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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Phase 2b Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects with Active Psoriatic Arthritis

    Summary
    EudraCT number
    		 2016-003937-62
    Trial protocol
    		 HU   ES   PL  
    Global end of trial date
    24 Sep 2019

    Results information
    Results version number
    		 v1
    This version publication date
    29 Oct 2020
    First version publication date
    29 Oct 2020
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    CLR_16_23
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02980692
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sun Pharma Global FZE
    Sponsor organisation address
    Office number 43 Bloc-Y, SAIF Zone, Sharjah, United Arab Emirates, 122304
    Public contact
    Head-Clinical Development, Sun Pharma Advanced Research Company Limited, +91 22 6645 5645, clinical.trials@sparcmail.com
    Scientific contact
    Head-Clinical Development, Sun Pharma Advanced Research Company Limited, +91 22 6645 5645, clinical.trials@sparcmail.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
    Interim
    Date of interim/final analysis
    24 Sep 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Mar 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Sep 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Parts 1 and 2 Primary Efficacy Objective - To evaluate the optimal dose regimen of tildrakizumab in subjects with psoriatic arthritis (PsA) as measured by the proportion of subjects achieving a 20% reduction from Baseline in American College of Rheumatology response criteria [ACR20]) at Week 24. Primary safety Objective (Parts 1 and 2): - To assess the safety/tolerability and immunogenicity of multiple-dose administration of tildrakizumab in subjects with PsA.
    Protection of trial subjects
    The trial and site activities were monitored according to the ICH-GCP guidelines considering every aspect of the trial, ensuring that the rights, safety and well-being of patients are protected and consistent with the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Apr 2017
    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
    Argentina: 5
    Country: Number of subjects enrolled
    Mexico: 43
    Country: Number of subjects enrolled
    Russian Federation: 46
    Country: Number of subjects enrolled
    Ukraine: 40
    Country: Number of subjects enrolled
    United States: 73
    Country: Number of subjects enrolled
    Poland: 133
    Country: Number of subjects enrolled
    Spain: 38
    Country: Number of subjects enrolled
    Hungary: 13
    Worldwide total number of subjects
    391
    EEA total number of subjects
    184
    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)
    391
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 500 participants screened, 391 subjects randomized.

    Period 1
    Period 1 title
    Double blind placebo controlled period (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
    		 SUNPG1623 I
    Arm description
    		 Short-term dose SUNPG1623 I: injection
    Arm type
    		 Experimental

    Investigational medicinal product name
    SUNPG1623 I
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    SUNPG1623 I administered by SC injection q4 weeks up until Week 48

    Arm title
    		 SUNPG1623 II
    Arm description
    		 Mid-term dose SUNPG1623 II: injection PLACEBO: injection
    Arm type
    		 Experimental

    Investigational medicinal product name
    SUNPG1623 II
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    SUNPG1623 II administered SC q12 weeks up until Week 48

    Arm title
    		 SUNPG1623 dose III
    Arm description
    		 Mid-term dose SUNPG1623 III: injection PLACEBO: injection
    Arm type
    		 Experimental

    Investigational medicinal product name
    SUNPG1623 dose III
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    SUNPG1623 dose III administered SC q12 weeks up until Week 48

    Arm title
    		 SUNPG1623 dose IV
    Arm description
    		 Mid to long-term dose SUNPG1623 IV: injection PLACEBO: injection
    Arm type
    		 Experimental

    Investigational medicinal product name
    SUNPG1623 dose IV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    SUNPG1623 dose IV administered SC up until Week 48

    Arm title
    		 Placebo
    Arm description
    		 Mid to long-term dose PLACEBO: injection
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo administered SC up until Week 48

