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    Clinical Trial Results:
    LEO 90100 twice weekly maintenance regimen for psoriasis vulgaris

    Summary
    EudraCT number
    		 2016-000556-95
    Trial protocol
    		 GB   FR   PL  
    Global end of trial date
    27 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jul 2020
    First version publication date
    01 Jul 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    LP0053-1004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02899962
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LEO Pharma A/S
    Sponsor organisation address
    Industriparken 55, Ballerup, Denmark, 2750
    Public contact
    Clinical Disclosure Specialist, LEO Pharma A/S, LEO Pharma A/S, 45 4494 5888, disclosure@leo-pharma.com
    Scientific contact
    Clinical Disclosure Specialist, LEO Pharma A/S, LEO Pharma A/S, 45 4494 5888, disclosure@leo-pharma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Jun 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the efficacy of a twice weekly maintenance regimen with LEO 90100 compared to vehicle in the prevention of relapse in subjects with psoriasis vulgaris.
    Protection of trial subjects
    This clinical trial was conducted in accordance with the revision, current at the start of the trial, of the World Medical Association’s Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. All subjects received written and verbal information concerning the clinical trial. This information emphasised that participation in the clinical trial was voluntary and that the subject could withdraw from the clinical trial at any time and for any reason. All subjects were given an opportunity to ask questions and were given sufficient time to consider before consenting. Subjects' signed and dated informed consent to participate in the clinical trial were obtained prior to any trial related activities being carried out in accordance with ICH Good Clinical Practice (GCP) Section 4.8 and all applicable laws and regulations. Overdosage with calcipotriol may be associated with hypercalcaemia, and clinically important hypercalcaemia could be managed at the investigator’s discretion with rehydration, biphosphonate administration or according to local instructions. Overdosage with betamethasone dipropionate may result in suppression of the pituitary adrenal function, and could be treated symptomatically at the investigator's discretion. There is a risk of allergic hypersensitivity reactions with administration of Cortrosyn®/Synacthen®. Prior to the injection of Cortrosyn®/Synacthen®, the physician administering the injection was prepared to treat any possible hypersensitivity reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Oct 2016
    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: 60
    Country: Number of subjects enrolled
    United Kingdom: 79
    Country: Number of subjects enrolled
    France: 61
    Country: Number of subjects enrolled
    Germany: 59
    Country: Number of subjects enrolled
    United States: 228
    Country: Number of subjects enrolled
    Canada: 163
    Worldwide total number of subjects
    650
    EEA total number of subjects
    259
    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)
    516
    From 65 to 84 years
    134
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Adults with psoriasis on body: Subj. not performing HPA axis test: Plaque psoriasis ≥2% BSA, ≥mild severity; Subj. performing HPA axis test: Plaque psoriasis ≥10% BSA, ≥ moderate severity, normal HPA-axis function 722 screened, 650 assigned to treatment, 52 screening failures, 15 withdrew consent, 2 lost to follow-up, 2 other reasons, 1 AE

    Period 1
    Period 1 title
    Open-label phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 LEO 90100
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    LEO 90100
    Investigational medicinal product code
    Other name
    Enstilar®
    Pharmaceutical forms
    Cutaneous foam
    Routes of administration
    Topical use
    Dosage and administration details
    LEO 90100 is formulated as an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate). LEO 90100 was applied once daily on psoriasis lesions on the body. The maximum weekly use of LEO 91000 is estimated at 100 g per week (which corresponds to 15 g per day) for once-daily treatment with treatment duration of 4 weeks.

    Number of subjects in period 1
    		LEO 90100
    Started
    650
    Completed
    623
    Not completed
    27
         Consent withdrawn by subject
    7
         Adverse event, non-fatal
    2
         Other reasons
    9
         Lost to follow-up
    9
    Period 2
    Period 2 title
    Maintenance phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    The packaging and labelling of the IMPs contained no evidence of the identity of IMPs. It was not considered possible to differentiate between the IMPs solely by sensory evaluation. No effects of the IMPs which would reveal the identity of the individual treatment allocations were expected. Consequently, it was expected that the subjects and the site staff remained unaware of the individual treatment assignment during the conduct of the clinical trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LEO 90100
    Arm description
    		 LEO 90100 was to be applied twice-weekly 3 or 4 days apart on specific days. If an application was missed, the medication was to be applied as soon as subject remembered. The next application was to be made at the next scheduled dosing date. Upon confirmation of relapse, LEO 90100 for 4 weeks once daily was applied.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LEO 90100
    Investigational medicinal product code
    Other name
    Enstilar®
    Pharmaceutical forms
    Cutaneous foam
    Routes of administration
    Topical use
    Dosage and administration details
    LEO 90100 is formulated as an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate). LEO 90100 was applied twice weekly on psoriasis lesions on the body with a maximum weekly use of 30 g (15 g per day) for twice weekly treatment with treatment duration of up to 52 weeks.

