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    Clinical Trial Results:
    Comparison of the bacterial microbiota in the skin and gut of psoriasis patients before and after sytemic treatment with adalimumab and ustekinumab or cyclosporin

    Summary
    EudraCT number
    		 2014-003022-40
    Trial protocol
    		 DE  
    Global end of trial date
    11 Sep 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Sep 2018
    First version publication date
    23 Sep 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UKM14_0008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1159-2065
    Sponsors
    Sponsor organisation name
    Universitätsklinikum Münster
    Sponsor organisation address
    Albert-Schweitzer Campus 1, Münster, Germany, 48149
    Public contact
    Hautklinik, Universitätsklinikum Münster, +49 2518352953, Karin.Loser@ukmuenster.de
    Scientific contact
    Hautklinik, Universitätsklinikum Münster, +49 2518352953, Karin.Loser@ukmuenster.de
    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
    11 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Sep 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Change in the composition of the cutaneous microbiota in lesional skin of psoriasis patients after systemic treatment with adalimumab, ustekinumab or cyclosporine (baseline versus 4 weeks after start of treatment).
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki and the ICH Guidelines in Good Clinical Practice. The study was not started before the competent ethics committee had given a favorable opinion. Written informed consent was obtained from all patients and the study was only conducted as approved by the Ethics committee and the competent authority. Amendments were only implemented after approval. All included participants of the clinical trial are covered by a volunteers' trial insurance according to § 40 AMG (insured as part of a group insurance plan of the Uniklinik Münster).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2015
    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
    Germany: 37
    Worldwide total number of subjects
    37
    EEA total number of subjects
    37
    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)
    37
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between June 2015 and September 2017, about 100 subjects with a moderate to severe Psoriasis were recruited at the outpatient clinic of the Department of Dermatology (University Hospital of Muenster) and referred to the Central Study Coordination for innovative Dermatology (ZID) of the Department of Dermatology (University Hospital of Muenster).

    Pre-assignment
    Screening details
    		 At the ZID, 37 were positively screened for moderate to severe psoriasis with a need for systemic therapy and included to the study. Due to a drop out before therapy, one patient was excluded from the trial. The remaining 36 patients were evenly split to the treatment arms. One patient (PASI <10) did not meet the screening criteria but was included

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Adalimumab
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Humira
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen, Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Initial dose of 80 mg, followed by 40 mg given every other week starting 1 week after initial dose.

    Arm title
    		 Ciclosporin
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ciclosporin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Initial dose 2.5 - 3 mg/kg/day orally. If no improvement, the daily dose can be increased to a max. 5.0 mg/kg/day (dosage usage and administration according to the guidelines for the treatment of Psoriasis vulgaris and the package leaflet)

    Arm title
    		 Ustekinumab
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Stelara
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter. For patients with a body weight > 100 kg the initial dose is 90 mg administered subcutaneously, followed by a 90 mg dose 4 weeks later, and then every 12 weeks thereafter.

    Number of subjects in period 1
    		Adalimumab Ciclosporin Ustekinumab
    Started
    12
    12
    12
    Completed
    7
    8
    6
    Not completed
    5
    4
    7
         Physician decision
    2
    1
    -
         Consent withdrawn by subject
    -
    -
    1
         Adverse event, non-fatal
    1
    3
    2
         Lost to follow-up
    1
    -
    2
         Lack of efficacy
    1
    -
    -
         Protocol deviation
    -
    -
    2
    Joined
    0
    0
    1
         Late recruitment
         Late recruitment reason:
    -
             
    -
             
    1
             One patient dropped out before recieving any medication due to lost to follow up

    Baseline characteristics

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

    Reporting group title
    Ciclosporin
    Reporting group description
    		 -

    Reporting group title
    Ustekinumab
    Reporting group description
    		 -

    Reporting group values
    		 Adalimumab Ciclosporin Ustekinumab Total
    Number of subjects
    		 12 12 13 37
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 12 12 13 37
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44 ( 13 ) 40 ( 13 ) 46 ( 12 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 4 5 11
        Male
    		 10 8 8 26
    PASI
    Psoriasis area severety index
    Units: unit(s)
        arithmetic mean (standard deviation)
    		 15.4 ( 7.0 ) 17.2 ( 7.7 ) 14.4 ( 5.2 ) -
    BSA
    Body surface area
    Units: percent
        arithmetic mean (standard deviation)
    		 16.3 ( 13.1 ) 21.8 ( 15.8 ) 13.3 ( 6.5 ) -
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 93.8 ( 14.3 ) 88.8 ( 33.7 ) 100.5 ( 21.4 ) -

    End points

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    End points reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    		 -

    Reporting group title
    Ciclosporin
    Reporting group description
    		 -

    Reporting group title
    Ustekinumab
    Reporting group description
    		 -

    Subject analysis set title
    Cutaneous microbiome before treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The analysis set includes all available samples regardless of skin site (limb or trunk) or if the subjects completed the full therapy regime. To aquire the relative abundances of the main cutaneous phyla in the lesional skin, all untreated subjects of the 3 treatment arms (Adalimumab, Ciclosporin and Ustekinumab) have been combined.

