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    Clinical Trial Results:
    A randomized, double-blind, placebo controlled, parallel group, proof of concept study evaluating the efficacy,safety, pharmacokinetics and pharmacodynamics of QGE031 in the treatment of patients with moderate to severe atopic dermatitis

    Summary
    EudraCT number
    		 2011-002112-84
    Trial protocol
    		 AT   DE   NL  
    Global end of trial date
    28 Aug 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jul 2016
    First version publication date
    05 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CQGE031X2201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01552629
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002 , Basel, Switzerland,
    Public contact
    Novartis Pharma AG, Novartis Pharma AG, +41 613241111,
    Scientific contact
    Novartis Pharma AG, Novartis Pharma AG, +41 613241111,
    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 Aug 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Aug 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To demonstrate the efficacy of QGE031 relative to placebo at 12 weeks in patients with atopic dermatitis (AD) as assessed by Eczema Area and Severity Index (EASI)
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial. The use of topical rescue medication was allowed at all times during the trial but was restricted. Twice daily application of mild or moderate strength topical corticosteroids (using the European four category classification system of mild, moderate, potent and very potent) was allowed. These rescue medications were provided by the study site and used to control the patient’s atopic dermatitis and the resulting symptoms not adequately controlled on study drug. The combination of allowed topical rescue medications that most closely approximates the patient’s current regimen was dispensed at screening, and full tube weights obtained. The use of oral antihistamines as a rescue medication for itch not controlled by the study drug was allowed at all times during the trial; this medication was provided by the study site. Use of rescue medication was required to be recorded in the eCRF.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Jan 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
    Austria: 14
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 4
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    22
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Approximately 30 patients were planned to be randomly assigned to one of three treatment groups conducted in parallel. Based upon the results of the first interim analysis, the study was terminated after 22 patients were enrolled.

    Pre-assignment
    Screening details
    		 The study consisted of up to a 28-day screening period (Day -28 to Day -1), a treatment period of 12 weeks, a follow-up period of 12 weeks, and an End of Study (EoS) evaluation.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 QGE031
    Arm description
    		 QGE031 will be administered as a subcutaneous dose every two weeks (q2)
    Arm type
    		 Experimental

    Investigational medicinal product name
    QGE031
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    subcutaneous injection, which was administered 280 mg once every two weeks

    Arm title
    		 Placebo
    Arm description
    		 A QGE031 matched placebo will be administered as a subcutaneous dose q2 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
    subcutaneous injection, which was administered once every two weeks

    Arm title
    		 Cyclosporine A
    Arm description
    		 Cyclosporine A will be administered (as per label) for atopic dermatitis. 2.5 – 5.0 mg/kg BID
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cyclosporine A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    2.5 – 5.0 mg/kg oral daily dose split twice a day

    Number of subjects in period 1
    		QGE031 Placebo Cyclosporine A
    Started
    10
    10
    2
    Randomized
    10
    10
    2
    Completed
    7
    9
    1
    Not completed
    3
    1
    1
         Consent withdrawn by subject
    1
    -
    -
         Adverse event, non-fatal
    1
    -
    1
         Administrative problems
    -
    1
    -
         Lost to follow-up
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    QGE031
    Reporting group description
    		 QGE031 will be administered as a subcutaneous dose every two weeks (q2)

    Reporting group title
    Placebo
    Reporting group description
    		 A QGE031 matched placebo will be administered as a subcutaneous dose q2 weeks

    Reporting group title
    Cyclosporine A
    Reporting group description
    		 Cyclosporine A will be administered (as per label) for atopic dermatitis. 2.5 – 5.0 mg/kg BID

    Reporting group values
    		 QGE031 Placebo Cyclosporine A Total
    Number of subjects
    		 10 10 2 22
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 10 10 2 22
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35 ( 12.6 ) 32.4 ( 10.1 ) 52.5 ( 7.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5 1 11
        Male
    		 5 5 1 11

    End points

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    End points reporting groups
    Reporting group title
    QGE031
    Reporting group description
    		 QGE031 will be administered as a subcutaneous dose every two weeks (q2)

    Reporting group title
    Placebo
    Reporting group description
    		 A QGE031 matched placebo will be administered as a subcutaneous dose q2 weeks

    Reporting group title
    Cyclosporine A
    Reporting group description
    		 Cyclosporine A will be administered (as per label) for atopic dermatitis. 2.5 – 5.0 mg/kg BID

    Primary: Change in Eczema Area and Severity Index (EASI) from baseline to week 12