    Investigational medicinal product name
    LEO 90100 rescue medication
    Investigational medicinal product code
    Other name
    Enstilar®
    Pharmaceutical forms
    Cutaneous foam
    Routes of administration
    Topical use
    Dosage and administration details
    Rescue medication: If subjects experienced a confirmed relapse (PGA≥2; i.e. at least ‘mild’) during the maintenance phase, they were to be provided with rescue medication. LEO 90100 is formulated as an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate). LEO 90100 was applied once daily on psoriasis lesions on the body: 100 g per week (15 g per day) for once-daily treatment with treatment duration of 4 weeks.

    Arm title
    		 Vehicle
    Arm description
    		 Vehicle was to be applied twice-weekly 3 or 4 days apart on specific days. If an application was missed, the medication was to be applied as soon as subject remembered. The next application was to be made at the next scheduled dosing date. Upon confirmation of relapse, LEO 90100 for 4 weeks once daily was applied.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Vehicle foam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous foam
    Routes of administration
    Topical use
    Dosage and administration details
    Aerosol foam vehicle contains the same ingredients as LEO 90100 except the active ingredients (calcipotriol and betamethasone). The vehicle was applied twice weekly on psoriasis lesions on the body with a maximum weekly use of 30 g (15 g per day) for twice weekly treatment with treatment duration of up to 52 weeks.

    Investigational medicinal product name
    LEO 90100 rescue medication
    Investigational medicinal product code
    Other name
    Enstilar®
    Pharmaceutical forms
    Cutaneous foam
    Routes of administration
    Topical use
    Dosage and administration details
    Rescue medication: If subjects experienced a confirmed relapse (PGA≥2; i.e. at least ‘mild’) during the maintenance phase, they were to be provided with rescue medication. LEO 90100 is formulated as an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate). LEO 90100 was applied once daily psoriasis lesions on the body with a maximum 100 g per week (15 g per day) for once-daily treatment with treatment duration of 4 weeks.

    Number of subjects in period 2 [1]
    		LEO 90100 Vehicle
    Started
    272
    273
    Completed
    131
    120
    Not completed
    141
    153
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    30
    36
         Adverse event, non-fatal
    2
    1
         Other
    9
    13
         No treatment success after initial 4 weeks
    3
    2
         Subjects not clear/almost clear after rescue med
    65
    70
         Lost to follow-up
    12
    14
         Lack of efficacy
    20
    16
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Subjects who did not achieve treatment success according to PGA scale were not randomized into the maintenance phase. In addition, among subjects randomized to maintenance phase, 24 had not achieved treatment success and therefore they were randomized in error.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Open-label phase
    Reporting group description
    		 -

    Reporting group values
    		 Open-label phase Total
    Number of subjects
    		 650 650
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.8 ± 14.2 -
    Gender categorical
    Units: Subjects
        Female
    		 226 226
        Male
    		 424 424
    PGA at baseline
    Units: Subjects
        Mild
    		 83 83
        Moderate
    		 509 509
        Severe
    		 58 58
    m-PASI at baseline
    Units: units on scale
        arithmetic mean (full range (min-max))
    		 7.7 (2.0 to 32.4) -
    Body surface area
    Extent of psoriasis affecting body surface area
    Units: Percentage
        arithmetic mean (full range (min-max))
    		 8.2 (1.0 to 38.0) -

    End points

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    End points reporting groups
    Reporting group title
    LEO 90100
    Reporting group description
    		 -
    Reporting group title
    LEO 90100
    Reporting group description
    		 LEO 90100 was to be applied twice-weekly 3 or 4 days apart on specific days. If an application was missed, the medication was to be applied as soon as subject remembered. The next application was to be made at the next scheduled dosing date. Upon confirmation of relapse, LEO 90100 for 4 weeks once daily was applied.

    Reporting group title
    Vehicle
    Reporting group description
    		 Vehicle was to be applied twice-weekly 3 or 4 days apart on specific days. If an application was missed, the medication was to be applied as soon as subject remembered. The next application was to be made at the next scheduled dosing date. Upon confirmation of relapse, LEO 90100 for 4 weeks once daily was applied.

