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    Clinical Trial Results:
    A Randomized, Subject-blind, Investigator-blind, Placebo-controlled, Single-dose, Dose-escalating Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of UCB4940 in Patients with Mild to Moderate Psoriasis

    Summary
    EudraCT number
    2012-002086-35
    Trial protocol
    GB  
    Global end of trial date
    13 Jan 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    UP0008
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Celltech
    Sponsor organisation address
    208 Bath Road, Slough, United Kingdom, SL1 3WE
    Public contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 2173 48 15 15, clinicaltrials@ucb.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 2173 48 15 15, clinicaltrials@ucb.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
    07 Feb 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in subjects with mild-to-moderate plaque psoriasis.
    Protection of trial subjects
    Subject’s informed consent was obtained and documented in accordance with local regulations, ICH-GCP requirements, and the ethical principles that have their origin in the principles of the Declaration of Helsinki. Prior to obtaining informed consent, information was given in a language and at a level of complexity understandable to the subject in both oral and written form by the Investigator or designee. Each subject had the opportunity to discuss the study and its alternatives with the Investigator.
    Background therapy
    Not applicable.
    Evidence for comparator
    Not applicable.
    Actual start date of recruitment
    22 Nov 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
    United Kingdom: 39
    Worldwide total number of subjects
    39
    EEA total number of subjects
    39
    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)
    38
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The UP0008 study began recruitment in November 2012. The study concluded in January 2014.

    Pre-assignment
    Screening details
    Participant Flow data consists of the Full Analysis Set (FAS), which consists of all randomized subjects who received IMP (UCB4940 or placebo) and will be used for the safety analysis.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Full Analysis - UCB4940
    Arm description
    UCB4940 subjects in the Full Analysis Set.
    Arm type
    Experimental

    Investigational medicinal product name
    UCB4940
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Strength: 8-640 mg

    Arm title
    Full Analysis - Placebo
    Arm description
    Placebo subjects in the Full Analysis Set.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.9% sodium chloride aqueous solution (physiological saline, preservative free) of pharmacopoeia (USP/Ph.Eur) quality in a 10 mL glass vial.

    Number of subjects in period 1
    Full Analysis - UCB4940 Full Analysis - Placebo
    Started
    26
    13
    Completed
    24
    13
    Not completed
    2
    0
         Consent withdrawn by subject
             2
             -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Full Analysis - UCB4940
    Reporting group description
    UCB4940 subjects in the Full Analysis Set.

    Reporting group title
    Full Analysis - Placebo
    Reporting group description
    Placebo subjects in the Full Analysis Set.

    Reporting group values
    Full Analysis - UCB4940 Full Analysis - Placebo Total
    Number of subjects
    26 13 39
    Age Categorical
    Units: Subjects
        Between 18 and 65 years
    26 12 38
        >=65 years
    0 1 1
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    39.7 ± 8.8 37.7 ± 13.5 -
    Gender Categorical
    Units: Subjects
        Female
    8 1 9
        Male
    18 12 30
    Racial Group
    Units: Subjects
        Asian
    1 0 1
        Other/ Mixed
    1 0 1
        White
    24 13 37
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    26 13 39

    End points

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    End points reporting groups
    Reporting group title
    Full Analysis - UCB4940
    Reporting group description
    UCB4940 subjects in the Full Analysis Set.

    Reporting group title
    Full Analysis - Placebo
    Reporting group description
    Placebo subjects in the Full Analysis Set.

    Subject analysis set title
    Full Analysis - Placebo
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects dosed with Placebo.

    Subject analysis set title
    Per Protocol - UCB4940 40 mg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    The Per-Protocol Set (PPS) is a subset of the FAS, consisting of those subjects who had no important protocol deviations affecting the PK or PD variables, as confirmed during a preanalysis review of the data prior to database lock.

    Subject analysis set title
    Full Analysis - UCB4940
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) will consist of all randomized subjects who received IMP and will be used for the safety Analysis.

    Subject analysis set title
    Per Protocol - UCB4940 8 mg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    The Per-Protocol Set (PPS) is a subset of the FAS, consisting of those subjects who had no important protocol deviations affecting the PK or PD variables, as confirmed during a preanalysis review of the data prior to database lock.

    Subject analysis set title
    Per Protocol - UCB4940 640 mg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    The Per-Protocol Set (PPS) is a subset of the FAS, consisting of those subjects who had no important protocol deviations affecting the PK or PD variables, as confirmed during a preanalysis review of the data prior to database lock.

    Subject analysis set title
    Per Protocol - UCB4940 160 mg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    The Per-Protocol Set (PPS) is a subset of the FAS, consisting of those subjects who had no important protocol deviations affecting the PK or PD variables, as confirmed during a preanalysis review of the data prior to database lock.

