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    Clinical Trial Results:
    A 2:1 randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of Fumaderm® in young patients aged 10 to 17 years with moderate to severe psoriasis vulgaris (KIFUderm study).

    Summary
    EudraCT number
    2012-000035-82
    Trial protocol
    DE  
    Global end of trial date
    20 Sep 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Apr 2017
    First version publication date
    05 Apr 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    027-008
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Biogen GmbH
    Sponsor organisation address
    Carl-Zeiss-Ring 6, Ismaning, Germany, 85737
    Public contact
    Biogen Study Medical Director, Biogen, clinicaltrials@biogen.com
    Scientific contact
    Biogen Study Medical Director, Biogen, clinicaltrials@biogen.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Sep 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to assess the efficacy and safety of Fumaderm® treatment in patients aged 10 to 17 after 20 weeks compared to placebo.
    Protection of trial subjects
    As paediatric subjects do not possess legal right capacity and ability to enter into agreements, fully informed consent was obtained from the parents/legal guardian(s). Subjects and their parents/legal guardians were given adequate time to review the information in the informed consent and were allowed to ask, and have answered, questions concerning all portions of the conduct of the study. Through the informed consent process each subject was made aware of the purpose of the study, the procedures, the benefits and risks of the study, the discomforts and the precautions taken. Any side effects or other health issues occurring during the study were followed up by the study doctor. Subjects were able to stop taking part in the study at any time without giving any reason.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    20 Dec 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
    Germany: 135
    Worldwide total number of subjects
    135
    EEA total number of subjects
    135
    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)
    23
    Adolescents (12-17 years)
    112
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study was conducted at 22 study centres in Germany from 20-December 2012 (first patient randomised) to 20 September 2016 (last patient out).

    Pre-assignment
    Screening details
    In total, 163 patients were screened, resulting in the randomisation of 135 patients, of whom 134 patients received the investigational treatment at least once. Eligible patients were randomised 2:1 at visit 1 to receive either Fumaderm® Initial / Fumaderm® or matching placebo. All patients received basic therapy for skin care (Basiscreme DAC).

    Period 1
    Period 1 title
    Double-blind Treatment Phase (20 weeks)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Assessor, Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Fumaderm/Fumaderm
    Arm description
    Participants first received Fumaderm Initial for three weeks, titrating up from one tablet/day in the first week of the study (week 0) to three tablets/day in week 2. Participants were then switched to Fumaderm, and were up-titrated from one tablet/day in the fourth week of the study (week 3) to three tablets/day in week 5. Participants continued to receive 3 tablets/day until week 19, unless they met protocol-specified criteria allowing further up-titration to 4 tablets/day from week 12 onwards.
    Arm type
    Experimental

    Investigational medicinal product name
    Fumaderm® Initial
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received one tablet per day in week 0, two tablets per day in week 1 and three tablets per day in week 2 of the study. Each tablet consists of dimethyl fumarate 30 mg, calcium ethyl fumarate 67 mg, magnesium ethyl fumarate 5 mg, and zinc ethyl fumarate 3 mg.

    Investigational medicinal product name
    Fumaderm®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received one tablet per day in week 3, two tablets per day in week 4 and three tablets per day from week 5 to week 19. After week 12, patients could have been up-titrated to 4 tablets per day if they met criteria defined in the protocol. Each tablet consists of dimethyl fumarate 120 mg, calcium ethyl fumarate 87 mg, magnesium ethyl fumarate 5 mg, and zinc ethyl fumarate 3 mg.

    Arm title
    Placebo/Fumaderm
    Arm description
    Participants received matching placebo tablets for 20 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received matching placebo tablets.

    Number of subjects in period 1
    Fumaderm/Fumaderm Placebo/Fumaderm
    Started
    91
    44
    Received Study Drug
    91
    43
    Completed
    75
    26
    Not completed
    16
    18
         Protocol deviation
    -
    1
         Other
    1
    2
         Lack of efficacy
    6
    6
         Pregnancy
    1
    -
         Adverse event, non-fatal
    5
    2
         Consent withdrawn by subject
    3
    3
         Lost to follow-up
    -
    4
    Period 2
    Period 2 title
    Open-label Treatment Phase (20 weeks)
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Fumaderm/Fumaderm
    Arm description
    Participants continued to receive Fumaderm at the same dose they had received at the end of the first 20 weeks for another 20 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Fumaderm®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received three tablets per day for 20 weeks. Each tablet consists of dimethyl fumarate 120 mg, calcium ethyl fumarate 87 mg, magnesium ethyl fumarate 5 mg, and zinc ethyl fumarate 3 mg.

