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    Clinical Trial Results:
    A Double-Blind, Placebo-Controlled Parallel-Group Study to Assess the Efficacy, Safety and Tolerability of CAT-354

    Summary
    EudraCT number
    		 2007-002090-31
    Trial protocol
    		 GB   DE   NL  
    Global end of trial date
    10 Oct 2008

    Results information
    Results version number
    		 v2(current)
    This version publication date
    16 Feb 2017
    First version publication date
    19 Jun 2016
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    CAT-354-0603
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00640016
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MedImmune, LLC
    Sponsor organisation address
    Milstein Building, Granta Park, Cambridge, United Kingdom, CB21 6GH
    Public contact
    Rene van der Merwe, MedImmune, LLC, +44 3013980000, vandermerwer@medimmune.com
    Scientific contact
    Rene van der Merwe, MedImmune, LLC, +44 3013980000, vandermerwer@medimmune.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Oct 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Oct 2008
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of this study was to investigate the effects of CAT-354 on airway hyperresponsiveness (AHR) in uncontrolled (refractory) asthma.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Participating participant signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Mar 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    United Kingdom: 12
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    14
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Ninety (90) participants were screened for this study, and a total of 14 participants were randomized. Thirteen (13) of the 14 randomized participants were included in the safety population.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Carer, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.

    Arm title
    		 CAT-354 1 mg/kg
    Arm description
    		 CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CAT-354
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

    Arm title
    		 CAT-354 5 mg/kg
    Arm description
    		 CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CAT-354
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

    Arm title
    		 CAT-354 10 mg/kg
    Arm description
    		 CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CAT-354
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

    Number of subjects in period 1
    		Placebo CAT-354 1 mg/kg CAT-354 5 mg/kg CAT-354 10 mg/kg
    Started
    3
    3
    4
    4
    Treated
    3
    2
    4
    4
    Completed
    1
    1
    1
    1
    Not completed
    2
    2
    3
    3
         Consent withdrawn by subject
    -
    1
    -
    -
         Study termination
    2
    1
    3
    2
         Adverse event, non-fatal
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.

    Reporting group title
    CAT-354 1 mg/kg
    Reporting group description
    		 CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

    Reporting group title
    CAT-354 5 mg/kg
    Reporting group description
    		 CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

    Reporting group title
    CAT-354 10 mg/kg
    Reporting group description
    		 CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

    Reporting group values
    		 Placebo CAT-354 1 mg/kg CAT-354 5 mg/kg CAT-354 10 mg/kg Total
    Number of subjects
    		 3 3 4 4 14
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 3 3 4 4 14
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    		 34 ( 11.136 ) 34 ( 14.933 ) 37.75 ( 9.878 ) 40.75 ( 15.086 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 3 3 2 3 11
        Male
    		 0 0 2 1 3

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.

    Reporting group title
    CAT-354 1 mg/kg
    Reporting group description
    		 CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

    Reporting group title
    CAT-354 5 mg/kg
    Reporting group description
    		 CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

    Reporting group title
    CAT-354 10 mg/kg
    Reporting group description
    		 CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

    Subject analysis set title
    Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects (N=8) included who received CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

    Subject analysis set title
    Sub-therapeutic Dose (placebo or CAT-354 1mg/kg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects (N=5) included who received Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

    Primary: Change From Baseline in Doubling Concentration of Methacholine at Day 28

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    End point title
    		 Change From Baseline in Doubling Concentration of Methacholine at Day 28 [1]
    End point description
    Change in doubling concentrations of methacholine was calculated as Log2 PC20 (Visit x) - Log2 PC20 (Baseline), where x was the post-baseline assessment (Day 28) and PC20 was provocative concentration of methacholine causing 20 percent fall in forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Change in doubling concentration was summarized as per planned analysis.
    End point type
    Primary
    End point timeframe
    Baseline and Day 28
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg) Sub-therapeutic Dose (placebo or CAT-354 1mg/kg)
    Number of subjects analysed
    8
    5
    Units: log2 milligram/deciliter (mg/dL)
    arithmetic mean (standard deviation)
        Baseline (n=8, 5)
    -0.604 ( 2.408 )
    -1.545 ( 0.8952 )
        Change at Day 28 (n=5, 4)
    -0.207 ( 1.045 )
    0.125 ( 2.3433 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Doubling concentration of Methacholine at Day 56, 84 or Early Termination