    Subject analysis set title
    Intestinal microbiome before treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The analysis set includes all available samples (subjects who completed the full therapy regimes and drop outs). To aquire the relative abundances of the main phyla of the intestine, all untreated subjects of the 3 treatment arms (Adalimumab, Ciclosporin and Ustekinumab) have been combined.

    Primary: Lesional skin microbiota at baseline

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    End point title
    		 Lesional skin microbiota at baseline [1]
    End point description
    Relative Abundances of the main phyla of the cutaneous microbiome of all subjects who participated in the study, regardless of body site (limp or trunk) or successful completion of the therapy regime.
    End point type
    Primary
    End point timeframe
    Baseline: before systemic treatment with Adalimumab, Ciclosporin or Ustekinumab.
    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: As an explorative pilot study utilising only a small number of subjects, the results are not to be interpreted in a confirmatory sense but are meant to generate initial hypotheses.
    End point values
    		 Cutaneous microbiome before treatment
    Number of subjects analysed
    35
    Units: percent
    arithmetic mean (standard deviation)
        Bacteriodetes
    4.3 ( 5.5 )
        Firmicutes
    45.2 ( 17.3 )
        Proteobacteria
    20.6 ( 12.3 )
        Actinobacteria
    22.4 ( 8.9 )
        Other
    7.6 ( 10.9 )
    No statistical analyses for this end point

    Primary: Lesional skin microbiota after 4 weeks of treatment

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    End point title
    		 Lesional skin microbiota after 4 weeks of treatment [2]
    End point description
    Relative abundances of the main phyla of the cutaneous microbiome of all subjects who participated in the study, regardless of body site (limp or trunk) or successful completion of the therapy regime.
    End point type
    Primary
    End point timeframe
    4 weeks after systemic treatment with Adalimumab, Ciclosporin or Ustekinumab.
    Notes
    [2] - 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: As an explorative pilot study utilising only a small number of subjects, the results are not to be interpreted in a confirmatory sense but are meant to generate initial hypotheses.
    End point values
    		 Adalimumab Ciclosporin Ustekinumab
    Number of subjects analysed
    11
    12
    12
    Units: percent
    arithmetic mean (standard deviation)
        Bacteriodetes
    4.0 ( 2.5 )
    2.8 ( 4.3 )
    4.2 ( 5.4 )
        Firmicutes
    43.9 ( 20.2 )
    45.0 ( 15.7 )
    39.0 ( 23.3 )
        Proteobacteria
    24.3 ( 14.3 )
    19.5 ( 7.5 )
    25.8 ( 18.4 )
        Actinobacteria
    23.9 ( 9.6 )
    28.2 ( 14.7 )
    26.0 ( 14.4 )
        Other
    4.0 ( 3.7 )
    4.5 ( 4.7 )
    4.9 ( 5.7 )
    No statistical analyses for this end point

    Primary: Lesional skin microbiota at baseline - Limb

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    End point title
    		 Lesional skin microbiota at baseline - Limb [3]
    End point description
    This analysis only includes subjects with the sample site at the limbs and who completed the full treatment regime (24 weeks of Adalimumab, Ciclosporin or Ustekinumab).
    End point type
    Primary
    End point timeframe
    Baseline: before systemic treatment with Adalimumab, Ciclosporin or Ustekinumab.
    Notes
    [3] - 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: As an explorative pilot study utilising only a small number of subjects, the results are not to be interpreted in a confirmatory sense but are meant to generate initial hypotheses.
    End point values
    		 Adalimumab Ciclosporin Ustekinumab
    Number of subjects analysed
    4
    5
    4
    Units: percent
    arithmetic mean (standard deviation)
        Bacteriodetes
    3.0 ( 2.4 )
    2.1 ( 2.2 )
    3.3 ( 5.5 )
        Firmicutes
    28.8 ( 4.8 )
    45.7 ( 15.7 )
    45.6 ( 21.6 )
        Proteobacteria
    32.5 ( 9.1 )
    14.2 ( 9.0 )
    23.0 ( 21.6 )
        Actinobacteria
    27.6 ( 7.0 )
    21.3 ( 6.9 )
    23.8 ( 8.7 )
        Other
    8.1 ( 8.0 )
    16.6 ( 22.7 )
    4.2 ( 3.7 )
    No statistical analyses for this end point

