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    Clinical Trial Results:
    A Phase IIa, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT-1303 in Subjects with Moderate to Severe Chronic Plaque Psoriasis

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    		 2012-005750-27
    Trial protocol
    		 LV   HU   EE   PL   BG  
    Global end of trial date
    21 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jul 2016
    First version publication date
    16 Jul 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MT-1303-E06
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01987843
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Mitsubishi Tanabe Pharma Corporation
    Sponsor organisation address
    17-10, Nihonbashi-Koamicho, Chuo-ku, Tokyo, Japan, 103-8405
    Public contact
    General Information, Mitsubishi Tanabe Pharma Europe Ltd. (MTPE), regulatory@mt-pharma-eu.com
    Scientific contact
    General Information, Mitsubishi Tanabe Pharma Europe Ltd. (MTPE), regulatory@mt-pharma-eu.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
    18 Mar 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to evaluate the safety and tolerability of 3 dose levels of MT‑1303 in subjects with moderate to severe chronic plaque psoriasis. It is also to evaluate the efficacy of 3 dose levels of MT-1303 in subjects with moderate to severe chronic plaque psoriasis compared to placebo after 16 weeks of treatment on Psoriasis Area and Severity Index (PASI).
    Protection of trial subjects
    Subjects will be permanently withdrawn from study medication in the following circumstances: • Confirmed absolute lymphocyte count values <200/μL, on 2 consecutive occasions • Development of any clinically significant abnormalities on ECG, including but not limited to: Symptomatic bradycardia; New onset 2nd degree AV block, Mobitz Type II; New onset 3rd degree AV block; Confirmed QTcF interval prolongation >500msec and/or QTcF interval increase from baseline >60msec • Development of any clinically significant liver dysfunction as follows: o ALT or AST > 8 × ULN, or o ALT or AST >5 × ULN and persists for more than 2 consecutive visits, or o ALT or AST >3 × ULN in conjunction with elevated total bilirubin >2 × ULN or o ALT or AST >3 × ULN with appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash and/or eosinophilia (>5%) • Development of macular oedema during the study • Initiation of treatment with a disease-modifying medication for a worsening of psoriasis • Recurrence of the abnormality at re-challenge • Interruption to study medication lasting more than 14 days. In addition, a subject may voluntarily withdraw or be permanently withdrawn from the study at any time for reasons including, but not limited to, the following: • The subject wishes to withdraw from further participation • The subject is non-compliant with the protocol • The treatment blind is broken for the subject for the reasons other than regulatory reporting • Continuation in the study would be detrimental to the subject’s safety in the opinion of the Investigator • Pregnancy • The Investigator or the Sponsor, for any reason, stops the study
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Oct 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 46
    Country: Number of subjects enrolled
    Bulgaria: 3
    Country: Number of subjects enrolled
    Estonia: 1
    Country: Number of subjects enrolled
    Germany: 33
    Country: Number of subjects enrolled
    Hungary: 9
    Country: Number of subjects enrolled
    Latvia: 21
    Country: Number of subjects enrolled
    Russian Federation: 18
    Country: Number of subjects enrolled
    Ukraine: 11
    Worldwide total number of subjects
    142
    EEA total number of subjects
    113
    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)
    142
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 142 subjects randomised across 40 sites in 8 countries (Bulgaria, Estonia, Germany, Hungary, Latvia, Poland, Russia, and Ukraine). FSFV (screen) 02 Oct 2013, LSI (screen) 22 Apr 2014. FSFV (randomised) 21 Oct 2013. LSI (randomised) 13 May 2014. The study was conducted in university/public/private hospitals and specialised dermatology practices.

    Pre-assignment
    Screening details
    		 Up to 4 week screening period

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    Lymphotcyte count and WBC differential were not provided to any site/study personel except the Unblinded Independent Monitor to maintain the study medication blind. PK results were not provided by the PK lab until after database lock. MT-1303/placebo capsules appeared the same and same number of capsules were given.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Once daily oral placebo capsules taken from Baseline Week 0 to End of Treatment
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 capsule, containing placebo taken orally daily for 16 weeks.