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    End point title
    		 Change From Baseline in Doubling concentration of Methacholine at Day 56, 84 or Early Termination
    End point description
    Change in doubling concentrations of methacholine was calculated as Log2 PC20 (Visit x) - Log2 PC20 (Baseline), where x was the post-baseline assessment (Day 28) and PC20 was provocative concentration of methacholine causing 20 percent fall in forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Change in doubling concentration was summarized as per planned analysis. Safety population included all participants who received at least 1 dose of study medication. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure, and 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 56, 84 or early termination (any time before Day 84)
    End point values
    		 Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg) Sub-therapeutic Dose (placebo or CAT-354 1mg/kg)
    Number of subjects analysed
    3
    2
    Units: log2 mg/dL
    arithmetic mean (standard deviation)
        Change at Day 56 (n=2, 2)
    0.062 ( 1.1309 )
    -1.423 ( 0.4059 )
        Change at Day 84 (n=2, 2)
    -0.038 ( 0.141 )
    -1.846 ( 0.0431 )
        Change at Early termination (n=3, 2)
    -0.514 ( 0.8636 )
    0.417 ( 0.984 )
    No statistical analyses for this end point

    Secondary: Forced expiratory volume in 1 second (FEV1)

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    End point title
    		 Forced expiratory volume in 1 second (FEV1)
    End point description
    The FEV1 was maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was summarized as per planned analysis.
    End point type
    Secondary
    End point timeframe
    Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, 63, 84 or early termination (any time before Day 84)
    End point values
    		 Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg) Sub-therapeutic Dose (placebo or CAT-354 1mg/kg)
    Number of subjects analysed
    8
    5
    Units: liters
    arithmetic mean (standard deviation)
        Day 0: Predose (n=8, 5)
    2.718 ( 0.5458 )
    2.64 ( 0.3994 )
        Day 0: 30 minutes postdose (n=8, 5)
    2.684 ( 0.5695 )
    2.624 ( 0.4126 )
        Day 0: 6 hours postdose (n=8, 5)
    2.606 ( 0.5731 )
    2.55 ( 0.4304 )
        Day 4 (n=8, 5)
    2.814 ( 0.6048 )
    2.606 ( 0.2919 )
        Day 14 (n=6, 5)
    2.323 ( 0.5703 )
    2.52 ( 0.0812 )
        Day 28: Predose (n=5, 4)
    2.598 ( 0.4676 )
    2.85 ( 0.2082 )
        Day 28: 30 minutes postdose (n=4, 4)
    2.535 ( 0.5639 )
    2.918 ( 0.2822 )
        Day 28: 6 hours postdose (n=4, 4)
    2.4 ( 0.5254 )
    2.665 ( 0.2748 )
        Day 35 (n= 4, 4)
    2.26 ( 0.5464 )
    2.778 ( 0.4228 )
        Day 56: Predose (n=2, 2)
    2.555 ( 0.6718 )
    2.7 ( 0.3677 )
        Day 56: 30 minutes postdose (n=2, 2)
    2.705 ( 0.799 )
    2.83 ( 0.1697 )
        Day 56: 6 hours postdose (n=2, 2)
    2.51 ( 0.7071 )
    2.69 ( 0.2404 )
        Day 63 (n= 2, 2)
    2.505 ( 0.6859 )
    2.58 ( 0.0283 )
        Day 84: (n=2, 2)
    2.68 ( 0.7778 )
    2.54 ( 0.4101 )
        Early Termination (n=4, 3)
    3.018 ( 0.5803 )
    2.867 ( 0.44 )
    No statistical analyses for this end point

    Secondary: Forced Vital Capacity (FVC)