    Primary: Time to first relapse

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    End point title
    		 Time to first relapse
    End point description
    Time to first relapse (at least ‘mild’ according to the Physician’s Global Assessment of disease severity [PGA]). A five-point scale (clear, almost clear, mild, moderate, and severe) of PGA was used.
    End point type
    Primary
    End point timeframe
    From the start of maintenance phase after randomisation until subjects experienced first relapse or end of treatment (Week 56 or early withdrawal)
    End point values
    		 LEO 90100 Vehicle
    Number of subjects analysed
    256
    265
    Units: days
        median (confidence interval 95%)
    56 (34 to 59)
    30 (29 to 31)
    Statistical analysis title
    		 Primary analysis
    Statistical analysis description
    The primary endpoint was time to first relapse during the maintenance phase, where relapse was an exacerbation of psoriasis defined as a PGA of at least ‘mild’. This was calculated as the number of days from randomisation to the day where the subject had the first relapse confirmed. For subjects who either did not encounter a relapse or were withdrawn from the trial, the number of days was treated as a censored observation at the day of end of trial visit.
    Comparison groups
    LEO 90100 v Vehicle
    Number of subjects included in analysis
    521
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.001
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 0.69
    Notes
    [1] - The primary endpoint was analysed using a Cox proportional hazards model with treatment group, pooled sites, and disease severity at maintenance baseline (as determined by the PGA) as factors. Maintenance baseline (Week 4) was used in the model as compared to baseline at Week 0

    Secondary: Proportion of days in remission

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    End point title
    		 Proportion of days in remission
    End point description
    The proportion of days in remission (‘clear’ or ‘almost clear’ according to the PGA) during the maintenance phase was compared between LEO 90100 and vehicle
    End point type
    Secondary
    End point timeframe
    52 weeks in the maintenance phase
    End point values
    		 LEO 90100 Vehicle
    Number of subjects analysed
    256
    265
    Units: Percentage
        arithmetic mean (standard deviation)
    70.2 ± 21.7
    60.8 ± 20.1
    Statistical analysis title
    		 Analysis of proportion of days in remission
    Statistical analysis description
    The number of days in remission was calculated as the sum of days where the subject was in remission periods. The proportion of days in remission was calculated as the number of days in remission divided by the length of the maintenance phase in days.
    Comparison groups
    LEO 90100 v Vehicle
    Number of subjects included in analysis
    521
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.08
         upper limit
    		 0.14
    Notes
    [2] - Multiple imputation of data for withdrawn subjects was done using 100 imputations. In order not to favour any treatment arm, the imputation approach depended on whether the subject’s reason for withdrawal potentially was related to IMP or not. For the imputation, the length of the maintenance phase was assumed to be 52 weeks, corresponding to 364 days.

    Secondary: Number of relapses

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    End point title
    		 Number of relapses
    End point description
    To compare the number of relapses during the maintenance phase between LEO 90100 and vehicle
    End point type
    Secondary
    End point timeframe
    52 weeks in the maintenance phase
    End point values
    		 LEO 90100 Vehicle
    Number of subjects analysed
    256
    265
    Units: Numbers
        arithmetic mean (standard deviation)
    2.0 ± 1.7
    3.1 ± 2.2
    Statistical analysis title
    		 Analysis of number of relapses
    Statistical analysis description
    The number of relapses was calculated as the sum of confirmed relapses for each subject.
    Comparison groups
    LEO 90100 v Vehicle
    Number of subjects included in analysis
    521
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.001
    Method
    		 Poisson regression
    Parameter type
    		 rate ratio
    Point estimate
    0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 0.63
    Notes
    [3] - The number of relapses was analysed using a Poisson regression model with treatment group, pooled sites, and disease severity at maintenance baseline as factors, subject as random effect, and time at risk as an offset. Maintenance baseline was used in the model as compared to baseline

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Week 0 until end of 52-week maintenance phase
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    LEO 90100 maintenance
    Reporting group description
    		 Subjects who received LEO 90100 (once daily for 4 weeks) in the open-label phase and randomised to receive LEO 90100 (twice weekly for up to 52 weeks) in the maintenance phase with rescue medication LEO 90100 (once daily for 4 weeks) provided upon confirmation of a relapse

