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    Clinical Trial Results:
    A Randomized, Placebo-Controlled, Phase IIb Dose-Finding Study of CYT003-QbG10, a TLR9-Agonist, in Patients with Moderate to Severe Allergic Asthma not Sufficiently Controlled on Current Standard Therapy (GINA Steps 3+4)

    Summary
    EudraCT number
    		 2012-003070-39
    Trial protocol
    		 HU   DE   CZ   PL  
    Global end of trial date
    14 Apr 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    17 Jul 2016
    First version publication date
    25 Feb 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    correction needed due to EudraCT downtime between Jul-2015 and Jan 2016
    Summary report(s)
    		 Study report
    Appendix 16.1.5 Signatures
    Addendum 17.1 Safety
    Addendum 17.2 Efficacy

    Trial information

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    Trial identification
    Sponsor protocol code
    CYT003-QbG1012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01673672
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cytos Biotechnology AG
    Sponsor organisation address
    Wagistrasse 25, Schlieren, Switzerland, 8952
    Public contact
    Information Desk, Cytos Biotechnology AG, 0041 447334747, info@cytos.com
    Scientific contact
    Information Desk, Cytos Biotechnology AG, 0041 447334747, info@cytos.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
    14 Apr 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Apr 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to assess the therapeutic potential and safety/tolerability of CYT003-QbG10 at 3 dose levels versus placebo in patients with persistent moderate to severe allergic asthma not sufficiently controlled on current standard therapy
    Protection of trial subjects
    Usual standard of care; study drug as add-on therapy
    Background therapy
    		 Current standard inhaled corticosteroids (ICS) with or without long-acting β2 agonist (±LABA) therapy (Global Initiative for Asthma [GINA] steps 3 and 4)
    Evidence for comparator
    		 No comparator used
    Actual start date of recruitment
    14 Oct 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 34
    Country: Number of subjects enrolled
    Czech Republic: 22
    Country: Number of subjects enrolled
    Germany: 44
    Country: Number of subjects enrolled
    Hungary: 39
    Country: Number of subjects enrolled
    United States: 115
    Country: Number of subjects enrolled
    Israel: 22
    Country: Number of subjects enrolled
    Russian Federation: 15
    Country: Number of subjects enrolled
    Ukraine: 74
    Worldwide total number of subjects
    365
    EEA total number of subjects
    139
    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)
    365
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First patient first visit: 14-Oct-2012; Last patient last visit: 24-Jan-2014. Patient assessments performed at Investigator sites.

    Pre-assignment
    Screening details
    		 606 patients have been screened; 241 patients were screening failures; 365 patients have been included and dosed.

    Period 1
    Period 1 title
    Treatment phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Study was kept double-blind until study report was finalized

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo (buffer)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    7 subcutaneous injections of 1 ml over 10 weeks

    Arm title
    		 0.3 mg
    Arm description
    		 0.3 mg CYT003
    Arm type
    		 Experimental

    Investigational medicinal product name
    0.3 mg CYT003
    Investigational medicinal product code
    0.3 mg CYT003
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    7 subcutaneous injections of 1 ml over 10 weeks

    Arm title
    		 1.0 mg
    Arm description
    		 1.0 mg CYT003
    Arm type
    		 Experimental

    Investigational medicinal product name
    1.0 mg CYT003
    Investigational medicinal product code
    1.0 mg CYT003
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    7 subcutaneous injections of 1 ml over 10 weeks

    Arm title
    		 2.0 mg
    Arm description
    		 2.0 mg CYT003
    Arm type
    		 Experimental

    Investigational medicinal product name
    2.0 mg CYT003
    Investigational medicinal product code
    2.0 mg CYT003
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    7 subcutaneous injections of 1 ml over 10 weeks

    Number of subjects in period 1
    		Placebo 0.3 mg 1.0 mg 2.0 mg
    Started
    89
    91
    94
    91
    Completed
    87
    88
    90
    89
    Not completed
    2
    3
    4
    2
         Consent withdrawn by subject
    2
    3
    4
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (buffer)

    Reporting group title
    0.3 mg
    Reporting group description
    		 0.3 mg CYT003

    Reporting group title
    1.0 mg
    Reporting group description
    		 1.0 mg CYT003

    Reporting group title
    2.0 mg
    Reporting group description
    		 2.0 mg CYT003