    Primary: Lesional skin microbiota after 4 weeks of treatment - Limb

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    End point title
    		 Lesional skin microbiota after 4 weeks of treatment - Limb [4]
    End point description
    This analysis only includes subjects with the sample site at the limbs and who completed the full treatment regime (24 weeks of Adalimumab, Ciclosporin or Ustekinumab).
    End point type
    Primary
    End point timeframe
    4 weeks of systemic treatment with Adalimumab, Ciclosporin or Ustekinumab.
    Notes
    [4] - 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: As an explorative pilot study utilising only a small number of subjects, the results are not to be interpreted in a confirmatory sense but are meant to generate initial hypotheses.
    End point values
    		 Adalimumab Ciclosporin Ustekinumab
    Number of subjects analysed
    4
    5
    2
    Units: percent
    arithmetic mean (standard deviation)
        Bacteriodetes
    3.4 ( 2.6 )
    0 ( 0 )
    1.3 ( 1.9 )
        Firmicutes
    33.8 ( 13.2 )
    53.2 ( 18.6 )
    32.2 ( 0.8 )
        Proteobacteria
    33.2 ( 15.8 )
    20.3 ( 8.9 )
    18.9 ( 20.4 )
        Actinobacteria
    26.2 ( 5.9 )
    22.4 ( 12.1 )
    45.8 ( 22.7 )
        Other
    3.4 ( 1.1 )
    4.2 ( 3.3 )
    1.8 ( 0.3 )
    No statistical analyses for this end point

    Primary: Lesional skin microbiota at baseline - Trunk

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    End point title
    		 Lesional skin microbiota at baseline - Trunk [5]
    End point description
    This analysis only includes subjects with the sample site at the trunk and who completed the full treatment regime (24 weeks of Adalimumab, Ciclosporin or Ustekinumab).
    End point type
    Primary
    End point timeframe
    Baseline: before systemic treatment with Adalimumab, Ciclosporin or Ustekinumab.
    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: As an explorative pilot study utilising only a small number of subjects, the results are not to be interpreted in a confirmatory sense but are meant to generate initial hypotheses.
    End point values
    		 Adalimumab Ciclosporin Ustekinumab
    Number of subjects analysed
    3
    2
    2
    Units: percent
    arithmetic mean (standard deviation)
        Bacteriodetes
    2.9 ( 5.0 )
    0.6 ( 0.9 )
    7.6 ( 10.7 )
        Firmicutes
    48.5 ( 1.8 )
    42.3 ( 30.6 )
    39.6 ( 29.5 )
        Proteobacteria
    21.3 ( 7.8 )
    21.4 ( 13.4 )
    20.5 ( 18.9 )
        Actinobacteria
    21.8 ( 3.9 )
    30.7 ( 12.4 )
    29.6 ( 1.8 )
        Other
    5.5 ( 3.3 )
    5.0 ( 5.7 )
    2.7 ( 1.7 )
    No statistical analyses for this end point

    Primary: Lesional skin microbiota after 4 weeks of treatment - Trunk

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    End point title
    		 Lesional skin microbiota after 4 weeks of treatment - Trunk [6]
    End point description
    This analysis only includes subjects with the sample site at the trunk and who completed the full treatment regime (24 weeks of Adalimumab, Ciclosporin or Ustekinumab).
    End point type
    Primary
    End point timeframe
    4 weeks of systemic treatment with Adalimumab, Ciclosporin or Ustekinumab.
    Notes
    [6] - 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: As an explorative pilot study utilising only a small number of subjects, the results are not to be interpreted in a confirmatory sense but are meant to generate initial hypotheses.
    End point values
    		 Adalimumab Ciclosporin Ustekinumab
    Number of subjects analysed
    2
    1
    2
    Units: percent
    arithmetic mean (standard deviation)
        Bacteriodetes
    4.3 ( 3.9 )
    0 ( 0 )
    0 ( 0 )
        Firmicutes
    43.7 ( 10.0 )
    20.2 ( 0 )
    40.8 ( 40.9 )
        Proteobacteria
    23.6 ( 0.2 )
    15.9 ( 0 )
    28.3 ( 37.3 )
        Actinobacteria
    21.0 ( 2.1 )
    62.0 ( 0 )
    29.5 ( 2.8 )
        Other
    7.4 ( 8.0 )
    1.9 ( 0 )
    1.3 ( 0.8 )
    No statistical analyses for this end point

    Secondary: Lesional skin microbiota after 12 weeks of treatment

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    End point title
    		 Lesional skin microbiota after 12 weeks of treatment
    End point description
    Relative abundances of the main phyla of the cutaneous microbiome of all subjects who participated in the study, regardless of body site (limp or trunk) or successful completion of the therapy regime.
    End point type
    Secondary
    End point timeframe
    12 weeks of systemic treatment with Adalimumab, Ciclosporin or Ustekinumab.
    End point values
    		 Adalimumab Ciclosporin Ustekinumab
    Number of subjects analysed
    8
    12
    9
    Units: percent
    arithmetic mean (standard deviation)
        Bacteriodetes
    4.4 ( 3.8 )
    2.4 ( 3.1 )
    6.2 ( 10.4 )
        Firmicutes
    39.1 ( 15.1 )
    44.2 ( 11.7 )
    35.9 ( 25.6 )
        Proteobacteria
    29.1 ( 15.7 )
    20.2 ( 10.4 )
    30.1 ( 16.3 )
        Actinobacteria
    22.5 ( 4.5 )
    28.1 ( 13.9 )
    23.5 ( 11.0 )
        Other
    5.0 ( 4.1 )
    5.1 ( 2.0 )
    4.4 ( 3.7 )
    No statistical analyses for this end point

