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    Summary
    EudraCT Number:2008-007844-33
    Sponsor's Protocol Code Number:CAT-354-MI-CP199
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-08-28
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2008-007844-33
    A.3Full title of the trial
    A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study to Evaluate the Efficacy and Safety of CAT-354, a Fully Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), on Asthma Control in Adults with Uncontrolled, Moderate-to-severe, Persistent Asthma
    A.4.1Sponsor's protocol code numberCAT-354-MI-CP199
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMedImmune Limited
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameCAT-354
    D.3.2Product code CAT-354
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNN/A
    D.3.9.1CAS number 1044515-88-9
    D.3.9.2Current sponsor codeCAT-354
    D.3.9.3Other descriptive nameN/A
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 typeIgG4 Engineered Human Monoclonal Antibody
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the effect of three SC treatment regimens of CAT-354 on asthma control at Study Day 92 versus placebo in adults with uncontrolled, moderate-to-severe, persistent asthma.
    E.2.2Secondary objectives of the trial
    1) Evaulate the effect on the safety profile in this subject population;
    2) Evaluate the effect on the time to asthma control through Study Days 92 and 169;
    3) Evaluate the effect on the proportion of subjects achieving a change from baseline in ACQ score consistent with well controlled and partly controlled asthma;
    4) Evaluate the effect on the time to first asthma exacerbation;
    5) Evaluate the effect on asthma exacerbation rates and severity (hospitalizations);
    6) Evaluate the effect on the variability of airflow obstruction using parameters of forced expiratory volume within 1 second (FEV1) and peak expiratory flow (PEF);
    7) Evaluate the effect on a subject's requirement for concomitant asthma controller or rescue medications;
    8) Evaluate the effect on the patient reported outcomes including health-related quality of life using the AQLQ(S) and the patient global impression of change;
    9) PK and immunogenicity of SC CAT-354.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male or female subjects.
    2) Age 18 to 65 years at the time of screening.
    3) Subjects must have a body mass index (BMI) between 18 and 40 kg/m2.
    4) Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
    5) Physician-diagnosed moderate-to-severe, persistent asthma requiring treatment with appropriate asthma controller medication.
    6) Shows FEV1 reversibility postbronchodilator of ≥ 12% and ≥ 200 mL or have shown such values in a previous test within the last year, or have a positive AHR test result in the last year.
    7) Pre-bronchodilator FEV1 value ≥ 40% of individual predicted value at Visits 1 and 3.
    8) Uncontrolled asthma consistent with Expert Panel Report (EPR)-3. In the 2 to 4 weeks preceding screening, subjects should have a history of one or more of the following: (i) Daytime asthma symptoms ≥ 2 days/week; (ii) Nighttime awakening ≥ 1 night/week; (iii) Salbutamol use ≥ 2 days/week.
    9) An ACQ score ≥ 1.5 at Visits 1 and 3.
    10) At least one occurrence of asthma exacerbation in the past year that required an unscheduled medical encounter.
    11) Women of child-bearing potential, unless surgically sterile (including tubal ligation) and/or at least 2 years postmenopausal must have a negative pregnancy test prior to the first dose of investigational product, and must agree to use 2 effective methods of avoiding pregnancy (including oral, injectable, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, use of condom by male sexual partner); or abstinence or sterile sexual partner from screening through Study Day 169. Women of childbearing potential must continue to practice birth control during the study and for at least 2 months after completing the study.
    12) Men, unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide) and must use such precautions from Study Day 1 through Study Day 169.
    13) Otherwise healthy by medical history and physical examination for that age group.
    14) A chest x-ray or CT scan within the previous 12 months before entering the study with no findings suggestive of acute or chronic respiratory pathology other than asthma.
    15) Ability and willingness to complete the follow-up period until Study Day 169 as required by the protocol.
    E.4Principal exclusion criteria
    1) Known history of allergy or reaction to any component of the investigational product formulation.
    2) Acute illness other than asthma at the start of the study.
    3) History of an active infection within 4 weeks prior to screening, or evidence of clinically significant active infection, including ongoing chronic infection.
    4) History of ingestion of untreated water in a location known to be infected with parasites, resulting in acute or chronic diarrhea; or a diagnosis of parasitic infection within 6 months prior to screening.
    5) Use of immunosuppressive medication (except oral prednisone up to 10 mg/day and inhaled and topical corticosteroids) within 30 days before randomization into the study.
    6) Receipt of immunoglobulin or blood products within 30 days before randomization into the study.
    7) Receipt of any investigational drug therapy or use of any biologicals including omalizumab within 6 months before the first dose of investigational product in this study or within 5 half-lives of an investigational agent or biologic, whichever is longer.
    8) History of any known immunodeficiency disorder.
    9) A positive hepatitis B surface antigen, or hepatitis C virus antibody, as determined by medical history and/or subject's verbal report.
    10) A positive human immunodeficiency virus test or is taking antiretroviral medications, as determined by medical history and/or subject's verbal report.
    11) A live or attenuated vaccination received within 4 weeks prior to screening.
    12) Previous medical history, or evidence, of an intercurrent illness that may compromise the safety of the subject in the study.
    13) History of clinically significant abnormality on electrocardiogram (ECG) in the opinion of the investigator.
    14) Lactation (women).
    15) History of treatment for alcohol or drug abuse within the past year.
    16) History suggestive of chronic obstructive pulmonary disease (COPD) and of cigarette smoking ≥ 10 pack-years.
    17) Evidence of any systemic disease on physical examination.
    18) History of cancer, apart from basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≤ 1 year prior to Study Day 1 or other malignancies treated with apparent success with curative therapy ≤ 5 years prior to entry.
    19) Known exposure to inhaled occupational agents or fumes.
    20) Any condition (eg, cystic fibrosis [CF] or COPD) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of study results.
    21) Individuals who are legally institutionalized.
    22) Employees of the clinical study site or any other individuals involved with the conduct of the study, or family members of such individuals.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from baseline in the mean ACQ score at Study Day 92.
    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 Yes
    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.8.3 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    Last subject last visit
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 state144
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 192
    F.4.2.2In the whole clinical trial 192
    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)
    Local standard of care
    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 Decision2009-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-08-03
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