    Number of subjects in period 1
    		SUNPG1623 I SUNPG1623 II SUNPG1623 dose III SUNPG1623 dose IV Placebo
    Started
    78
    79
    77
    78
    79
    Completed
    69
    73
    65
    69
    68
    Not completed
    9
    6
    12
    9
    11
         Consent withdrawn by subject
    4
    3
    6
    6
    7
         Physician decision
    -
    -
    1
    1
    -
         Others
    1
    -
    -
    -
    -
         Adverse event, non-fatal
    -
    2
    -
    -
    1
         Other
    -
    1
    1
    1
    2
         Lost to follow-up
    3
    -
    4
    1
    1
         Subject Died
    1
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SUNPG1623 I
    Reporting group description
    		 Short-term dose SUNPG1623 I: injection

    Reporting group title
    SUNPG1623 II
    Reporting group description
    		 Mid-term dose SUNPG1623 II: injection PLACEBO: injection

    Reporting group title
    SUNPG1623 dose III
    Reporting group description
    		 Mid-term dose SUNPG1623 III: injection PLACEBO: injection

    Reporting group title
    SUNPG1623 dose IV
    Reporting group description
    		 Mid to long-term dose SUNPG1623 IV: injection PLACEBO: injection

    Reporting group title
    Placebo
    Reporting group description
    		 Mid to long-term dose PLACEBO: injection

    Reporting group values
    		 SUNPG1623 I SUNPG1623 II SUNPG1623 dose III SUNPG1623 dose IV Placebo Total
    Number of subjects
    		 78 79 77 78 79 391
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 78 79 77 78 79 391
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.1 ( 13.28 ) 49.3 ( 11.24 ) 49.2 ( 11.85 ) 47.2 ( 13.35 ) 48.1 ( 13.30 ) -
    Gender categorical
    Units: Subjects
        Female
    		 46 37 47 41 44 215
        Male
    		 32 42 30 37 35 176

    End points

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    End points reporting groups
    Reporting group title
    SUNPG1623 I
    Reporting group description
    		 Short-term dose SUNPG1623 I: injection

    Reporting group title
    SUNPG1623 II
    Reporting group description
    		 Mid-term dose SUNPG1623 II: injection PLACEBO: injection

    Reporting group title
    SUNPG1623 dose III
    Reporting group description
    		 Mid-term dose SUNPG1623 III: injection PLACEBO: injection

    Reporting group title
    SUNPG1623 dose IV
    Reporting group description
    		 Mid to long-term dose SUNPG1623 IV: injection PLACEBO: injection

    Reporting group title
    Placebo
    Reporting group description
    		 Mid to long-term dose PLACEBO: injection

    Primary: Proportion of subjects who achieve ACR20 Response Criteria at Week 24

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    End point title
    		 Proportion of subjects who achieve ACR20 Response Criteria at Week 24
    End point description
    End point type
    Primary
    End point timeframe
    week 24
    End point values
    		 SUNPG1623 I SUNPG1623 II SUNPG1623 dose III SUNPG1623 dose IV Placebo
    Number of subjects analysed
    78
    79
    77
    78
    79
    Units: percentage of response rate
        number (not applicable)
    79.49
    77.22
    71.43
    73.08
    50.63
    Statistical analysis title
    		 Cochran-Mantel-Haenszel Analysis of ACR20 Response
    Comparison groups
    Placebo v SUNPG1623 I
    Number of subjects included in analysis
    157
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference (%)
    Point estimate
    28.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14.84
         upper limit
    		 42.74
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.12

    Secondary: Proportion of Subjects Achieving ACR50 Response Criteria at Week 24

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    End point title
    		 Proportion of Subjects Achieving ACR50 Response Criteria at Week 24
    End point description
    End point type
    Secondary
    End point timeframe
    week 24
    End point values
    		 SUNPG1623 I SUNPG1623 II SUNPG1623 dose III SUNPG1623 dose IV Placebo
    Number of subjects analysed
    78
    79
    77
    78
    79
    Units: percentage of response rate
        number (not applicable)
    52.56
    50.63
    45.45
    39.74
    24.05
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving ACR70 Response Criteria at Week 24