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    End point title
    		 Forced Vital Capacity (FVC)
    End point description
    The FVC was volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was summarized as per planned analysis.
    End point type
    Secondary
    End point timeframe
    Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, 63, 84 or early termination (any time before Day 84)
    End point values
    		 Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg) Sub-therapeutic Dose (placebo or CAT-354 1mg/kg)
    Number of subjects analysed
    8
    5
    Units: liters
    arithmetic mean (standard deviation)
        Day 0: Predose (n= 8, 5)
    3.828 ( 0.8215 )
    3.666 ( 0.6068 )
        Day 0: 30 minutes postdose (n= 8, 5)
    3.823 ( 0.65 )
    3.722 ( 0.6752 )
        Day 0: 6 hours postdose (n= 8, 5)
    3.808 ( 0.7718 )
    3.722 ( 0.7297 )
        Day 4 (n= 8, 5)
    3.988 ( 0.6058 )
    3.824 ( 0.7415 )
        Day 14 (n=6, 5)
    3.462 ( 0.5926 )
    3.71 ( 0.522 )
        Day 28: Predose (n=5, 4)
    3.908 ( 0.767 )
    3.883 ( 0.6412 )
        Day 28: 30 minutes postdose (n=4, 4)
    3.878 ( 0.7876 )
    3.98 ( 0.7951 )
        Day 28: 6 hours postdose (n=4, 4)
    3.81 ( 0.7409 )
    3.79 ( 0.483 )
        Day 35 (n=4, 4)
    3.613 ( 0.6874 )
    3.92 ( 0.7777 )
        Day 56: Predose (n=2, 2)
    3.7 ( 0.5233 )
    3.41 ( 0.3818 )
        Day 56: 30 minutes postdose (n=2, 2)
    3.775 ( 0.5303 )
    3.54 ( 0.4667 )
        Day 56: 6 hours postdose (n=2, 2)
    3.715 ( 0.6435 )
    3.545 ( 0.3748 )
        Day 63 (n=2, 2)
    3.705 ( 0.5162 )
    3.575 ( 0.502 )
        Day 84: (n=2, 2)
    3.71 ( 0.6505 )
    3.415 ( 0.3323 )
        Early Termination (n=4, 3)
    3.908 ( 0.807 )
    4.193 ( 0.8364 )
    No statistical analyses for this end point

    Secondary: Forced Expiratory Volume in 1 second (FEV1) as Percentage of Forced Vital Capacity (FVC)

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    End point title
    		 Forced Expiratory Volume in 1 second (FEV1) as Percentage of Forced Vital Capacity (FVC)
    End point description
    Percentage of FEV1 was calculated as (FEV1/FVC)*100. It signified the percentage of the total amount of air exhaled from the lungs during the first second of forced exhalation. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Result was summarized as per planned analysis.
    End point type
    Secondary
    End point timeframe
    Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, Day 63, 84 or early termination (any time before Day 84)
    End point values
    		 Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg) Sub-therapeutic Dose (placebo or CAT-354 1mg/kg)
    Number of subjects analysed
    8
    5
    Units: percentage of FVC
    arithmetic mean (standard deviation)
        Day 0: Predose (n=8, 5)
    71.875 ( 10.3156 )
    72.6 ( 11.4149 )
        Day 0: 30 minutes postdose (n=8, 5)
    70.25 ( 9.1613 )
    71.6 ( 13.1833 )
        Day 0: 6 hours postdose (n=8, 5)
    69.125 ( 12.5178 )
    69.6 ( 12.1984 )
        Day 4 (n=8, 5)
    71 ( 13.1909 )
    69.4 ( 8.7063 )
        Day 14 (n=6, 5)
    66.667 ( 7.5011 )
    68.8 ( 8.167 )
        Day 28: Predose (n=5, 4)
    67.4 ( 13.1263 )
    74.5 ( 11.2694 )
        Day 28: 30 minutes postdose (n=4, 4)
    66.5 ( 13.9881 )
    74.5 ( 9.6782 )
        Day 28: 6 hours postdose (n=4, 4)
    63.75 ( 12.339 )
    71.25 ( 13.8173 )
        Day 35 (n=4, 4)
    62.5 ( 7.5498 )
    71.75 ( 7.8049 )
        Day 56: Predose (n=2, 2)
    68 ( 8.4853 )
    80 ( 19.799 )
        Day 56: 30 minutes postdose (n=2, 2)
    71 ( 11.3137 )
    81 ( 15.5563 )
        Day 56: 6 hours postdose (n=2, 2)
    67 ( 7.0711 )
    76.5 ( 14.8492 )
        Day 63 (n=2, 2)
    66.5 ( 9.1924 )
    72.5 ( 9.1924 )
        Day 84 (n=2, 2)
    71.5 ( 9.1924 )
    75.5 ( 19.0919 )
        Early Termination (n=4, 3)
    77.75 ( 9.8107 )
    69 ( 5.5678 )
    No statistical analyses for this end point