    Reporting group values
    		 Placebo 0.3 mg 1.0 mg 2.0 mg Total
    Number of subjects
    		 89 91 94 91 365
    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)
    		 89 91 94 91 365
        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)
    		 47.5 ( 12.37 ) 47.2 ( 11.94 ) 47.3 ( 12.39 ) 48 ( 12.05 ) -
    Gender categorical
    Units: Subjects
        Female
    		 52 56 58 57 223
        Male
    		 37 35 36 34 142
    Asthma Control Questionnaire (ACQ)
    Units: ACQ score
        arithmetic mean (standard deviation)
    		 2.63 ( 0.61 ) 2.57 ( 0.61 ) 2.62 ( 0.65 ) 2.56 ( 0.69 ) -
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS was analyzed according to Intent to Treat principle and a last Obesrvation Carried Forward procedure was adopted.

    Subject analysis sets values
    		 Full Analysis Set (FAS)
    Number of subjects
    365
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    365
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    47.5 ( 12.15 )
    Gender categorical
    Units: Subjects
        Female
    223
        Male
    142
    Asthma Control Questionnaire (ACQ)
    Units: ACQ score
        arithmetic mean (standard deviation)
    ( )

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (buffer)

    Reporting group title
    0.3 mg
    Reporting group description
    		 0.3 mg CYT003

    Reporting group title
    1.0 mg
    Reporting group description
    		 1.0 mg CYT003

    Reporting group title
    2.0 mg
    Reporting group description
    		 2.0 mg CYT003

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS was analyzed according to Intent to Treat principle and a last Obesrvation Carried Forward procedure was adopted.

    Primary: ACQ score - Change from Baseline at week 12

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    End point title
    		 ACQ score - Change from Baseline at week 12
    End point description
    Change in Asthma Controm Questionnaire Score at week 12 compared to Baseline score
    End point type
    Primary
    End point timeframe
    12 weeks treatment period for each patient
    End point values
    		 Placebo 0.3 mg 1.0 mg 2.0 mg
    Number of subjects analysed
    89
    91
    94
    91
    Units: Delta ACQ score
        arithmetic mean (standard deviation)
    -0.649 ( 0.7631 )
    -0.641 ( 0.8799 )
    -0.546 ( 0.8176 )
    -0.544 ( 0.7147 )
    Statistical analysis title
    		 Primary Efficacy Analysis 0.3 mg
    Statistical analysis description
    The treatment effect was evaluated as a contrast of each active treatment versus placebo.
    Comparison groups
    0.3 mg v Placebo
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.818 [2]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [1] - ANCOVA
    [2] - Hochberg procedure to control for multiple comparisons.
    Statistical analysis title
    		 Primary Efficacy Analysis 1.0 mg
    Statistical analysis description
    The treatment effect was evaluated as a contrast of each active treatment versus placebo.
    Comparison groups
    1.0 mg v Placebo
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.4025 [4]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [3] - ANCOVA
    [4] - Hochberg procedure to control for multiple comparisons.
    Statistical analysis title
    		 Primary Efficacy Analysis 2.0 mg
    Statistical analysis description
    The treatment effect was evaluated as a contrast of each active treatment versus placebo.
    Comparison groups
    2.0 mg v Placebo
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0.4883 [6]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [5] - ANCOVA
    [6] - Hochberg procedure to control for multiple comparisons.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 weeks
    Adverse event reporting additional description
    Treatment phase
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo buffer

    Reporting group title
    1.0 mg
    Reporting group description
    		 1.0 mg CYT003

    Reporting group title
    2.0 mg
    Reporting group description
    		 2.0 mg CYT003

    Reporting group title
    0.3 mg
    Reporting group description
    		 0.3 mg CYT003