    Subject analysis set title
    Per Protocol - UCB4940 480 mg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    The Per-Protocol Set (PPS) is a subset of the FAS, consisting of those subjects who had no important protocol deviations affecting the PK or PD variables, as confirmed during a preanalysis review of the data prior to database lock.

    Primary: Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (20 Weeks)

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    End point title
    Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (20 Weeks) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to 20 Weeks
    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: The primary objective of study UP0008 was to evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in subjects with mild to moderate plaque psoriasis. So the purpose of the study was the description of the safety profile of UCB4940 across several safety variables. Therefore no statistical comparisons were applied in this safety study.
    End point values
    Full Analysis - Placebo Full Analysis - UCB4940
    Number of subjects analysed
    13
    26
    Units: participants
        number
    10
    22
    No statistical analyses for this end point

    Primary: Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (20 Weeks)

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    End point title
    Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (20 Weeks) [2]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to 20 Weeks
    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: The primary objective of study UP0008 was to evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in subjects with mild to moderate plaque psoriasis. So the purpose of the study was the description of the safety profile of UCB4940 across several safety variables. Therefore no statistical comparisons were applied in this safety study.
    End point values
    Full Analysis - Placebo Full Analysis - UCB4940
    Number of subjects analysed
    13
    26
    Units: participants
        number
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (20 Weeks)

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    End point title
    Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (20 Weeks) [3]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to 20 Weeks
    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: The primary objective of study UP0008 was to evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in subjects with mild to moderate plaque psoriasis. So the purpose of the study was the description of the safety profile of UCB4940 across several safety variables. Therefore no statistical comparisons were applied in this safety study.
    End point values
    Full Analysis - Placebo Full Analysis - UCB4940
    Number of subjects analysed
    13
    26
    Units: participants
        number
    0
    1
    No statistical analyses for this end point

    Secondary: Maximum plasma concentration (Cmax)

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    End point title
    Maximum plasma concentration (Cmax)
    End point description
    End point type
    Secondary
    End point timeframe
    Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
    End point values
    Per Protocol - UCB4940 8 mg Per Protocol - UCB4940 40 mg Per Protocol - UCB4940 160 mg Per Protocol - UCB4940 480 mg Per Protocol - UCB4940 640 mg
    Number of subjects analysed
    4
    4
    6
    6
    6
    Units: ug/ml
    geometric mean (geometric coefficient of variation)
        GeoMean (GeoCV)
    2.929 ± 27.09
    17.54 ± 16.42
    60.87 ± 30.37
    211.1 ± 11.67
    260 ± 21.4
    No statistical analyses for this end point

    Secondary: Area under the plasma concentration-time curve from time 0 to infinity (AUC(0-inf))

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    End point title
    Area under the plasma concentration-time curve from time 0 to infinity (AUC(0-inf))
    End point description
    End point type
    Secondary
    End point timeframe
    Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
    End point values
    Per Protocol - UCB4940 8 mg Per Protocol - UCB4940 40 mg Per Protocol - UCB4940 160 mg Per Protocol - UCB4940 480 mg Per Protocol - UCB4940 640 mg
    Number of subjects analysed
    4
    4
    6
    5
    6
    Units: day*ug/ml
    geometric mean (geometric coefficient of variation)
        GeoMean (GeoCV)
    42.818 ± 58.215
    222.74 ± 64.147
    1019 ± 22.028
    3298 ± 36.271
    3787 ± 39.034
    No statistical analyses for this end point

    Secondary: Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration (AUC(0-t))

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    End point title
    Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration (AUC(0-t))
    End point description
    End point type
    Secondary
    End point timeframe
    Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
    End point values
    Per Protocol - UCB4940 8 mg Per Protocol - UCB4940 40 mg Per Protocol - UCB4940 160 mg Per Protocol - UCB4940 480 mg Per Protocol - UCB4940 640 mg
    Number of subjects analysed
    4
    4
    6
    5
    6
    Units: day*ug/ml
    geometric mean (geometric coefficient of variation)
        GeoMean (GeoCV)
    34.99 ± 61.182
    216.03 ± 64.29
    988.62 ± 21.583
    3251 ± 35.12
    3709 ± 36.649
    No statistical analyses for this end point

    Secondary: Time to reach Cmax (Tmax)

