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    The EU Clinical Trials Register currently displays   36835   clinical trials with a EudraCT protocol, of which   6081   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-000275-14
    Sponsor's Protocol Code Number:GB29260
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-14
    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 ConcernedUK - MHRA
    A.2EudraCT number2014-000275-14
    A.3Full title of the trial
    A Phase II, randomized, double-blind, placebo-controlled bronchoscopy study to evaluate the effects of Lebrikizumab on airway eosinophilic inflammation in patients with uncontrolled asthma on inhaled corticosteroids and a second controller medication
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Evaluating the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Patients with Uncontrolled Asthma.
    A.4.1Sponsor's protocol code numberGB29260
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02099656
    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/F01-02
    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 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 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
    Asthma
    E.1.1.1Medical condition in easily understood language
    Asthma
    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 18.1
    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
    To evaluate the effect of lebrikizumab in reducing airway eosinophilic inflammation, as measured by a relative change in the number of airway submucosal eosinophils per surface area of basal lamina (cells/mm2) obtained via endobronchial biopsy.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of lebrikizumab on airway eosinophilic inflammation, as measured by:- absolute change in the number of airway submucosal eosinophils per surface area of basal lamina (cells/mm2) obtained via endobronchial biopsy- relative and absolute changes in the number of airway epithelial eosinophils per surface area of basal lamina (cells/mm2) obtained via endobronchial biopsy- relative and absolute changes in number of airway submucosal eosinophils per volume of submucosa (cells/mm3) obtained via endobronchial biopsy- relative and absolute changes in number of airway epithelial eosinophils per volume of epithelium (cells/mm3) obtained via endobronchial biopsy.
    To evaluate the effect of lebrikizumab on serum periostin, IL-13-related and asthma-related (airway and blood) biomarkers including fractional exhaled nitric oxide (FeNO.)
    To evaluate the efficacy of lebrikizumab, as measured by the relative change in prebronchodilator forced expiratory volume in 1 second (FEV1).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    MINIMALLY-INVASIVE AIRWAY BIOMARKER SUBSTUDY IN ASSOCIATION WITH LEBRIKIZUMAB STUDY GB29260: A PHASE II, RANDOMIZED, DOUBLE‑BLIND, PLACEBO-CONTROLLED BRONCHOSCOPY STUDY TO EVALUATE THE EFFECTS OF LEBRIKIZUMAB ON AIRWAY EOSINOPHILIC INFLAMMATION IN PATIENTS WITH UNCONTROLLED ASTHMA ON INHALED CORTICOSTEROIDS AND A SECOND CONTROLLER MEDICATION

    version 2, 29 September 2015

    The objectives of this substudy are considered exploratory and are as follows:
    •To evaluate the effect of lebrikizumab in reducing sputum eosinophils
    •To evaluate the effects of lebrikizumab on asthma pathway related biomarkers in nasal mucosal lining fluid (MLF)
    •To evaluate serum, sputum, and nasal MLF lebrikizumab concentrations, if feasible
    •To evaluate the ability of serum periostin, fractional exhaled nitrous oxide (FeNO), and blood eosinophil counts to predict the effect of lebrikizumab on sputum eosinophils
    •To evaluate the ability of serum periostin, FeNO and blood eosinophil counts to predict the effect of lebrikizumab on asthma pathway related biomarkers in nasal MLF
    •To compare asthma pathway related biomarkers in nasal MLF with those obtained via endobronchial biopsy
    E.3Principal inclusion criteria
    - Age 18-75 years old at study start
    - Asthma diagnosis for >/= 12 months prior to study start
    - Documented Bronchodilator Reversibility within past 12 months or during screening
    - Pre-bronchodilator FEV1 of 40% - 80% predicted at both screening visits 2 and 3
    - On ICS therapy at a total daily dose of 500-2000 ug of fluticasone propionate dry powder inhaler (DPI) or equivalent for >/= 6 months prior to study start, with no changes within 4 weeks prior, and no anticipated changes throughout the study
    - On an eligible second controller medication (LABA, LTRA, LAMA, or theophylline) for 6 months prior to study start, with no changes within 4 weeks prior, and no anticipated changes throughout the study
    - Uncontrolled asthma at screenings visits 1 and/or 2, and at visit 3
    - Chest X-ray or computed tomography (CT) scan within 12 months prior to Visit 1 or chest X-ray during the screening period that confirms the absence of other clinically significant lung disease
