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    Clinical Trial Results:
    A Double Blind, Randomised, Placebo Controlled Multi-Centre Field Study to Assess the Efficacy and Safety of Cat-PAD Peptide Immunotherapy in Cat Allergic Subjects

    Summary
    EudraCT number
    		 2012-001733-13
    Trial protocol
    		 PL   BE   CZ   DE   HU   SK   LT   LV   EE  
    Global end of trial date
    02 Feb 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Mar 2018
    First version publication date
    03 Mar 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CP007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01620762
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Circassia Limited
    Sponsor organisation address
    Robert Robinson Avenue, Oxford, United Kingdom, OX4 4GA
    Public contact
    CP007-ClinicalTrialInformation-Desk, Circassia Limited, +44 1865 598078, CP007ClinicalTrialInformationDesk@circassia.co.uk
    Scientific contact
    CP007-ClinicalTrialInformation-Desk, Circassia Limited, +44 1865 598078, CP007ClinicalTrialInformationDesk@circassia.co.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001054-PIP01-10
    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
    03 Mar 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Feb 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of the novel desensitising immunotherapy Cat-PAD in the reduction of symptoms and the use of allergy rescue medication associated with cat allergy in subjects with clinically relevant symptoms.
    Protection of trial subjects
    None
    Background therapy
    		 Subjects were permitted to use allergy rescue medications in accordance with the rescue medication plan.
    Evidence for comparator
    		 No comparators used
    Actual start date of recruitment
    23 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: 411
    Country: Number of subjects enrolled
    Slovakia: 2
    Country: Number of subjects enrolled
    Belgium: 28
    Country: Number of subjects enrolled
    Czech Republic: 103
    Country: Number of subjects enrolled
    Germany: 94
    Country: Number of subjects enrolled
    Hungary: 5
    Country: Number of subjects enrolled
    Russian Federation: 91
    Country: Number of subjects enrolled
    Canada: 261
    Country: Number of subjects enrolled
    United States: 413
    Worldwide total number of subjects
    1408
    EEA total number of subjects
    643
    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)
    90
    Adults (18-64 years)
    1297
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 3741 Subjects screened. 2333 Subjects were not randomised. Subjects were recruited outside of the pollen season over a total duration of 3 years. Due to poor recruitment, additional countries were added to the study after the first season.

    Pre-assignment
    Screening details
    		 Blood samples taken for measurement of specific IgE and subjects given a diary card to record symptom scores. Subjects returned for full study screening in accordance with the protocol. Once all screening tests were complete, subjects completed a daily e-diary entry for symptom scores and medication use. If successful randomisation occurred.

    Period 1
    Period 1 title
    Randomisation
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Arm title
    		 Randomisation
    Arm description
    		 All subjects randomised
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cat-PAD
    Investigational medicinal product code
    Cat-PAD
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    A single course of Cat-PAD 4 x 6 nmol 4 weeks apart followed by 4 x placebo 4 weeks apart.

    Investigational medicinal product name
    Cat-PAD
    Investigational medicinal product code
    Cat-PAD
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    A single course of Cat-PAD 4 x 6 nmol 4 weeks apart followed by a second course of Cat-PAD 4 x 6 nmol 4 weeks apart

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    placebo
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    2 courses of 4 x placebo 4 weeks apart

    Number of subjects in period 1
    		Randomisation
    Started
    1408
    Completed
    1408
    Period 2
    Period 2 title
    Treatment and Assessment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment Group 1
    Arm description
    		 A single course of Cat-PAD 4 x 6 nmol 4 weeks apart followed by 4 x placebo 4 weeks apart.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cat-PAD
    Investigational medicinal product code
    Cat-PAD
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    A single course of Cat-PAD 4 x 6 nmol 4 weeks apart followed by 4 x placebo 4 weeks apart.

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    placebo
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    A single course of Cat-PAD 4 x 6 nmol 4 weeks apart followed by 4 x placebo 4 weeks apart.

