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    Summary
    EudraCT Number:2011-004205-24
    Sponsor's Protocol Code Number:GB27864
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-05-15
    Trial 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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2011-004205-24
    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.
    Fáza III randomizovanej, dvojito zaslepenej, placebom kontrolovanej štúdie na vyhodnotenie účinnosti a bezpečnosti lebrikizumabu u pacientov s nekontrolovanou astmou, ktorí užívajú inhalačné kortikosteroidy a druhý kontrolujúci liek
    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.
    A.3.2Name or abbreviated title of the trial where available
    Verse
    A.4.1Sponsor's protocol code numberGB27864
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01545453
    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.
    E.1.1.1Medical condition in easily understood language
    Uncontrolled asthma despite daily therapy.
    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.
    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 β-agonists [SABA]), and health care utilization.
    E.2.3Trial contains a sub-study No
    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.
    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.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of asthma exacerbations.
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks
    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 concerned4
    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 of study treatment.
    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 state60
    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.
    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 Decision2012-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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