    Secondary: Lesional skin microbiota after 24 weeks of treatment

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    End point title
    		 Lesional skin microbiota after 24 weeks of treatment
    End point description
    Relative abundances of the main phyla of the cutaneous microbiome of all subjects who participated in the study, regardless of body site (limp or trunk) or successful completion of the therapy regime.
    End point type
    Secondary
    End point timeframe
    24 weeks of systemic treatment with Adalimumab, Ciclosporin or Ustekinumab.
    End point values
    		 Adalimumab Ciclosporin Ustekinumab
    Number of subjects analysed
    8
    7
    7
    Units: percent
    arithmetic mean (standard deviation)
        Bacteriodetes
    3.5 ( 2.9 )
    1.7 ( 3.2 )
    1.5 ( 2.1 )
        Firmicutes
    33.1 ( 17.9 )
    46.5 ( 15.2 )
    42.0 ( 21.5 )
        Proteobacteria
    33.8 ( 23.0 )
    17.1 ( 11.0 )
    21.6 ( 11.9 )
        Actinobacteria
    21.0 ( 9.0 )
    33.0 ( 21.0 )
    30.3 ( 8.4 )
        Other
    8.6 ( 11.0 )
    1.8 ( 0.7 )
    4.5 ( 3.8 )
    No statistical analyses for this end point

    Secondary: Healthy skin microbiota at baseline - Limb

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    End point title
    		 Healthy skin microbiota at baseline - Limb
    End point description
    This analysis only includes subjects with the sample site at the limbs and who completed the full treatment regime (24 weeks of Adalimumab, Ciclosporin or Ustekinumab).
    End point type
    Secondary
    End point timeframe
    Baseline: before systemic treatment with Adalimumab, Ciclosporin or Ustekinumab.
    End point values
    		 Adalimumab Ciclosporin Ustekinumab
    Number of subjects analysed
    4
    5
    4
    Units: percent
    arithmetic mean (standard deviation)
        Bacteriodetes
    5.9 ( 7.5 )
    6.7 ( 14.9 )
    1.5 ( 3.0 )
        Firmicutes
    34.6 ( 13.7 )
    50.2 ( 17.3 )
    59.2 ( 16.6 )
        Proteobacteria
    32.9 ( 11.5 )
    25.6 ( 21.2 )
    6.9 ( 1.6 )
        Actinobacteria
    21.8 ( 8.6 )
    11.2 ( 8.9 )
    3.2 ( 2.0 )
        Other
    4.9 ( 4.5 )
    6.3 ( 8.3 )
    1.1 ( 0.8 )
    No statistical analyses for this end point

    Secondary: Healthy skin microbiota at baseline - Trunk

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    End point title
    		 Healthy skin microbiota at baseline - Trunk
    End point description
    This analysis only includes subjects with the sample site at the trunk and who completed the full treatment regime (24 weeks of Adalimumab, Ciclosporin or Ustekinumab).
    End point type
    Secondary
    End point timeframe
    Baseline: before systemic treatment with Adalimumab, Ciclosporin or Ustekinumab.
    End point values
    		 Adalimumab Ciclosporin Ustekinumab
    Number of subjects analysed
    3
    2
    2
    Units: percent
    arithmetic mean (standard deviation)
        Bacteriodetes
    7.0 ( 6.0 )
    0.8 ( 1.1 )
    0 ( 0 )
        Firmicutes
    42.8 ( 13.0 )
    49.2 ( 45.6 )
    45.1 ( 12.8 )
        Proteobacteria
    22.8 ( 6.3 )
    12.4 ( 17.5 )
    11.6 ( 11.9 )
        Actinobacteria
    19.8 ( 9.5 )
    35.3 ( 25.1 )
    37.8 ( 0.9 )
        Other
    7.6 ( 4.3 )
    2.4 ( 1.9 )
    5.5 ( 1.9 )
    No statistical analyses for this end point

    Secondary: Lesional skin microbiota after 12 weeks of treatment - Limb

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    End point title
    		 Lesional skin microbiota after 12 weeks of treatment - Limb
    End point description
    This analysis only includes subjects with the sample site at the limbs and who completed the full treatment regime (24 weeks of Adalimumab, Ciclosporin or Ustekinumab).
    End point type
    Secondary
    End point timeframe
    12 weeks of systemic treatment with Adalimumab, Ciclosporin or Ustekinumab.
    End point values
    		 Adalimumab Ciclosporin Ustekinumab
    Number of subjects analysed
    4
    5
    4
    Units: percent
    arithmetic mean (standard deviation)
        Bacteriodetes
    5.0 ( 5.2 )
    2.0 ( 3.1 )
    9.1 ( 14.5 )
        Firmicutes
    27.5 ( 4.1 )
    47.3 ( 5.1 )
    26.7 ( 11.9 )
        Proteobacteria
    38.2 ( 13.5 )
    20.5 ( 11.5 )
    36.5 ( 18.0 )
        Actinobacteria
    24.9 ( 3.1 )
    25.7 ( 16.5 )
    25.8 ( 8.3 )
        Other
    4.4 ( 4.6 )
    4.5 ( 1.7 )
    1.9 ( 1.6 )
    No statistical analyses for this end point