    Arm title
    		 MT-1303 0.1mg
    Arm description
    		 Once daily oral MT-1303 0.1mg capsules taken from Baseline Week 0 to End of Treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    MT-1303
    Investigational medicinal product code
    MT-1303
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 capsule, containing MT-1303 0.1mg taken orally daily for 16 weeks.

    Arm title
    		 MT-1303 0.2mg
    Arm description
    		 Once daily oral MT-1303 0.2mg capsules taken from Baseline Week 0 to End of Treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    MT-1303
    Investigational medicinal product code
    MT-1303
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 capsule, containing MT-1303 0.2mg taken orally daily for 16 weeks.

    Arm title
    		 MT-1303 0.4mg
    Arm description
    		 Once daily oral MT-1303 0.4mg capsules taken from Baseline Week 0 to End of Treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    MT-1303
    Investigational medicinal product code
    MT-1303
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 capsule, containing MT-1303 0.4mg taken orally daily for 16 weeks.

    Number of subjects in period 1
    		Placebo MT-1303 0.1mg MT-1303 0.2mg MT-1303 0.4mg
    Started
    35
    36
    35
    36
    Completed
    30
    30
    25
    32
    Not completed
    5
    6
    10
    4
         Consent withdrawn by subject
    3
    3
    4
    1
         Adverse event, non-fatal
    2
    1
    2
    1
         Other
    -
    1
    2
    1
         Lost to follow-up
    -
    1
    1
    -
         Lack of efficacy
    -
    -
    1
    -
         Protocol deviation
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Once daily oral placebo capsules taken from Baseline Week 0 to End of Treatment

    Reporting group title
    MT-1303 0.1mg
    Reporting group description
    		 Once daily oral MT-1303 0.1mg capsules taken from Baseline Week 0 to End of Treatment

    Reporting group title
    MT-1303 0.2mg
    Reporting group description
    		 Once daily oral MT-1303 0.2mg capsules taken from Baseline Week 0 to End of Treatment

    Reporting group title
    MT-1303 0.4mg
    Reporting group description
    		 Once daily oral MT-1303 0.4mg capsules taken from Baseline Week 0 to End of Treatment

    Reporting group values
    		 Placebo MT-1303 0.1mg MT-1303 0.2mg MT-1303 0.4mg Total
    Number of subjects
    		 35 36 35 36 142
    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)
    		 35 36 35 36 142
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.7 ( 9.8 ) 42 ( 11.2 ) 39 ( 11.2 ) 40.9 ( 9.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 11 6 11 37
        Male
    		 26 25 29 25 105
    Baseline PASI Score
    Psoriasis severity index score taken at baseline
    Units: Not Applicable
        arithmetic mean (standard deviation)
    		 19.26 ( 5.78 ) 19.05 ( 6.77 ) 18.04 ( 5.34 ) 19.41 ( 7.15 ) -
    Subject analysis sets

    Subject analysis set title
    ITT - placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT pop will include all randomised subjects who received at least one dose of study medication and have at least one post-dose PASI score

    Subject analysis set title
    ITT - 0.1mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT pop will include all randomised subjects who received at least one dose of study medication and have at least one post-dose PASI score

    Subject analysis set title
    ITT - 0.2mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT pop will include all randomised subjects who received at least one dose of study medication and have at least one post-dose PASI score

    Subject analysis set title
    ITT - 0.4mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT pop will include all randomised subjects who received at least one dose of study medication and have at least one post-dose PASI score

