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    Clinical Trial Results:
    The role of anti-IgE (omalizumab) in the management of severe recalcitrant paediatric atopic eczema

    Summary
    EudraCT number
    2010-020841-29
    Trial protocol
    GB  
    Global end of trial date
    31 Aug 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    02 May 2019
    First version publication date
    02 May 2019
    Other versions
    Summary report(s)
    FINAL STUDY REPORT

    Trial information

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    Trial identification
    Sponsor protocol code
    ADAPT
    Additional study identifiers
    ISRCTN number
    ISRCTN15090567
    US NCT number
    NCT02300701
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    King's College London
    Sponsor organisation address
    The Strand, London, United Kingdom, WC2R 2LS
    Public contact
    Susan Chan, King's College London, +44 02071889730, susan.chan@kcl.ac.uk
    Scientific contact
    Susan Chan, King's College London, +44 02071889730, susan.chan@kcl.ac.uk
    Sponsor organisation name
    Guy's and St Thomas' NHS Foundation Trust
    Sponsor organisation address
    Great Maze Pond, London, United Kingdom, SE19RT
    Public contact
    Dr Susan Chan, Guy`s & St Thomas` NHS Foundation Trust, +44 02071889730, susan.chan@kcl.ac.uk
    Scientific contact
    Dr Susan Chan, Guy`s & St Thomas` NHS Foundation Trust, +44 02071889730, susan.chan@kcl.ac.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
    31 Aug 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Aug 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Our hypothesis is that anti-IgE will reduce the levels of IgE in children with severe eczema, thereby alleviating their symptoms.
    Protection of trial subjects
    Management of exacerbations and any additional therapy (eg.oral steroids or antibiotics) will be recorded. All adverse events and side effects will be recorded in the CRF as per the Trial assessments, with the exception of abnormal blood results that are considered not clinically significant by the Investigator and will be managed as below. Adverse events linked to the existing condition (atopic dermatitis) will be collected separately to help distinguish between expected events related to condition or side effects of concomitant medications.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Dec 2014
    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
    United Kingdom: 62
    Worldwide total number of subjects
    62
    EEA total number of subjects
    62
    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)
    36
    Adolescents (12-17 years)
    25
    Adults (18-64 years)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were recruited from a single clinical site in London between 2016 and 2017.

    Pre-assignment
    Screening details
    Inclusion Criteria 1. Children aged 4-19yrs with:- 2. Severe eczema an objective SCORAD (a validated eczema severity score) of over 40 ii. in a patient unresponsive to optimal topical therapy (potent topical steroids and topical calcineurin inhibitors) or systemic therapy1 iii. in whom there is no impression of lack of compliance iv. with a (C

    Period 1
    Period 1 title
    Whole Group (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    Participants will be allocated to treatment arm via an online dynamic algorithm which will be developed and hosted by the UKCRC registered King’s College London CTU. The use of the online system will ensure concealment of treatment allocation for clinicians who are recruiting participants.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Omalizumab
    Arm description
    Children will receive omalizumab treatment for 24 week.
    Arm type
    Experimental

    Investigational medicinal product name
    Xolair
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection/skin-prick test
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The appropriate dose and dosing frequency of Xolair (omalizumab) is determined by baseline total IgE (range: 30 to 1 500 IU/ml), measured before the start of treatment, and body weight (kg). Prior to initial dosing, patients will have their IgE level determined by serum total IgE assay for their dose assignment. Based on these measurements, the dose of Xolair (omalizumab) will be calculated using the formula: 0.016 x weight (kg) x total IgE level (kU/l) or using the latest manufacturers dosing tables (according to the current Summary of Product Characteristics). 75 600 mg of Xolair (omalizumab) in 1 to 4 injections may be needed for each administration as shown in the tables. The dose of Xolair (omalizumab) stated on the table, closest to that child's weight and IgE levels, will be administered. Thus, if the total IgE level is above the upper limit stated on the dosing table, the highest dose of Xolair. They will remain on this dose throughout the 24 weeks of treatment

    Arm title
    Placebo
    Arm description
    Children on placebo for 24 weeks
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The appropriate dose and dosing frequency of placebo is determined in the same way as for Xolair by baseline total IgE (range: 30 to 1 500 IU/ml), measured before the start of treatment, and body weight (kg). Prior to initial dosing, patients will have their IgE level determined by serum total IgE assay for their dose assignment. Based on these measurements, the dose of placebo will be calculated using the formula: 0.016 x weight (kg) x total IgE level (kU/l) or using the latest manufacturers dosing tables (according to the current Summary of Product Characteristics for Xolair). They will remain on this dose throughout the 24 weeks of treatment.

