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    Summary
    EudraCT Number:2012-001791-11
    Sponsor's Protocol Code Number:KB003-04
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-09-04
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2012-001791-11
    A.3Full title of the trial
    A Phase 2, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of KB003 in Subjects with Asthma Inadequately Controlled by Corticosteroids
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to look at the safety, tolerability and effect of KB003 in people with asthma.
    A.4.1Sponsor's protocol code numberKB003-04
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01603277
    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 SponsorKaloBios Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportKaloBios Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChiltern International Limited
    B.5.2Functional name of contact pointRegulatory Service
    B.5.3 Address:
    B.5.3.1Street Address171 Bath Road
    B.5.3.2Town/ citySlough, Berkshire
    B.5.3.3Post codeSL1 4AA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441753512 000
    B.5.5Fax number+441753511 116
    B.5.6E-mailregulatory.service@chiltern.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.3.2Product code KB003
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRecombinant Anti-Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF) IgG1κ Monoclonal Antibody
    D.3.9.2Current sponsor codeKB003
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Asthma inadequately controlled by corticosteroids
    E.1.1.1Medical condition in easily understood language
    Asthma
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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 primary objective of study KB003-04 is to evaluate the effect of KB003 on lung function in subjects with asthma inadequately controlled by corticosteroids, as measured by absolute change in percent predicted FEV1.
    E.2.2Secondary objectives of the trial
    Secondary objectives of this study are to evaluate the following:
    • Efficacy of KB003 as measured by exacerbation rate
    • Effect of KB003 on peak expiratory flow rate (PEFR)
    • Effect of KB003 on Asthma Control Questionnaire (ACQ) scores, asthma symptoms, and rescue SABA use (Daily Diary)
    • Safety and tolerability of KB003
    • PK and immunogenicity of KB003
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written and signed informed consent from subject (or assent from legal guardian if under 18 years of age, or legal representative if applicable) prior to any study-specific assessments, and permission to use protected health information in accordance with regional regulations.
    2. Males or females aged 16 to 75 years inclusive at Screening Visit.
    3. Females of childbearing potential may participate if they have a negative pregnancy test, are nonlactating, and agree to practice a highly effective birth control method (e.g., abstinence [when this is the usual lifestyle choice of the subject], combination barrier and spermicide, hormonal) for the duration of the study and for 6 months following the last dose of study drug.
    4. Physician diagnosis of asthma established for at least 2 years prior to Screening Visit.
    5. Symptomatic asthma defined as having an ACQ score ≥1.5 at Screening and Randomization Visits.
    6. Symptomatic asthma despite chronic treatment with inhaled corticosteroids ≥500 μg/day fluticasone (dry powder or hydrofluoroalkane [HFA] inhaler) or budesonide, or equivalent doses of other inhaled corticosteroids, for at least 12 weeks prior to Screening Visit. A stable dose is required for at least 4 weeks prior
    to Screening Visit.
    7. For the subset of subjects taking oral corticosteroids, asthma is symptomatic despite treatment with ≥7.5 mg of prednisolone per day for at least 12 weeks prior to screening. A stable dose is required for at least 4 weeks prior to Screening Visit.
    8. Currently receiving LABA. Subjects not receiving LABA must have documented LABA intolerability or lack of responsiveness to LABA.
    9. FEV1 from 40% to 80% of the predicted value at Screening and Randomization Visits.
    10. At Screening or Randomization visits, demonstrated FEV1 bronchodilator response of ≥12% (i.e., reversibility) from baseline measurements 15 to 30 minutes after SABA administration.
    11. At least 2 exacerbations (no more than 6) in the previous 12 months that required systemic corticosteroids or at least a doubling of daily oral dose for 3 or more days.