    Secondary: Asthma Control Questionnaire (ACQ) Total Score

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    End point title
    		 Asthma Control Questionnaire (ACQ) Total Score
    End point description
    The ACQ is questionnaire that comprises of 7-questions evaluating participant’s asthma control. Six self-administered questions assess asthma control over the past week covering nocturnal waking, morning symptoms, activity limitations, shortness of breath, wheezing, and short-acting bronchodilator use; using 7-point ordinal rating scale from 0 (good control) to 6 (poor control). Seventh question is completed by a health professional on forced expiratory volume in 1 second (FEV1) percentage (%) predicted; scale: 0 (greater than [>] 95% predicted) to 6 (less than [<] 50% predicted. Final score is the average score of the 7 questions, with a score range of 0 (well controlled) to 6 (extremely poor controlled). Result was summarized as per planned analysis.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 28, 56, 84 or early termination (any time before Day 84)
    End point values
    		 Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg) Sub-therapeutic Dose (placebo or CAT-354 1mg/kg)
    Number of subjects analysed
    8
    5
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n=8, 5)
    2.44 ( 0.737 )
    1.77 ( 0.861 )
        Day 28 (n=5, 4)
    2 ( 0.416 )
    1.46 ( 0.914 )
        Day 56 (n=2, 2)
    1.43 ( 0.808 )
    1.5 ( 1.111 )
        Day 84 (n=2, 2)
    1.57 ( 1.01 )
    2.36 ( 0.101 )
        Early Termination (n=5, 3)
    1.72 ( 1.304 )
    0.57 ( 0.378 )
    No statistical analyses for this end point

    Secondary: Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

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    End point title
    		 Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
    End point description
    The FEV1 was maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.
    End point type
    Secondary
    End point timeframe
    Day 0 to 84
    End point values
    		 Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg) Sub-therapeutic Dose (placebo or CAT-354 1mg/kg)
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: liters
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [2] - Study was prematurely terminated, hence data was not collected and analyzed for this end point.
    [3] - Study was prematurely terminated, hence data was not collected and analyzed for this end point.
    No statistical analyses for this end point

    Secondary: Number of Participants With Diary Data

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    End point title
    		 Number of Participants With Diary Data
    End point description
    Participants recorded asthma symptoms, use of reliever inhalers (beta-agonist use for symptom relief and as prophylaxis), and morning and evening peak expiratory flow (PEF) measurements in a diary.
    End point type
    Secondary
    End point timeframe
    Day 0, 4, 14, 28, 35, 56, 63 to Day and 84
    End point values
    		 Placebo CAT-354 1 mg/kg CAT-354 5 mg/kg CAT-354 10 mg/kg
    Number of subjects analysed
    0 [4]
    0 [5]
    0 [6]
    0 [7]
    Units: participants
    Notes
    [4] - Study was prematurely terminated, hence data was not collected and analyzed for this end point.
    [5] - Study was prematurely terminated, hence data was not collected and analyzed for this end point.
    [6] - Study was prematurely terminated, hence data was not collected and analyzed for this end point.
    [7] - Study was prematurely terminated, hence data was not collected and analyzed for this end point.
    No statistical analyses for this end point

