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    Clinical Trial Results:
    A Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral VB-201 in Patients with Moderate to Severe Plaque Psoriasis

    Summary
    EudraCT number
    		 2012-002763-10
    Trial protocol
    		 DE   ES  
    Global end of trial date
    26 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Dec 2016
    First version publication date
    01 Dec 2016
    Other versions
    Summary report(s)
    		 Synopsis for Eudract 2012-002763-10

    Trial information

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    Trial identification
    Sponsor protocol code
    VB-201-079
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Vascular Biogenics Ltd
    Sponsor organisation address
    6 Jonathan Netanyahu St, Or Yehuda, Israel, 60376
    Public contact
    Project Manager, SCIderm GmbH, 49 040554401146, doris.greiling@sciderm.com
    Scientific contact
    Project Manager, SCIderm GmbH, 49 040554401146, doris.greiling@sciderm.com
    Sponsor organisation name
    VBL
    Sponsor organisation address
    6 Jonathan Netanyahu St., Or Yehuda, Israel, 60376
    Public contact
    Namit Sheer, Vascular Biogenics Ltd., 972 3-6346450, noalow@vblrx.com
    Scientific contact
    Ron Goldblum, MD, Vascular Biogenics Ltd., 972 3-6346450, noalow@vblrx.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Nov 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Safety Objective To examine the safety and tolerability of up to 24 weeks’ treatment with VB-201 or placebo in patients with psoriasis. Efficacy Objective Stage 1: To examine the effect of treatment with two different doses of VB-201 compared to placebo (initial 16 weeks) on measures of disease activity in patients with psoriasis. Stage 2: To examine the effect of treatment with two different doses of VB-201 compared to placebo (24 weeks) on measures of disease activity in patients with psoriasis. Exploratory Biomarker To examine the effect of up to 24 weeks treatment with two different doses of VB-201 as compared with placebo on inflammatory related biomarkers.
    Protection of trial subjects
    The protocol defined Patient Stopping Rules The following stopping rules will be utilized in this study: 1. If a subject experiences nausea and vomiting for >24 hours, study medication should be discontinued until these symptoms resolve. After resolution of these adverse events or if an alternate explanation for these symptoms is present, the subject may resume study medication. If nausea and vomiting recur, the subject may be removed from the study, at the Investigator’s discretion. If a subject experiences worsening of his psoriasis, as demonstrated by a 50% increase in his PASI score, the subject must permanently discontinue study medication. Furthermore, subjects who permanently discontinue study medication shall return for an Early Termination visit and subsequently for a final safety visit 4 weeks from the last dose.
    Background therapy
    		 -
    Evidence for comparator
    		 placebo
    Actual start date of recruitment
    01 Oct 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 27
    Country: Number of subjects enrolled
    Spain: 31
    Country: Number of subjects enrolled
    Germany: 122
    Country: Number of subjects enrolled
    Israel: 14
    Worldwide total number of subjects
    194
    EEA total number of subjects
    180
    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)
    189
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First subject has been included 20 Nov 2012, lPLV was 26 Nov 2014. Due to recruitment difficulties Israel has been added as addtional country

    Pre-assignment
    Screening details
    		 Subjects were screened for eligibility and, up to 28 days later, at the baseline visit, randomized to one of three treatments Groups.

    Period 1
    Period 1 title
    Stage 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 placebo
    Arm description
    		 placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Study drug will be supplied to the study sites as capsules in blister packs. During the initial double-blind phase of the study (Stage 1), VB-201 or placebo capsules will be administered orally twice daily at breakfast time and dinner time with food for a total of 16 weeks. Subjects randomized to the VB-201 80 mg/day (80 mg QD) treatment will receive 80 mg in the morning and placebo in the evening.

    Arm title
    		 80 mg VB-201
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    80 mg VB-201
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Study drug will be supplied to the study sites as capsules in blister packs. During the initial double-blind phase of the study (Stage 1), VB-201 or placebo capsules will be administered orally twice daily at breakfast time and dinner time with food for a total of 16 weeks. Subjects randomized to the VB-201 80 mg/day (80 mg QD) treatment will receive 80 mg in the morning and placebo in the evening.