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    End point title
    Time to reach Cmax (Tmax)
    End point description
    End point type
    Secondary
    End point timeframe
    Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
    End point values
    Per Protocol - UCB4940 8 mg Per Protocol - UCB4940 40 mg Per Protocol - UCB4940 160 mg Per Protocol - UCB4940 480 mg Per Protocol - UCB4940 640 mg
    Number of subjects analysed
    4
    4
    6
    6
    6
    Units: day
    median (full range (min-max))
        median (min - max)
    0.06285 (0.041 to 0.125)
    0.0521 (0.041 to 0.125)
    0.0639 (0.0618 to 0.126)
    0.0941 (0.0625 to 0.21)
    0.0646 (0.0625 to 0.125)
    No statistical analyses for this end point

    Secondary: Terminal elimination half-life (t1/2)

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    End point title
    Terminal elimination half-life (t1/2)
    End point description
    End point type
    Secondary
    End point timeframe
    Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
    End point values
    Per Protocol - UCB4940 8 mg Per Protocol - UCB4940 40 mg Per Protocol - UCB4940 160 mg Per Protocol - UCB4940 480 mg Per Protocol - UCB4940 640 mg
    Number of subjects analysed
    4
    4
    6
    5
    6
    Units: day
    geometric mean (geometric coefficient of variation)
        GeoMean (GeoCV)
    21.58 ± 46.98
    17.13 ± 40.24
    22.02 ± 14.94
    20.24 ± 32.39
    20.25 ± 39.32
    No statistical analyses for this end point

    Secondary: First order terminal elimination rate constant (λz)

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    End point title
    First order terminal elimination rate constant (λz)
    End point description
    End point type
    Secondary
    End point timeframe
    Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
    End point values
    Per Protocol - UCB4940 8 mg Per Protocol - UCB4940 40 mg Per Protocol - UCB4940 160 mg Per Protocol - UCB4940 480 mg Per Protocol - UCB4940 640 mg
    Number of subjects analysed
    4
    4
    6
    5
    6
    Units: 1/day
    geometric mean (geometric coefficient of variation)
        GeoMean (GeoCV)
    0.03211 ± 47.14
    0.04041 ± 40.02
    0.03153 ± 14.97
    0.03423 ± 32.42
    0.03418 ± 39.28
    No statistical analyses for this end point

    Secondary: Total body clearance (CL)

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    End point title
    Total body clearance (CL)
    End point description
    End point type
    Secondary
    End point timeframe
    Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
    End point values
    Per Protocol - UCB4940 8 mg Per Protocol - UCB4940 40 mg Per Protocol - UCB4940 160 mg Per Protocol - UCB4940 480 mg Per Protocol - UCB4940 640 mg
    Number of subjects analysed
    4
    4
    6
    5
    6
    Units: L/day
    geometric mean (geometric coefficient of variation)
        GeoMean (GeoCV)
    0.1866 ± 58.28
    0.1794 ± 64.12
    0.157 ± 22.08
    0.1455 ± 36.21
    0.169 ± 38.97
    No statistical analyses for this end point

    Secondary: Volume of distribution in terminal phase (Vz)

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    End point title
    Volume of distribution in terminal phase (Vz)
    End point description
    End point type
    Secondary
    End point timeframe
    Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
    End point values
    Per Protocol - UCB4940 8 mg Per Protocol - UCB4940 40 mg Per Protocol - UCB4940 160 mg Per Protocol - UCB4940 480 mg Per Protocol - UCB4940 640 mg
    Number of subjects analysed
    4
    4
    6
    5
    6
    Units: Liter
    geometric mean (geometric coefficient of variation)
        GeoMean (GeoCV)
    5.818 ± 11.12
    4.447 ± 29.92
    4.983 ± 23.11
    4.248 ± 26.95
    4.943 ± 25.93
    No statistical analyses for this end point

    Secondary: Percentage Change from Baseline to Week 12 in the Lesion Severity Score (LSS)

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    End point title
    Percentage Change from Baseline to Week 12 in the Lesion Severity Score (LSS)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    Full Analysis - Placebo Full Analysis - UCB4940
    Number of subjects analysed
    13
    24
    Units: units on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -24.3 ± 32.5
    -81.1 ± 39.4
    No statistical analyses for this end point

    Secondary: Percentage Change from Baseline to Week 12 in thickness of the plaque

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    End point title
    Percentage Change from Baseline to Week 12 in thickness of the plaque
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    Full Analysis - Placebo Full Analysis - UCB4940
    Number of subjects analysed
    13
    22
    Units: mm
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -23.08 ± 56.33
    -81.82 ± 39.48
    No statistical analyses for this end point