    Secondary: Number of Participants With Exacerbations

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    End point title
    		 Number of Participants With Exacerbations
    End point description
    Exacerbation was defined as: Mild (determined from diary data) - 2 consecutive days satisfying the same or 1 of the following criteria: any night with awakening(s) due to asthma or morning PEF 20 % or more below baseline where baseline = average of the 10 days before randomization or as-needed medication use of 2 inhalations or more in 24 hours above baseline where baseline = average of the 10 days before randomization. Severe (determined by taking an exacerbation update and history): deterioration of asthma resulting in emergency treatment or hospitalization or need for oral steroids for 3 days or more (as judged by the Investigator).
    End point type
    Secondary
    End point timeframe
    Day 0 to Day 84
    End point values
    		 Placebo CAT-354 1 mg/kg CAT-354 5 mg/kg CAT-354 10 mg/kg
    Number of subjects analysed
    0 [8]
    0 [9]
    0 [10]
    0 [11]
    Units: participants
    Notes
    [8] - Study was prematurely terminated, hence data was not collected and analyzed for this end point.
    [9] - Study was prematurely terminated, hence data was not collected and analyzed for this end point.
    [10] - Study was prematurely terminated, hence data was not collected and analyzed for this end point.
    [11] - Study was prematurely terminated, hence data was not collected and analyzed for this end point.
    No statistical analyses for this end point

    Secondary: Morning Peak Flow and Peak Flow Variability

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    End point title
    		 Morning Peak Flow and Peak Flow Variability
    End point description
    Peak flow is a participant’s maximum speed of expiration.
    End point type
    Secondary
    End point timeframe
    Day 0 to Day 84
    End point values
    		 Placebo CAT-354 1 mg/kg CAT-354 5 mg/kg CAT-354 10 mg/kg
    Number of subjects analysed
    0 [12]
    0 [13]
    0 [14]
    0 [15]
    Units: liters/minute
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    Notes
    [12] - Study was prematurely terminated, hence data was not collected and analyzed for this end point.
    [13] - Study was prematurely terminated, hence data was not collected and analyzed for this end point.
    [14] - Study was prematurely terminated, hence data was not collected and analyzed for this end point.
    [15] - Study was prematurely terminated, hence data was not collected and analyzed for this end point.
    No statistical analyses for this end point

    Secondary: Adult Asthma Quality of Life (QoL) Questionnaire Final Score

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    End point title
    		 Adult Asthma Quality of Life (QoL) Questionnaire Final Score
    End point description
    The AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants are asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. The 4 domain scores are the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment).
    End point type
    Secondary
    End point timeframe
    Day 0, 28, 84 or early termination (any time before Day 84)
    End point values
    		 Placebo CAT-354 1 mg/kg CAT-354 5 mg/kg CAT-354 10 mg/kg
    Number of subjects analysed
    0 [16]
    0 [17]
    0 [18]
    0 [19]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    Notes
    [16] - Study was prematurely terminated, hence data was not collected and analyzed for this end point.
    [17] - Study was prematurely terminated, hence data was not collected and analyzed for this end point.
    [18] - Study was prematurely terminated, hence data was not collected and analyzed for this end point.
    [19] - Study was prematurely terminated, hence data was not collected and analyzed for this end point.
    No statistical analyses for this end point

    Secondary: Maximum Observed Serum Concentration (Cmax) for CAT-354

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    End point title
    		 Maximum Observed Serum Concentration (Cmax) for CAT-354 [20]
    End point description
    In the below table, '99999' indicates that data was not estimable due to only 1 participant was evaluable in the reporting group. Pharmacokinetic (PK) population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
    End point type
    Secondary
    End point timeframe
    Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 CAT-354 1 mg/kg CAT-354 5 mg/kg CAT-354 10 mg/kg
    Number of subjects analysed
    1
    1
    1
    Units: microgram/milliliter (mcg/mL)
    arithmetic mean (standard deviation)
        After first dose (Day 0)
    27.7 ( 99999 )
    219 ( 99999 )
    163 ( 99999 )
        After second dose (Day 28)
    34.5 ( 99999 )
    255 ( 99999 )
    235 ( 99999 )
        After third dose (Day 56)
    33.4 ( 99999 )
    338 ( 99999 )
    251 ( 99999 )
    No statistical analyses for this end point