    Arm title
    		 160 mg VB-201
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    160 mg VB-201
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Study drug will be supplied to the study sites as capsules in blister packs. During the initial double-blind phase of the study (Stage 1), VB-201 or placebo capsules will be administered orally twice daily at breakfast time and dinner time with food for a total of 16 weeks. Subjects randomized to the VB-201 80 mg/day (80 mg QD) treatment will receive 80 mg in the morning and placebo in the evening.

    Number of subjects in period 1
    		placebo 80 mg VB-201 160 mg VB-201
    Started
    81
    34
    79
    Completed
    70
    26
    57
    Not completed
    11
    8
    22
         Consent withdrawn by subject
    6
    1
    9
         Physician decision
    1
    1
    -
         Adverse event, non-fatal
    1
    2
    4
         Lost to follow-up
    3
    4
    9
    Period 2
    Period 2 title
    Stage 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 80 mg VB-201
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    80 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Study drug will be supplied to the study sites as capsules in blister packs. During the initial double-blind phase of the study (Stage 1), VB-201 or placebo capsules will be administered orally twice daily at breakfast time and dinner time with food for a total of 16 weeks. Subjects randomized to the VB-201 80 mg/day (80 mg QD) treatment will receive 80 mg in the morning and placebo in the evening. At Week 16 (Stage 2), all subjects on placebo will be crossed over the active drug, 160 mg (80mg BID). VB-201 will be administered orally twice daily at breakfast time and dinner time with food for an additional eight weeks.

    Arm title
    		 160 mg VB-201
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    160 mg VB-201
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Study drug will be supplied to the study sites as capsules in blister packs. During the initial double-blind phase of the study (Stage 1), VB-201 or placebo capsules will be administered orally twice daily at breakfast time and dinner time with food for a total of 16 weeks. Subjects randomized to the VB-201 80 mg/day (80 mg QD) treatment will receive 80 mg in the morning and placebo in the evening. At Week 16 (Stage 2), all subjects on placebo will be crossed over the active drug, 160 mg (80mg BID). VB-201 will be administered orally twice daily at breakfast time and dinner time with food for an additional eight weeks.

    Arm title
    		 placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Study drug will be supplied to the study sites as capsules in blister packs. During the initial double-blind phase of the study (Stage 1), VB-201 or placebo capsules will be administered orally twice daily at breakfast time and dinner time with food for a total of 16 weeks. Subjects randomized to the VB-201 80 mg/day (80 mg QD) treatment will receive 80 mg in the morning and placebo in the evening. At Week 16 (Stage 2), all subjects on placebo will be crossed over the active drug, 160 mg (80mg BID). VB-201 will be administered orally twice daily at breakfast time and dinner time with food for an additional eight weeks.

    Number of subjects in period 2
    		80 mg VB-201 160 mg VB-201 placebo
    Started
    26
    57
    70
    Completed
    25
    49
    64
    Not completed
    1
    8
    6
         Consent withdrawn by subject
    1
    5
    4
         Lost to follow-up
    -
    2
    1
         non-compliance
    -
    1
    -
         Protocol deviation
    -
    -
    1

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    placebo
    Reporting group description
    		 placebo

    Reporting group title
    80 mg VB-201
    Reporting group description
    		 -

    Reporting group title
    160 mg VB-201
    Reporting group description
    		 -
    Reporting group title
    80 mg VB-201
    Reporting group description
    		 -

    Reporting group title
    160 mg VB-201
    Reporting group description
    		 -

    Reporting group title
    placebo
    Reporting group description
    		 -

    Primary: Proportion of subjects in each of the VB-201 treatment groups and in the combined VB-201 treatment grozups who achieved at least 50% improvement from the baseline PASI score at week 16 and week 24 compared to placebo