    Subject analysis sets values
    		 ITT - placebo ITT - 0.1mg ITT - 0.2mg ITT - 0.4mg
    Number of subjects
    35
    35
    34
    35
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
        Adults (18-64 years)
    35
    35
    34
    35
        From 65-84 years
    0
    0
    0
    0
        85 years and over
    0
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    38.7 ( 9.8 )
    42.1 ( 11.3 )
    39.4 ( 11.1 )
    41.1 ( 9.7 )
    Gender categorical
    Units: Subjects
        Female
    9
    11
    5
    10
        Male
    26
    24
    29
    25
    Baseline PASI Score
    Psoriasis severity index score taken at baseline
    Units: Not Applicable
        arithmetic mean (standard deviation)
    19.26 ( 5.78 )
    18.95 ( 6.84 )
    18.01 ( 5.42 )
    19.43 ( 7.26 )

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Once daily oral placebo capsules taken from Baseline Week 0 to End of Treatment

    Reporting group title
    MT-1303 0.1mg
    Reporting group description
    		 Once daily oral MT-1303 0.1mg capsules taken from Baseline Week 0 to End of Treatment

    Reporting group title
    MT-1303 0.2mg
    Reporting group description
    		 Once daily oral MT-1303 0.2mg capsules taken from Baseline Week 0 to End of Treatment

    Reporting group title
    MT-1303 0.4mg
    Reporting group description
    		 Once daily oral MT-1303 0.4mg capsules taken from Baseline Week 0 to End of Treatment

    Subject analysis set title
    ITT - placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT pop will include all randomised subjects who received at least one dose of study medication and have at least one post-dose PASI score

    Subject analysis set title
    ITT - 0.1mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT pop will include all randomised subjects who received at least one dose of study medication and have at least one post-dose PASI score

    Subject analysis set title
    ITT - 0.2mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT pop will include all randomised subjects who received at least one dose of study medication and have at least one post-dose PASI score

    Subject analysis set title
    ITT - 0.4mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT pop will include all randomised subjects who received at least one dose of study medication and have at least one post-dose PASI score

    Primary: The proportion of subjects that achieved PASI 75 (at least 75% reduction from baseline in PASI score) at Week 16 (LOCF)

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    End point title
    		 The proportion of subjects that achieved PASI 75 (at least 75% reduction from baseline in PASI score) at Week 16 (LOCF)
    End point description
    The least squares mean are back transformed into estimates of the odds of achieving PASI 75
    End point type
    Primary
    End point timeframe
    Week 16 LOCF
    End point values
    		 ITT - placebo ITT - 0.1mg ITT - 0.2mg ITT - 0.4mg
    Number of subjects analysed
    35
    35
    34
    35
    Units: Proportion of subjects
        least squares mean (confidence interval 95%)
    0.06 (0.01 to 0.24)
    0.09 (0.03 to 0.3)
    0.27 (0.12 to 0.61)
    0.28 (0.13 to 0.63)
    Statistical analysis title
    		 PASI 75 at week 16 LOCF 0.1 mg vs placebo
    Statistical analysis description
    Estimated odds and odds ratios were based on logistic regression model with treatment fixed effect and baseline PASI score as a covariate. Two sided 95% Cis and p-values were computed using Wald's test
    Comparison groups
    ITT - placebo v ITT - 0.1mg
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.644
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.24
         upper limit
    		 9.97
    Statistical analysis title
    		 PASI 75 at week 16 LOCF 0.2 mg vs placebo
    Statistical analysis description
    Estimated odds and odds ratios were based on logistic regression model with treatment fixed effect and baseline PASI score as a covariate. Two sided 95% Cis and p-values were computed using Wald's test
    Comparison groups
    ITT - placebo v ITT - 0.2mg
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.073
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 24.13
    Statistical analysis title
    		 PASI 75 at week 16 LOCF 0.4 mg vs placebo
    Statistical analysis description
    Estimated odds and odds ratios were based on logistic regression model with treatment fixed effect and baseline PASI score as a covariate. Two sided 95% Cis and p-values were computed using Wald's test
    Comparison groups
    ITT - placebo v ITT - 0.4mg
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.058
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 25.05

    Secondary: The proportion of subjects that achieved PASI 75 (at least 75% reduction from baseline in PASI score) at Weeks 4, 8 and 12