    12. Weight from 40 to 125 kg at Screening Visit.
    13. Ability to perform spirometry tests according to protocol-specified standards as indicated in the Spirometry Manual.
    14. Chest X-ray (CXR) within 12 months of Screening Visit with no evidence of clinically significant abnormality. For subjects who have had an intervening significant cardiac or pulmonary event, a post-event CXR should be obtained.
    15. Ability to understand and comply with study requirements including study visits, diary completion. and daily peak flow measurements, as demonstrated during the run-in period.
    E.4Principal exclusion criteria
    1. Acute asthma worsening (defined as requiring emergency room visit, hospitalization, urgent care, physician visit, or change in asthma medications) or lower respiratory tract infection requiring the use of antibiotics within 4 weeks prior to Screening Visit.
    2. History of life-threatening asthma, with admission to the intensive care unit requiring the use of mechanical ventilation, within the past 12 months.
    3. Use of any immunosuppressive or immunomodulatory agents within 12 weeks or use of an investigational agent within 4 weeks prior to Screening Visit.
    4. History of any cardiovascular, neurological, hepatic, renal, or other medical condition that in the Investigator’s opinion may interfere with the interpretation of data or the subject’s participation in the study.
    5. History of cigarette or marijuana smoking within the 12 months prior to screening, a >10 pack-year history, or a positive test for nicotine (cotinine).
    6. History of alcohol or drug abuse that in the opinion of the Investigator would preclude appropriate compliance with study procedures.
    7. Omalizumab (Xolair) therapy within 12 weeks prior to Screening Visit.
    8. History of malignancy within the last 5 years. Basal or squamous cell skin carcinoma adequately treated is allowed.
    9. Known immunodeficiency including but not limited to human immunodeficiency virus (HIV) infection.
    10. Pre-existing lung disease other than asthma that in the Investigator’s opinion may interfere with the interpretation of data or the subject’s participation in the study.
    11. Known history of tuberculosis, chronic fungal infection (e.g., histoplasmosis, coccidioidomycosis), or hepatitis C.
    12. Prior allergic reaction to a monoclonal antibody. Mild to moderate infusion reactions that are transient and easily treated with medications are allowed.
    13. Inability to give consent/assent or unwillingness or inability to comply with study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the absolute change from baseline in percent predicted FEV1 over 24 weeks of treatment with study drug.
    E.5.1.1Timepoint(s) of evaluation of this end point
    FEV1 will be measured at screening, randomisation and visits at study weeks 2, 4, 8, 12, 16, 20, 24 and 28.
    E.5.2Secondary end point(s)
    Secondary endpoints are:
    • Exacerbation rate over 24 weeks
    • Change from baseline in morning peak PEFR over 24 weeks
    • Change from baseline in asthma control as assessed by the ACQ over 24 weeks
    • Change from baseline in asthma symptoms as measured by Daily Diary over 24 weeks
    • Change from baseline in rescue SABA use over 24 weeks
    • Safety and tolerability over 32 weeks
    • Pharmacokinetic assessment
    • Immunogenicity assessment
    E.5.2.1Timepoint(s) of evaluation of this end point
    Exacerbations: randomisation and visits at study weeks 2, 4, 8, 12, 16, 20, 24 and 28.
    Change from baseline in morning peak PEFR, in asthma symptoms as measured by Daily Diary, in rescue SABA use and safety and tolerability will be recorded throughout the study.
    Change from baseline in asthma control as assessed by the ACQ: screening, randomisation and visits at study weeks 2, 4, 8, 12, 16, 20, 24 and 28.
    Pharmacokinetic assessment: randomisation and visits at study weeks 4, 8, 12, 16, 20, 24 and 28.
    Immunogenicity assessment: randomisation and visits at study weeks 2, 4, 12, 24 and 28.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Ukraine
    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 years1
    E.8.9.1In the Member State concerned months4
    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 months1
    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 Yes
    F.1.1Number of subjects for this age range: 5
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 117
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 150
    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)
    Expected normal treatment for asthma.
    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 Decision2012-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-22
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