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    End point title
    		 Proportion of subjects in each of the VB-201 treatment groups and in the combined VB-201 treatment grozups who achieved at least 50% improvement from the baseline PASI score at week 16 and week 24 compared to placebo
    End point description
    End point type
    Primary
    End point timeframe
    week 16 week 24
    End point values
    		 placebo 80 mg VB-201 160 mg VB-201 80 mg VB-201 160 mg VB-201 placebo
    Number of subjects analysed
    68
    24
    57
    23
    48
    68
    Units: Proportion of subjects
    29
    7
    17
    10
    19
    29
    Statistical analysis title
    		 PASI 50 responder rate
    Comparison groups
    placebo v 80 mg VB-201 v 160 mg VB-201 v 80 mg VB-201 v 160 mg VB-201 v placebo
    Number of subjects included in analysis
    288
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2447 [1]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [1] - 0.1387 for 160 mg (Stage 1) 0.9445 for 80 mg (Stage 2) 0.7414 for 160 mg (Stage 2)

    Secondary: Proportion of subjects in each of the VB-201 treatment groups who achieved at least 75% PASI improvement from the baseline at week 16 and 24 compared to placebo

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    End point title
    		 Proportion of subjects in each of the VB-201 treatment groups who achieved at least 75% PASI improvement from the baseline at week 16 and 24 compared to placebo
    End point description
    End point type
    Secondary
    End point timeframe
    week 16 week 24
    End point values
    		 placebo 80 mg VB-201 160 mg VB-201 80 mg VB-201 160 mg VB-201 placebo
    Number of subjects analysed
    68
    24
    57
    23
    48
    68
    Units: Responders
    14
    4
    6
    6
    8
    14
    Statistical analysis title
    		 P Value global PASI 75
    Comparison groups
    placebo v 80 mg VB-201 v 160 mg VB-201 v 80 mg VB-201 v 160 mg VB-201 v placebo
    Number of subjects included in analysis
    288
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.6772 [2]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [2] - 0.1264 for 160 mg (Stage 1) 0.5820 for 80 mg (Stage 2) 0.5957 for 160 mg (Stage 2)

    Secondary: Mean change in the PASI score from baseline to week 16 and 24 in each of the two VB-201 treatment groups and in the combined groups compared to the mean change in the placebo group

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    End point title
    		 Mean change in the PASI score from baseline to week 16 and 24 in each of the two VB-201 treatment groups and in the combined groups compared to the mean change in the placebo group
    End point description
    End point type
    Secondary
    End point timeframe
    week 16 week 24
    End point values
    		 placebo 80 mg VB-201 160 mg VB-201 80 mg VB-201 160 mg VB-201 placebo
    Number of subjects analysed
    68
    24
    57
    23
    48
    68
    Units: Mean change
        geometric mean (standard deviation)
    14.5 ± 2.5
    14.9 ± 3.13
    14.3 ± 2.93
    -6.1 ± 6.5
    -5.3 ± 6.32
    -5.2 ± 6.02
    No statistical analyses for this end point

    Secondary: Change in affected Body Surface Area (BSA) from baseline to week 16 and 24 in each of the VB-201 treatment groups and in the combined VB 201 treatment groups compared to placebo

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    End point title
    		 Change in affected Body Surface Area (BSA) from baseline to week 16 and 24 in each of the VB-201 treatment groups and in the combined VB 201 treatment groups compared to placebo
    End point description
    End point type
    Secondary
    End point timeframe
    week 16 week 24
    End point values
    		 placebo 80 mg VB-201 160 mg VB-201 80 mg VB-201 160 mg VB-201 placebo
    Number of subjects analysed
    68
    24
    57
    23
    48
    68
    Units: Change in BSA
        arithmetic mean (standard deviation)
    16.7 ± 5.25
    16.7 ± 6.85
    15.4 ± 5.59
    -5.6 ± 13.01
    -3.5 ± 8.49
    -4.4 ± 7.86
    No statistical analyses for this end point

    Secondary: Change in PGA scorees from baseline to week 16 and 24 in each of the VB-201 treatment groups and in the combined treatment groups compared to placebo