    Secondary: Lesional skin microbiota after 24 weeks of treatment - Limb

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    End point title
    		 Lesional skin microbiota after 24 weeks of treatment - Limb
    End point description
    This analysis only includes subjects with the sample site at the limbs and who completed the full treatment regime (24 weeks of Adalimumab, Ciclosporin or Ustekinumab).
    End point type
    Secondary
    End point timeframe
    24 weeks of systemic treatment with Adalimumab, Ciclosporin or Ustekinumab.
    End point values
    		 Adalimumab Ciclosporin Ustekinumab
    Number of subjects analysed
    4
    5
    4
    Units: percent
    arithmetic mean (standard deviation)
        Bacteriodetes
    3.1 ( 1.4 )
    0.9 ( 1.4 )
    2.3 ( 2.6 )
        Firmicutes
    27.5 ( 20.8 )
    50.7 ( 9.1 )
    36.9 ( 9.3 )
        Proteobacteria
    38.7 ( 29.3 )
    20.6 ( 12.9 )
    25.6 ( 10.2 )
        Actinobacteria
    18.8 ( 10.2 )
    25.8 ( 12.3 )
    32.2 ( 0.9 )
        Other
    11.8 ( 15.2 )
    2.2 ( 0.6 )
    3.0 ( 1.1 )
    No statistical analyses for this end point

    Secondary: Lesional skin microbiota after 12 weeks of treatment - Trunk

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    End point title
    		 Lesional skin microbiota after 12 weeks of treatment - Trunk
    End point description
    This analysis only includes subjects with the sample site at the trunk and who completed the full treatment regime (24 weeks of Adalimumab, Ciclosporin or Ustekinumab).
    End point type
    Secondary
    End point timeframe
    12 weeks of systemic treatment with Adalimumab, Ciclosporin or Ustekinumab.
    End point values
    		 Adalimumab Ciclosporin Ustekinumab
    Number of subjects analysed
    3
    2
    2
    Units: percent
    arithmetic mean (standard deviation)
        Bacteriodetes
    4.5 ( 2.4 )
    0 ( 0 )
    1.9 ( 0.8 )
        Firmicutes
    45.8 ( 9.2 )
    27.5 ( 16.7 )
    29.2 ( 19.5 )
        Proteobacteria
    23.4 ( 13.8 )
    21.9 ( 15.3 )
    32.3 ( 9.0 )
        Actinobacteria
    19.4 ( 5.4 )
    47.2 ( 1.1 )
    30.5 ( 12.1 )
        Other
    6.8 ( 4.0 )
    3.4 ( 2.5 )
    6.1 ( 0.7 )
    No statistical analyses for this end point

    Secondary: Lesional skin microbiota after 24 weeks of treatment - Trunk

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    End point title
    		 Lesional skin microbiota after 24 weeks of treatment - Trunk
    End point description
    This analysis only includes subjects with the sample site at the trunk and who completed the full treatment regime (24 weeks of Adalimumab, Ciclosporin or Ustekinumab).
    End point type
    Secondary
    End point timeframe
    24 weeks of systemic treatment with Adalimumab, Ciclosporin or Ustekinumab
    End point values
    		 Adalimumab Ciclosporin Ustekinumab
    Number of subjects analysed
    3
    2
    2
    Units: percent
    arithmetic mean (standard deviation)
        Bacteriodetes
    2.2 ( 2.7 )
    0 ( 0 )
    0.8 ( 1.1 )
        Firmicutes
    32.5 ( 11.5 )
    30.8 ( 24.4 )
    32.7 ( 26.6 )
        Proteobacteria
    34.0 ( 17.4 )
    10.3 ( 2.9 )
    23.6 ( 8.9 )
        Actinobacteria
    24.6 ( 9.7 )
    58.0 ( 27.8 )
    34.9 ( 9.6 )
        Other
    6.7 ( 4.8 )
    0.9 ( 0.5 )
    8.1 ( 7.0 )
    No statistical analyses for this end point

