asthma who are on inhaled corticosteroids and second controller medication.
    Estudio de fase III aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y seguridad de lebrikizumab en pacientes con asma no controlada que reciben corticoesteroides inhalados y una segunda medicación para control
    A.3.2Name or abbreviated title of the trial where available
    Lute
    Lute
    A.4.1Sponsor's protocol code numberGB27862
    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 SponsorF. Hoffmann-La Roche Ltd
    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.5.6E-mailglobal.rochegenentechtrials@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/F01-01
    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 INNlebrikizumab
    D.3.9.1CAS number 953400-68-5
    D.3.9.2Current sponsor codeRO5490255
    D.3.9.3Other descriptive nameTNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 mutated Fc for increased stability that binds specifically to soluble interleukin-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 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
    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.3.9.1CAS number 953400-68-5
    D.3.9.2Current sponsor codeRO5490255
    D.3.9.3Other descriptive nameTNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 mutated Fc for increased stability that binds specifically to soluble interleukin-13 (IL-13).
    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
    Uncontrolled asthma despite the use of an inhaled corticosteroid
    and a second controller medication.
    Asma no controlada a pesar del uso de un corticosteroide inhalado y un segundo medicamento de control
    E.1.1.1Medical condition in easily understood language
    Uncontrolled asthma despite daily therapy.
    Asma no controlada a pesar de una terapia diaria
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal 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 efficacy of lebrikizumab compared with placebo as measured by the rate of exacerbations
    ? The safety of lebrikizumab compared with placebo
    ? Periostin as a predictive biomarker (diagnostic)
    ? The efficacy and safety of different dose levels of lebrikizumab compared to placebo.
    La eficacia de lebrikizumab en comparación con el placebo, valorado mediante la tasa de reagudizaciones
    ? La seguridad de lebrikizumab en comparación con el placebo
    ? El uso de periostina como biomarcador predictivo (diagnóstico)
    ? La seguridad y la eficacia de diferentes dosis de lebrikizumab en comparación con el placebo
    E.2.2Secondary objectives of the trial
    The efficacy of lebrikizumab compared with placebo with respect to lung function, time to first exacerbation, fractional exhaled nitric oxide (FeNO), asthma-specific health-related quality of life, rescue medication use (i.e. short-acting ?-agonists [SABA]), and health care utilization.
    La eficacia de lebrikizumab frente a placebo con respecto a la función pulmonar,
    tiempo transcurrido hasta la primera reagudización, FeNO, calidad de vida
    relacionada con la salud específica del asma, uso de medicamentos de rescate
    (como ? agonistas de acción corta [SABA]) y utilización de recursos sanitarios
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ECG SUBSTUDY date 8 November IN ASSOCIATION WITH LEBRIKIZUMAB STUDY GB27862: A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH UNCONTROLLED ASTHMA WHO ARE ON INHALED CORTICOSTEROIDS AND A SECOND CONTROLLER MEDICATION.
    The primary objective of this substudy is as follows:
    ? To evaluate the effect of lebrikizumab treatment on cardiac repolarization on the basis of prolongation of the QT interval in surface ECGs in patients with uncontrolled asthma.
    The secondary objectives of this substudy are as follows:
    ? To evaluate the effect of lebrikizumab treatment on other ECG measures
    ? To assess the effect of lebrikizumab treatment on ECG morphology.
    Subestudio ECG EN ASOCIACION CON EL ESTUDIO LEBRIKIZUMAB GB27862: fase III, aleatorizado, doble ciego, controlado con placebo ESTUDIO PARA EVALUAR LA EFICACIA Y SEGURIDAD DE LOS PACIENTES con LEBRIKIZUMAB con asma no controlada con corticosteroides inhalados y un segundo medicamento de control.
    E.3Principal inclusion criteria
    - Ability and willingness to provide written informed consent and to comply with the study protocol
    - 18?75 years old at screening
    - Asthma diagnosis for ? 12 months prior to the start of screening
    - Bronchodilator response (defined as a minimum 12% relative improvement in the volume of FEV1 after bronchodilator administration) during the screening period
    - Pre-bronchodilator FEV1 40%?80% of predicted
    - On ICS (500-2000 µg/day of fluticasone propionate DPI or equivalent, total daily dose) for ? 6 months prior to the start of screening
    - On an eligible second controller medication for 6 months prior to the start of screening
    - Uncontrolled asthma demonstrated during the screening period
    - Chest X-ray or computed tomography (CT) scan obtained within 12 months prior to screening or chest X-ray during the screening period confirming the absence of other lung disease
    - Demonstrated adherence with controller medication during the screening period.