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    End point title
    		 Proportion of Subjects Achieving ACR70 Response Criteria at Week 24
    End point description
    End point type
    Secondary
    End point timeframe
    week 24
    End point values
    		 SUNPG1623 I SUNPG1623 II SUNPG1623 dose III SUNPG1623 dose IV Placebo
    Number of subjects analysed
    78
    79
    77
    78
    79
    Units: percentage of response rate
        number (not applicable)
    28.21
    29.11
    22.08
    16.67
    10.13
    No statistical analyses for this end point

    Secondary: Change From Baseline in Tender Joint Counts at Week 24

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    End point title
    		 Change From Baseline in Tender Joint Counts at Week 24
    End point description
    End point type
    Secondary
    End point timeframe
    week 24
    End point values
    		 SUNPG1623 I SUNPG1623 II SUNPG1623 dose III SUNPG1623 dose IV Placebo
    Number of subjects analysed
    77
    78
    76
    78
    79
    Units: Change from Baseline
        least squares mean (standard error)
    -11.9 ( 1.04 )
    -12.6 ( 1.01 )
    -12.9 ( 1.03 )
    -12.0 ( 1.04 )
    -9.4 ( 1.02 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Swollen Joint Counts at Week 24

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    End point title
    		 Change from Baseline in Swollen Joint Counts at Week 24
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 SUNPG1623 I SUNPG1623 II SUNPG1623 dose III SUNPG1623 dose IV Placebo
    Number of subjects analysed
    77
    78
    76
    78
    79
    Units: Change From Baseline
        least squares mean (standard error)
    -8.3 ( 0.52 )
    -7.7 ( 0.51 )
    -8.2 ( 0.52 )
    -7.6 ( 0.52 )
    -6.5 ( 0.51 )
    No statistical analyses for this end point

    Secondary: Physician Global Assessment of Disease Activity VAS at Week 24

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    End point title
    		 Physician Global Assessment of Disease Activity VAS at Week 24
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 SUNPG1623 I SUNPG1623 II SUNPG1623 dose III SUNPG1623 dose IV Placebo
    Number of subjects analysed
    77
    78
    76
    78
    79
    Units: change from baseline
        least squares mean (standard error)
    -36.5 ( 2.15 )
    -38.8 ( 2.08 )
    -37.5 ( 2.11 )
    -36.3 ( 2.14 )
    -23.5 ( 2.09 )
    No statistical analyses for this end point

    Secondary: Health Assessment Questionnaire- Disability Index at Week 24

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    End point title
    		 Health Assessment Questionnaire- Disability Index at Week 24
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 SUNPG1623 I SUNPG1623 II SUNPG1623 dose III SUNPG1623 dose IV Placebo
    Number of subjects analysed
    77
    78
    76
    78
    79
    Units: Change From Baseline in HAQ-DI
        least squares mean (standard error)
    -0.3013 ( 0.05196 )
    -0.3314 ( 0.05054 )
    -0.3337 ( 0.05128 )
    -0.2376 ( 0.05187 )
    -0.1827 ( 0.05102 )
    No statistical analyses for this end point

    Secondary: Subjects Requiring Adjustment of Background Therapy at Week 16

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    End point title
    		 Subjects Requiring Adjustment of Background Therapy at Week 16
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 SUNPG1623 I SUNPG1623 II SUNPG1623 dose III SUNPG1623 dose IV Placebo
    Number of subjects analysed
    78
    79
    77
    78
    79
    Units: percentage
        number (confidence interval 95%)
    0.00 (0.00 to 0.00)
    1.27 (0.00 to 3.73)
    1.30 (0.00 to 3.83)
    2.56 (0.00 to 6.07)
    1.27 (0.00 to 3.73)
    No statistical analyses for this end point

    Secondary: Minimal Disease Activity at Week 24

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    End point title
    		 Minimal Disease Activity at Week 24
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 SUNPG1623 I SUNPG1623 II SUNPG1623 dose III SUNPG1623 dose IV Placebo
    Number of subjects analysed
    78
    79
    77
    78
    79
    Units: percentage response rate
        number (not applicable)
    33.33
    34.18
    28.57
    19.23
    6.33
    No statistical analyses for this end point