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    End point title
    		 Change in Eczema Area and Severity Index (EASI) from baseline to week 12 [1]
    End point description
    The EASI was used to make an assessment of the extent and severity of each patient’s atopic dermatitis. Erythema, induration/papulation, excoriation and lichenification were scored in each of four body areas, head/neck (H), upper limbs (UL), trunk (T), and lower limbs (LL) assigned proportionate body surface areas of 10% (H), 20% (UL), 30% (T), and 40% (LL). The severity for each sign was scored on a scale from 0-3 (none, mild, moderate and severe) where half-points were allowed. The area within each body region with the key signs of inflammation was estimated as a percentage of the total area of that particular body region.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    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: No statistical analysis has been performed for this endpoint.
    End point values
    		 QGE031 Placebo Cyclosporine A
    Number of subjects analysed
    10 [2]
    10 [3]
    2 [4]
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Baseline
    25.37 ( 9.624 )
    24.73 ( 4.514 )
    22.95 ( 7.566 )
        Week 12 (n = 9, 10, 2)
    19.82 ( 10.932 )
    18.4 ( 7.281 )
    1.18 ( 0.813 )
        Change from baseline (n = 9, 10, 2)
    -7.48 ( 10.995 )
    -6.33 ( 5.296 )
    -21.78 ( 6.753 )
    Notes
    [2] - Subjects with any available EASI PD data for a minimum of 4 weeks and no major protocol deviations
    [3] - Subjects with any available EASI PD data for a minimum of 4 weeks and no major protocol deviations
    [4] - Subjects with any available EASI PD data for a minimum of 4 weeks and no major protocol deviations
    No statistical analyses for this end point

    Primary: Combined EASI50 responders

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    End point title
    		 Combined EASI50 responders [5]
    End point description
    Combined EASI50 responders are defined as those with 50% decrease from baseline in Eczema Area and Severity Index (EASI) plus no more than a 25% increase in topical rescue medication use.
    End point type
    Primary
    End point timeframe
    Week 12
    Notes
    [5] - 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: No statistical analysis has been performed for this endpoint.
    End point values
    		 QGE031 Placebo Cyclosporine A
    Number of subjects analysed
    10 [6]
    10 [7]
    2 [8]
    Units: percent
        number (not applicable)
    11
    10
    100
    Notes
    [6] - Subjects with any available EASI PD data for a minimum of 4 weeks and no major protocol deviations
    [7] - Subjects with any available EASI PD data for a minimum of 4 weeks and no major protocol deviations
    [8] - Subjects with any available EASI PD data for a minimum of 4 weeks and no major protocol deviations
    No statistical analyses for this end point

    Secondary: Change in Investigator Global Assessment (IGA) for atopic dermatitis

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    End point title
    		 Change in Investigator Global Assessment (IGA) for atopic dermatitis
    End point description
    Participants dermatitis will be visually assessed and an IGA score will be determined by the Investigator using a prespecified evaluation criteria. The number of patients reported as per their IGA score. Majority of cases were reported as mild, moderate or severe. There were very few cases reported as clear or almost clear during the study.
    End point type
    Secondary
    End point timeframe
    Weeks 6, 12
    End point values
    		 QGE031 Placebo Cyclosporine A
    Number of subjects analysed
    10 [9]
    10 [10]
    2 [11]
    Units: percent
    number (not applicable)
        Week 0 - Clear
    0
    0
    0
        Week 0 - Almost clear
    0
    0
    0
        Week 0 - Mild
    0
    0
    0
        Week 0 - Moderate
    60
    50
    50
        Week 0 - Severe
    40
    40
    50
        Week 0 - Very severe
    0
    10
    0
        Week 6 - Clear
    0
    0
    0
        Week 6 - Almost clear
    0
    0
    50
        Week 6 - Mild
    0
    10
    50
        Week 6 - Moderate
    70
    50
    0
        Week 6 - Severe
    30
    40
    0
        Week 6 - Very severe
    0
    0
    0
        Week 12 - Clear
    0
    0
    0
        Week 12 - Almost clear
    0
    0
    100
        Week 12 - Mild
    20
    20
    0
        Week 12 - Moderate
    50
    60
    0
        Week 12 - Severe
    10
    10
    0
        Week 12 - Very severe
    10
    10
    0
    Notes
    [9] - Subjects with any available EASI PD data for a minimum of 4 weeks and no major protocol deviations
    [10] - Subjects with any available EASI PD data for a minimum of 4 weeks and no major protocol deviations
    [11] - Subjects with any available EASI PD data for a minimum of 4 weeks and no major protocol deviations
    No statistical analyses for this end point