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    End point title
    		 Change in PGA scorees from baseline to week 16 and 24 in each of the VB-201 treatment groups and in the combined treatment groups compared to placebo
    End point description
    End point type
    Secondary
    End point timeframe
    week 16 week 24
    End point values
    		 placebo 80 mg VB-201 160 mg VB-201 80 mg VB-201 160 mg VB-201 placebo
    Number of subjects analysed
    68
    24
    57
    23
    48
    68
    Units: Change in PGA score
        number (not applicable)
    9
    3
    5
    2
    7
    9
    No statistical analyses for this end point

    Secondary: Change in Patient Psoriasis Global Assessment scores from baseline to Week 16 and 24 in each of the Vb-201 treatment groups and in the combined treatment groups compared to placebo

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    End point title
    		 Change in Patient Psoriasis Global Assessment scores from baseline to Week 16 and 24 in each of the Vb-201 treatment groups and in the combined treatment groups compared to placebo
    End point description
    End point type
    Secondary
    End point timeframe
    week 16 week 24
    End point values
    		 placebo 80 mg VB-201 160 mg VB-201 80 mg VB-201 160 mg VB-201 placebo
    Number of subjects analysed
    68
    24
    57
    23
    48
    68
    Units: Change in score
        number (not applicable)
    18
    7
    13
    8
    15
    18
    No statistical analyses for this end point

    Secondary: The proportion of subjects in the VB-201 80 mg/ day treatment group who achieved at least 50% improvement from the baseline PASI score at week 16 compared to placebo

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    End point title
    		 The proportion of subjects in the VB-201 80 mg/ day treatment group who achieved at least 50% improvement from the baseline PASI score at week 16 compared to placebo
    End point description
    Stage 1
    End point type
    Secondary
    End point timeframe
    week 16
    End point values
    Number of subjects analysed
    Units: proportion of responders
        number (not applicable)
    No statistical analyses for this end point

    Secondary: Change in itching VAs from baseline to week 16 and 24 in each of the VB-201 treatment groups and in the combined groups compared to placebo

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    End point title
    		 Change in itching VAs from baseline to week 16 and 24 in each of the VB-201 treatment groups and in the combined groups compared to placebo
    End point description
    End point type
    Secondary
    End point timeframe
    week 16 week 24
    End point values
    		 placebo 80 mg VB-201 160 mg VB-201 80 mg VB-201 160 mg VB-201 placebo
    Number of subjects analysed
    68
    24
    57
    21
    43
    62
    Units: Change in itching VAS
        number (not applicable)
    53
    48.9
    49.6
    -26
    -17.9
    -16.7
    Statistical analysis title
    		 Summary Change Itching VAS
    Comparison groups
    placebo v 80 mg VB-201 v 160 mg VB-201 v 80 mg VB-201 v 160 mg VB-201 v placebo
    Number of subjects included in analysis
    275
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.3018 [3]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [3] - 0.6144 for 160 mg (Stage 1) 0.1275 for 80 mg (Stage 2) 0.5595 for 160 mg (Stage 2)

    Secondary: Change in Pain VAS from baseline to week 16 and 24 in each of the VB 201 treatment groups and in the combined VB-201 treatment groups compared to placebo

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    End point title
    		 Change in Pain VAS from baseline to week 16 and 24 in each of the VB 201 treatment groups and in the combined VB-201 treatment groups compared to placebo
    End point description
    End point type
    Secondary
    End point timeframe
    week 16 week 24
    End point values
    		 placebo 80 mg VB-201 160 mg VB-201 80 mg VB-201 160 mg VB-201 placebo
    Number of subjects analysed
    68
    24
    57
    13
    28
    46
    Units: Change in pain VAS score
        number (not applicable)
    30.9
    22.8
    27.8
    -19.2
    -22.6
    -12.3
    Statistical analysis title
    		 Summary of change in Pain VAS
    Comparison groups
    placebo v 80 mg VB-201 v 160 mg VB-201 v 80 mg VB-201 v 160 mg VB-201 v placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.1155 [4]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [4] - 0.3494 for 160 mg (Stage 1) 0.1801 for 80 mg (Stage 2) 0.1175 for 160 mg (Stage 2)