    Number of subjects in period 1
    Omalizumab Placebo
    Started
    30
    32
    Completed
    28
    31
    Not completed
    2
    1
         Withdrawn before starting IMP
             1
             -
         Adverse event, non-fatal
             1
             -
         Consent withdrawn by subject
             -
             1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Whole Group
    Reporting group description
    -

    Reporting group values
    Whole Group Total
    Number of subjects
    62 62
    Age categorical
    Units: Subjects
        Children (2-11 years)
    36 36
        Adolescents (12-17 years)
    25 25
        Adults (18-64 years)
    1 1
    Gender categorical
    Units: Subjects
        Female
    30 30
        Male
    32 32

    End points

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    End points reporting groups
    Reporting group title
    Omalizumab
    Reporting group description
    Children will receive omalizumab treatment for 24 week.

    Reporting group title
    Placebo
    Reporting group description
    Children on placebo for 24 weeks

    Primary: Mean difference in oSCORAD between arms

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    End point title
    Mean difference in oSCORAD between arms [1]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to week 24
    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: Please see attached study report for results
    End point values
    Omalizumab Placebo
    Number of subjects analysed
    30
    32
    Units: Whole
    32
    32
    Attachments
    Summary results
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline to week 48 post randomisation.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Omalizumab
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Serious adverse events
    Omalizumab Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 30 (20.00%)
    6 / 32 (18.75%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Whiplash
    Additional description: Admitted for observation following car accident. Whiplash injury including headache and abdominal pain and joint ache.
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Eosinophilic oesophagitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
    Additional description: Unknown cause
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suspected anaphylaxis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic
    Additional description: Reaction to unknown food
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Infected eczema
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema herpeticum
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exacerbation of eczema
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 32 (9.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Omalizumab Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 30 (96.67%)
    32 / 32 (100.00%)
    Vascular disorders
    Angiodema
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Circumcision
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Immune system disorders
    Urticaria
         subjects affected / exposed
    7 / 30 (23.33%)
    1 / 32 (3.13%)
         occurrences all number
    7
    1
    Allergy to animal
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Allergic reaction to excipient
         subjects affected / exposed
    10 / 30 (33.33%)
    10 / 32 (31.25%)
         occurrences all number
    10
    10
    Allergic rhinitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Itchy eyes
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    0
    2
    Chicken pox
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Breast lump
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Hot flush
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Nightmare
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 32 (3.13%)
         occurrences all number
    1
    1
    Pyrexia
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 32 (3.13%)
         occurrences all number
    1
    1
    Secondary suture of wound
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Shaking
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Sore feet
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Thirsty
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 32 (3.13%)
         occurrences all number
    1
    1
    Toothache
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Unwell
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Vitamin D deficiency
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Needle issue
    Additional description: Accidental needle stick
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Head injury
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma aggravated
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Asthma
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    Chest infection
         subjects affected / exposed
    0 / 30 (0.00%)
    5 / 32 (15.63%)
         occurrences all number
    0
    5
    Cold
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 32 (9.38%)
         occurrences all number
    1
    3
    Cold symptoms
         subjects affected / exposed
    1 / 30 (3.33%)
    6 / 32 (18.75%)
         occurrences all number
    1
    6
    Congestion
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    0
    2
    Coryzal symptoms
         subjects affected / exposed
    6 / 30 (20.00%)
    12 / 32 (37.50%)
         occurrences all number
    6
    12
    Cough
         subjects affected / exposed
    2 / 30 (6.67%)
    10 / 32 (31.25%)
         occurrences all number
    2
    10
    Difficulty breathing
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    0
    2
    Exacerbation of asthma
         subjects affected / exposed
    1 / 30 (3.33%)
    7 / 32 (21.88%)
         occurrences all number
    1
    7
    Pneumonia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Tightness in chest
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Wheezing
         subjects affected / exposed
    4 / 30 (13.33%)
    4 / 32 (12.50%)
         occurrences all number
    4
    4
    Blood and lymphatic system disorders
    Iron deficiency
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 32 (9.38%)
         occurrences all number
    3
    3
    Nervous system disorders
    Headaches
         subjects affected / exposed
    10 / 30 (33.33%)
    4 / 32 (12.50%)
         occurrences all number
    10
    4
    Dizziness
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 30 (13.33%)
    1 / 32 (3.13%)
         occurrences all number
    6
    1
    Acid reflux