    Secondary: Patient's Pain Assessment up to Week 24

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    End point title
    		 Patient's Pain Assessment up to Week 24
    End point description
    End point type
    Secondary
    End point timeframe
    week 24
    End point values
    		 SUNPG1623 I SUNPG1623 II SUNPG1623 dose III SUNPG1623 dose IV Placebo
    Number of subjects analysed
    77
    78
    76
    78
    79
    Units: units
        least squares mean (standard error)
    -35.1 ( 2.69 )
    -31.6 ( 2.60 )
    -32.1 ( 2.64 )
    -28.8 ( 2.68 )
    -21.5 ( 2.63 )
    No statistical analyses for this end point

    Secondary: Acute Phase C - Reactive Protein at Week 24

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    End point title
    		 Acute Phase C - Reactive Protein at Week 24
    End point description
    End point type
    Secondary
    End point timeframe
    week 24
    End point values
    		 SUNPG1623 I SUNPG1623 II SUNPG1623 dose III SUNPG1623 dose IV Placebo
    Number of subjects analysed
    77
    78
    76
    78
    79
    Units: units
        least squares mean (standard error)
    -3.56 ( 1.088 )
    -2.33 ( 1.054 )
    -3.23 ( 1.071 )
    -2.06 ( 1.088 )
    0.55 ( 1.065 )
    No statistical analyses for this end point

    Secondary: Erythrocyte Sedimentation Rate at Week 24

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    End point title
    		 Erythrocyte Sedimentation Rate at Week 24
    End point description
    End point type
    Secondary
    End point timeframe
    week 24
    End point values
    		 SUNPG1623 I SUNPG1623 II SUNPG1623 dose III SUNPG1623 dose IV Placebo
    Number of subjects analysed
    70
    68
    69
    68
    62
    Units: units
        least squares mean (standard error)
    -8.0 ( 1.86 )
    -6.9 ( 1.85 )
    -8.2 ( 1.84 )
    -8.7 ( 1.89 )
    -2.3 ( 1.95 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Leeds Dactylitis Index (LDI) at Week 24

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    End point title
    		 Change from Baseline in Leeds Dactylitis Index (LDI) at Week 24
    End point description
    End point type
    Secondary
    End point timeframe
    week 24
    End point values
    		 SUNPG1623 I SUNPG1623 II SUNPG1623 dose III SUNPG1623 dose IV Placebo
    Number of subjects analysed
    53
    56
    46
    48
    54
    Units: units
        least squares mean (standard error)
    -22.987 ( 3.5112 )
    -25.123 ( 3.2307 )
    -27.572 ( 3.5088 )
    -19.873 ( 3.4520 )
    -24.706 ( 3.2252 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Leeds Enthesitis Index (LEI) at Week 24

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    End point title
    		 Change from Baseline in Leeds Enthesitis Index (LEI) at Week 24
    End point description
    End point type
    Secondary
    End point timeframe
    week 24
    End point values
    		 SUNPG1623 I SUNPG1623 II SUNPG1623 dose III SUNPG1623 dose IV Placebo
    Number of subjects analysed
    72
    77
    75
    76
    78
    Units: units
        least squares mean (standard error)
    -1.3 ( 0.16 )
    -0.9 ( 0.15 )
    -1.2 ( 0.15 )
    -1.1 ( 0.15 )
    -0.8 ( 0.15 )
    No statistical analyses for this end point

