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    Summary
    EudraCT Number:2011-001360-21
    Sponsor's Protocol Code Number:D2210L00001(CD-RI-CAT-354-1049)
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-17
    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 ConcernedGermany - PEI
    A.2EudraCT number2011-001360-21
    A.3Full title of the trial
    A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults with Uncontrolled, Severe Asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to investigate the effects of tralokinumab, a drug used in clinical research, in adults with uncontrolled, severe asthma, a disease that causes variable and recurring inflammation of the airways leading to difficulty in breathing.
    A.4.1Sponsor's protocol code numberD2210L00001(CD-RI-CAT-354-1049)
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportMedImmune Ltd
    B.4.2CountryCzech Republic
    B.4.1Name of organisation providing supportMedImmune Ltd
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportMedImmune Ltd
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportMedImmune Ltd
    B.4.2CountryPoland
    B.4.1Name of organisation providing supportMedImmune Ltd
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportMedImmune Ltd
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportMedImmune Ltd
    B.4.2CountryRussian Federation
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Centre
    B.5.3 Address:
    B.5.3.1Street AddressPepparedsleden 1
    B.5.3.2Town/ cityMölndal
    B.5.3.3Post codeSE-431 83
    B.5.3.4CountrySweden
    B.5.6E-mailinformation.centre@astrazeneca.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 nametralokinumab
    D.3.2Product code CAT-354
    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 INNtralokinumab
    D.3.9.1CAS number 1044515-88-9
    D.3.9.2Current sponsor codeCAT-354
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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
    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 Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    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 two SC treatment regimens of 300 mg tralokinumab compared with placebo by assessing the effect on asthma exacerbation rate over 52 weeks in adults with uncontrolled, severe asthma requiring high-dose ICS and LABA with or without additional asthma controller medications.
    E.2.2Secondary objectives of the trial
    1) To evaluate the safety and tolerability of tralokinumab.
    2) To evaluate the effect of tralokinumab on pulmonary function: clinic spirometry,
    including pre- and post-bronchodilator FEV1, forced expiratory volume in 6 seconds
    (FEV6), FVC, inspiratory capacity (IC); and PEF and FEV1 measured at home.
    3) To evaluate the effect of tralokinumab on Patient Reported Outcomes: Asthma
    Control Questionnaire (6-item version; ACQ-6) score, HRQoL using Asthma Quality
    of Life Questionnaire Standardised Version (AQLQ[S]), and EQ-5D.
    4) To evaluate the effect of tralokinumab on asthma symptoms using the Assessing
    Symptoms of Moderate-to-severe Asthma (ASMA) diary and use of rescue
    medication.
    5) To describe the pharmacokinetics (PK) and immunogenicity of tralokinumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Age 18-75 years of age at the time of screening (Visit 1).
    2) Written informed consent
    3) Body mass index (BMI) between 16-40 kg/m2 at Visit 1.
    4) Documented physician-diagnosed asthma for at least 12 months prior to Visit 1 and
    EITHER
    - Proof of postbronchodilator reversibility of FEV1 ≥ 12% and ≥ 200 mL to a SABA documented within 36 months prior to Visit 1; OR
    - Proof of a positive response to a methacholine (PC20 ≤ 8 mg/mL), histamine or mannitol challenge documented within 36 months prior to Visit 1; OR
    - A postbronchodilator increase in FEV1 ≥ 12% and ≥ 200 mL at Visit 1.
    5) Subjects must have received an asthma controller regimen consistent with that described at Step 4 or 5 of the GINA guidelines (GINA, 2009) for at least 6 of the 12 months prior to Visit 1 and must have used physician prescribed high-dose ICS in combination with LABA for at least 30 days prior to Visit 1
    6) For subjects receiving an alternative combination of ICS/LABA prior to Visit 1, a willingness to switch to fluticasone/salmeterol either as a DPI at a dose of 500/50 μg, one inhalation twice per day, or as an MDI 250 μg/25 μg (delivered dose 220 μg/21 μg), 2 inhalations twice per day, once eligibility has been confirmed at Visit 2.
    7) Where applicable, the dose of other asthma controller medications (leukotriene modifiers, theophylline, secondary ICS, OCS, or cromones) must have been stable for at least 30 days prior to Visit 1.
    8) Subjects must have a history of at least 2 but no more than 6 documented asthma exacerbation events within the 12 months prior to Visit 1.
    9) At both Visits 1 and 4, subjects must have at least one of the following; a morning prebronchodilator FEV1 value of between 40% and 80% predicted or an ACQ-6 score for the preceding week of ≥ 1.5.
    10) A chest x-ray taken during the screening period or within the 12 months before Visit 1 that, according to the investigator, is normal for an asthmatic subject and excludes significant alternative respiratory disease.
    11) Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception from screening, and must agree to continue using such precautions through Week 75 of the study.
    - A highly effective method of contraception is defined as one that results in a low failure rate (ie, less than 1% per year) when used consistently and correctly.
    12) Nonsterilized males or sterilized males who are ≤ 1 year post-vasectomy who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception (see Table 4.2.1-1) from Day 1 through Week 75.