    Secondary: Intestinal microbiome at baseline

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    End point title
    		 Intestinal microbiome at baseline
    End point description
    Relative abundances of the main phyla of the intestinal microbiome of all subjects who participated in the study, regardless of successful completion of the therapy regime.
    End point type
    Secondary
    End point timeframe
    Baseline: before systemic treatment with Adalimumab, Ciclosporin or Ustekinumab
    End point values
    		 Intestinal microbiome before treatment
    Number of subjects analysed
    29
    Units: percent
    arithmetic mean (standard deviation)
        Bacteriodetes
    41.2 ( 10.8 )
        Firmicutes
    40.5 ( 10.1 )
        Proteobacteria
    11.0 ( 9.3 )
        Actinobacteria
    3.5 ( 3.4 )
        Verrucomicrobia
    1.8 ( 4.0 )
        Other
    2.1 ( 3.5 )
    No statistical analyses for this end point

    Secondary: Intestinal microbiome after 4 weeks of treatment

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    End point title
    		 Intestinal microbiome after 4 weeks of treatment
    End point description
    Relative abundances of the main phyla of the intestinal microbiome of all subjects who participated in the study, regardless of successful completion of the therapy regime.
    End point type
    Secondary
    End point timeframe
    4 weeks after systemic treatment with Adalimumab, Ciclosporin or Ustekinumab.
    End point values
    		 Adalimumab Ciclosporin Ustekinumab
    Number of subjects analysed
    7
    10
    10
    Units: percent
    arithmetic mean (standard deviation)
        Bacteriodetes
    37.5 ( 11.8 )
    35.6 ( 10.2 )
    36.9 ( 15.8 )
        Firmicutes
    44.9 ( 16.3 )
    35.2 ( 12.1 )
    44.8 ( 20.1 )
        Proteobacteria
    8.6 ( 6.7 )
    16.3 ( 11.6 )
    11.5 ( 11.6 )
        Actinobacteria
    4.9 ( 4.6 )
    2.4 ( 3.5 )
    5.3 ( 6.2 )
        Verrucomicrobia
    1.5 ( 4.1 )
    2.8 ( 4.1 )
    0 ( 0 )
        Other
    2.6 ( 2.7 )
    7.6 ( 13.2 )
    1.5 ( 0.9 )
    No statistical analyses for this end point

    Secondary: Intestinal microbiome after 12 weeks of treatment

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    End point title
    		 Intestinal microbiome after 12 weeks of treatment
    End point description
    Relative abundances of the main phyla of the intestinal microbiome of all subjects who participated in the study, regardless of successful completion of the therapy regime.
    End point type
    Secondary
    End point timeframe
    12 weeks after systemic treatment with Adalimumab, Ciclosporin or Ustekinumab.
    End point values
    		 Adalimumab Ciclosporin Ustekinumab
    Number of subjects analysed
    7
    7
    6
    Units: percent
    arithmetic mean (standard deviation)
        Bacteriodetes
    37.1 ( 11.6 )
    41.7 ( 6.3 )
    37.7 ( 7.2 )
        Firmicutes
    40.8 ( 11.5 )
    38.9 ( 6.6 )
    38.5 ( 10.4 )
        Proteobacteria
    7.5 ( 7.2 )
    9.9 ( 7.6 )
    19.0 ( 9.1 )
        Actinobacteria
    3.8 ( 5.5 )
    2.9 ( 3.2 )
    4.2 ( 5.8 )
        Verrucomicrobia
    0.2 ( 0.5 )
    3.9 ( 6.7 )
    4.2 ( 7.5 )
        Other
    10.5 ( 15.0 )
    2.6 ( 3.0 )
    1.2 ( 1.1 )
    No statistical analyses for this end point

    Secondary: Intestinal microbiome after 24 weeks of treatment

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    End point title
    		 Intestinal microbiome after 24 weeks of treatment
    End point description
    Relative abundances of the main phyla of the intestinal microbiome of all subjects who participated in the study, regardless of successful completion of the therapy regime.
    End point type
    Secondary
    End point timeframe
    24 weeks after systemic treatment with Adalimumab, Ciclosporin or Ustekinumab.
    End point values
    		 Adalimumab Ciclosporin Ustekinumab
    Number of subjects analysed
    6
    4
    4
    Units: percent
    arithmetic mean (standard deviation)
        Bacteriodetes
    37.8 ( 11.8 )
    44.5 ( 8.3 )
    46.4 ( 6.3 )
        Firmicutes
    36.0 ( 11.8 )
    37.8 ( 9.6 )
    40.2 ( 4.9 )
        Proteobacteria
    11.5 ( 5.2 )
    8.0 ( 5.1 )
    8.7 ( 5.9 )
        Actinobacteria
    3.3 ( 4.4 )
    3.8 ( 6.0 )
    1.4 ( 1.7 )
        Verrucomicrobia
    2.5 ( 2.8 )
    4.6 ( 7.4 )
    1.4 ( 2.8 )
        Other
    8.8 ( 10.5 )
    1.2 ( 0.4 )
    1.9 ( 1.1 )
    No statistical analyses for this end point

    Secondary: Intestinal microbiome at baseline (without drop outs)