    Secondary: Number of participants with adverse events

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    End point title
    		 Number of participants with adverse events
    End point description
    Adverse events will be determined by observation and non-leading questioning of patients, and by measuring safety parameters (electrocardiograms, clinical laboratory, blood pressure)
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 QGE031 Placebo Cyclosporine A
    Number of subjects analysed
    10 [12]
    10 [13]
    2 [14]
    Units: percent
        number (not applicable)
    90
    90
    100
    Notes
    [12] - All patients that received at least one dose of study drug
    [13] - All patients that received at least one dose of study drug
    [14] - All patients that received at least one dose of study drug
    No statistical analyses for this end point

    Secondary: QGE031 plasma concentrations

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    End point title
    		 QGE031 plasma concentrations [15]
    End point description
    Blood samples will be collected for determination of QGE031 serum levels
    End point type
    Secondary
    End point timeframe
    24 weeks
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only plasma concentrations were reported for the compound QGE031.
    End point values
    		 QGE031
    Number of subjects analysed
    10 [16]
    Units: µg/mL
    arithmetic mean (standard deviation)
        Day 1 n=10
    0.12 ( 0.379 )
        Day 15 n=10
    11 ( 4.51 )
        Day 29 n=9
    14 ( 5.58 )
        Day 43 n=10
    16.7 ( 6.54 )
        Day 57 n=10
    18 ( 7.54 )
        Day 71 n=10
    18.1 ( 7.28 )
        Day 85 n=9
    17.8 ( 7.78 )
        Day 99 n=8
    10.4 ( 5.71 )
        Day 113 n=8
    4.72 ( 2.79 )
        Day 127 n=7
    3.05 ( 2.12 )
        Day 141 n=7
    1.74 ( 1.46 )
        Day 155 n=5
    0.91 ( 1.07 )
        Day 169 n=9
    1.16 ( 1.42 )
    Notes
    [16] - Patients with evaluable (or complete) PK parameter data.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    QGE031
    Reporting group description
    		 QGE031

    Reporting group title
    Cyclosporine
    Reporting group description
    		 Cyclosporine

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 QGE031 Cyclosporine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 10 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 QGE031 Cyclosporine Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 10 (90.00%)
    2 / 2 (100.00%)
    9 / 10 (90.00%)
    Investigations
    White blood cell count increased
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 2 (50.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Rib fracture
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Post procedural complication
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    3 / 10 (30.00%)
         occurrences all number
    0
    0
    11
    Syncope
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Injury associated with device
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 2 (50.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Eyelids pruritus
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 2 (50.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Lip blister
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Duodenogastric reflux
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    2
    Nausea
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Cough
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 2 (50.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Erythema
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    Urticaria
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    2
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    1
    Fracture pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Herpes simplex
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Groin abscess
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 2 (50.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Folliculitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 2 (50.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Influenza
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    4 / 10 (40.00%)
    0 / 2 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    5
    0
    2
    Molluscum contagiosum
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 2 (50.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Oral herpes
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    1
    Rhinitis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Postoperative wound infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Otitis externa
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 2 (0.00%)
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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Oct 2011
    The purpose of Amendment 1 was to clarify, and correct, certain criteria and procedures in the protocol and to make the length of the QGE031/placebo and cyclosporine treatment periods consistent.
    22 Nov 2011
    Amendment 2 of the protocol was made to add an exclusion criterion: Patients with a history of schistosomiasis, or stool examination positive for ova or parasites at Screening, or travel to an area endemic with schistosomiasis (in the six months prior to Screening).
    23 Jan 2012
    Amendment 3 of the protocol was made to address concerns of the potential for QGE031 to cause thrombocytopenia. Thrombocytopenia has been observed in pre-clinical studies with omalizumab, an anti-IgE monoclonal antibody with a related mechanism of action, although it has not emerged as a safety concern in man for this drug. Thrombocytopenia has thus far not been observed with QGE031 in the conducted toxicology studies in non-human primates or in man.
    14 May 2012
    Amendment 4 of the protocol :As new clinical data from other studies became available, these new data were incorporated into the protocol. In addition, it was requested that study endpoints be specified in the protocol.
    19 Jun 2012
    The protocol allowed some flexibility to replace patients whose atopic dermatitis was not stable and thus worsened shortly after starting study treatment. As this caused concern that it would lead to replacement of patients showing a clear lack of efficacy, which would bias the estimation of efficacy, this flexibility has been removed from the protocol. After a request to change study eligibility criteria to include a population more closely reflecting that of the cyclosporine label, it was decided to stop the cyclosporine arm instead.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    23 Apr 2013
    Decision to terminate study.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    In April 2013, Novartis informed the Health Authorities about its decision to terminate the study. Any ongoing patients enrolled at the time of termination were allowed to complete the study according to the approved protocol. The last follow-up vi
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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
    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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