    Arm title
    		 Treatment Group 2
    Arm description
    		 A single course of Cat-PAD 4 x 6 nmol 4 weeks apart followed by a second course of Cat-PAD 4 x 6 nmol 4 weeks apart.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cat-PAD
    Investigational medicinal product code
    Cat-PAD
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    A single course of Cat-PAD 4 x 6 nmol 4 weeks apart followed by a second course of Cat-PAD 4 x 6 nmol 4 weeks apart

    Arm title
    		 Treatment Group 3
    Arm description
    		 2 courses of 4 x placebo 4 weeks apart.
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    placebo
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    2 courses of 4 x placebo 4 weeks apart

    Number of subjects in period 2
    		Treatment Group 1 Treatment Group 2 Treatment Group 3
    Started
    468
    470
    470
    Completed
    420
    412
    417
    Not completed
    48
    58
    53
         Use of prohibited therapies
    -
    1
    1
         Consent withdrawn by subject
    23
    26
    27
         Non specified
    3
    -
    -
         Adverse event, non-fatal
    9
    5
    2
         Protocol violation
    1
    1
    1
         Not specified
    -
    6
    5
         Lost to follow-up
    11
    17
    10
         Subject deterioration
    -
    1
    1
         Protocol deviation
    1
    1
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Randomisation
    Reporting group description
    		 -

    Reporting group values
    		 Randomisation Total
    Number of subjects
    		 1408 1408
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 93 93
        Adults (18-64 years)
    		 1312 1312
        From 65-84 years
    		 3 3
    Gender categorical
    Units: Subjects
        Female
    		 934 934
        Male
    		 474 474

    End points

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    End points reporting groups
    Reporting group title
    Randomisation
    Reporting group description
    		 All subjects randomised
    Reporting group title
    Treatment Group 1
    Reporting group description
    		 A single course of Cat-PAD 4 x 6 nmol 4 weeks apart followed by 4 x placebo 4 weeks apart.

    Reporting group title
    Treatment Group 2
    Reporting group description
    		 A single course of Cat-PAD 4 x 6 nmol 4 weeks apart followed by a second course of Cat-PAD 4 x 6 nmol 4 weeks apart.

    Reporting group title
    Treatment Group 3
    Reporting group description
    		 2 courses of 4 x placebo 4 weeks apart.

    Primary: The mean Combined Score in the Cat-PAD treatment groups compared with the mean Combined Score in the placebo group

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    End point title
    		 The mean Combined Score in the Cat-PAD treatment groups compared with the mean Combined Score in the placebo group
    End point description
    End point type
    Primary
    End point timeframe
    Weeks 52-54 after randomisation
    End point values
    		 Treatment Group 1 Treatment Group 2 Treatment Group 3
    Number of subjects analysed
    417
    414
    414
    Units: Combined Score
        least squares mean (standard error)
    1.04 ( 0.068 )
    1.00 ( 0.068 )
    1.05 ( 0.068 )
    Statistical analysis title
    		 Mean daily CS in PAC3 active compared to placebo
    Comparison groups
    Treatment Group 1 v Treatment Group 2 v Treatment Group 3
    Number of subjects included in analysis
    1245
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Secondary: Mean TRSS in Cat-PAD treatment groups compared with placebo

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    End point title
    		 Mean TRSS in Cat-PAD treatment groups compared with placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 52-54 after randomisation
    End point values
    		 Treatment Group 1 Treatment Group 2 Treatment Group 3
    Number of subjects analysed
    417
    414
    414
    Units: TRSS score
        least squares mean (standard error)
    5.67 ( 0.358 )
    5.54 ( 0.356 )
    5.87 ( 0.357 )
    No statistical analyses for this end point

    Secondary: Mean daily TNSS in Cat-PAD treatment groups compared with placebo

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    End point title
    		 Mean daily TNSS in Cat-PAD treatment groups compared with placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 52 - 54 post randomisation
    End point values
    		 Treatment Group 1 Treatment Group 2 Treatment Group 3
    Number of subjects analysed
    417
    414
    414
    Units: TNSS
        least squares mean (standard error)
    3.48 ( 0.197 )
    3.36 ( 0.196 )
    3.44 ( 0.196 )
    No statistical analyses for this end point

    Secondary: Mean daily TOSS in Cat-PAD compared to placebo

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    End point title
    		 Mean daily TOSS in Cat-PAD compared to placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 52 - 54 post randomisation
    End point values
    		 Treatment Group 1 Treatment Group 2 Treatment Group 3
    Number of subjects analysed
    417
    414
    414
    Units: TOSS
        least squares mean (standard error)
    2.20 ( 0.179 )
    2.19 ( 0.178 )
    2.42 ( 0.179 )
    No statistical analyses for this end point