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    End point title
    		 Intestinal microbiome at baseline (without drop outs)
    End point description
    This analysis only includes subjects who completed the full treatment regime (24 weeks of Adalimumab, Ciclosporin or Ustekinumab).
    End point type
    Secondary
    End point timeframe
    Baseline: before systemic treatment with Adalimumab, Ciclosporin or Ustekinumab.
    End point values
    		 Adalimumab Ciclosporin Ustekinumab
    Number of subjects analysed
    4
    4
    4
    Units: percent
    arithmetic mean (standard deviation)
        Bacteriodetes
    37.0 ( 7.1 )
    45.9 ( 6.9 )
    51.0 ( 10.0 )
        Firmicutes
    35.7 ( 4.6 )
    40.1 ( 3.0 )
    35.9 ( 7.4 )
        Proteobacteria
    11.7 ( 3.0 )
    5.5 ( 4.3 )
    10.6 ( 5.6 )
        Verrucomicrobia
    5.9 ( 6.9 )
    4.1 ( 5.9 )
    0 ( 0 )
        Actinobacteria
    3.9 ( 3.7 )
    1.7 ( 1.5 )
    0.3 ( 0.6 )
        Other
    5.8 ( 8.1 )
    2.6 ( 2.3 )
    2.2 ( 3.6 )
    No statistical analyses for this end point

    Secondary: Intestinal microbiome after 4 weeks of treatments (without drop outs)

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    End point title
    		 Intestinal microbiome after 4 weeks of treatments (without drop outs)
    End point description
    This analysis only includes subjects who completed the full treatment regime (24 weeks of Adalimumab, Ciclosporin or Ustekinumab).
    End point type
    Secondary
    End point timeframe
    4 weeks of systemic treatment with Adalimumab, Ciclosporin or Ustekinumab.
    End point values
    		 Adalimumab Ciclosporin Ustekinumab
    Number of subjects analysed
    3
    4
    3
    Units: percent
    arithmetic mean (standard deviation)
        Bacteriodetes
    42.4 ( 6.7 )
    42.6 ( 4.7 )
    42.2 ( 5.6 )
        Firmicutes
    37.1 ( 5.8 )
    38.4 ( 6.4 )
    45.8 ( 4.2 )
        Proteobacteria
    11.0 ( 7.0 )
    10.3 ( 10.7 )
    10.4 ( 3.8 )
        Verrucomicrobia
    3.6 ( 6.2 )
    2.9 ( 4.3 )
    0 ( 0 )
        Actinobacteria
    1.8 ( 0.7 )
    2.6 ( 2.2 )
    0.4 ( 0.6 )
        Other
    4.1 ( 3.9 )
    3.3 ( 2.8 )
    1.2 ( 0.9 )
    No statistical analyses for this end point

    Secondary: Intestinal microbiome after 12 weeks of treatments (without drop outs)

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    End point title
    		 Intestinal microbiome after 12 weeks of treatments (without drop outs)
    End point description
    This analysis only includes subjects who completed the full treatment regime (24 weeks of Adalimumab, Ciclosporin or Ustekinumab).
    End point type
    Secondary
    End point timeframe
    12 weeks of systemic treatment with Adalimumab, Ciclosporin or Ustekinumab.
    End point values
    		 Adalimumab Ciclosporin Ustekinumab
    Number of subjects analysed
    4
    4
    3
    Units: percent
    arithmetic mean (standard deviation)
        Bacteriodetes
    44.4 ( 8.4 )
    39.8 ( 6.9 )
    37.5 ( 6.9 )
        Firmicutes
    39.9 ( 6.9 )
    40.6 ( 8.6 )
    43.9 ( 10.4 )
        Proteobacteria
    6.0 ( 6.0 )
    8.9 ( 9.6 )
    16.6 ( 13.1 )
        Verrucomicrobia
    0.4 ( 0.7 )
    4.6 ( 9.2 )
    0 ( 0 )
        Actinobacteria
    1.4 ( 0.1 )
    2.2 ( 1.7 )
    0.5 ( 0.8 )
        Other
    7.9 ( 11.3 )
    4.1 ( 3.4 )
    1.5 ( 1.3 )
    No statistical analyses for this end point

    Secondary: Intestinal microbiome after 24 weeks of treatments (without drop outs)

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    End point title
    		 Intestinal microbiome after 24 weeks of treatments (without drop outs)
    End point description
    This analysis only includes subjects who completed the full treatment regime (24 weeks of Adalimumab, Ciclosporin or Ustekinumab).
    End point type
    Secondary
    End point timeframe
    24 weeks after systemic treatment with Adalimumab, Ciclosporin or Ustekinumab.
    End point values
    		 Adalimumab Ciclosporin Ustekinumab
    Number of subjects analysed
    4
    4
    4
    Units: percent
    arithmetic mean (standard deviation)
        Bacteriodetes
    33.0 ( 7.8 )
    44.5 ( 8.3 )
    46.4 ( 6.3 )
        Firmicutes
    37.3 ( 10.6 )
    37.8 ( 9.6 )
    40.2 ( 4.9 )
        Proteobacteria
    12.6 ( 2.1 )
    8.0 ( 5.1 )
    8.7 ( 5.9 )
        Verrucomicrobia
    3.8 ( 2.6 )
    4.2 ( 7.5 )
    1.4 ( 2.8 )
        Actinobacteria
    2.1 ( 1.8 )
    4.2 ( 5.8 )
    1.4 ( 1.7 )
        Other
    11.2 ( 12.6 )
    1.2 ( 0.4 )
    1.9 ( 1.1 )
    No statistical analyses for this end point