    Disposición y capacidad para otorgar el consentimiento informado por escrito
    y para cumplir los procedimientos del estudio
    - 18?75 años de edad en la visita 1
    - Antecedentes de asma durante ? 12 meses antes de la visita de selección
    - Respuesta al broncodilatador La respuesta a un broncodilatador requiere una mejoría mínima relativa del 12 % del FEV1 después de la administración del broncodilatador
    - Un FEV1 antes del broncodilatador del 40-80 % del valor previsto
    - Tratamiento con CI en dosis de 500?2000 µg/día de propionato de fluticasona DPI o equivalente durante
    ? 6 meses antes del inicio de la selección
    - Tratamiento con una segunda medicación de control apto (LABA, AMAP,
    ARLT o teofilina, en el intervalo posológico prescrito) durante 6 meses antes
    del inicio de la selección
    - Asma no controlada, demostrada durante el período de selección
    -Radiografía de tórax o tomografía computerizada (TC) obtenida en los
    12 meses previos a la visita 1, o radiografía de tórax obtenida durante el
    período de selección.
    Cumplimiento demostrado de la medicación de control ? 70 % durante el
    período de selección.
    E.4Principal exclusion criteria
    - History of a severe allergic reaction or anaphylactic reaction to a biologic agent
    - Daily or alternate day oral corticosteroid maintenance therapy within the 3 months prior to screening
    - Treatment with systemic corticosteroids within the 4 weeks prior to, or at anytime during the screening period
    - Recent major episode of infection
    - Active parasitic infection or Listeria monocytogenes infection within the 6 months prior to screening
    - Active tuberculosis requiring treatment within the 12 months prior to screening
    - Known immunodeficiency, including, but not limited to, HIV infection
    - Evidence of acute or chronic hepatitis or known liver cirrhosis
    - History of cystic fibrosis, chronic obstructive pulmonary disease, and/or other clinically significant lung disease other than asthma
    - Known current malignancy or current evaluation for a potential malignancy
    - Other clinically significant medical disease that is uncontrolled despite treatment or that is likely, in the opinion of the investigator, to require a change in therapy or impact the ability to participate in the study
    - History of alcohol, drug, or chemical abuse
    - Current smoker (cigarettes, pipe, cigar, or marijuana) or former smoker with a smoking history of > 10 pack-years
    - Current use of an immunomodulatory/immunosuppressive therapy or past use within 3 months or 5 drug half-lives (whichever is longer) prior to screening
    - Use of a biologic therapy including omalizumab (Xolair) at any time during the 6 months prior to screening
    - Use of zileuton (ZYFLO) or roflumilast (Daxas, Daliresp) at any time during the 6 months prior to screening
    - Treatment with an investigational agent within 30 days of screening (or 5 half lives of the investigational agent, whichever is longer)
    - Receipt of a live/attenuated vaccine within the 4 weeks prior to sreening
    - Female patients who are pregnant or lactating or unwilling to use a highly effective method of contraception
    - Body mass index > 38 kg/m2
    - Body weight < 40 kg.
    Antecedentes de reacción alérgica o reacción anafiláctica graves a un agente
    biológico,
    - Mantenimiento con corticoesteroides orales, definido como tratamiento de
    mantenimiento diario o en días alternos con corticoesteroides orales en los
    3 meses anteriores
    - Tratamiento con corticoesteroides sistémicos (orales, i.v. o i.m.) en las
    4 semanas anteriores a la visita 1 o en algún momento durante el período de
    selección
    - Un episodio reciente de infección
    - Infección parasitaria activa o infección por Listeria monocytogenes en los 6 meses anteriores a la visita 1
    - Tuberculosis activa que requiera tratamiento en los 12 meses anteriores a la
    visita 1
    - Inmunodeficiencia conocida, incluida, entre otras, la infección por el VIH
    - Indicios de hepatitis aguda o crónica, o diagnóstico de cirrosis hepática
    - Antecedentes de fibrosis quística, EPOC u otra neumopatía de trascendencia
    clínica distinta del asma
    - Proceso maligno actual diagnosticado o posible en proceso de evaluación
    - Otra afección médica significativa que no se controle a pesar del tratamiento,
    o que es probable que, en opinión del investigador, requiera modificaciones
    del tratamiento o afecte a la capacidad de participar en el estudio
    - Antecedentes de alcoholismo, abuso de fármacos o toxicomanía.