    Arm title
    Placebo/Fumaderm
    Arm description
    At week 20 participants switched from placebo to receive Fumaderm Initial for three weeks, starting at one tablet/day in week 20 and titrating up to three tablets/day in week 22. Participants were then switched to receive Fumaderm, starting at one tablet/day in week 23 and titrating up to three tablets/day in week 25. Participants continued to received 3 tablets/day until week 40, unless they met protocol-specified criteria allowing up-titration to 4 tablets/day from week 32 onwards.
    Arm type
    Experimental

    Investigational medicinal product name
    Fumaderm®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received one tablet per day in week 23, two tablets per day in week 24 and three tablets per day from week 25 to week 40. After week 32, patients could have been up-titrated to 4 tablets per day if they met criteria defined in the protocol. Each tablet consists of dimethyl fumarate 120 mg, calcium ethyl fumarate 87 mg, magnesium ethyl fumarate 5 mg, and zinc ethyl fumarate 3 mg.

    Investigational medicinal product name
    Fumaderm® Initial
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received one tablet per day in week 20, two tablets per day in week 21 and three tablets per day in week 22 during the open-label phase of the study. Each tablet consists of dimethyl fumarate 30 mg, calcium ethyl fumarate 67 mg, magnesium ethyl fumarate 5 mg, and zinc ethyl fumarate 3 mg.

    Number of subjects in period 2 [1]
    Fumaderm/Fumaderm Placebo/Fumaderm
    Started
    73
    24
    Completed
    40
    8
    Not completed
    33
    16
         Protocol deviation
    1
    -
         Other
    4
    3
         Lack of efficacy
    7
    1
         Adverse event, non-fatal
    3
    2
         Consent withdrawn by subject
    18
    9
         Lost to follow-up
    -
    1
    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: Four participants completed the double-blind treatment phase but did not start the open-label treatment phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fumaderm/Fumaderm
    Reporting group description
    Participants first received Fumaderm Initial for three weeks, titrating up from one tablet/day in the first week of the study (week 0) to three tablets/day in week 2. Participants were then switched to Fumaderm, and were up-titrated from one tablet/day in the fourth week of the study (week 3) to three tablets/day in week 5. Participants continued to receive 3 tablets/day until week 19, unless they met protocol-specified criteria allowing further up-titration to 4 tablets/day from week 12 onwards.

    Reporting group title
    Placebo/Fumaderm
    Reporting group description
    Participants received matching placebo tablets for 20 weeks.

    Reporting group values
    Fumaderm/Fumaderm Placebo/Fumaderm Total
    Number of subjects
    91 44 135
    Age categorical
    Units: Subjects
        Children (2-11 years)
    14 9 23
        Adolescents (12-17 years)
    77 35 112
    Age continuous
    Data are reported for the full analysis set population, which included 91 and 43 participants in each treatment group respectively.
    Units: years
        arithmetic mean (standard deviation)
    14.2 ± 2.12 13.9 ± 2.41 -
    Gender categorical
    Units: Subjects
        Female
    40 20 60
        Male
    51 24 75
    Race
    Units: Subjects
        White
    86 43 129
        Black
    0 0 0
        Asian
    1 1 2
        Other
    4 0 4
    Duration of Psoriasis
    Data are reported for the full analysis set population, which included 91 and 43 participants in each treatment group respectively.
    Units: years
        arithmetic mean (standard deviation)
    4.84 ± 4.08 4.71 ± 3.58 -
    Psoriasis Area and Severity Index (PASI) Score
    The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0) to very severe (4), together with the involved skin area rated on a scale from 0 to 6 performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (clear skin) to 72 (most severe psoriasis). Data are reported for the full analysis set population, which included 91 and 43 participants in each treatment group respectively.
    Units: units on a scale
        arithmetic mean (standard deviation)
    16.77 ± 7.534 16.04 ± 7.293 -
    Physician Global Assessment (PGA) Score
    The physician’s global assessment (PGA) describes the severity of psoriasis using 7 categories: Score 0 = Clear (no signs of psoriasis (post-inflammatory hyperpigmentation may be present)); Score 1 = Almost clear; Score 2 = Mild; Score 3 = Mild to moderate; Score 4 = Moderate; Score 5 = Moderate to severe; Score 6 = Severe. Data are reported for the full analysis set population, which included 91 and 43 participants in each treatment group respectively.
    Units: units on a scale
        arithmetic mean (standard deviation)
    4.4 ± 0.83 4.3 ± 0.77 -

    End points

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    End points reporting groups
    Reporting group title
    Fumaderm/Fumaderm
    Reporting group description
    Participants first received Fumaderm Initial for three weeks, titrating up from one tablet/day in the first week of the study (week 0) to three tablets/day in week 2. Participants were then switched to Fumaderm, and were up-titrated from one tablet/day in the fourth week of the study (week 3) to three tablets/day in week 5. Participants continued to receive 3 tablets/day until week 19, unless they met protocol-specified criteria allowing further up-titration to 4 tablets/day from week 12 onwards.

    Reporting group title
    Placebo/Fumaderm
    Reporting group description
    Participants received matching placebo tablets for 20 weeks.
    Reporting group title
    Fumaderm/Fumaderm
    Reporting group description
    Participants continued to receive Fumaderm at the same dose they had received at the end of the first 20 weeks for another 20 weeks.