    Secondary: Percentage Change from Baseline to Week 12 in lesion area

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    End point title
    Percentage Change from Baseline to Week 12 in lesion area
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    Full Analysis - Placebo Full Analysis - UCB4940
    Number of subjects analysed
    13
    24
    Units: mm^2
    arithmetic mean (standard deviation)
        mean (standard deviation)
    13.68 ± 71.31
    -77.18 ± 48.07
    No statistical analyses for this end point

    Secondary: Percentage Change from Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)

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    End point title
    Percentage Change from Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    Full Analysis - Placebo Full Analysis - UCB4940
    Number of subjects analysed
    13
    24
    Units: units on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -19.81 ± 27.19
    -71.93 ± 39.54
    No statistical analyses for this end point

    Secondary: Percentage Change from Baseline to Week 12 in Physician's Global Assessment (PGA)

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    End point title
    Percentage Change from Baseline to Week 12 in Physician's Global Assessment (PGA)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    Full Analysis - Placebo Full Analysis - UCB4940
    Number of subjects analysed
    13
    24
    Units: units on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -14.74 ± 20.46
    -69.1 ± 44.61
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent Adverse Events (TEAEs) were recording during the study, which began in November 2012 and concluded in January 2014.
    Adverse event reporting additional description
    TEAE reporting consists of the Full Analysis Set, which consists of all randomized subjects who received IMP (UCB4940 or placebo) and will be used for the safety analysis.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group title
    UCB4940
    Reporting group description
    -

    Serious adverse events
    Placebo UCB4940
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Placebo UCB4940
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 13 (76.92%)
    22 / 26 (84.62%)
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 13 (0.00%)
    5 / 26 (19.23%)
         occurrences all number
    0
    5
    Cough
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Dyspnoea
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 13 (15.38%)
    6 / 26 (23.08%)
         occurrences all number
    2
    8
    Dizziness
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    2
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Influenza like illness
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Medical device site reaction
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 26 (11.54%)
         occurrences all number
    0
    3
    Fatigue
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    2
    Catheter site erythema
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Catheter site related reaction
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Infusion site bruising
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Lip dry
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Abdominal distension
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    2
    Nausea
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    3
    Abdominal discomfort
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 26 (3.85%)
         occurrences all number
    3
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Mouth ulceration
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Oral mucosal blistering
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    2
    Vomiting
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    Skin irritation
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Psoriasis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Rash erythematous
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Back pain
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 26 (3.85%)
         occurrences all number
    1
    2
    Limb discomfort
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Infections and infestations
    Postoperative wound infection
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Tooth abscess
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 13 (7.69%)
    4 / 26 (15.38%)
         occurrences all number
    1
    6
    Ear infection
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    2
    Otitis externa
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Oct 2012
    This substantial amendment was to modify the protocol following comments from the Medicines and Healthcare Products Regulatory Agency during review of the clinical trial authorization application. - Section 5.2 of the protocol concerning study stopping rules was amended to explicitly state that no dose escalation was permitted if any of the predefined stopping rules were met. Moreover, additional LFTs (AST, ALP, and bilirubin) were added and toxicity criteria were provided indicating the level of change that may have led to the dose escalation being stopped. For completeness, the range of anticipated exposure that was not to be exceeded (based on exposure observed at NOAEL in the 8-week, repeat-dose toxicology study) was added. - The inclusion criterion for contraception was amended to include specific contraception requirements for female subjects of childbearing potential and for male subjects with partners of childbearing potential. The duration of contraceptive use after treatment was defined.
    06 Feb 2013
    The purpose of this substantial amendment was to remove the vitamin D requirement for subjects to be eligible to participate in the study. The original inclusion criterion was based upon standard definitions of vitamin D3 deficiency and did not take into account data showing that, in normal circumstances, 50 % of the healthy white UK population has low vitamin D3 levels in the winter and spring (Barts and The London School of Medicine and Dentistry Clinical Effectiveness Group, 2011; Hyppönen and Power, 2007). This revision was intended to allow recruitment of subjects with stable vitamin D3 levels to enable longitudinal intraindividual monitoring of any changes to selected psoriatic lesions as a result of treatment with UCB4940. Vitamin D levels continued to be measured at the Screening Visit, and oral daily doses of up to 800 IU/day vitamin D were a permitted concomitant medication in the study. This dose was considered suitable for the management of vitamin D insufficiency in healthy adults (Barts and The London School of Medicine and Dentistry Clinical Effectiveness Group, 2011). The Sponsor did not believe that the proposed change to remove this inclusion criterion would affect subject safety.
    30 Oct 2013
    The purpose of this nonsubstantial amendment was to describe the process of sharing unblinded summary results with key UCB personnel prior to database lock. Individual subject data were kept blinded. The intention was to facilitate additional Clinical Planning or Portfolio Management decisions for strategic reasons.

    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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