    - Demonstrated adherence with controller medication during the screening period
    - Use of effective contraception, as defined by the protocol, until 24 weeks after the last dose
    E.4Principal exclusion criteria
    - Maintenance oral corticosteroid therapy, defined as daily or alternate-day oral corticosteroid maintenance therapy within 3 months prior to study start
    - Treatment with systemic corticosteroids within 4 weeks prior to study start or during the screening period for any reason
    - Any infection requiring hospital, IV or IM antibiotic treatment or any respiratory infection within 4 weeks of study start or during screening. Any infection requiring oral antibiotic treatment with 2 weeks of study start, or any parasitic infection within 6 months of study start or during screening
    - Active tuberculosis requiring treatment within 12 months prior to study start or during screening
    - Known immunodeficiency, including, but not limited to, HIV infection
    - History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma
    - Known current malignancy or current evaluation for a potential malignancy
    - Unable to safely undergo elective flexible fiberoptic bronchoscopy
    - Clinically significant abnormality found during screening or clinically significant medical disease that is uncontrolled despite treatment, that is likely, in the opinion of the investigator, to impact the patient's ability to participate in the study, or impact the study assessments
    - History of alcohol or drug abuse that would impair or risk the patients full participation in the study, in the opinion of the investigator
    - Current or history of smoking ( > 10 pack-years), or unwillingness to abstain from smoking for the duration of the study
    - Past and/or current use of any anti-IL-13 or anti-IL-4/IL-13 therapy, including lebrikizumab
    - Use of a licensed or investigational monoclonal antibody other than anti-IL-13 or anti-IL-4/IL-13, including, but not limited to, omalizumab, anti-IL-5, or anti-IL-17, within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening
    - Use of a systemic immunomodulatory or immunosuppressive therapy within 3 months or 5 drug half-lives prior to study start or during screening
    - Use of other investigational therapy within 4 weeks or 5 drug half-lives prior to study start (whichever is longer) or during screening
    - Initiation of or increase in allergen immunotherapy within 3 months prior to study start or during screening
    - Body mass index > 38 kg/m2
    - Body weight < 40 kg
    - History of bronchial thermoplasty
    E.5 End points
    E.5.1Primary end point(s)
    Relative change in number of airway submucosal eosinophils per surface area of basal lamina (cells/mm2)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline to Week 12
    E.5.2Secondary end point(s)
    1. Absolute change in number of airway submucosal eosinophils per surface area of basal lamina (cells/mm2)
    2. Relative change in the number of airway epithelial eosinophils per surface area of basal lamina (cells/mm2)
    3. Absolute change in the number of airway epithelial eosinophils per surface area of basal lamina (cells/mm2)
    4. Relative change in number of airway submucosal eosinophils per volume of submucosa (cells/mm3)
    5. Absolute change in number of airway submucosal eosinophils per volume of submucosa (cells/mm3)
    6. Relative change in number of airway epithelial eosinophils per volume of epithelium (cells/mm3)
    7. Absolute change in number of airway epithelial eosinophils per volume of epithelium (cells/mm3)
    8. Changes in asthma-related biomarkers
    9. Change in lung epithelial cell gene expression
    10. Relative change in fractional exhaled nitric oxide (FeNO)
    11. Relative change in forced expiratory volume in 1 second (FEV1)
    12. Incidence of adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 to 11. From Baseline to Week 12
    12. Up to week 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 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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Ireland
    Sweden
    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'
    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 months29
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial months31
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 21
    F.4.2.2In the whole clinical trial 80
    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)
    Roche will evaluate the appropriateness of continuing to provide lebrikizumab to study patients after the study is completed.
    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 Decision2014-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-13
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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