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Loose stools
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    5 / 30 (16.67%)
    1 / 32 (3.13%)
         occurrences all number
    5
    1
    Stomach ache
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Stomach pain
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    Vomiting
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 32 (9.38%)
         occurrences all number
    1
    3
    Hepatobiliary disorders
    Eczema aggravated
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Blisters
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Burning sensation
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    cold sore
         subjects affected / exposed
    0 / 30 (0.00%)
    6 / 32 (18.75%)
         occurrences all number
    0
    6
    Eczema aggravated
         subjects affected / exposed
    25 / 30 (83.33%)
    29 / 32 (90.63%)
         occurrences all number
    25
    29
    Exacerbated eczema
         subjects affected / exposed
    7 / 30 (23.33%)
    5 / 32 (15.63%)
         occurrences all number
    7
    5
    Eczema weeping
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Eczema herpeticum
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Hives
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 32 (3.13%)
         occurrences all number
    1
    1
    Infected eczema
         subjects affected / exposed
    18 / 30 (60.00%)
    27 / 32 (84.38%)
         occurrences all number
    18
    27
    Paronychia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Pruritis
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    0
    2
    Pustules
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    0
    2
    Rash
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    0
    2
    Infected skin
         subjects affected / exposed
    3 / 30 (10.00%)
    5 / 32 (15.63%)
         occurrences all number
    3
    5
    Peeling skin
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Thinning skin
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Swelling
    Additional description: swelling to ear
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Urticaria
         subjects affected / exposed
    6 / 30 (20.00%)
    0 / 32 (0.00%)
         occurrences all number
    6
    0
    Musculoskeletal and connective tissue disorders
    Aching limb
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Wrist fracture
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Pain in jaw
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Leg pain muscular
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Pain in arms and legs
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Swollen ankles
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 30 (30.00%)
    13 / 32 (40.63%)
         occurrences all number
    9
    13
    Infected penis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Head lice
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Ear infection
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Runny nose
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 32 (9.38%)
         occurrences all number
    0
    3
    Infected nail bed
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Infection of gum
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Sore throat
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Viral infection
         subjects affected / exposed
    7 / 30 (23.33%)
    2 / 32 (6.25%)
         occurrences all number
    7
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 May 2014
    Protocol change: • Baseline systemic steroids omitted. • Addition of treatment failure and alternative systemic therapies as secondary outcome measures as it was thought important to address whether treatment/placebo was associated with more failure of treatment • EASI eczema scoring added as this is increasingly used in studies • Samples to be stored for genetics studies (subject to consent). Also administrative changes to the protocol.
    26 Sep 2014
    Changes to the secondary outcome measures and Secondary efficacy parameters. The age group between treatment group changed, Participants will be allocated to treatment group using minimisation. This is to ensure that there will be minimal imbalance of total IgE (≤1500, >1500) and age (<10 or ≥10 years) between treatment groups. In addition, there are various other administrative changes throughout the whole protocol and the labels
    30 Jul 2015
    The inclusion of the Transepidermal Water Loss test (TEWL), an additional optional test at Baseline, Week 24, 36 and 48.The exclusion criteria has been amended with pre-existing hepatic or renal impairment being removed, and the definition of ‘Exacerbations of eczema’ in section 6.2 of the protocol has been clarified. Additionally, the timepoint for urine testing has been changed from baseline to screening and the protocol has been revised to clarify the Xolair dosing for IgE levels at the limits of the dosing table. In addition, skin swabs will now not be taken from family members or at the end of treatment for any infections. There have been various other administrative changes and clarifications throughout the protocol and section 8.3 has been updated to bring it in line with the statistical analysis plan.
    27 Sep 2016
    Inclusion of a new secondary outcome measure as listed below and the statistics section has also been updated in line with the new version of the Statistical analysis plan. Below is a list of all changes made to the protocol: 1. Trial Flowchart TEWL timing updated from screening to baseline visit, in line with the rest of the protocol. 2. Clarification of primary outcome measures 3. Inclusion of a new secondary outcome measure - ‘Change in use of potent topical steroids and calcineurin inhibitors: the weight, extent and frequency of use will be recorded at each visit.’ 4. Clarification of inclusion criteria 5. Clarification on treatment of eczema exacerbations to include that treatment can follow that ‘as decided by the supervising physician’ as well as the regimen included in the protocol. 6. Statistics section updated in line with latest version of the Statistical Analysis Plan (SAP, version 2.0) 7. Addition of protocol version history 8. Staff update on the ADAPTrial study website and administrative corrections to the parent and child consent forms.

    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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/28330497
    http://www.ncbi.nlm.nih.gov/pubmed/28535776
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