    Secondary: Patient’s Global Assessment of Disease Activity at Week 24

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    End point title
    		 Patient’s Global Assessment of Disease Activity at Week 24
    End point description
    End point type
    Secondary
    End point timeframe
    week 24
    End point values
    		 SUNPG1623 I SUNPG1623 II SUNPG1623 dose III SUNPG1623 dose IV Placebo
    Number of subjects analysed
    77
    78
    76
    78
    79
    Units: units
        least squares mean (standard error)
    -35.0 ( 2.60 )
    -33.3 ( 2.52 )
    -33.4 ( 2.56 )
    -30.4 ( 2.60 )
    -21.7 ( 2.54 )
    No statistical analyses for this end point

    Secondary: Disease Activity Score (DAS) 28 (joints) C - reactive protein (DAS28-CRP) response rate at Week 24

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    End point title
    		 Disease Activity Score (DAS) 28 (joints) C - reactive protein (DAS28-CRP) response rate at Week 24
    End point description
    End point type
    Secondary
    End point timeframe
    week 24
    End point values
    		 SUNPG1623 I SUNPG1623 II SUNPG1623 dose III SUNPG1623 dose IV Placebo
    Number of subjects analysed
    78
    79
    77
    78
    79
    Units: response rate (%)
        number (not applicable)
    58.97
    64.56
    58.44
    53.85
    30.38
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    52 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    SUNPG1623 I
    Reporting group description
    		 Short-term dose SUNPG1623 I: injection

    Reporting group title
    SUNPG1623 II
    Reporting group description
    		 Mid-term dose SUNPG1623 II: injection PLACEBO: injection

    Reporting group title
    SUNPG1623 dose III
    Reporting group description
    		 Mid-term dose SUNPG1623 III: injection PLACEBO: injection

    Reporting group title
    SUNPG1623 dose IV
    Reporting group description
    		 Mid to long-term dose SUNPG1623 IV: injection PLACEBO: injection

    Reporting group title
    Placebo
    Reporting group description
    		 Mid to long-term dose PLACEBO: injection

    Serious adverse events
    		 SUNPG1623 I SUNPG1623 II SUNPG1623 dose III SUNPG1623 dose IV Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         number of deaths (all causes)
    1
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Intraductal proliferative breast lesion
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parathyroid tumour benign
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Lumbar radiculopathy
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple sclerosis
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst ruptured
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic tonsillitis
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pnemonia
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    5 / 78 (6.41%)
    3 / 79 (3.80%)
    3 / 77 (3.90%)
    4 / 78 (5.13%)
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 SUNPG1623 I SUNPG1623 II SUNPG1623 dose III SUNPG1623 dose IV Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 78 (2.56%)
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    1 / 78 (1.28%)
    1 / 79 (1.27%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Intraductal proliferative breast lesion
         subjects affected / exposed
    2 / 78 (2.56%)
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    1 / 78 (1.28%)
    1 / 79 (1.27%)
         occurrences all number
    0
    0
    0
    1
    0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    2 / 78 (2.56%)
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    1 / 78 (1.28%)
    1 / 79 (1.27%)
         occurrences all number
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Pleurisy
         subjects affected / exposed
    2 / 78 (2.56%)
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    1 / 78 (1.28%)
    1 / 79 (1.27%)
         occurrences all number
    1
    0
    0
    0
    0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 78 (2.56%)
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    1 / 78 (1.28%)
    1 / 79 (1.27%)
         occurrences all number
    1
    0
    0
    0
    0
    Pyelonephritis
         subjects affected / exposed
    2 / 78 (2.56%)
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    1 / 78 (1.28%)
    1 / 79 (1.27%)
         occurrences all number
    0
    0
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 78 (2.56%)
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    1 / 78 (1.28%)
    1 / 79 (1.27%)
         occurrences all number
    0
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Mar 2018
    The revisions are summarized as follows. • Addition of reference to LTE study throughout. • Correction of text describing definition of minimal response. • Addition of text describing requirements for subjects taking low-potency opioids. • Clarification of use of topical corticosteroids. • Clarification that measurement of height was only required once, at Screening. • Addition of text clarifying visits requiring measurement of BSA. • Change of protocol version number and date. • Correction of minor typographical errors throughout.

    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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    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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