    Serious adverse events
    		 Placebo 1.0 mg 2.0 mg 0.3 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 94 (1.06%)
    0 / 91 (0.00%)
    0 / 91 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma exacerbation
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 94 (1.06%)
    0 / 91 (0.00%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Placebo 1.0 mg 2.0 mg 0.3 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 89 (40.45%)
    62 / 94 (65.96%)
    61 / 91 (67.03%)
    53 / 91 (58.24%)
    Investigations
    blood creatinkinase increased
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 94 (1.06%)
    0 / 91 (0.00%)
    3 / 91 (3.30%)
         occurrences all number
    36
    62
    61
    53
    Body temperature increased
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 94 (0.00%)
    4 / 91 (4.40%)
    0 / 91 (0.00%)
         occurrences all number
    36
    62
    61
    53
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 89 (6.74%)
    3 / 94 (3.19%)
    7 / 91 (7.69%)
    6 / 91 (6.59%)
         occurrences all number
    36
    62
    61
    53
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    0 / 89 (0.00%)
    24 / 94 (25.53%)
    27 / 91 (29.67%)
    20 / 91 (21.98%)
         occurrences all number
    36
    62
    61
    53
    Injection site swelling
         subjects affected / exposed
    0 / 89 (0.00%)
    27 / 94 (28.72%)
    23 / 91 (25.27%)
    20 / 91 (21.98%)
         occurrences all number
    36
    62
    61
    53
    Injection site pruritus
         subjects affected / exposed
    2 / 89 (2.25%)
    19 / 94 (20.21%)
    11 / 91 (12.09%)
    11 / 91 (12.09%)
         occurrences all number
    36
    62
    61
    53
    Injection site pain
         subjects affected / exposed
    1 / 89 (1.12%)
    12 / 94 (12.77%)
    16 / 91 (17.58%)
    10 / 91 (10.99%)
         occurrences all number
    36
    62
    61
    53
    Injection site induration
         subjects affected / exposed
    0 / 89 (0.00%)
    2 / 94 (2.13%)
    4 / 91 (4.40%)
    3 / 91 (3.30%)
         occurrences all number
    36
    62
    61
    53
    Injection site reaction
         subjects affected / exposed
    0 / 89 (0.00%)
    3 / 94 (3.19%)
    1 / 91 (1.10%)
    0 / 91 (0.00%)
         occurrences all number
    36
    62
    61
    53
    Influenza like illness
         subjects affected / exposed
    2 / 89 (2.25%)
    7 / 94 (7.45%)
    3 / 91 (3.30%)
    0 / 91 (0.00%)
         occurrences all number
    36
    62
    61
    53
    Pyrexia
         subjects affected / exposed
    2 / 89 (2.25%)
    2 / 94 (2.13%)
    5 / 91 (5.49%)
    0 / 91 (0.00%)
         occurrences all number
    36
    62
    61
    53
    Fatigue
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 94 (0.00%)
    0 / 91 (0.00%)
    3 / 91 (3.30%)
         occurrences all number
    36
    62
    61
    53
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 89 (2.25%)
    4 / 94 (4.26%)
    2 / 91 (2.20%)
    2 / 91 (2.20%)
         occurrences all number
    36
    62
    61
    53
    Wheezing
         subjects affected / exposed
    1 / 89 (1.12%)
    1 / 94 (1.06%)
    3 / 91 (3.30%)
    1 / 91 (1.10%)
         occurrences all number
    36
    62
    61
    53
    Oropharyngeal pain
         subjects affected / exposed
    0 / 89 (0.00%)
    3 / 94 (3.19%)
    0 / 91 (0.00%)
    2 / 91 (2.20%)
         occurrences all number
    36
    62
    61
    53
    Rhinitis allergic
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 94 (0.00%)
    1 / 91 (1.10%)
    3 / 91 (3.30%)
         occurrences all number
    36
    62
    61
    53
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 89 (4.49%)
    5 / 94 (5.32%)
    6 / 91 (6.59%)
    5 / 91 (5.49%)
         occurrences all number
    36
    62
    61
    53
    Bronchitis
         subjects affected / exposed
    1 / 89 (1.12%)
    1 / 94 (1.06%)
    2 / 91 (2.20%)
    5 / 91 (5.49%)
         occurrences all number
    36
    62
    61
    53
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 89 (1.12%)
    4 / 94 (4.26%)
    4 / 91 (4.40%)
    0 / 91 (0.00%)
         occurrences all number
    36
    62
    61
    53
    Acute sinusitis
         subjects affected / exposed
    0 / 89 (0.00%)
    3 / 94 (3.19%)
    0 / 91 (0.00%)
    2 / 91 (2.20%)
         occurrences all number
    36
    62
    61
    53
    Respiratory tract infection viral
         subjects affected / exposed
    3 / 89 (3.37%)
    0 / 94 (0.00%)
    0 / 91 (0.00%)
    0 / 91 (0.00%)
         occurrences all number
    36
    62
    61
    53

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Mar 2013
    Global amendment 1: Several minor changes such as additional details on analysis populations
    20 Dec 2013
    Global amendment 2: several minor changes such as biomarkers

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Jan 2013
    Delay in study drug availability
    15 May 2013

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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