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    Summary
    EudraCT Number:2013-001163-24
    Sponsor's Protocol Code Number:GB28547
    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:2013-11-06
    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 number2013-001163-24
    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 IDIOPATHIC PULMONARY FIBROSIS.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis.
    A.4.1Sponsor's protocol code numberGB28547
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01872689
    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.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 ESBRIET
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPIRFENIDONE
    D.3.9.1CAS number 53179-13-8
    D.3.9.2Current sponsor codeRO0220912
    D.3.9.4EV Substance CodeSUB09907MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number267
    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
    IDIOPATHIC PULMONARY FIBROSIS
    E.1.1.1Medical condition in easily understood language
    IDIOPATHIC PULMONARY FIBROSIS
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    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 lebrikizumab compared with placebo as monotherapy or as combination therapy with pirfenidone background compared with placebo in patients with IPF, as measured by the annualized rate of decline in percent predicted forced vital capacity (FVC) over 52 weeks.
    E.2.2Secondary objectives of the trial
    •To evaluate lebrikizumab compared with placebo as monotherapy or as combination therapy with pirfenidone background therapy compared with placebo in patients with IPF as measured by:
    oEfficacy on the basis of progression free survival (PFS), pulmonary function, diffusion capacity, non elective hospitalization for any cause, acute IPF exacerbation, proportion of patients with at least 10% decline in percent predicted FVC or death, and all cause death
    oThe distance walked in 6 minutes and health-related quality of life questionnaires
    •To evaluate the safety of lebrikizumab as monotherapy compared with placebo in patients with IPF
    •To evaluate the safety of lebrikizumab with pirfenidone as background therapy compared with placebo with pirfenidone as background therapy in patients with IPF
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patient, >/= 40 years of age
    - Have a diagnosis of IPF according to the 2011 ATS/ERS/JRS/ALAT consensus statement on IPF within the previous 5 years from time of screening and confirmed at baseline
    - Forced vital capacity (FVC) >/= 40% and </=100% predicted at screening
    - Stable baseline lung function as evidenced by a difference of < 10% in FVC (L) measurements between screening and Day 1, Visit 2 prior to randomization
    - Diffusion capacity of the lung for carbon monoxide >/= 25% and </= 90% predicted at screening
    - Ability to walk >/= 100 meters unassisted in 6 minutes.
    - Cohort A (monotherapy): No background IPF therapy for >=4 weeks allowed prior to randomization and throughout the placebo controlled study period
    - Cohort B (combination therapy): Tolerated dose of pirfenidone <=2403 milligrams/once daily (mg/QD) for >=4 weeks required prior to randomization and throughout the placebo controlled study period
    E.4Principal exclusion criteria
    - History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
    - Evidence of other known causes of interstitial lung disease (ILD)
    - Lung transplant expected within 12 months of screening
    - Evidence of clinically significant lung disease other than IPF
    - Post bronchodilator forced expiratory volume in 1 second (FEV1)/FVC ratio < 0.7 at screening
    - Positive bronchodilator response, evidenced by an increase of >/= 12% predicted and 200 mL increase in FEV1 or FVC
    - Class IV New York Heart Association chronic heart failure or historical evidence of left ventricular ejection fraction < 35%
    - Hospitalization due to an exacerbation of IPF within 4 weeks prior to or during screening
    - Known current malignancy or current evaluation for potential malignancy
    - An active upper or lower respiratory tract infection occurring at any time within the screening period prior to the randomization visit
    - Listeria monocytogenes infection or active parasitic infections within 6 months prior to Day 1, Visit 2.
    - Active tuberculosis requiring treatment within 12 months of screening
    - Known immunodeficiency, including but not limited to HIV infection
    - Past use of any anti-IL-13 or anti-IL-14/IL-13 therapy, including lebrikizumab
    - Evidence of acute or chronic hepatitis or known liver cirrhosis
    - Chronic treatment with pirfenidone within 4 weeks or five half lives prior to screening (whichever is longer) to the end of the placebo-controlled period (Day 365/Visit 16)(limited to Cohort A)
    - For Cohort B: Known achalasia, esophageal stricture, or esophageal dysfunction sufficient to limit the ability to swallow oral medication; Tobacco smoking or use of tobacco-related products within 3 months of screening or unwillingness to avoid smoking thoughout the study; any condition that, as assessed by the investigator, might be significantly exacerbated by the known side effects associated with pirfenidone; known or suspected peptic ulcer; use of strong CYP1A2 inhibitors (eg, fluvoxamine or enoxacin) or moderate CYP1A2 inducers (limited to tobacco smoking and tobacco related products) within 4 weeks of randomization or during the study
    E.5 End points
    E.5.1Primary end point(s)
    Annualized rate of decrease in percent predicted FVC over 52 weeks (% FVC/year)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to Week 52
    E.5.2Secondary end point(s)
    1. Progression-free survival
    2. Annualized rate of decrease in pulmonary function (FVC) over a 52 week period (mL/year)
    3. Time from randomization to first occurrence of a of >= 10% absolute decline in percent predicted FVC or death from any cause
    4. Annualized rate of decrease in percent predicted in diffusion capacity of the lung for carbon monoxide over 52 weeks
    5. Annualized rate of decrease in ATAQ IPF total score over a 52 week period
    6. Time from randomization to non-elective hospitalization or death from any cause
    7. Annualized rate of decline in six minute walk test distance over 52 weeks
    8. Time from randomization to first event of acute IPF exacerbation
    9. Time from randomization to first occurrence of the St. George’s Respiratory Questionnaire (SGRQ) worsening
    10. Safety: Incidence of adverse events

    E.5.2.1Timepoint(s) of evaluation of this end point
    1-9. Up to Week 52
    10. Up to 2.9 years
    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
    pirfenidone titration run-in period for cohort B/ combination therapy
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Belgium
    Canada
    France
    Germany
    Italy
    Japan
    Mexico
    Peru
    Poland
    Spain
    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
    'LVLS'
    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 months9
    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 months11
    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: 105
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 375
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 155
    F.4.2.2In the whole clinical trial 480
    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-study access to the study drug lebrikizumab and/or pirfenidone free of charge to eligible patients 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 Decision2013-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-06
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