    Reporting group title
    Placebo/Fumaderm
    Reporting group description
    At week 20 participants switched from placebo to receive Fumaderm Initial for three weeks, starting at one tablet/day in week 20 and titrating up to three tablets/day in week 22. Participants were then switched to receive Fumaderm, starting at one tablet/day in week 23 and titrating up to three tablets/day in week 25. Participants continued to received 3 tablets/day until week 40, unless they met protocol-specified criteria allowing up-titration to 4 tablets/day from week 32 onwards.

    Primary: Proportion of Participants with a 75% Improvement in PASI Score from Baseline (PASI 75) at Week 20

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    End point title
    Proportion of Participants with a 75% Improvement in PASI Score from Baseline (PASI 75) at Week 20
    End point description
    The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the involved skin area rated on a scale from 0 to 6 performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (clear skin) to 72 (most severe psoriasis). The full analysis set was used for this analysis; last observation carried forward imputation was used for participants with missing data.
    End point type
    Primary
    End point timeframe
    Baseline and week 20
    End point values
    Fumaderm/Fumaderm Placebo/Fumaderm
    Number of subjects analysed
    91
    43
    Units: proportion of participants
        number (confidence interval 95%)
    0.55 (0.44 to 0.65)
    0.19 (0.08 to 0.33)
    Statistical analysis title
    Primary Analysis
    Statistical analysis description
    The PASI 75 responder rate at week 20 was compared using Fisher’s exact test at a study-wise two-sided type I error rate of α = 0.0253. 95% confidence intervals (CI) for the rate were calculated according to Clopper & Pearson. Due to testing of two primary endpoints (PASI and PGA) the significance levels for the single tests was adjusted to restrict the familywise error rate to 0.05.
    Comparison groups
    Placebo/Fumaderm v Fumaderm/Fumaderm
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Fisher exact
    Parameter type
    Difference in Responder Rates
    Point estimate
    0.36
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.2
         upper limit
    0.53

    Primary: Proportion of Participants with a Physician’s Global Assessment of Clear or Almost Clear at Week 20

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    End point title
    Proportion of Participants with a Physician’s Global Assessment of Clear or Almost Clear at Week 20
    End point description
    The physician’s global assessment (PGA) describes the severity of psoriasis according to the following 7 categories: Score 0 = Clear (no signs of psoriasis (post-inflammatory hyperpigmentation may be present); Score 1 = Almost clear (intermediate between mild and clear); Score 2 = Mild (slight plaque elevation, scaling, and / or erythema); Score 3 = Mild to moderate (intermediate between moderate and mild); Score 4 = Moderate (moderate plaque elevation, scaling, and / or erythema); Score 5 = Moderate to severe (marked plaque elevation, scaling, and / or erythema); Score 6 = Severe (very marked plaque elevation, scaling, and / or erythema). The full analysis set was used for this analysis; last observation carried forward imputation was used for participants with missing data.
    End point type
    Primary
    End point timeframe
    Week 20
    End point values
    Fumaderm/Fumaderm Placebo/Fumaderm
    Number of subjects analysed
    91
    43
    Units: proportion of participants
        number (confidence interval 95%)
    0.42 (0.32 to 0.53)
    0.07 (0.01 to 0.19)
    Statistical analysis title
    Primary Analysis
    Statistical analysis description
    The PGA responder rate at week 20 was compared using Fisher’s exact test at a study-wise two-sided type I error rate of α = 0.0253. 95% confidence intervals (CI) for the rate were calculated according to Clopper & Pearson. Due to testing of two primary endpoints (PASI and PGA) the significance levels for the single tests was adjusted to restrict the familywise error rate to 0.05.
    Comparison groups
    Placebo/Fumaderm v Fumaderm/Fumaderm
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Fisher exact
    Parameter type
    Difference in Responder Rates
    Point estimate
    0.35
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.21
         upper limit
    0.49