    Reporting group title
    Vehicle maintenance
    Reporting group description
    		 Subjects who received LEO 90100 (once daily for 4 weeks) in the open-label phase and randomised to receive Vehicle (twice weekly for up to 52 weeks) in the maintenance phase with rescue medication LEO 90100 (once daily for 4 weeks) provided upon confirmation of a relapse

    Reporting group title
    LEO 90100 open-label
    Reporting group description
    		 Subjects who received LEO 90100 (once daily for 4 weeks) in the open-label phase. The same subjects were randomised into LEO 90100 or vehicle in the maintenance phase

    Serious adverse events
    		 LEO 90100 maintenance Vehicle maintenance LEO 90100 open-label
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 272 (5.15%)
    11 / 273 (4.03%)
    4 / 650 (0.62%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 273 (0.00%)
    1 / 650 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Arterial stenosis
         subjects affected / exposed
    2 / 272 (0.74%)
    0 / 273 (0.00%)
    0 / 650 (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
    Hypertension
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 273 (0.00%)
    0 / 650 (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
    Venous thrombosis
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 273 (0.37%)
    0 / 650 (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
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 273 (0.00%)
    0 / 650 (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
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 273 (0.00%)
    0 / 650 (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
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 273 (0.37%)
    0 / 650 (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
    Pulmonary embolism
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 273 (0.37%)
    0 / 650 (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
    Intentional overdose
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 273 (0.37%)
    1 / 650 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gun shot wound
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 273 (0.37%)
    0 / 650 (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
    Cardiac disorders
    Myocardial ischaemia
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 273 (0.00%)
    0 / 650 (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
    Coronary artery occlusion
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 273 (0.00%)
    0 / 650 (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
    Acute myocardial infarction
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 273 (0.00%)
    0 / 650 (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
    Atrial fibrillation
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 273 (0.00%)
    0 / 650 (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
    Mitral valve incompetence
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 273 (0.37%)
    0 / 650 (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
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 273 (0.00%)
    1 / 650 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 273 (0.00%)
    0 / 650 (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
    Alcoholic pancreatitis
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 273 (0.37%)
    0 / 650 (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
    Small intestinal obstruction
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 273 (0.37%)
    0 / 650 (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
    Colitis
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 273 (0.00%)
    0 / 650 (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
    Musculoskeletal and connective tissue disorders
    Myositis
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 273 (0.00%)
    1 / 650 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 273 (0.37%)
    0 / 650 (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
    Atypical pneumonia
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 273 (0.00%)
    0 / 650 (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
    Appendicitis
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 273 (0.37%)
    0 / 650 (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
    Endocarditis
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 273 (0.37%)
    0 / 650 (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
    Electrolyte imbalance
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 273 (0.00%)
    0 / 650 (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: 1%
    Non-serious adverse events
    		 LEO 90100 maintenance Vehicle maintenance LEO 90100 open-label
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    129 / 272 (47.43%)
    128 / 273 (46.89%)
    112 / 650 (17.23%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    5 / 272 (1.84%)
    0 / 273 (0.00%)
    0 / 650 (0.00%)
         occurrences all number
    5
    0
    0
    Ligament sprain
         subjects affected / exposed
    1 / 272 (0.37%)
    4 / 273 (1.47%)
    1 / 650 (0.15%)
         occurrences all number
    2
    4
    1
    Joint injury
         subjects affected / exposed
    3 / 272 (1.10%)
    0 / 273 (0.00%)
    0 / 650 (0.00%)
         occurrences all number
    3
    0
    0
    Laceration