    Secondary: Minimum Observed Serum Concentration (Cmin) for CAT-354

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    End point title
    		 Minimum Observed Serum Concentration (Cmin) for CAT-354 [21]
    End point description
    In the below table, '99999' indicates that data was not estimable due to only 1 participant was evaluable in the reporting group. PK population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
    End point type
    Secondary
    End point timeframe
    Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 CAT-354 1 mg/kg CAT-354 5 mg/kg CAT-354 10 mg/kg
    Number of subjects analysed
    1
    1
    1
    Units: mcg/mL
    arithmetic mean (standard deviation)
        After first dose (Day 0)
    4.84 ( 99999 )
    51.8 ( 99999 )
    52.8 ( 99999 )
        After second dose (Day 28)
    7.91 ( 99999 )
    54.1 ( 99999 )
    64.4 ( 99999 )
        After third dose (Day 56)
    9.7 ( 99999 )
    85.5 ( 99999 )
    68.4 ( 99999 )
    No statistical analyses for this end point

    Secondary: Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC [0 - t]) for CAT-354

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    End point title
    		 Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC [0 - t]) for CAT-354 [22]
    End point description
    In the below table, '99999' indicates that data was not estimable due to only 1 participant was evaluable in the reporting group. PK population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
    End point type
    Secondary
    End point timeframe
    Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56
    Notes
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 CAT-354 1 mg/kg CAT-354 5 mg/kg CAT-354 10 mg/kg
    Number of subjects analysed
    1
    1
    1
    Units: microgram*day/milliliter (mcg*day/mL)
    arithmetic mean (standard deviation)
        After first dose (Day 0)
    335 ( 99999 )
    2820 ( 99999 )
    2090 ( 99999 )
        After second dose (Day 28)
    408 ( 99999 )
    4720 ( 99999 )
    3080 ( 99999 )
        After third dose (Day 56)
    499 ( 99999 )
    3690 ( 99999 )
    3420 ( 99999 )
    No statistical analyses for this end point

    Secondary: Accumulation Ratio for CAT-354 (RA)

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    End point title
    		 Accumulation Ratio for CAT-354 (RA) [23]
    End point description
    Accumulation ratio (RA) is calculated for Cmax, Cmin and AUC as RA for Cmax = Cmax (56 - 84)/Cmax (0 - 28); Similarily, RA for Cmin = Cmin (56 - 84)/Cmin (0 - 28) and RA for AUC= AUC (56 - 84)/AUC (0 - 28) where Cmax (0 - 28) and Cmax (56 - 84) are the maximum observed serum concentration after first dose (Day 0 to Day 28) and after third dose (Day 56 to Day 84), respectively; Cmin (0 - 28) and Cmin (56 - 84) are the minimum observed serum concentration after first and third dose, respectively; AUC (0 - 28) and AUC (56 - 84) are the area under the serum concentration time curve over a dosage interval determined after first and third dose, respectively. In the below table, '99999' indicates that data was not estimable due to only 1 participant was evaluable in the reporting group. Here 'N' (number of participants analyzed) signifies, evaluable participants for this measure, and 'n' signifies, evaluable participants at specified time points for each group, respectively.
    End point type
    Secondary
    End point timeframe
    Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56
    Notes
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 CAT-354 1 mg/kg CAT-354 5 mg/kg CAT-354 10 mg/kg
    Number of subjects analysed
    1 [24]
    1 [25]
    1 [26]
    Units: ratio
    arithmetic mean (standard deviation)
        RA for Cmin
    1.2 ( 99999 )
    1.54 ( 99999 )
    1.73 ( 99999 )
        RA for Cmax
    2 ( 99999 )
    1.65 ( 99999 )
    1.3 ( 99999 )
        RA for AUC
    1.49 ( 99999 )
    1.31 ( 99999 )
    1.64 ( 99999 )
    Notes
    [24] - PK population
    [25] - PK population
    [26] - PK population
    No statistical analyses for this end point