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    End point title
    		 The proportion of subjects that achieved PASI 75 (at least 75% reduction from baseline in PASI score) at Weeks 4, 8 and 12
    End point description
    The least square means are back transformed into estimates of the odds of achieving PASI 75
    End point type
    Secondary
    End point timeframe
    Weeks 4
    End point values
    		 ITT - placebo ITT - 0.1mg ITT - 0.2mg ITT - 0.4mg
    Number of subjects analysed
    34
    33 [1]
    33
    34 [2]
    Units: Proportion of subjects
        least squares mean (confidence interval 95%)
    0 (0 to 0)
    0 (0 to 999)
    0.03 (0 to 0.25)
    0 (0 to 999)
    Notes
    [1] - '999' represents a non evaluable value (NE). The system does not allow to enter 'NE'.
    [2] - '999' represents a non evaluable value (NE). The system does not allow to enter 'NE'.
    Statistical analysis title
    		 PASI 75 at week 4 0.1 mg vs placebo
    Statistical analysis description
    Estimated odds and odds ratios were based on logistic regression model with treatment fixed effect and baseline PASI score as a covariate. Two sided 95% Cis and p-values were computed using Wald's test
    Comparison groups
    ITT - placebo v ITT - 0.1mg
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 999 [3]
    Method
    		 Regression, Logistic
    Confidence interval
    Notes
    [3] - 999' represents a non evaluable value (NE). The system does not allow to enter 'NE'.
    Statistical analysis title
    		 PASI 75 at week 4 0.2 mg vs placebo
    Statistical analysis description
    Estimated odds and odds ratios were based on logistic regression model with treatment fixed effect and baseline PASI score as a covariate. Two sided 95% Cis and p-values were computed using Wald's test
    Comparison groups
    ITT - placebo v ITT - 0.2mg
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 999 [4]
    Method
    		 Regression, Logistic
    Confidence interval
    Notes
    [4] - 999' represents a non evaluable value (NE). The system does not allow to enter 'NE'.
    Statistical analysis title
    		 PASI 75 at week 4 0.4 mg vs placebo
    Statistical analysis description
    Estimated odds and odds ratios were based on logistic regression model with treatment fixed effect and baseline PASI score as a covariate. Two sided 95% Cis and p-values were computed using Wald's test
    Comparison groups
    ITT - placebo v ITT - 0.4mg
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 999 [5]
    Method
    		 Regression, Logistic
    Confidence interval
    Notes
    [5] - 999' represents a non evaluable value (NE). The system does not allow to enter 'NE'.

    Secondary: The proportion of subjects that achieved PASI 75 (at least 75% reduction from baseline in PASI score) at Weeks 4, 8 and 12

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    End point title
    		 The proportion of subjects that achieved PASI 75 (at least 75% reduction from baseline in PASI score) at Weeks 4, 8 and 12
    End point description
    The least squares mean are back transformed into estimates of the odds of achieving PASI 75
    End point type
    Secondary
    End point timeframe
    Weeks 8
    End point values
    		 ITT - placebo ITT - 0.1mg ITT - 0.2mg ITT - 0.4mg
    Number of subjects analysed
    33
    31
    27
    33
    Units: Proportion of subjects
        least squares mean (confidence interval 95%)
    0.02 (0 to 0.19)
    0.02 (0 to 0.22)
    0.12 (0.03 to 0.41)
    0.04 (0.01 to 0.22)
    Statistical analysis title
    		 PASI 75 at week 8 0.1 mg vs placebo
    Statistical analysis description
    Estimated odds and odds ratios were based on logistic regression model with treatment fixed effect and baseline PASI score as a covariate. Two sided 95% Cis and p-values were computed using Wald's test
    Comparison groups
    ITT - placebo v ITT - 0.1mg
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.976
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.05
         upper limit
    		 17.91
    Statistical analysis title
    		 PASI 75 at week 8 0.2 mg vs placebo
    Statistical analysis description
    Estimated odds and odds ratios were based on logistic regression model with treatment fixed effect and baseline PASI score as a covariate. Two sided 95% Cis and p-values were computed using Wald's test
    Comparison groups
    ITT - placebo v ITT - 0.2mg
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.198
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 51.56
    Statistical analysis title
    		 PASI 75 at week 8 0.4 mg vs placebo
    Statistical analysis description
    Estimated odds and odds ratios were based on logistic regression model with treatment fixed effect and baseline PASI score as a covariate. Two sided 95% Cis and p-values were computed using Wald's test
    Comparison groups
    ITT - placebo v ITT - 0.4mg
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.659
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.14
         upper limit
    		 21.72