    Secondary: Change in the DLQI score from baseline to week 24 in each of the VB201 treatment group and in the combined VB-201 treatment groups compared to placebo

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    End point title
    		 Change in the DLQI score from baseline to week 24 in each of the VB201 treatment group and in the combined VB-201 treatment groups compared to placebo
    End point description
    Stagé 2
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    Number of subjects analysed
    Units: Change in the DLQI score
        number (not applicable)
    No statistical analyses for this end point

    Other pre-specified: Change in itching VAS from baseline to week 16 in each of the VB-201 treatment groups and in the combined VB-201 treatment groups compared to placebo

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    End point title
    		 Change in itching VAS from baseline to week 16 in each of the VB-201 treatment groups and in the combined VB-201 treatment groups compared to placebo
    End point description
    Stage 1
    End point type
    Other pre-specified
    End point timeframe
    week 16
    End point values
    Number of subjects analysed
    Units: Change in itching scale
        arithmetic mean (standard deviation)
    No statistical analyses for this end point

    Other pre-specified: Change in Pain VAS from baseline to week 16 in each of the VB 201 treatment groups and in the combined VB-201 treatment groups compared to placebo

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    End point title
    		 Change in Pain VAS from baseline to week 16 in each of the VB 201 treatment groups and in the combined VB-201 treatment groups compared to placebo
    End point description
    Stage 1
    End point type
    Other pre-specified
    End point timeframe
    weeks 16
    End point values
    Number of subjects analysed
    Units: Change in pain VAS
        arithmetic mean (standard deviation)
    No statistical analyses for this end point

    Other pre-specified: Change in the product PGA x BSA from baseline to week 16 and 24 in each of the VB 210 treatment groups and in the combined VB-201 treatment groups compared to placebo

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    End point title
    		 Change in the product PGA x BSA from baseline to week 16 and 24 in each of the VB 210 treatment groups and in the combined VB-201 treatment groups compared to placebo
    End point description
    End point type
    Other pre-specified
    End point timeframe
    week 16 week 24
    End point values
    		 placebo 80 mg VB-201 160 mg VB-201 80 mg VB-201 160 mg VB-201 placebo
    Number of subjects analysed
    68
    24
    57
    23
    48
    68
    Units: change in the product PGA x BSA
        arithmetic mean (standard deviation)
    51.4 ± 18.04
    47.2 ± 17.57
    50.1 ± 22.38
    -15.6 ± 41.92
    -17.3 ± 27.46
    -15.8 ± 27.6
    No statistical analyses for this end point

    Other pre-specified: Change in the DLQI score from baseline to week 16 in each of the VB201 treatment group and in the combined VB-201 treatment groups compared to placebo

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    End point title
    		 Change in the DLQI score from baseline to week 16 in each of the VB201 treatment group and in the combined VB-201 treatment groups compared to placebo
    End point description
    Stage 1
    End point type
    Other pre-specified
    End point timeframe
    week 16
    End point values
    Number of subjects analysed
    Units: change in DLQI score
        arithmetic mean (standard deviation)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were reported from signature of Informed Consent through 28 days after the subject’s last dose
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    VB 80 mg
    Reporting group description
    		 -