    Secondary: Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

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    End point title
    		 Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
    End point description
    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pre-treatment state. Safety population included all participants who received at least 1 dose of study medication. Here, number of participants analysed, "N" signifies evaluable participants for the respective reporting group.
    End point type
    Secondary
    End point timeframe
    Day 0 to 84
    End point values
    		 Placebo CAT-354 1 mg/kg CAT-354 5 mg/kg CAT-354 10 mg/kg
    Number of subjects analysed
    3
    2
    4
    4
    Units: participants
        TEAEs
    2
    2
    4
    3
        TESAEs
    0
    0
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 0 to 84
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56

    Reporting group title
    CAT-354 1mg/kg
    Reporting group description
    		 CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

    Reporting group title
    CAT-354 5mg/kg
    Reporting group description
    		 CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

    Reporting group title
    CAT-354 10mg/kg
    Reporting group description
    		 CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

    Serious adverse events
    		 Placebo CAT-354 1mg/kg CAT-354 5mg/kg CAT-354 10mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo CAT-354 1mg/kg CAT-354 5mg/kg CAT-354 10mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 3 (66.67%)
    2 / 2 (100.00%)
    4 / 4 (100.00%)
    2 / 4 (50.00%)
    Investigations
    Forced expiratory volume decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Inflammation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    0
    0
    0
    3
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Constipation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 3 (66.67%)
    2 / 2 (100.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
         occurrences all number
    2
    2
    1
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Jun 2007
    - Determination of the atopic status of participants was to be required. Participants were considered atopic if they had documented hypersensitivity to a seasonal or perennial allergen as determined by skin test (prick or intradermal) or Radioallergosorbent Test (RAST) or equivalent test within 12 months prior to enrolment. - Coffee, tea, other caffeinated drinks, chocolate drinks, and chocolate foodstuffs were not to be consumed on challenge days before the test was completed. In addition, vigorous exercise was to be avoided on the day of the challenge before completion of the challenge test. - The means of determining the severity of exacerbations were clarified: mild-determined from diary data at each clinic visit and severe determined by taking an exacerbation update and history at each clinic visit.
    17 Aug 2007
    - Two additional exclusion criterion added: Significant, uncontrolled disease including serious psychological disorders, chronic renal failure, uncontrolled hypertension - systolic blood pressure greater than (>) 200 millimeter of mercury (mmHg), or diastolic blood pressure > 100 mmHg, heart disease, psoriasis requiring treatment and participants who have had a heart attack or stroke within the 3 months preceding Visit 1, or who have a known aneurysm. Known hypersensitivity to CAT-354 or its components, to the challenge agents used in the study or to related drugs. - Detail on study drug formulation was added. - Concomitant medications/treatments were adjusted to state that parenteral corticosteroids from one month prior to Visit 1 were not permissible, and corticosteroids (oral or injected) were allowed.
    13 Aug 2008
    - To remove all US specific reference as it was decided not to proceed with the study in the US due to feasibility and Key Opinion Leader feedback. - To document the changes resulting from reduced recruitment on the study design, interim analyses, and anticipated study objectives. - Changes were made to reduce the risk of hypersensitivity or infusion-related reactions and to remove investigations that were relatively invasive, and may have contributed to a number of adverse events. Specifically, planned changes in this regard were to: a. increase the infusion time of investigational medical product (IMP) from 30 to 60 minutes; b. to remove the mannitol challenge at all-time points; c. to remove the induced sputum collection at all-time points; d. to collect extra blood samples pre- and post-infusion of IMP in order to assess participant safety; e. to perform additional vital signs pre- and post-infusion of IMP in order to assess participant safety; f. to add that chlorphenamine and paracetamol could be administered 1.5 hours before infusion at Visits 5 and 7 for participants who experienced minor infusion reactions (without hemodynamic or respiratory compromise) after the infusion at Visit 2.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    10 Oct 2008
    Study was prematurely terminated by the sponsor due to slow recruitment rate, delay due to temporary halt and potential for expiry date of study drug.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Study was prematurely terminated by the sponsor due to slow recruitment rate, delay due to temporary halt and potential for expiry date of study drug. It was not considered possible to draw meaningful conclusions from the small dataset.
    For support, Contact us.
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