    Secondary: PASI (end of trial)

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    End point title
    		 PASI (end of trial)
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks of systemic treatment with Adalimumab, Ciclosporin or Ustekinumab.
    End point values
    		 Adalimumab Ciclosporin Ustekinumab
    Number of subjects analysed
    7
    8
    6
    Units: unit(s)
    arithmetic mean (standard deviation)
        PASI
    3.9 ( 8.0 )
    5.9 ( 5.2 )
    2.6 ( 3.3 )
    No statistical analyses for this end point

    Secondary: BSA (end of trial)

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    End point title
    		 BSA (end of trial)
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks of systemtic treatment with Adalimumab, Ciclosporin or Ustekinumab.
    End point values
    		 Adalimumab Ciclosporin Ustekinumab
    Number of subjects analysed
    7
    8
    6
    Units: percent
    arithmetic mean (standard deviation)
        BSA
    6.1 ( 10.5 )
    5.6 ( 3.7 )
    5.3 ( 7.9 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The timeframe for adverse event reporting is max. 24 weeks (completion of the full treatment regime).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    		 -

    Reporting group title
    Ciclosporin
    Reporting group description
    		 -

    Reporting group title
    Ustekinumab
    Reporting group description
    		 -

    Serious adverse events
    		 Adalimumab Ciclosporin Ustekinumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    General disorders and administration site conditions
    Condition aggravated
    Additional description: Worsening of chronic venous insufficiency
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         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
    Gastroenteritis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    1 / 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: 0%
    Non-serious adverse events
    		 Adalimumab Ciclosporin Ustekinumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 12 (50.00%)
    10 / 12 (83.33%)
    9 / 12 (75.00%)
    Investigations
    Biopsy
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Occult blood
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Weight increased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Post-traumatic pain
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Vascular disorders
    Peripheral venous disease
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    2
    Surgical and medical procedures
    Skin neoplasm excision
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Wisdom teeth removal
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    1
    Hypoaesthesia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    0
    Paraesthesia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Gingival bleeding
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    0
    Nausea
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    1 / 12 (8.33%)
         occurrences all number
    0
    2
    1
    Crohn's disease
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    0
    Gingival hypertrophy
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal discomfort
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Alopecia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Skin striae
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Psoriasis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Joint effusion
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Arthralgia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Spinal pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Tonsillitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Pulpitis dental
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    3 / 12 (25.00%)
    5 / 12 (41.67%)
    1 / 12 (8.33%)
         occurrences all number
    5
    8
    1
    Bronchitis bacterial
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Bacterial infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Viral tonsillitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Lice infestation
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Oral herpes
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Herpes simplex
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Increased appetite
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Vitamin D deficiency
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Jul 2015
    - Sampling of healthy skin and biopsies only taken at baseline before treatment. Reasoning: No changes of the microbiome in healthy skin is to be expected due to systemic therapy - Biopsie wounds are closed by suture instead of using a patch: Reasoning: for the best possible cosmetic result
    18 Dec 2015
    - Adjustment of exclusion criteria for all patients: Prophylaxis of tuberculosis using Isoniazid is no longer an exclusion criteria: Reasoning: effect of Isoniazid treatment is selective for mycobacterium tuberculosis and mycobacterium bovis. No impact on the study results is to be expected. Subjects with latent tuberculosis or with a history of latent or active tuberculosis without proof of an adequate treatment can be included in the study - Additional exclusion of subjects which are positive for the hepatitis-C virus (HPV-PCR positive) for safety reasons - For safety reasons while in treatment with Adalimumab or Ustekinumab: subjects with latent tuberculosis or with a history of latent or active tuberculosis without proof of an adequate treatment and subjects with several or significant risk factors for tuberculosis have to be additionally treated with a tuberculosis prophylaxis. - Deletion of an additional exclusion criteria for subjects of the ciclosporin treatment arm: Deleted exclusion Criteria 10: long-term treatment with methotrexate Reasoning: Criteria missing in the updated product characteristics of Immunosporin® soft capsules 07/2015 - Determination of the Estimated Glomerular Filtration Rate (eGFR) introduced to the monitoring of the patients during the visits of Ciclosporin treated subjects In case of an decreasing eGFR: adjustments to the dosage based on recommendations given in the updated product characteristics of Immunosporin® soft capsules 07/2015 Reasoning: Recommendation of the updated product characteristics of Immunosporin® soft capsules 07/2015

    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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