    Secondary: The proportion of subjects that achieved PASI 75 (at least 75% reduction from baseline in PASI score) at Weeks 4, 8 and 12

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    End point title
    		 The proportion of subjects that achieved PASI 75 (at least 75% reduction from baseline in PASI score) at Weeks 4, 8 and 12
    End point description
    The least squares mean are back transformed into estimates of the odds of achieving PASI 75
    End point type
    Secondary
    End point timeframe
    Weeks 12
    End point values
    		 ITT - placebo ITT - 0.1mg ITT - 0.2mg ITT - 0.4mg
    Number of subjects analysed
    30
    30
    26
    33
    Units: Proportion of subjects
        least squares mean (confidence interval 95%)
    0.03 (0 to 0.24)
    0.07 (0.02 to 0.31)
    0.18 (0.06 to 0.53)
    0.25 (0.11 to 0.6)
    Statistical analysis title
    		 PASI 75 at week 12 0.1 mg vs placebo
    Statistical analysis description
    Estimated odds and odds ratios were based on logistic regression model with treatment fixed effect and baseline PASI score as a covariate. Two sided 95% Cis and p-values were computed using Wald's test
    Comparison groups
    ITT - placebo v ITT - 0.1mg
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.522
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.19
         upper limit
    		 26.34
    Statistical analysis title
    		 PASI 75 at week 12 0.2 mg vs placebo
    Statistical analysis description
    Estimated odds and odds ratios were based on logistic regression model with treatment fixed effect and baseline PASI score as a covariate. Two sided 95% Cis and p-values were computed using Wald's test
    Comparison groups
    ITT - placebo v ITT - 0.2mg
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.141
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    5.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 52.85
    Statistical analysis title
    		 PASI 75 at week 12 0.4 mg vs placebo
    Comparison groups
    ITT - placebo v ITT - 0.4mg
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.065
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    7.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 67.01

    Secondary: Mean percent change from baseline in PASI score at Weeks 4, 8, 12 and 16

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    End point title
    		 Mean percent change from baseline in PASI score at Weeks 4, 8, 12 and 16
    End point description
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 ITT - placebo ITT - 0.1mg ITT - 0.2mg ITT - 0.4mg
    Number of subjects analysed
    35
    35
    34
    35
    Units: %
        least squares mean (standard error)
    -13.52 ( 4.04 )
    -12.51 ( 4.09 )
    -10.83 ( 4.1 )
    -16.17 ( 4.04 )
    Statistical analysis title
    		 % change from baseline at wk 4 0.1mg vs placebo
    Statistical analysis description
    P-values are based on a mixed model for repeated measures with percentage change from baseline in PASI Score at each post-baseline scheduled visit as the response variable. The independent variables are treatment, visit, treatment-by-visit interaction as fixed effects and baseline PASI Score and baseline PASI score-by-visit interaction as the covariates. Covariance Structure: Unstructured.
    Comparison groups
    ITT - placebo v ITT - 0.1mg
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.86
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.36
         upper limit
    		 12.39
    Statistical analysis title
    		 % change from baseline at wk 4 0.2mg vs placebo
    Statistical analysis description
    P-values are based on a mixed model for repeated measures with percentage change from baseline in PASI Score at each post-baseline scheduled visit as the response variable. The independent variables are treatment, visit, treatment-by-visit interaction as fixed effects and baseline PASI Score and baseline PASI score-by-visit interaction as the covariates. Covariance Structure: Unstructured.
    Comparison groups
    ITT - placebo v ITT - 0.2mg
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.641
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.71
         upper limit
    		 14.09
    Statistical analysis title
    		 % change from baseline at wk 4 0.4mg vs placebo
    Statistical analysis description
    P-values are based on a mixed model for repeated measures with percentage change from baseline in PASI Score at each post-baseline scheduled visit as the response variable. The independent variables are treatment, visit, treatment-by-visit interaction as fixed effects and baseline PASI Score and baseline PASI score-by-visit interaction as the covariates. Covariance Structure: Unstructured.
    Comparison groups
    ITT - placebo v ITT - 0.4mg
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.643
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.93
         upper limit
    		 8.64