    Secondary: Mean RMS in Cat-PAD treatment groups compared with placebo

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    End point title
    		 Mean RMS in Cat-PAD treatment groups compared with placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 52-54 post randomisation
    End point values
    		 Treatment Group 1 Treatment Group 2 Treatment Group 3
    Number of subjects analysed
    417
    414
    414
    Units: RMS
        least squares mean (standard error)
    0.34 ( 0.038 )
    0.31 ( 0.037 )
    0.32 ( 0.037 )
    No statistical analyses for this end point

    Secondary: Mean RQLQ score in Cat-PAD treatment groups compared with placebo

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    End point title
    		 Mean RQLQ score in Cat-PAD treatment groups compared with placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 52-54 post randomisation
    End point values
    		 Treatment Group 1 Treatment Group 2 Treatment Group 3
    Number of subjects analysed
    396
    403
    393
    Units: RQLQ score
        least squares mean (standard error)
    1.26 ( 0.080 )
    1.26 ( 0.079 )
    1.25 ( 0.079 )
    No statistical analyses for this end point

    Secondary: Number of days subjects have no moderate or severe TRSS symptoms without rescue medication usage

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    End point title
    		 Number of days subjects have no moderate or severe TRSS symptoms without rescue medication usage
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 52-54 post randomisation
    End point values
    		 Treatment Group 1 Treatment Group 2 Treatment Group 3
    Number of subjects analysed
    417
    414
    414
    Units: Days
        least squares mean (standard error)
    9.44 ( 0.560 )
    10.11 ( 0.556 )
    9.76 ( 0.557 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Time from randomisation to end of study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Treatment Group 1
    Reporting group description
    		 A single course of Cat-PAD 4 x 6 nmol 4 weeks apart followed by 4 x placebo 4 weeks apart.

    Reporting group title
    Treatment Group 2
    Reporting group description
    		 A single course of Cat-PAD 4 x 6 nmol 4 weeks apart followed by a second course of Cat-PAD 4 x 6 nmol 4 weeks apart

    Reporting group title
    Treatment Group 3
    Reporting group description
    		 2 courses of 4 x placebo 4 weeks apart.