    E.4Principal exclusion criteria
    1) Employee of the clinical study site or any other individuals directly involved with the conduct of the study, or immediate family members of such individuals.
    2) Pregnant or breastfeeding women.
    3) Individuals who are legally institutionalized.
    4) Subjects unable to demonstrate acceptable inhaler and peak flow meter/spirometry techniques as judged by the investigator.
    5) Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product.
    6) Concurrent enrollment in another clinical study where the subject is receiving an investigational product.
    7) Previous receipt of tralokinumab.
    8) Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives prior to Visit 1, whichever is longer
    9) Receipt of any investigational nonbiologic agent within 3 months or 5 half-lives prior to Visit 1, whichever is longer
    10) Subjects who have received a live attenuated vaccine within 4 weeks prior to Visit 1.
    11) Use of systemic immunosuppressive medication within 3 months prior to Visit 1.
    12) Current use of any excluded medications listed in Section 4.6.2 of protocol.
    13) Occurrence of an asthma exacerbation event requiring a burst of systemic corticosteroids from 30 days prior to Visit 1, up to and including Visit 4.
    14) Known history of allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy.
    15) Known exposure to inhaled occupational agents or fumes with an established diagnosis of occupational asthma.
    16) Current tobacco smoking (smoking must have stopped for ≥ 3 months prior to screening) or a history of tobacco smoking ≥ 10 pack-years.
    17) Previous medical history or evidence of an uncontrolled intercurrent illness that in the opinion of the investigator and/or medical monitor may compromise the safety of the subject in the study or interfere with evaluation of the investigational product or reduce the subject’s ability to participate in the study.
    18) Any clinically relevant abnormal findings in physical examination, electrocardiogram (ECG), vital signs, hematology, clinical chemistry, or urinalysis during screening/runin period, which in the opinion of the investigator or medical monitor may compromise the safety of the subject in the study or interfere with evaluation of the investigational product or reduce the subject’s ability to participate in the study.
    19) Evidence of active liver disease, including jaundice or aspartate transaminase, alanine transaminase, or alkaline phosphatase greater than twice the upper limit of normal.
    20) History of a clinically significant infection from 30 days prior to Visit 1, up to and including Visit 4.
    21) Subjects who in the opinion of the investigator have evidence of active TB, either treated or untreated, or latent TB without completion of an appropriate course of treatment or appropriate ongoing prophylactic treatment.
    22) A history of an untreated systemic helminth parasitic infestation; diagnosis of a helminth parasitic infestation within 6 months prior to Visit 1; history of living with a person known to have had a helminth parasitic infestation within 12 months prior to Visit 1.
    23) History of chronic alcohol or drug abuse within 12 months of Visit 1, or any condition associated with poor compliance as judged by the investigator.
    24) History of any known primary immunodeficiency disorder excluding asymptomatic selective immunoglobulin A or immunoglobulin G (IgG) subclass deficiency.
    25) History of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≥ 12 months prior to screening or other malignancies treated with apparent success with curative therapy ≥ 5 years prior to screening.
    26) Positive hepatitis B surface antigen or hepatitis C virus antibody serology. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enrol.
    27) A positive human immunodeficiency virus (HIV) test at screening or subject taking antiretroviral medications, as determined by medical history and/or subject’s verbal report.
    28) Major surgery within 8 weeks prior to Visit 1, or planned in-patient surgery or hospitalisation during the study period.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to evaluate the effect of two SC treatment regimens of
    300 mg tralokinumab compared with placebo by assessing the asthma exacerbation rate over
    52 weeks in adults with uncontrolled, severe asthma requiring high-dose ICS and LABA with
    or without additional controller medications.
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    E.5.2Secondary end point(s)
    1) To evaluate the safety and tolerability of tralokinumab.
    2) To evaluate the effect of tralokinumab on pulmonary function: clinic spirometry,
    including pre- and post-bronchodilator FEV1, forced expiratory volume in 6 seconds
    (FEV6), FVC, inspiratory capacity (IC); and PEF and FEV1 measured at home.
    3) To evaluate the effect of tralokinumab on Patient Reported Outcomes: Asthma
    Control Questionnaire (6-item version; ACQ-6) score, HRQoL using Asthma Quality
    of Life Questionnaire Standardised Version (AQLQ[S]), and EQ-5D.
    4) To evaluate the effect of tralokinumab on asthma symptoms using the Assessing
    Symptoms of Moderate-to-severe Asthma (ASMA) diary and use of rescue
    medication.
    5) To describe the pharmacokinetics (PK) and immunogenicity of tralokinumab.
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks. Safety follow up at 74 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 Yes
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 EEA30
    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
    Brazil
    Canada
    Chile
    Czech Republic
    France
    Germany
    Korea, Republic of
    Mexico
    Philippines
    Poland
    Russian Federation
    Spain
    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
    The end of the study (“study completion”) is defined as the date of the last protocol-specified visit/assessment (including telephone contact) for the last subject in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    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 months6
    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: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state37
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 390
    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)
    No plans that are different from the expected normal treatment for the condition.
    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 Decision2011-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-22
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