    Secondary: Mean PASI Scores Over Time

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    End point title
    Mean PASI Scores Over Time
    End point description
    The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the involved skin area rated on a scale from 0 to 6 performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (clear skin) to 72 (most severe psoriasis). This analysis was performed using the full analysis set population with non-missing data at each time point. Participants in the Fumaderm/Fumaderm treatment group did not have study visits at weeks 26, 28, 30 and 36; "99999" indicates not applicable.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 2, 4, 6, 8, 10, 12, 16, 20, 22, 24, 26, 28, 30, 32, 36, 40, 46, 52, and 60
    End point values
    Fumaderm/Fumaderm Placebo/Fumaderm
    Number of subjects analysed
    91
    43
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 91, 43)
    16.77 ± 7.534
    16.04 ± 7.293
        Week 2 (N = 89, 42)
    15.11 ± 7.844
    15.43 ± 9.326
        Week 4 (83, 41)
    12.41 ± 7.131
    14.91 ± 11.147
        Week 6 (N = 82, 36)
    9.92 ± 6.627
    13.48 ± 11.071
        Week 8 (N = 75, 34)
    8.08 ± 6.125
    12.31 ± 8.761
        Week 10 (N = 74, 29)
    6.74 ± 4.783
    10.68 ± 9.732
        Week 12 (N = 76, 28)
    5.61 ± 4.473
    10 ± 10.872
        Week 16 (N = 77, 26)
    4.34 ± 4.303
    9.3 ± 11.697
        Week 20 (N = 75, 26)
    3.5 ± 3.792
    9.15 ± 11.731
        Week 22 (N = 71, 23)
    3.14 ± 3.627
    9.46 ± 12.433
        Week 24 (N = 71, 22)
    2.68 ± 3.006
    8.07 ± 10.005
        Week 26 (N = 0, 22)
    99999 ± 99999
    6.97 ± 9.916
        Week 28 (N = 0, 21)
    99999 ± 99999
    6.3 ± 8.171
        Week 30 (N = 0, 20)
    99999 ± 99999
    6.45 ± 9.267
        Week 32 (N = 66, 21)
    2.35 ± 2.53
    5.8 ± 8.022
        Week 36 (N = 0, 19)
    99999 ± 99999
    3.04 ± 2.505
        Week 40 (N = 59, 15)
    2.98 ± 3.242
    2.49 ± 1.918
        Week 46 (N = 46, 10)
    3.37 ± 3.259
    3.52 ± 3.524
        Week 52 (N = 42, 9)
    4.82 ± 4.851
    3.44 ± 5.014
        Week 60 (N = 40, 8)
    5.16 ± 5.215
    3.55 ± 3.851
    No statistical analyses for this end point

    Secondary: Percentage of Participants with a PASI 50 Response Over Time

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    End point title
    Percentage of Participants with a PASI 50 Response Over Time
    End point description
    The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the involved skin area rated on a scale from 0 to 6 performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (clear skin) to 72 (most severe psoriasis). A PASI 50 response is defined as the percentage of participants achieving at least a 50% reduction (improvement) in PASI score from baseline. The full analysis set was used for this analysis; participants with missing data were counted as non-responders. Participants in the Fumaderm/Fumaderm treatment group did not have study visits at weeks 26, 28, 30 and 36; "99999" indicates not applicable.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 2, 4, 6, 8, 10, 12, 16, 20, 22, 24, 26, 28, 30, 32, 36, 40, 46, 52, and 60
    End point values
    Fumaderm/Fumaderm Placebo/Fumaderm
    Number of subjects analysed
    91
    43
    Units: percentage of participants
    number (not applicable)
        Week 2
    3.3
    2.3
        Week 4
    14.3
    7
        Week 6
    26.4
    9.3
        Week 8
    42.9
    18.6
        Week 10
    45.1
    27.9
        Week 12
    57.1
    30.2
        Week 16
    68.1
    25.6
        Week 20
    67
    23.3
        Week 22
    68.1
    2.3
        Week 24
    70.3
    2.3
        Week 26
    99999
    11.6
        Week 28
    99999
    9.3
        Week 30
    99999
    18.6
        Week 32
    68.1
    23.3
        Week 36
    99999
    25.6
        Week 40
    57.1
    25.6
        Week 46
    46.2
    11.6
        Week 52
    38.5
    11.6
        Week 60
    34.1
    9.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants with a PASI 75 Response Over Time

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    End point title
    Percentage of Participants with a PASI 75 Response Over Time
    End point description
    The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the involved skin area rated on a scale from 0 to 6 performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (clear skin) to 72 (most severe psoriasis). A PASI 75 response is defined as the percentage of participants achieving at least a 75% reduction (improvement) in PASI score from baseline. The full analysis set was used for this analysis; participants with missing data were counted as non-responders. Participants in the Fumaderm/Fumaderm treatment group did not have study visits at weeks 26, 28, 30 and 36; "99999" indicates not applicable.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 2, 4, 6, 8, 10, 12, 16, 20, 22, 24, 26, 28, 30, 32, 36, 40, 46, 52, and 60
    End point values
    Fumaderm/Fumaderm Placebo/Fumaderm
    Number of subjects analysed
    91
    43
    Units: percentage of participants
    number (not applicable)
        Week 2
    1.1
    0
        Week 4
    4.4
    0
        Week 6
    9.9
    0
        Week 8
    18.7
    4.7
        Week 10
    25.3
    2.3
        Week 12
    35.2
    14
        Week 16
    45.1
    14
        Week 20
    52.7
    18.6
        Week 22
    52.7
    2.3
        Week 24
    54.9
    2.3
        Week 26
    99999
    4.7
        Week 28
    99999
    4.7
        Week 30
    99999
    4.7
        Week 32
    59.3
    4.7
        Week 36
    99999
    14
        Week 40
    46.2
    11.6
        Week 46
    31.9
    9.3
        Week 52
    23.1
    7
        Week 60
    22
    7
    No statistical analyses for this end point

    Secondary: Percentage of Participants with a PASI 90 Response Over Time

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    End point title
    Percentage of Participants with a PASI 90 Response Over Time
    End point description
    The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the involved skin area rated on a scale from 0 to 6 performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (clear skin) to 72 (most severe psoriasis). A PASI 90 response is defined as the percentage of participants achieving at least a 90% reduction (improvement) in PASI score from baseline. The full analysis set was used for this analysis; participants with missing data were counted as non-responders. Participants in the Fumaderm/Fumaderm treatment group did not have study visits at weeks 26, 28, 30 and 36; "99999" indicates not applicable.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 2, 4, 6, 8, 10, 12, 16, 20, 22, 24, 26, 28, 30, 32, 36, 40, 46, 52, and 60
    End point values
    Fumaderm/Fumaderm Placebo/Fumaderm
    Number of subjects analysed
    91
    43
    Units: percentage of participants
    number (not applicable)
        Week 2
    0
    0
        Week 4
    1.1
    0
        Week 6
    3.3
    0
        Week 8
    5.5
    0
        Week 10
    8.8
    2.3
        Week 12
    16.5
    2.3
        Week 16
    26.4
    9.3
        Week 20
    31.9
    4.7
        Week 22
    35.2
    0
        Week 24
    38.5
    0
        Week 26
    99999
    0
        Week 28
    99999
    0
        Week 30
    99999
    0
        Week 32
    31.9
    0
        Week 36
    99999
    2.3
        Week 40
    30.8
    2.3
        Week 46
    18.7
    2.3
        Week 52
    15.4
    2.3
        Week 60
    14.3
    4.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants with a Physician’s Global Assessment of Clear or Almost Clear Over Time

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    End point title
    Percentage of Participants with a Physician’s Global Assessment of Clear or Almost Clear Over Time
    End point description
    The physician’s global assessment (PGA) describes the severity of psoriasis according to the following 7 categories: Score 0 = Clear (no signs of psoriasis (post-inflammatory hyperpigmentation may be present); Score 1 = Almost clear (intermediate between mild and clear); Score 2 = Mild (slight plaque elevation, scaling, and / or erythema); Score 3 = Mild to moderate (intermediate between moderate and mild); Score 4 = Moderate (moderate plaque elevation, scaling, and / or erythema); Score 5 = Moderate to severe (marked plaque elevation, scaling, and / or erythema); Score 6 = Severe (very marked plaque elevation, scaling, and / or erythema). The full analysis set was used for this analysis; participants with missing data were counted as non-responders. Participants in the Fumaderm/Fumaderm treatment group did not have study visits at weeks 26, 28, 30 and 36; "99999" indicates not applicable.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, 8, 10, 12, 16, and 20
    End point values
    Fumaderm/Fumaderm Placebo/Fumaderm
    Number of subjects analysed
    91
    43
    Units: percentage of participants
    number (not applicable)
        Week 2
    1.1
    0
        Week 4
    3.3
    0
        Week 6
    5.5
    0
        Week 8
    9.9
    0
        Week 10
    17.6
    2.3
        Week 12
    23.1
    7
        Week 16
    34.1
    7
        Week 20
    41.8
    7
        Week 22
    38.5
    4.7
        Week 24
    45.1
    4.7
        Week 26
    99999
    7
        Week 28
    99999
    9.3
        Week 30
    99999
    16.3
        Week 32
    44
    18.6
        Week 36
    99999
    14
        Week 40
    33
    14
        Week 46
    23.1
    14
        Week 52
    14.3
    14
        Week 60
    11
    11.6
    No statistical analyses for this end point