    Reporting group title
    VB-201 160 mg
    Reporting group description
    		 -

    Reporting group title
    VB 201 160 mg crossover
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo VB 80 mg VB-201 160 mg VB 201 160 mg crossover
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 81 (2.47%)
    1 / 34 (2.94%)
    1 / 79 (1.27%)
    0 / 70 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Congenital, familial and genetic disorders
    Auricular perichondritis
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 34 (0.00%)
    0 / 79 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 34 (0.00%)
    0 / 79 (0.00%)
    0 / 70 (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
    0 / 81 (0.00%)
    1 / 34 (2.94%)
    0 / 79 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protusion
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 34 (0.00%)
    1 / 79 (1.27%)
    0 / 70 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo VB 80 mg VB-201 160 mg VB 201 160 mg crossover
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    54 / 81 (66.67%)
    26 / 34 (76.47%)
    61 / 79 (77.22%)
    23 / 70 (32.86%)
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    2 / 81 (2.47%)
    2 / 34 (5.88%)
    4 / 79 (5.06%)
    0 / 70 (0.00%)
         occurrences all number
    2
    2
    4
    0
    Any Event 5
         subjects affected / exposed
    3 / 81 (3.70%)
    1 / 34 (2.94%)
    5 / 79 (6.33%)
    0 / 70 (0.00%)
         occurrences all number
    3
    1
    5
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 81 (13.58%)
    2 / 34 (5.88%)
    13 / 79 (16.46%)
    0 / 70 (0.00%)
         occurrences all number
    11
    2
    13
    0
    Any event 3
         subjects affected / exposed
    3 / 81 (3.70%)
    0 / 34 (0.00%)
    1 / 79 (1.27%)
    0 / 70 (0.00%)
         occurrences all number
    3
    0
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 81 (2.47%)
    4 / 34 (11.76%)
    14 / 79 (17.72%)
    0 / 70 (0.00%)
         occurrences all number
    2
    4
    14
    0
    Diarrhoea
         subjects affected / exposed
    2 / 81 (2.47%)
    1 / 34 (2.94%)
    9 / 79 (11.39%)
    0 / 70 (0.00%)
         occurrences all number
    2
    1
    9
    0
    Abdominal pain upper
         subjects affected / exposed
    2 / 81 (2.47%)
    2 / 34 (5.88%)
    6 / 79 (7.59%)
    0 / 70 (0.00%)
         occurrences all number
    2
    2
    6
    0
    Dyspepsia
         subjects affected / exposed
    3 / 81 (3.70%)
    1 / 34 (2.94%)
    4 / 79 (5.06%)
    0 / 70 (0.00%)
         occurrences all number
    3
    1
    4
    0
    Any event 2
         subjects affected / exposed
    5 / 81 (6.17%)
    3 / 34 (8.82%)
    0 / 79 (0.00%)
    0 / 70 (0.00%)
         occurrences all number
    5
    3
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 81 (2.47%)
    1 / 34 (2.94%)
    5 / 79 (6.33%)
    0 / 70 (0.00%)
         occurrences all number
    2
    1
    5
    0
    Any Event 4
         subjects affected / exposed
    7 / 81 (8.64%)
    1 / 34 (2.94%)
    6 / 79 (7.59%)
    0 / 70 (0.00%)
         occurrences all number
    7
    1
    6
    0
    Infections and infestations
    Nasopharnygitis
         subjects affected / exposed
    16 / 81 (19.75%)
    7 / 34 (20.59%)
    15 / 79 (18.99%)
    23 / 70 (32.86%)
         occurrences all number
    127
    60
    181
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 81 (2.47%)
    2 / 34 (5.88%)
    4 / 79 (5.06%)
    0 / 70 (0.00%)
         occurrences all number
    2
    2
    4
    0
    Any Event
         subjects affected / exposed
    10 / 81 (12.35%)
    0 / 34 (0.00%)
    10 / 79 (12.66%)
    0 / 70 (0.00%)
         occurrences all number
    10
    0
    10
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Sep 2012
    Sub-Group (SG) Analysis VB-201 Levels - SG1: Adequate Levels was defined if lastlevel was >50% of highest Level Weight at baseline - SG2: Weight max 80 kg, SG3: Weight above 80 kg Baseline PASI, 2 analyses for SG -SG 4: PASI 10-12, SG5 PASI >12-20 Baseline PASI, 2 analyses for SG -SG6: PASI 10-14,3, SG7: PASI >14.3 Classification of AEs as TEAEs was added Modelling of week 24 Placebo Group resonse was added. PPGA (0,1) and PPGA (3-5) responder rates were to be analyzed For efficacy variable additional time Points for analysis were to be added within the Framework of scheduled visits.

    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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