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    Summary
    EudraCT Number:2015-001122-42
    Sponsor's Protocol Code Number:WB29804
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-09-16
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-001122-42
    A.3Full title of the trial
    A Phase II, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lebrikizumab in patients with chronic obstructive pulmonary disease and a history of exacerbations
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Lebrikizumab in Patients with Chronic Obstructive Pulmonary Disease
    A.4.1Sponsor's protocol code numberWB29804
    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/ city4070
    B.5.3.3Post codeBasel
    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
    Chronic Obstructive Pulmonary Disease (COPD)
    E.1.1.1Medical condition in easily understood language
    COPD is a chronic lung disease that is often due to smoking. COPD makes it hard to breathe
    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 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    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 efficacy of lebrikizumab compared with placebo in improving lung function, as measured by the absolute change in pre-bronchodilator forced expiratory volume in one second (FEV1) in patients with COPD and a history of exacerbations in the biomarker-high group (elevated serum periostin and blood eosinophils) and biomarker low group.
    E.2.2Secondary objectives of the trial
    • To evaluate in the biomarker high and biomarker-low groups the rate of moderate and severe COPD exacerbations, change in post-bronchodilator FEV1, time to first exacerbation, and change in health-related quality of life and change in symptoms as measured by the Saint George’s Respiratory Questionnaire for COPD patients (SGRQ-C), EXAcerbations of Chronic Pulmonary Disease Tool (EXACT), and Baseline Dyspnea Index/Transition Dyspnea Index (BDI/TDI)
    • To evaluate the safety of lebrikizumab compared with placebo in patients with COPD and a history of exacerbations, focusing on the nature, frequency, and severity of serious and non-serious adverse events
    • To evaluate serum lebrikizumab concentrations and PK parameters in patients with COPD and a history of exacerbations
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Computed Tomography Substudy in association with Lebrikizumab : A phase II, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of Lebrikizumab in patients with COPD and a history of exacerbations.