    Secondary: Mean Children's Dermatology Life Quality Index Scores Over Time

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    End point title
    Mean Children's Dermatology Life Quality Index Scores Over Time
    End point description
    The Children's Dermatology Life Quality Index (CDLQI) was completed by study participants who were younger than 17 years old at screening. The questionnaire consists of 10 questions addressing disease-related quality of life over the last week. Each question is answered on a scale from 0 (not at all) to 3 (very much). The total score is calculated by summing the scores from each question and ranges from 0 to 30; the higher the score, the more quality of life is impaired. This analysis was performed using the full analysis set population aged 10-16 with non-missing data at each time point. Participants in the Fumaderm/Fumaderm treatment group did not have study visits at weeks 26, 28, 30 and 36; "99999" indicates not applicable.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 2, 4, 6, 8, 10, 12, 16, 20, 22, 24, 26, 28, 30, 32, 36, 40, 46, 52, and 60
    End point values
    Fumaderm/Fumaderm Placebo/Fumaderm
    Number of subjects analysed
    76 [1]
    34 [2]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 76, 34)
    9.89 ± 6.636
    9.59 ± 7.007
        Week 2 (N = 74, 34)
    8.42 ± 6.387
    8.79 ± 7.277
        Week 4 (N = 71, 33)
    7.87 ± 6.622
    7.73 ± 6.043
        Week 6 (N = 70, 29)
    6.94 ± 6.225
    8 ± 6.285
        Week 8 (N = 63, 27)
    5.89 ± 6.07
    6.52 ± 5.944
        Week 10 (N = 63, 24)
    4.22 ± 4.794
    6.29 ± 5.812
        Week 12 (N = 65, 21)
    3.74 ± 4.331
    6.48 ± 5.501
        Week 16 (N = 65, 21)
    3.52 ± 4.213
    6.62 ± 5.757
        Week 20 (N = 64, 21)
    2.89 ± 4.056
    6.95 ± 5.643
        Week 22 (N = 59, 19)
    2.58 ± 3.692
    7 ± 7.055
        Week 24 (N = 61, 18)
    2.28 ± 3.513
    5.28 ± 5.571
        Week 26 (N = 0, 18)
    99999 ± 99999
    4.33 ± 5.145
        Week 28 (N = 0, 17)
    99999 ± 99999
    4.41 ± 4.345
        Week 30 (N = 0, 17)
    99999 ± 99999
    4.29 ± 4.058
        Week 32 (N = 56, 18)
    2.34 ± 3.9
    3.72 ± 3.478
        Week 36 (N = 0, 17)
    99999 ± 99999
    3.29 ± 3.158
        Week 40 (N = 51, 13)
    2.86 ± 5.056
    3.92 ± 3.013
        Week 46 (N = 40, 9)
    2.18 ± 3.129
    5.22 ± 4.522
        Week 52 (N = 37, 8)
    2.57 ± 3.678
    3.88 ± 3.758
        Week 60 (N = 35, 7)
    3.31 ± 5.661
    4.57 ± 3.309
    Notes
    [1] - Participants age 10 to 16 years at screening
    [2] - Participants age 10 to 16 years at screening
    No statistical analyses for this end point

    Secondary: Mean Dermatology Life Quality Index Scores Over Time

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    End point title
    Mean Dermatology Life Quality Index Scores Over Time
    End point description
    The Dermatology Life Quality Index (DLQI) was completed by participants who were 17 years or older at screening. The DLQI consists of 10 questions addressing disease-related quality of life during the last 7 days. Each question is answered on a scale from 0 (not at all) to 3 (very much). The total score is calculated by summing the scores from each question and ranges from 0 to 30; the higher the score, the more quality of life is impaired. The analysis was conducted using the full analysis set aged 17 with non-missing data at each time point. Participants in the Fumaderm/Fumaderm treatment group did not have study visits at weeks 26, 28, 30 and 36; "99999" indicates not applicable.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 2, 4, 6, 8, 10, 12, 16, 20, 22, 24, 26, 28, 30, 32, 36, 40, 46, 52, and 60
    End point values
    Fumaderm/Fumaderm Placebo/Fumaderm
    Number of subjects analysed
    14 [3]
    9 [4]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 14, 9)
    9.21 ± 3.806
    10.44 ± 6.425
        Week 2 (N = 13, 7)
    7.92 ± 3.861
    10.14 ± 8.03
        Week 4 (N = 12, 8)
    7.5 ± 3.802
    9.5 ± 8.071
        Week 6 (N = 12, 7)
    5.83 ± 3.157
    6.43 ± 5.682
        Week 8 (N = 11, 6)
    6.36 ± 4.589
    6.17 ± 6.178
        Week 10 (N = 12, 5)
    5.5 ± 4.815
    6 ± 6.205
        Week 12 (N = 12, 5)
    4.33 ± 4.716
    6.8 ± 6.686
        Week 16 (N = 11, 5)
    2.82 ± 3.401
    6.4 ± 7.021
        Week 20 (N = 10, 5)
    1.3 ± 2.263
    7.4 ± 6.841
        Week 22 (N = 11, 4)
    2 ± 3.194
    7.5 ± 7.55
        Week 24 (N = 10, 4)
    2 ± 3.333
    7.25 ± 8.139
        Week 26 (N = 0, 4)
    99999 ± 99999
    7.25 ± 8.261
        Week 28 (N = 0, 3)
    99999 ± 99999
    8 ± 6.557
        Week 30 (N = 0, 3)
    99999 ± 99999
    8 ± 6
        Week 32 (N = 9, 3)
    0.89 ± 1.691
    8.67 ± 6.658
        Week 36 (N = 0, 2)
    99999 ± 9999
    14 ± 7.071
        Week 40 (N = 8, 2)
    1.38 ± 1.598
    14 ± 7.071
        Week 46 (N = 6, 1)
    0.67 ± 0.816
    5 ± 99999
        Week 52 (N = 4, 1)
    0.5 ± 0.577
    3 ± 99999
        Week 60 (N = 5, 1)
    0.6 ± 0.548
    9 ± 99999
    Notes
    [3] - Participants age 17 years at screening
    [4] - Participants age 17 years at screening
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Phase 1 (double-blind treatment phase): 20 weeks Phase 2 (open-label treatment phase plus follow-up phase): 40 weeks
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Phase 1: Fumaderm
    Reporting group description
    Participants first received Fumaderm Initial for three weeks, titrating up from one tablet/day in the first week of the study (week 0) to three tablets/day in week 2. Participants were then switched to Fumaderm, and were up-titrated from one tablet/day in the fourth week of the study (week 3) to three tablets/day in week 5. Participants continued to receive 3 tablets/day until week 19, unless they met protocol-specified criteria allowing further up-titration to 4 tablets/day from week 12 onwards.