    - Pacientes fumadores o exfumadores, con antecedentes de tabaquismo de
    > 10 paquetes-año
    -Tratamiento actual con algún agente inmunomodulador/inmunodepresor, o
    tratamiento anterior en los 3 meses o 5 semividas (el período que sea más
    prolongado) antes de la visita 1
    - Uso de un tratamiento biológico, incluido omalizumab, en cualquier momento
    durante los 6 meses anteriores a la visita 1
    - Uso de zileuton o roflumilast en algún momento durante los 6 meses
    anteriores a la visita 1
    - Tratamiento con algún fármaco en investigación en los 30 días anteriores a la
    visita 1 (o 5 semividas del fármaco en investigación, el período que sea más
    prolongado).
    - Vacunación con vacunas de virus vivos/atenuados en las cuatro semanas
    anteriores a la visita 1
    - Mujeres en edad fértil que no estén dispuestas a utilizar un método
    - Índice de masa corporal > 38 kg/m2
    - Peso corporal < 40 kg
    E.5 End points
    E.5.1Primary end point(s)
    Rate of asthma exacerbations.
    Tasa de reagudizaciones de asma
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 semanas
    E.5.2Secondary end point(s)
    ? Frequency of adverse events during the 52-week placebo-controlled period
    ? Severity of adverse events during the 52-week placebo-controlled period
    ? Incidence of anti-therapeutic antibodies during the study relative to the incidence at baseline
    ? Frequency and severity of adverse events during the 52-week active-treatment extension and during the 24-week safety follow-up period.
    Frecuencia de acontecimientos adversos durante el período de 52 semanas controlado
    con placebo
    ? Intensidad de los acontecimientos adversos durante el período de 52 semanas controlado con placebo
    ? Incidencia de anticuerpos contra el tratamiento durante el estudio en relación con la incidencia en el período inicial
    Frecuencia e intensidad de los acontecimientos adversos durante el período de extensión de 52 semanas con tratamiento activo y durante el período de seguimiento para seguridad de 24 semanas
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 semanas
    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) 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 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 EEA62
    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
    Argentina
    Australia
    Brazil
    Bulgaria
    Canada
    Chile
    China
    Colombia
    Czech Republic
    France
    Germany
    Hungary
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Peru
    Poland
    Russian Federation
    Slovakia
    South Africa
    Spain
    Turkey
    Ukraine
    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
    The end of the study is defined as the date when the last patient, last visit (LPLV) occurs. The LPLV is expected to occur a maximum of 124 weeks after the last patient is enrolled and randomized into the study. This timeframe includes the 52-week placebo-controlled period and a maximum of an additional 52-week active-treatment extension followed by the safety follow-up period. All patients will be followed for safety for 24 weeks after the last dose
    El final se define como la fecha en que el último paciente completa la última visita (UVUP). Se espera tenga lugar como máximo 124 semanas después de la aleatorización del último paciente en el estudio. Este tiempo incluye el período de 52 semanas controlado con placebo y un máximo de otras 52 semanas de extensión con tratamiento activo, seguidos por un período de seguimiento de seguridad. Se evaluará a todos los pacientes por seguridad hasta 24 semanas después de la última dosis
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 1300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state105
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 271
    F.4.2.2In the whole clinical trial 1400
    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 study drug lebrikizumab is for experimental use only and it will not yet be approved for use at the time of the completion of this study. There are other therapies available to treat asthma. There are no plans for continued treatment with lebrikizumab or medical supervision of the patients after the end of the trial. Decisions concerning the care of the patient will be left with the patients? treating physician after completion of the trial.
    El fármaco en estudio lebrikizumab es sólo para uso experimental y no esta aprobado para su uso en el momento de la realización de este estudio. Hay otros tratamientos disponibles para tratar el asma. No hay planes para continuar el tratamiento bajo la supervisión de lebrikizumab o médica de los pacientes después de la final del estudio. Las decisiones relativas al cuidado del paciente se quedará con el médico de los pacientes el tratamiento después de la finalización del ensayo
    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 Decision2012-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed Apr 24 09:10:49 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA