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    Clinical Trial Results:
    A Randomized, Placebo-Controlled Phase IIb Study to Evaluate the Efficacy, Safety and Tolerability of 0.05%, 0.1% and 0.5% w/w Topical CT327 When Applied Twice Daily in Subjects with Psoriasis Vulgaris

    Summary
    EudraCT number
    		 2011-004640-21
    Trial protocol
    		 GB  
    Global end of trial date
    17 Sep 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jul 2019
    First version publication date
    14 Jul 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CT327-2003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01465282
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sienna Biopharmaceuticals SA
    Sponsor organisation address
    14 Rue Edward Steichen, Luxembourg, Luxembourg, L-2540
    Public contact
    Head of Clinical Operations, Sienna Biopharmaceuticals SA, 001 818-629-2256, ClinicalTrials@siennabio.com
    Scientific contact
    Head of Clinical Operations, Sienna Biopharmaceuticals SA, 001 818-629-2256, ClinicalTrials@siennabio.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
    11 Feb 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Sep 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Sep 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy of 3 strengths of CT327 ointment (0.05%, 0.1% and 0.5%) compared to placebo ointment, when applied twice daily to psoriasis vulgaris lesions for up to 8 weeks.
    Protection of trial subjects
    Written informed consent was obtained prior to the subject entering the study and prior to initiation of any protocol-specified procedures. The investigator or designee explained the nature, purpose, and risks of the study to each subject. Each subject was informed that he/she could withdraw from the study at any time and for any reason and was given sufficient time to consider the implications of the study before deciding whether to participate. Safety evaluations included adverse events (including local site reactions), blood pressure, pulse, electrocardiogram, laboratory variables, and physical examination.
    Background therapy
    		 No background therapy was used by all subjects.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Dec 2011
    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 States: 72
    Country: Number of subjects enrolled
    United Kingdom: 88
    Worldwide total number of subjects
    160
    EEA total number of subjects
    88
    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)
    140
    From 65 to 84 years
    19
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 242 subjects were screened to randomise 160 subjects.

    Pre-assignment
    Screening details
    		 Subjects had psoriasis involving up to 10% of body surface area with a minimum Psoriasis Area Severity Index score of extent of 2 in at least 1 body region. In addition, subjects were required to have at least 1 target plaque with a plaque elevation of at least marked severity (grade ≥3 on PASI lesion scale).

    Period 1
    Period 1 title
    Treatment Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    The study was double-blind. Each study site was instructed on how to break the study blind using either the interactive web response system (IWRS) or telephone. Investigators were asked, where possible, to contact the Creabilis medical monitor prior to breaking the blind. Reason for breaking the blind was to be documented in the IWRS system and the study case report form. The blind was not broken early for any subject.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment Group 1
    Arm description
    		 0.05% (w/w) CT327 ointment
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT327
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects received twice-daily topical applications of CT327 ointment for up to 8 weeks.

    Arm title
    		 Treatment Group 2
    Arm description
    		 0.1% (w/w) CT327 ointment
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT327
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects received twice-daily topical applications of CT327 ointment for up to 8 weeks.

    Arm title
    		 Treatment Group 3
    Arm description
    		 0.5% (w/w) CT327 ointment
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT327
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects received twice-daily topical applications of CT327 ointment for up to 8 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Placebo, vehicle only, no active ingredient
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT327 Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects received twice-daily topical applications of CT327 vehicle ointment for up to 8 weeks.

    Number of subjects in period 1
    		Treatment Group 1 Treatment Group 2 Treatment Group 3 Placebo
    Started
    40
    40
    40
    40
    Completed
    38
    33
    30
    33
    Not completed
    2
    7
    10
    7
         Consent withdrawn by subject
    2
    4
    1
    2
         Adverse event, non-fatal
    -
    -
    3
    2
         Non-compliance
    -
    -
    -
    1
         Lost to follow-up
    -
    3
    -
    1
         Lack of efficacy
    -
    -
    5
    1
         Protocol deviation
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Group 1
    Reporting group description
    		 0.05% (w/w) CT327 ointment

    Reporting group title
    Treatment Group 2
    Reporting group description
    		 0.1% (w/w) CT327 ointment

    Reporting group title
    Treatment Group 3
    Reporting group description
    		 0.5% (w/w) CT327 ointment

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo, vehicle only, no active ingredient

    Reporting group values
    		 Treatment Group 1 Treatment Group 2 Treatment Group 3 Placebo Total
    Number of subjects
    		 40 40 40 40 160
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 36 38 32 34 140
        From 65-84 years
    		 4 1 8 6 19
        85 years and over
    		 0 1 0 0 1
    Gender categorical
    Units: Subjects
        Female
    		 15 14 15 11 55
        Male
    		 25 26 25 29 105

    End points

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    End points reporting groups
    Reporting group title
    Treatment Group 1
    Reporting group description
    		 0.05% (w/w) CT327 ointment

    Reporting group title
    Treatment Group 2
    Reporting group description
    		 0.1% (w/w) CT327 ointment

    Reporting group title
    Treatment Group 3
    Reporting group description
    		 0.5% (w/w) CT327 ointment

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo, vehicle only, no active ingredient

    Primary: Controlled Disease

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    End point title
    		 Controlled Disease
    End point description
    Controlled disease: Binary response defined as ‘none’ or ‘minimal’ disease on the Investigator Global Assessment (IGA) and a minimum improvement of 2 categories from baseline at the assessment time-point, or ‘none’ on the IGA resulting in discontinuation
    End point type
    Primary
    End point timeframe
    From baseline to Week 8
    End point values
    		 Treatment Group 1 Treatment Group 2 Treatment Group 3 Placebo
    Number of subjects analysed
    40
    40
    40
    40
    Units: Percentage of subjects
    3
    3
    5
    10
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    At each post-baseline visit, odds ratios and exact 95% confidence intervals are presented for the comparison of each CT327 dose against placebo, with p-values from the Fisher Exact test presented according to the step-down procedure. Testing started at the highest dose and only progressed to the next lowest dose if the current test was statistically significant.
    Comparison groups
    Treatment Group 1 v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.02
         upper limit
    		 2.16
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    At each post-baseline visit, odds ratios and exact 95% confidence intervals are presented for the comparison of each CT327 dose against placebo, with p-values from the Fisher Exact test presented according to the step-down procedure. Testing started at the highest dose and only progressed to the next lowest dose if the current test was statistically significant.
    Comparison groups
    Treatment Group 2 v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.02
         upper limit
    		 2.16
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    At each post-baseline visit, odds ratios and exact 95% confidence intervals are presented for the comparison of each CT327 dose against placebo, with p-values from the Fisher Exact test presented according to the step-down procedure. Testing started at the highest dose and only progressed to the next lowest dose if the current test was statistically significant.
    Comparison groups
    Treatment Group 3 v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05 [1]
    Method
    		 ANCOVA
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.08
         upper limit
    		 2.75
    Notes
    [1] - p=0.6752

    Secondary: Change from baseline in mPASI score

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    End point title
    		 Change from baseline in mPASI score
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to Week 8 visit
    End point values
    		 Treatment Group 1 Treatment Group 2 Treatment Group 3 Placebo
    Number of subjects analysed
    40
    40
    40
    40
    Units: Score on a scale
        least squares mean (standard error)
    -4.06 ± 0.445
    -3.23 ± 0.445
    -3.30 ± 0.446
    -2.56 ± 0.446
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The mPASI scores were summarised by treatment using descriptive statistics for screening, baseline, each study evaluation, the change from baseline to each evaluation and the percentage change from baseline to each evaluation using LOCF. P-value was calculated from an ANCOVA including terms for treatment and baseline mPASI score. Testing started at the highest dose (CT327 0.5%) and only progressed to the next lowest dose if the current test was statistically significant.
    Comparison groups
    Treatment Group 1 v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.75
         upper limit
    		 0.26
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The mPASI scores were summarised by treatment using descriptive statistics for screening, baseline, each study evaluation, the change from baseline to each evaluation and the percentage change from baseline to each evaluation using LOCF. P-value was calculated from an ANCOVA including terms for treatment and baseline mPASI score. Testing started at the highest dose (CT327 0.5%) and only progressed to the next lowest dose if the current test was statistically significant.
    Comparison groups
    Treatment Group 2 v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.92
         upper limit
    		 0.57
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    The mPASI scores were summarised by treatment using descriptive statistics for screening, baseline, each study evaluation, the change from baseline to each evaluation and the percentage change from baseline to each evaluation using LOCF. P-value was calculated from an ANCOVA including terms for treatment and baseline mPASI score. Testing started at the highest dose (CT327 0.5%) and only progressed to the next lowest dose if the current test was statistically significant.
    Comparison groups
    Treatment Group 3 v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05 [2]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.99
         upper limit
    		 0.51
    Notes
    [2] - p=0.2436

    Secondary: Change from baseline in pruritus visual analogue scale (VAS) score

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    End point title
    		 Change from baseline in pruritus visual analogue scale (VAS) score
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to Week 8
    End point values
    		 Treatment Group 1 Treatment Group 2 Treatment Group 3 Placebo
    Number of subjects analysed
    40
    40
    40
    40
    Units: Score on a scale
        least squares mean (standard error)
    -14.11 ± 4.0
    -30.50 ± 3.9
    -27.59 ± 4.0
    -25.06 ± 4.0
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Change from baseline in the pruritus VAS score at week 8 was analysed using an analysis of covariance model with fixed terms for treatment and baseline VAS score. Each dose level of CT327 was compared to placebo using the step-down approach described for the primary analysis.
    Comparison groups
    Treatment Group 1 v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -16.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.47
         upper limit
    		 -5.31
    Notes
    [3] - The comparison of CT327 0.05% against placebo was not tested as part of the fixed sequence procedure.
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Change from baseline in the pruritus VAS score at week 8 was analysed using an analysis of covariance model with fixed terms for treatment and baseline VAS score. Each dose level of CT327 was compared to placebo using the step-down approach described for the primary analysis.
    Comparison groups
    Treatment Group 2 v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05 [4]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -10.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.07
         upper limit
    		 0.18
    Notes
    [4] - p=0.0537
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Change from baseline in the pruritus VAS score at week 8 was analysed using an analysis of covariance model with fixed terms for treatment and baseline VAS score. Each dose level of CT327 was compared to placebo using the step-down approach described for the primary analysis.
    Comparison groups
    Treatment Group 3 v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05 [5]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -13.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.75
         upper limit
    		 -2.21
    Notes
    [5] - p=0.0194

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from Day 1 to the Follow-up Treatment Visit (Day 83-87).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Treatment Group 1
    Reporting group description
    		 0.05% (w/w) CT327 ointment

    Reporting group title
    Treatment Group 2
    Reporting group description
    		 0.1% (w/w) CT327 ointment

    Reporting group title
    Treatment Group 3
    Reporting group description
    		 0.5% (w/w) CT327 ointment

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo, vehicle only, no active ingredient

    Serious adverse events
    		 Treatment Group 1 Treatment Group 2 Treatment Group 3 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Reproductive system and breast disorders
    Uterine cyst
    Additional description: A 33-year-old female subject being treated with placebo experienced a ruptured uterine cyst, 33 days after starting study treatment, which resulted in hospitalisation.
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         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
    Psychiatric disorders
    Depression
    Additional description: A 57-year-old male subject who was receiving placebo was hospitalised due to worsening of depression. The subject had a history of anxiety, depression, hypertension, hyperlipidaemia, and hip pain.
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment Group 1 Treatment Group 2 Treatment Group 3 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 40 (32.50%)
    17 / 40 (42.50%)
    22 / 40 (55.00%)
    21 / 40 (52.50%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    2
    3
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    4 / 40 (10.00%)
    2 / 40 (5.00%)
    3 / 40 (7.50%)
    6 / 40 (15.00%)
         occurrences all number
    4
    3
    4
    6
    Psoriasis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    2
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    3 / 40 (7.50%)
    1 / 40 (2.50%)
         occurrences all number
    1
    0
    3
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Dec 2011
    The protocol states that PK samples taken at Visit 5 will only be analysed if measureable levels of CT327 and CT340r are seen in the samples taken at Visit 3. As CT327 plasma stability data only supported 10 weeks storage at -20oC, at this time, it was decided that all samples would be analysed as they were received by the lab, rather than waiting to review the data for the Visit 3 samples, as the stability data was insufficient to delay the analysis of these samples.
    05 Jan 2012
    The target lesion module of the case report form was updated with the correct scale (0-4). In the amended scale the last category, very severe, was removed. Severe, very severe and very marked were all graded as 4.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/25594427
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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