    Date: 30-Sep-2015

    Version: 1

    Objectives:
    To evaluate the effect of lebrikizumab compared with placebo on the following airway and lobar volume parameters as measured by computerized tomography (CT) scan:
    • Change in airway wall thickness at total lung capacity (TLC) from baseline to Week 24
    • Change in airway resistance at functional residual capacity (FRC) and TLC from baseline to Week 24
    • Changes in lobar volume at FRC and TLC from baseline to Week 24
    • Changes in airway volume at FRC and TLC from baseline to Week 24
    • Change in air trapping at FRC from baseline to Week 24
    • Change in low attenuation score at TLC from baseline to Week 24
    • The correlation between physiological (FEV1) and functional changes will be explored, if appropriate
    E.3Principal inclusion criteria
    - Age 40−80 years old at Visit 1
    - Able and willing to use the electronic device for patient-reported data collection
    - Documented history of COPD diagnosis for >=12 months prior to Visit 1
    - Post-bronchodilator FEV1/forced vital capacity (FVC) <0.70 at Visit 1 or Visit 2
    - Post-bronchodilator FEV1 <80% predicted at Visit 1 or Visit 2
    - Documented history of one or more acute COPD exacerbations that required treatment with systemic corticosteroids and/or antibiotics or hospitalization within 12 months prior to Visit 1
    - Current tobacco smoker or former smoker (having stopped smoking for at least 6 months prior visit 1) with a history of smoking >=10 pack-years (20 cigarettes/day for 10 years)
    - On inhaled corticosteroids therapy for >=6 months prior to Visit 1
    - On an eligible bronchodilator medication for >=6 months prior to Visit 1
    - Chest X-ray or computed tomography scan within 3 months prior to Visit 1 or chest X-ray during the screening period (prior to Visit 2) that confirms the absence of clinically significant lung disease besides COPD
    - Demonstrated adherence with background COPD inhaler medication during the screening period.
    - For women who are not postmenopausal (>= 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year for the duration of the study
    E.4Principal exclusion criteria
    - History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
    - History of clinically significant pulmonary disease other than COPD
    - Diagnosis of alpha-1-antitrypsin deficiency
    - Lung volume reduction surgery or procedure within 12 months prior to Visit 1
    - Supplemental oxygen requirement >2 Liter/minute at rest or with exertion
    - Current diagnosis of asthma
    - Patients participating in, or scheduled for, an intensive COPD rehabilitation program
    - Maintenance oral corticosteroid therapy, defined as daily or alternate-day oral corticosteroid maintenance therapy, within 3 months prior to Visit 1
    - Treatment with systemic corticosteroids within 4 weeks prior to Visit 1 or during the screening period for any reason, including an acute exacerbation event
    - Unstable ischemic heart disease, arrhythmia, cardiomyopathy, or other relevant cardiovascular disorder that, in the opinion of the investigator, may put the patient at risk or negatively affect the study outcome
    - Any infection that resulted in hospital admission for >=24 hours and/or treatment with oral, intravenous (IV), or intramuscular (IM) antibiotics within 4 weeks prior to Visit 1 or during screening
    - Active tuberculosis requiring treatment within 12 months prior to Visit 1. Patients who have completed treatment for tuberculosis at least 12 months prior to Visit 1 and have no evidence of recurrent disease are permitted.
    - Known immunodeficiency, including, but not limited to, HIV infection
    - Evidence of acute or chronic hepatitis or known liver cirrhosis
    - Aspartate transaminase, Alanine transaminase, or total bilirubin elevation >=2.0 × the upper limit of normal (ULN) during screening
    - Clinically significant abnormality on screening electrocardiogram or laboratory tests (hematology, serum chemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the patient
    - Known current malignancy or current evaluation for a potential malignancy
    - Other 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 efficacy or safety assessments
    - History of alcohol or drug abuse that would impair or risk the patient’s full participation in the study, in the opinion of the investigator
    - Past and/or current use of any anti–interleukin 13 (IL-13) or anti–IL-4/IL-13 therapy, including lebrikizumab.
    - Treatment with an immunomodulatory or immunosuppressive monoclonal antibody within 6 months or 5 drug half-lives prior to Visit 1 or during screening
    - Use of an immunomodulatory or immunosuppressive therapy within 3 months or 5 drug half-lives prior to Visit 1 or during screening
    - Use of other investigational therapy not described above within 4 weeks or 5 drug half-lives prior to Visit 1 or during screening
    - Receipt of a live attenuated vaccine within 4 weeks prior to Visit 1 or during screening
    - Pregnant or lactating
    - Body weight <40 kilogram
    E.5 End points
    E.5.1Primary end point(s)
    Absolute change in pre-bronchodilator FEV1 (liters) from Baseline to Week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 12
    E.5.2Secondary end point(s)
    1. Rate of moderate/severe COPD exacerbations during the 24-week placebo-controlled period
    2. Absolute change in post-bronchodilator FEV1 (liters) from Baseline to Week 24
    3. Absolute change in pre-bronchodilator FEV1 (liters) from Baseline to Week 24
    4. Time to first COPD exacerbation during the 24-week placebo-controlled period
    5. Change in health-related quality of life, as assessed by the overall score of the SGRQ-C, from Baseline to Week 24
    6. Change in COPD symptoms as measured by the overall score on the EXACT from Baseline to Week 24
    7. Change in cough and sputum as measured by the cough and sputum domain of the EXACT from Baseline to Week 24
    8. Change in dyspnea, as assessed by the BDI/TDI from Baseline to Week 24
    9. Frequency and severity of adverse events during the 24-week placebo-controlled period
    10. Incidence of Anti-therapeutic antibody against lebrikizumab throughout the study
    11. Frequency and severity of adverse events during the safety follow-up period
    12. Predose trough (minimum concentration [Cmin]) serum lebrikizumab concentrations at Weeks 4 and Week 12 (Cmin, Week 4 and Cmin, Week 12)
    13. Serum lebrikizumab concentration at Week 24 (Cmin, Week 24)
    14. Elimination half-life (t1/2)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Upto 24 weeks
    2. Baseline to Week 24
    3. Baseline to Week 24
    4. Upto 24 weeks
    5. Baseline to Week 24
    6. Baseline to Week 24
    7. Baseline to Week 24
    8. Baseline to Week 24
    9. Upto 24 weeks
    10. Upto 36 weeks
    11. Week 25 to Week 36
    12. At Week 4 and Week 12
    13. At Week 24
    14. Week 24 to Week 36
    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 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 EEA19
    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
    Bulgaria
    Canada
    Denmark
    Hungary
    Mexico
    Poland
    Russian Federation
    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 years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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: 250
    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 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 2015-09-16. 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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    F.4.2.2In the whole clinical trial 300
    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)
    Currently, the Sponsor does not have any plans to provide lebrikizumab or any other study treatments or interventions to patients who have completed the study. The Sponsor will evaluate whether to continue providing lebrikizumab in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product.
    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 Decision2015-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-17
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