    Serious adverse events
    		 Treatment Group 1 Treatment Group 2 Treatment Group 3
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 467 (2.36%)
    13 / 470 (2.77%)
    9 / 470 (1.91%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    0
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma
         subjects affected / exposed
    0 / 467 (0.00%)
    0 / 470 (0.00%)
    1 / 470 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Benign breast neoplasm
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 470 (0.00%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 470 (0.00%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 470 (0.21%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 470 (0.21%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 470 (0.00%)
    1 / 470 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    0 / 467 (0.00%)
    0 / 470 (0.00%)
    1 / 470 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 470 (0.00%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 470 (0.21%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Major depression
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 470 (0.00%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 470 (0.21%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Rib fracture
         subjects affected / exposed
    0 / 467 (0.00%)
    0 / 470 (0.00%)
    1 / 470 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 470 (0.00%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    2 / 467 (0.43%)
    0 / 470 (0.00%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Comminuted fracture
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 470 (0.00%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 470 (0.21%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 470 (0.21%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 470 (0.21%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Nervous system disorders
    Vascular headache
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 470 (0.00%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 467 (0.00%)
    0 / 470 (0.00%)
    1 / 470 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 470 (0.00%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    IgA nephropathy
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 470 (0.21%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 467 (0.00%)
    0 / 470 (0.00%)
    1 / 470 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 467 (0.00%)
    0 / 470 (0.00%)
    1 / 470 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoroacetabular impingement
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 470 (0.21%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Acarodermatitis
         subjects affected / exposed
    0 / 467 (0.00%)
    0 / 470 (0.00%)
    1 / 470 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 467 (0.00%)
    0 / 470 (0.00%)
    1 / 470 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 467 (0.21%)
    1 / 470 (0.21%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 470 (0.00%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Scrotal abscess
         subjects affected / exposed
    1 / 467 (0.21%)
    0 / 470 (0.00%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 470 (0.21%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 470 (0.21%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 470 (0.21%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 467 (0.00%)
    1 / 470 (0.21%)
    0 / 470 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Treatment Group 1 Treatment Group 2 Treatment Group 3
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    298 / 467 (63.81%)
    299 / 470 (63.62%)
    305 / 470 (64.89%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    25 / 467 (5.35%)
    39 / 470 (8.30%)
    35 / 470 (7.45%)
         occurrences all number
    78
    86
    76
    General disorders and administration site conditions
    Injection site pruritus
         subjects affected / exposed
    19 / 467 (4.07%)
    13 / 470 (2.77%)
    11 / 470 (2.34%)
         occurrences all number
    51
    45
    41
    Injection site urticaria
         subjects affected / exposed
    17 / 467 (3.64%)
    9 / 470 (1.91%)
    7 / 470 (1.49%)
         occurrences all number
    95
    43
    38
    Pyrexia
         subjects affected / exposed
    6 / 467 (1.28%)
    12 / 470 (2.55%)
    6 / 470 (1.28%)
         occurrences all number
    6
    13
    7
    Immune system disorders
    Allergy to animal
         subjects affected / exposed
    9 / 467 (1.93%)
    9 / 470 (1.91%)
    11 / 470 (2.34%)
         occurrences all number
    9
    11
    13
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    9 / 467 (1.93%)
    12 / 470 (2.55%)
    3 / 470 (0.64%)
         occurrences all number
    10
    12
    3
    Diarrhoea
         subjects affected / exposed
    5 / 467 (1.07%)
    6 / 470 (1.28%)
    12 / 470 (2.55%)
         occurrences all number
    6
    7
    15
    Toothache
         subjects affected / exposed
    1 / 467 (0.21%)
    11 / 470 (2.34%)
    5 / 470 (1.06%)
         occurrences all number
    1
    12
    5
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    18 / 467 (3.85%)
    18 / 470 (3.83%)
    24 / 470 (5.11%)
         occurrences all number
    26
    27
    26
    Oropharyngeal pain
         subjects affected / exposed
    16 / 467 (3.43%)
    16 / 470 (3.40%)
    16 / 470 (3.40%)
         occurrences all number
    20
    20
    18
    Asthma
         subjects affected / exposed
    17 / 467 (3.64%)
    14 / 470 (2.98%)
    16 / 470 (3.40%)
         occurrences all number
    21
    15
    17
    Dyspnoea
         subjects affected / exposed
    12 / 467 (2.57%)
    7 / 470 (1.49%)
    11 / 470 (2.34%)
         occurrences all number
    19
    13
    12
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    12 / 467 (2.57%)
    9 / 470 (1.91%)
    15 / 470 (3.19%)
         occurrences all number
    20
    12
    20
    Arthralgia
         subjects affected / exposed
    7 / 467 (1.50%)
    12 / 470 (2.55%)
    16 / 470 (3.40%)
         occurrences all number
    8
    16
    16
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    85 / 467 (18.20%)
    87 / 470 (18.51%)
    90 / 470 (19.15%)
         occurrences all number
    124
    128
    127
    Upper respiratory tract infection
         subjects affected / exposed
    37 / 467 (7.92%)
    34 / 470 (7.23%)
    42 / 470 (8.94%)
         occurrences all number
    48
    41
    60
    Sinusitis
         subjects affected / exposed
    21 / 467 (4.50%)
    24 / 470 (5.11%)
    23 / 470 (4.89%)
         occurrences all number
    26
    29
    24
    Bronchitis
         subjects affected / exposed
    23 / 467 (4.93%)
    23 / 470 (4.89%)
    19 / 470 (4.04%)
         occurrences all number
    27
    25
    21
    Pharyngitis
         subjects affected / exposed
    11 / 467 (2.36%)
    18 / 470 (3.83%)
    14 / 470 (2.98%)
         occurrences all number
    11
    20
    17
    Influenza
         subjects affected / exposed
    9 / 467 (1.93%)
    5 / 470 (1.06%)
    19 / 470 (4.04%)
         occurrences all number
    9
    5
    20
    Urinary tract infection
         subjects affected / exposed
    9 / 467 (1.93%)
    12 / 470 (2.55%)
    11 / 470 (2.34%)
         occurrences all number
    11
    16
    13
    Tonsillitis
         subjects affected / exposed
    9 / 467 (1.93%)
    10 / 470 (2.13%)
    7 / 470 (1.49%)
         occurrences all number
    11
    12
    7
    Rhinitis
         subjects affected / exposed
    8 / 467 (1.71%)
    4 / 470 (0.85%)
    10 / 470 (2.13%)
         occurrences all number
    8
    5
    13

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jan 2015
    1. Change to the statistical analysis The study protocol has been amended to introduce a Bonferroni-Holm procedure in testing the primary hypothesis. Circassia has taken into account the scientific advice received from the Competent Authorities regarding the proposed statistical analysis and is adopting a change to the primary endpoint testing approach. This protocol amendment is designed to fulfil this requirement. 2. Increase in sample size An upper limit on the number of subjects to be randomised is being added.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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