    Reporting group title
    Phase 1: Placebo
    Reporting group description
    Participants received matching placebo tablets for 20 weeks.

    Reporting group title
    Phase 2: Fumaderm/Fumaderm
    Reporting group description
    Participants continued to receive Fumaderm at the same dose received at the end of the first 20 weeks for another 20 weeks.

    Reporting group title
    Phase 2: Placebo/Fumaderm
    Reporting group description
    At week 20 participants switched from placebo to receive Fumaderm Initial for three weeks, starting at one tablet/day in week 20 and titrating up to three tablets/day in week 22. Participants were then switched to receive Fumaderm, starting at one tablet/day in week 23 and titrating up to three tablets/day in week 25. Participants continued to received 3 tablets/day until week 40, unless they met protocol-specified criteria allowing up-titration to 4 tablets/day from week 32 onwards.

    Serious adverse events
    Phase 1: Fumaderm Phase 1: Placebo Phase 2: Fumaderm/Fumaderm Phase 2: Placebo/Fumaderm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 91 (9.89%)
    3 / 43 (6.98%)
    7 / 91 (7.69%)
    2 / 43 (4.65%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 43 (0.00%)
    1 / 91 (1.10%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 43 (0.00%)
    1 / 91 (1.10%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 43 (0.00%)
    1 / 91 (1.10%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 43 (0.00%)
    0 / 91 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus lesion
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 43 (0.00%)
    0 / 91 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Urobilinogen urine increased
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 43 (0.00%)
    0 / 91 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Nasal septum deviation
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 43 (0.00%)
    0 / 91 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 43 (0.00%)
    1 / 91 (1.10%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 43 (0.00%)
    1 / 91 (1.10%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 43 (0.00%)
    0 / 91 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 43 (0.00%)
    0 / 91 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 43 (2.33%)
    0 / 91 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 43 (0.00%)
    0 / 91 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 43 (0.00%)
    0 / 91 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Drug-induced liver injury
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 43 (0.00%)
    0 / 91 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    3 / 91 (3.30%)
    3 / 43 (6.98%)
    1 / 91 (1.10%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 43 (0.00%)
    1 / 91 (1.10%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 43 (0.00%)
    1 / 91 (1.10%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess jaw
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 43 (0.00%)
    0 / 91 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 43 (0.00%)
    1 / 91 (1.10%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Phase 1: Fumaderm Phase 1: Placebo Phase 2: Fumaderm/Fumaderm Phase 2: Placebo/Fumaderm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    82 / 91 (90.11%)
    36 / 43 (83.72%)
    59 / 91 (64.84%)
    23 / 43 (53.49%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    33 / 91 (36.26%)
    5 / 43 (11.63%)
    15 / 91 (16.48%)
    9 / 43 (20.93%)
         occurrences all number
    69
    5
    41
    21
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 43 (0.00%)
    0 / 91 (0.00%)
    2 / 43 (4.65%)
         occurrences all number
    1
    0
    0
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 91 (5.49%)
    1 / 43 (2.33%)
    1 / 91 (1.10%)
    0 / 43 (0.00%)
         occurrences all number
    6
    1
    1
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 91 (1.10%)
    2 / 43 (4.65%)
    1 / 91 (1.10%)
    0 / 43 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    0 / 91 (0.00%)
    2 / 43 (4.65%)
    0 / 91 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Joint injury
         subjects affected / exposed
    0 / 91 (0.00%)
    2 / 43 (4.65%)
    0 / 91 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 91 (6.59%)
    7 / 43 (16.28%)
    4 / 91 (4.40%)
    0 / 43 (0.00%)
         occurrences all number
    6
    10
    4
    0
    Oropharyngeal pain
         subjects affected / exposed
    5 / 91 (5.49%)
    4 / 43 (9.30%)
    3 / 91 (3.30%)
    2 / 43 (4.65%)
         occurrences all number
    6
    4
    3
    2
    Blood and lymphatic system disorders
    Eosinophilia
         subjects affected / exposed
    6 / 91 (6.59%)
    2 / 43 (4.65%)
    0 / 91 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    6
    2
    0
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    17 / 91 (18.68%)
    10 / 43 (23.26%)
    7 / 91 (7.69%)
    1 / 43 (2.33%)
         occurrences all number
    22
    15
    10
    5