    Secondary: Mean percent change from baseline in PASI score at Weeks 4, 8, 12 and 16

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    End point title
    		 Mean percent change from baseline in PASI score at Weeks 4, 8, 12 and 16
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 ITT - placebo ITT - 0.1mg ITT - 0.2mg ITT - 0.4mg
    Number of subjects analysed
    35
    35
    34
    35
    Units: %
        least squares mean (standard error)
    -19.84 ( 4.71 )
    -25.42 ( 4.81 )
    -20.27 ( 4.95 )
    -29.94 ( 4.71 )
    Statistical analysis title
    		 % change from baseline at wk 8 0.1mg vs placebo
    Statistical analysis description
    P-values are based on a mixed model for repeated measures with percentage change from baseline in PASI Score at each post-baseline scheduled visit as the response variable. The independent variables are treatment, visit, treatment-by-visit interaction as fixed effects and baseline PASI Score and baseline PASI score-by-visit interaction as the covariates. Covariance Structure: Unstructured.
    Comparison groups
    ITT - placebo v ITT - 0.1mg
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.409
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.89
         upper limit
    		 7.75
    Statistical analysis title
    		 % change from baseline at wk 8 0.2mg vs placebo
    Statistical analysis description
    P-values are based on a mixed model for repeated measures with percentage change from baseline in PASI Score at each post-baseline scheduled visit as the response variable. The independent variables are treatment, visit, treatment-by-visit interaction as fixed effects and baseline PASI Score and baseline PASI score-by-visit interaction as the covariates. Covariance Structure: Unstructured.
    Comparison groups
    ITT - placebo v ITT - 0.2mg
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.951
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.95
         upper limit
    		 13.11
    Statistical analysis title
    		 % change from baseline at wk 8 0.4mg vs placebo
    Statistical analysis description
    P-values are based on a mixed model for repeated measures with percentage change from baseline in PASI Score at each post-baseline scheduled visit as the response variable. The independent variables are treatment, visit, treatment-by-visit interaction as fixed effects and baseline PASI Score and baseline PASI score-by-visit interaction as the covariates. Covariance Structure: Unstructured.
    Comparison groups
    ITT - placebo v ITT - 0.4mg
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.132
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -10.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.27
         upper limit
    		 3.08

    Secondary: Mean percent change from baseline in PASI score at Weeks 4, 8, 12 and 16

