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    Clinical Trial Results:
    Open label, single-centre study to evaluate the efficacy of the bradykinin (BK) B2 receptor antagonist, Icatibant, in the relief of symptoms resulting from moderate to severe angioedema unresponsive to antihistamines

    Summary
    EudraCT number
    		 2011-002339-24
    Trial protocol
    		 GB  
    Global end of trial date
    03 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Mar 2019
    First version publication date
    27 Mar 2019
    Other versions
    Summary report(s)
    		 Adverse Events
    Con meds
    End of study data
    Demographics
    Medical history
    Patient response data

    Trial information

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    Trial identification
    Sponsor protocol code
    NA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Barts Health NHS Trust
    Sponsor organisation address
    Whitechapel Road, London, United Kingdom, E1 1BB
    Public contact
    Chief Investigator, Dr Hilary Longhurst, +44 020324602825, hilary.longhurst@bartsandthelondon.nhs.uk
    Scientific contact
    Chief Investigator, Dr Hilary Longhurst, +44 020324602825, hilary.longhurst@bartsandthelondon.nhs.uk
    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
    28 Jul 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    03 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of the bradykinin (BK) B2 antagonist, Icatibant, in the relief of symptoms resulting from moderate to severe angioedema of the face, neck, arms, genitals, tongue, pharynx and larynx, where the diagnosis is of Idiopathic Angioedema - unresponsive to antihistamines.
    Protection of trial subjects
    This trial will be overseen and reviewed by the Chief Investigator on an ongoing and regular basis, with the oversight of the sponsor (monitoring and auditing systems).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2012
    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
    United Kingdom: 9
    Worldwide total number of subjects
    9
    EEA total number of subjects
    9
    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)
    9
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients where recruited from clinics run by the PI at Barts Health NHS Trust

    Pre-assignment
    Screening details
    		 All subjects attend a screening visit and those meeting all of the inclusion and none of the exclusion criteria were eligible for enrolment into the study

    Period 1
    Period 1 title
    Treatment phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All patients
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ICATABANT
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    30mg SC

    Number of subjects in period 1
    		All patients
    Started
    9
    Completed
    9

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -

    Subject analysis set title
    Primary objective
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Time to onset of symptom relief Number of episodes 14 Mean 4.3 hrs Median 2.0 hrs standard deviation 5.7 hrs First quartile 1 hrs Second quartile 5 hrs Time to almost completed symtom relief Number of episodes 13 <20mm on VAS Mean 9.3 hrs Median 8.0 hrs standard deviation 8.2 hrs First quartile 2.0 hrs Third quartile 14.0 hrs VAS at 4 hrs Number of episodes 12 Mean 37.3 mm Median 24.0 mm standard deviation 32.7 mm First quartile 13.7 mm Third quartile 53.3 mm

    Primary: Time to onset of symptom relief

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    End point title
    		 Time to onset of symptom relief [1]
    End point description
    Skin Swelling : Mean 4.3hrs, Median =2hrs, SD=5.7, IQR=4. Skin Pain : Mean 8.5hrs, Median =2hrs, SD=14.6, IQR=5. Abdo Pain : Mean 4.3hrs, Median =1hrs, SD=6.6, IQR=4.625
    End point type
    Primary
    End point timeframe
    01/10/12- 03/05/15
    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 only
    End point values
    		 Primary objective
    Number of subjects analysed
    9
    Units: hrs
        arithmetic mean (standard deviation)
    4.3 ± 5.7
    No statistical analyses for this end point

    Secondary: VAS at 4hrs

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    End point title
    		 VAS at 4hrs
    End point description
    Skin Swelling VAS@4hrs, Mean 37.3, Median 24.0mm, SD=32.7mm IQR =39.6mm Skin Pain VAS@4hrs, Mean 31.1, Median 26.0mm, SD= 29.87mm IQR =39.6mm Abdo pain VAS@4hrs, Mean 37.3, Median 24.0mm, SD= 32.7mm IQR =45.7mm
    End point type
    Secondary
    End point timeframe
    01/10/12-03/05/15
    End point values
    		 Primary objective
    Number of subjects analysed
    9
    Units: mm
        arithmetic mean (standard deviation)
    37.3 ± 32.7
    No statistical analyses for this end point

    Secondary: Time to almost complete symtom relief

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    End point title
    		 Time to almost complete symtom relief
    End point description
    Skin Swelling Mean9.3hrs, Median 8.0hrs, SD=8.2hrs, IQR 8hrs Skin Pain Mean 6.8hrs, Median 6.0hrs, SD=5.5hrs, IQR 10.25hrs Abdo Pain Mean 5.8hrs, Median 2.0hrs, SD=8.4hrs, IQR 5.9hrs
    End point type
    Secondary
    End point timeframe
    01/10/12-03/05/15
    End point values
    		 Primary objective
    Number of subjects analysed
    Units: hrs
        arithmetic mean (standard deviation)
    9.3 ± 8.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were reported from 01/10/12 to 03/03/15
    Adverse event reporting additional description
    NA
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 AE description
    Dictionary version
    1
    Reporting groups
    Reporting group title
    All adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 All adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 9 (11.11%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Immune system disorders
    Angioedema
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 9 (77.78%)
    Nervous system disorders
    Migraine
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    heartburn
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    stomach cramps
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Abdominal pain
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Hepatobiliary disorders
    Fatty liver
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Respiratory tract infection
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Mouth ulceration
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    leg cramps
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Arthralgia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Infections and infestations
    flu like symptoms
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Injection site reaction
         subjects affected / exposed
    7 / 9 (77.78%)
         occurrences all number
    15
    weight loss
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    The study failed to recruit its target of 20 , only 9 patients being recruited. Therefore interpretation of the data and reaching any firm conclusions regarding this study are limited.
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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