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 91 (1.10%)
    2 / 43 (4.65%)
    0 / 91 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    27 / 91 (29.67%)
    6 / 43 (13.95%)
    8 / 91 (8.79%)
    4 / 43 (9.30%)
         occurrences all number
    42
    10
    12
    15
    Diarrhoea
         subjects affected / exposed
    26 / 91 (28.57%)
    3 / 43 (6.98%)
    6 / 91 (6.59%)
    5 / 43 (11.63%)
         occurrences all number
    34
    3
    7
    9
    Abdominal pain
         subjects affected / exposed
    21 / 91 (23.08%)
    4 / 43 (9.30%)
    5 / 91 (5.49%)
    5 / 43 (11.63%)
         occurrences all number
    35
    6
    5
    8
    Nausea
         subjects affected / exposed
    18 / 91 (19.78%)
    5 / 43 (11.63%)
    0 / 91 (0.00%)
    2 / 43 (4.65%)
         occurrences all number
    22
    7
    0
    2
    Vomiting
         subjects affected / exposed
    9 / 91 (9.89%)
    2 / 43 (4.65%)
    1 / 91 (1.10%)
    1 / 43 (2.33%)
         occurrences all number
    10
    2
    1
    1
    Abdominal discomfort
         subjects affected / exposed
    4 / 91 (4.40%)
    0 / 43 (0.00%)
    0 / 91 (0.00%)
    2 / 43 (4.65%)
         occurrences all number
    5
    0
    0
    2
    Toothache
         subjects affected / exposed
    0 / 91 (0.00%)
    3 / 43 (6.98%)
    0 / 91 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    6 / 91 (6.59%)
    1 / 43 (2.33%)
    3 / 91 (3.30%)
    2 / 43 (4.65%)
         occurrences all number
    6
    1
    4
    3
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    6 / 91 (6.59%)
    3 / 43 (6.98%)
    2 / 91 (2.20%)
    0 / 43 (0.00%)
         occurrences all number
    6
    5
    3
    0
    Acne
         subjects affected / exposed
    0 / 91 (0.00%)
    3 / 43 (6.98%)
    2 / 91 (2.20%)
    1 / 43 (2.33%)
         occurrences all number
    0
    3
    2
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    6 / 91 (6.59%)
    1 / 43 (2.33%)
    1 / 91 (1.10%)
    1 / 43 (2.33%)
         occurrences all number
    9
    1
    1
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 91 (1.10%)
    3 / 43 (6.98%)
    0 / 91 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    36 / 91 (39.56%)
    13 / 43 (30.23%)
    29 / 91 (31.87%)
    9 / 43 (20.93%)
         occurrences all number
    51
    20
    49
    10
    Gastrointestinal infection
         subjects affected / exposed
    1 / 91 (1.10%)
    2 / 43 (4.65%)
    2 / 91 (2.20%)
    1 / 43 (2.33%)
         occurrences all number
    1
    2
    2
    1
    Cystitis
         subjects affected / exposed
    2 / 91 (2.20%)
    2 / 43 (4.65%)
    2 / 91 (2.20%)
    0 / 43 (0.00%)
         occurrences all number
    2
    2
    2
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 43 (0.00%)
    0 / 91 (0.00%)
    2 / 43 (4.65%)
         occurrences all number
    1
    0
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 91 (0.00%)
    2 / 43 (4.65%)
    0 / 91 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Feb 2013
    The amendment included the following changes: • Change of 2 exclusion criteria: 1. Exclusion of topical therapy with Vitamin D3 analogues, dithranol, corticosteroids or any other topical treatment of psoriasis was changed from 1 month to within 2 weeks prior to study start or during the study. 2. The wording of the exclusion for patient or patient’s parents relationship to site personnel was updated. • The procedure for SAE follow-up reporting in the eCRF was changed: Follow-up information has to be sent to Sponsor’s Drug Safety department by updating the SAE report form for this specific SAE in eCRF and checking a tickbox that this is a follow-up to the previously reported SAE.
    04 Apr 2014
    The amendment included the following changes: • The approximate Duration of Study was increased from 30 months to 46 months. Synopsis: “The study is estimated to have duration of approximately 46 months from FPI to LPO. Competitive enrolment is planned. Enrolment will cease if the target number of patients is reached.” • In the inclusion criteria "a history of psoriasis vulgaris" was added to the definition of moderate to severe psoriasis vulgaris. • A new exclusion criteria "Values of lymphocytes and leukocytes below the normal range" was added. • Exclusion criteria "Differential blood count outside the normal range" was changed to "Remaining differential blood counts outside the normal range if judged as clinically significant." • Exclusion criteria "Platelet count outside the normal range" was changed to "Platelet count outside the normal range if judged as clinically significant." • Serum creatinine exclusion criteria were changed to "serum creatinine > upper limit of normal (ULN), reduced creatinine-clearance (calculated) (if the calculated creatinine clearance is reduced with a normal serum creatinine, undertake a 12 h urine collection and re-test the creatinine clearance in this sample)." • Abnormal values of lymphocytes or leukocytes was removed from Gamma-GT exclusion criteria.

    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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