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    End point title
    		 Mean percent change from baseline in PASI score at Weeks 4, 8, 12 and 16
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 ITT - placebo ITT - 0.1mg ITT - 0.2mg ITT - 0.4mg
    Number of subjects analysed
    35
    35
    34
    35
    Units: %
        least squares mean (standard error)
    -28.89 ( 5.22 )
    -33.16 ( 5.3 )
    -27.07 ( 5.54 )
    -45.32 ( 5.13 )
    Statistical analysis title
    		 % change from baseline at wk 12 0.1mg vs placebo
    Statistical analysis description
    "P-values are based on a mixed model for repeated measures with percentage change from baseline in PASI Score at each post-baseline scheduled visit as the response variable. The independent variables are treatment, visit, treatment-by-visit interaction as fixed effects and baseline PASI Score and baseline PASI score-by-visit interaction as the covariates. Covariance Structure: Unstructured.
    Comparison groups
    ITT - placebo v ITT - 0.1mg
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.567
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.02
         upper limit
    		 10.46
    Statistical analysis title
    		 % change from baseline at wk 12 0.2mg vs placebo
    Statistical analysis description
    "P-values are based on a mixed model for repeated measures with percentage change from baseline in PASI Score at each post-baseline scheduled visit as the response variable. The independent variables are treatment, visit, treatment-by-visit interaction as fixed effects and baseline PASI Score and baseline PASI score-by-visit interaction as the covariates. Covariance Structure: Unstructured.
    Comparison groups
    ITT - placebo v ITT - 0.2mg
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.812
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.27
         upper limit
    		 16.9
    Statistical analysis title
    		 % change from baseline at wk 12 0.4mg vs placebo
    Statistical analysis description
    "P-values are based on a mixed model for repeated measures with percentage change from baseline in PASI Score at each post-baseline scheduled visit as the response variable. The independent variables are treatment, visit, treatment-by-visit interaction as fixed effects and baseline PASI Score and baseline PASI score-by-visit interaction as the covariates. Covariance Structure: Unstructured.
    Comparison groups
    ITT - placebo v ITT - 0.4mg
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.026
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -16.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.91
         upper limit
    		 -1.96

    Secondary: Mean percent change from baseline in PASI score at Weeks 4, 8, 12 and 16

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    End point title
    		 Mean percent change from baseline in PASI score at Weeks 4, 8, 12 and 16
    End point description
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 ITT - placebo ITT - 0.1mg ITT - 0.2mg ITT - 0.4mg
    Number of subjects analysed
    35
    35
    34
    35
    Units: %
        least squares mean (standard error)
    -34.07 ( 5.48 )
    -41.35 ( 5.54 )
    -33.55 ( 5.87 )
    -47.92 ( 5.36 )
    Statistical analysis title
    		 % change from baseline at wk 16 0.1mg vs placebo
    Statistical analysis description
    P-values are based on a mixed model for repeated measures with percentage change from baseline in PASI Score at each post-baseline scheduled visit as the response variable. The independent variables are treatment, visit, treatment-by-visit interaction as fixed effects and baseline PASI Score and baseline PASI score-by-visit interaction as the covariates. Covariance Structure: Unstructured.
    Comparison groups
    ITT - placebo v ITT - 0.1mg
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.353
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.73
         upper limit
    		 8.17
    Statistical analysis title
    		 % change from baseline at wk 16 0.2mg vs placebo
    Statistical analysis description
    P-values are based on a mixed model for repeated measures with percentage change from baseline in PASI Score at each post-baseline scheduled visit as the response variable. The independent variables are treatment, visit, treatment-by-visit interaction as fixed effects and baseline PASI Score and baseline PASI score-by-visit interaction as the covariates. Covariance Structure: Unstructured.
    Comparison groups
    ITT - placebo v ITT - 0.2mg
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.949
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.39
         upper limit
    		 16.43
    Statistical analysis title
    		 % change from baseline at wk 16 0.4mg vs placebo
    Statistical analysis description
    P-values are based on a mixed model for repeated measures with percentage change from baseline in PASI Score at each post-baseline scheduled visit as the response variable. The independent variables are treatment, visit, treatment-by-visit interaction as fixed effects and baseline PASI Score and baseline PASI score-by-visit interaction as the covariates. Covariance Structure: Unstructured.
    Comparison groups
    ITT - placebo v ITT - 0.4mg
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.073
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -13.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.01
         upper limit
    		 1.32

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Start of double-blind treatment to end of 12 week follow-up period. Treatment-Emergent AEs were defined as those which started or worsened in severity after the first dose of double-blind study medication.
    Adverse event reporting additional description
    During the study visits regular questioning of each subject by study staff. No leading questions were asked. Data recorded under "Non-Serious Adverse Events" also includes serious adverse events as that is how data was reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Once daily oral placebo capsules taken from Baseline Week 0 to end of treatment