         subjects affected / exposed
    2 / 272 (0.74%)
    3 / 273 (1.10%)
    1 / 650 (0.15%)
         occurrences all number
    2
    3
    1
    Contusion
         subjects affected / exposed
    2 / 272 (0.74%)
    3 / 273 (1.10%)
    1 / 650 (0.15%)
         occurrences all number
    2
    3
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 272 (1.47%)
    3 / 273 (1.10%)
    6 / 650 (0.92%)
         occurrences all number
    4
    3
    6
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    4 / 272 (1.47%)
    3 / 273 (1.10%)
    0 / 650 (0.00%)
         occurrences all number
    4
    3
    0
    Dizziness
         subjects affected / exposed
    3 / 272 (1.10%)
    0 / 273 (0.00%)
    1 / 650 (0.15%)
         occurrences all number
    4
    0
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    3 / 272 (1.10%)
    0 / 273 (0.00%)
    1 / 650 (0.15%)
         occurrences all number
    3
    0
    1
    Eye disorders
    Cataract
         subjects affected / exposed
    3 / 272 (1.10%)
    0 / 273 (0.00%)
    0 / 650 (0.00%)
         occurrences all number
    4
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 272 (0.37%)
    3 / 273 (1.10%)
    2 / 650 (0.31%)
         occurrences all number
    1
    3
    2
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 272 (0.00%)
    3 / 273 (1.10%)
    0 / 650 (0.00%)
         occurrences all number
    0
    3
    0
    Skin and subcutaneous tissue disorders
    Rebound psoriasis
         subjects affected / exposed
    4 / 272 (1.47%)
    12 / 273 (4.40%)
    0 / 650 (0.00%)
         occurrences all number
    4
    12
    0
    Psoriasis
         subjects affected / exposed
    1 / 272 (0.37%)
    7 / 273 (2.56%)
    3 / 650 (0.46%)
         occurrences all number
    1
    7
    3
    Actinic keratosis
         subjects affected / exposed
    3 / 272 (1.10%)
    0 / 273 (0.00%)
    0 / 650 (0.00%)
         occurrences all number
    3
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 272 (1.47%)
    6 / 273 (2.20%)
    3 / 650 (0.46%)
         occurrences all number
    4
    6
    4
    Back pain
         subjects affected / exposed
    6 / 272 (2.21%)
    4 / 273 (1.47%)
    4 / 650 (0.62%)
         occurrences all number
    7
    4
    4
    Pain in extremity
         subjects affected / exposed
    4 / 272 (1.47%)
    2 / 273 (0.73%)
    3 / 650 (0.46%)
         occurrences all number
    4
    2
    3
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    16 / 272 (5.88%)
    15 / 273 (5.49%)
    7 / 650 (1.08%)
         occurrences all number
    17
    24
    7
    Nasopharyngitis
         subjects affected / exposed
    22 / 272 (8.09%)
    19 / 273 (6.96%)
    7 / 650 (1.08%)
         occurrences all number
    23
    24
    7
    Influenza
         subjects affected / exposed
    7 / 272 (2.57%)
    3 / 273 (1.10%)
    2 / 650 (0.31%)
         occurrences all number
    7
    3
    2
    Urinary tract infection
         subjects affected / exposed
    3 / 272 (1.10%)
    6 / 273 (2.20%)
    2 / 650 (0.31%)
         occurrences all number
    3
    6
    2
    Bronchitis
         subjects affected / exposed
    2 / 272 (0.74%)
    5 / 273 (1.83%)
    1 / 650 (0.15%)
         occurrences all number
    2
    5
    1
    Sinusitis
         subjects affected / exposed
    5 / 272 (1.84%)
    2 / 273 (0.73%)
    2 / 650 (0.31%)
         occurrences all number
    5
    3
    2
    Gastroenteritis
         subjects affected / exposed
    4 / 272 (1.47%)
    2 / 273 (0.73%)
    3 / 650 (0.46%)
         occurrences all number
    4
    2
    3
    Folliculitis
         subjects affected / exposed
    4 / 272 (1.47%)
    2 / 273 (0.73%)
    2 / 650 (0.31%)
         occurrences all number
    4
    2
    2
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 272 (1.10%)
    3 / 273 (1.10%)
    0 / 650 (0.00%)
         occurrences all number
    3
    3
    0
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    1 / 272 (0.37%)
    2 / 273 (0.73%)
    36 / 650 (5.54%)
         occurrences all number
    1
    2
    36

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Aug 2016
    The amendment was made to implement advice from the Food and Drug Administration (FDA) and the Danish Medicines Agency (DKMA). The following important changes were made: - Updates to the inclusion/exclusion criteria. - Criteria for entering the maintenance phase was changed from “a PGA score of clear or almost clear” to “a PGA score of clear or almost clear with at least a 2-step improvement”. Correspondingly the number of subjects to be enrolled has been increased. - Clarification that subjects were to apply IMP to areas of trunk and/or limbs where lesions have cleared and also to new lesions. Upon relapse, subjects were instructed to apply IMP on affected areas once-daily for up to 4 weeks.
    14 Dec 2016
    This amendment was made to describe a new treatment principle for non-active lesions during relapse treatment: - Clarification that only the active areas were to be treated with rescue medication upon relapse and the non-active psoriasis areas were to be treated with maintenance treatment. The following other important change were made: - Addition of an 8-week follow-up period at the end of the maintenance period.

    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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