    Reporting group title
    MT-1303 0.1mg
    Reporting group description
    		 Once daily oral MT-1303 0.1mg capsules taken from Baseline Week 0 to end of treatment

    Reporting group title
    MT-1303 0.2mg
    Reporting group description
    		 Once daily oral MT-1303 0.2mg capsules taken from Baseline Week 0 to end of treatment

    Reporting group title
    MT-1303 0.4mg
    Reporting group description
    		 Once daily oral MT-1303 0.4mg capsules taken from Baseline Week 0 to end of treatment

    Serious adverse events
    		 Placebo MT-1303 0.1mg MT-1303 0.2mg MT-1303 0.4mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    1 / 36 (2.78%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    1 / 36 (2.78%)
         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
    Blood bilirubin increased
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increaased
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    1 / 36 (2.78%)
         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
    Cardiac disorders
    AV Block 2nd Degree
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    0 / 36 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo MT-1303 0.1mg MT-1303 0.2mg MT-1303 0.4mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 35 (48.57%)
    20 / 36 (55.56%)
    25 / 35 (71.43%)
    26 / 36 (72.22%)
    Investigations
    Blood creatine phosphokinase increased
    Additional description: Number of occurrences were not reported
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 36 (5.56%)
    5 / 35 (14.29%)
    3 / 36 (8.33%)
         occurrences all number
    0
    0
    0
    0
    Gamma-glutamyltransferase increased
    Additional description: Number of occurrences were not reported
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 36 (5.56%)
    2 / 35 (5.71%)
    4 / 36 (11.11%)
         occurrences all number
    0
    0
    0
    0
    Aspartate aminotransferase increased
    Additional description: Number of occurrences were not reported
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 36 (0.00%)
    3 / 35 (8.57%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    0
    Alanine aminotransferase increased
    Additional description: Number of occurrences were not reported
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    2 / 35 (5.71%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    0
    Blood triglycerides increased
    Additional description: Number of occurrences were not reported
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    2 / 35 (5.71%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    Vascular disorders
    Hypertension
    Additional description: Number of occurrences were not reported
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 36 (2.78%)
    2 / 35 (5.71%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    Cardiac disorders
    Tachycardia
    Additional description: Number of occurrences were not reported
         subjects affected / exposed
    0 / 35 (0.00%)
    3 / 36 (8.33%)
    2 / 35 (5.71%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    0
    Supraventricular tachycardia
    Additional description: Number of occurrences were not reported
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 36 (5.56%)
    1 / 35 (2.86%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    0
    Ventricular tachycardia
    Additional description: Number of occurrences were not reported
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    1 / 35 (2.86%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    0
    Nervous system disorders
    Headache
    Additional description: Number of occurrences were not reported
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 36 (2.78%)
    4 / 35 (11.43%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    0
    Dizziness
    Additional description: Number of occurrences were not reported
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    2 / 35 (5.71%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    0
    General disorders and administration site conditions
    Pyrexia
    Additional description: Number of occurrences were not reported
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
    Additional description: Number of occurrences were not reported
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 36 (2.78%)
    2 / 35 (5.71%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Psoriasis
    Additional description: Number of occurrences were not reported
         subjects affected / exposed
    2 / 35 (5.71%)
    4 / 36 (11.11%)
    4 / 35 (11.43%)
    3 / 36 (8.33%)
         occurrences all number
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
    Additional description: Number of occurrences were not reported
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    1 / 35 (2.86%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
    Additional description: Number of occurrences were not reported
         subjects affected / exposed
    5 / 35 (14.29%)
    5 / 36 (13.89%)
    8 / 35 (22.86%)
    5 / 36 (13.89%)
         occurrences all number
    0
    0
    0
    0
    Rhinitis
    Additional description: Number of occurrences were not reported
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    0
    Oral viral infection
    Additional description: Number of occurrences were not reported
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 36 (5.56%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Jul 2014
    Clarification of safety follow up period for withdrawn subjects

    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
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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