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    Clinical Trial Results:
    A Phase 2b, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Subjects with Active Psoriatic Arthritis

    Summary
    EudraCT number
    		 2021-005888-52
    Trial protocol
    		 CZ  
    Global end of trial date
    02 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 May 2024
    First version publication date
    19 May 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    4858-202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05153148
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Takeda
    Sponsor organisation address
    95 Hayden Avenue, Lexington, United States, MA 02421
    Public contact
    Study Director, Takeda, TrialDisclosures@takeda.com
    Scientific contact
    Study Director, Takeda, TrialDisclosures@takeda.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
    02 Jun 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of this study was to assess the effect of TAK-279 at different doses on the rheumatological signs, symptoms, and function in participants with active psoriatic arthritis (PsA).
    Protection of trial subjects
    Each participant signed an informed consent form (ICF) before participating in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jan 2022
    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: 58
    Country: Number of subjects enrolled
    Poland: 167
    Country: Number of subjects enrolled
    Germany: 25
    Country: Number of subjects enrolled
    Czechia: 40
    Worldwide total number of subjects
    290
    EEA total number of subjects
    232
    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)
    255
    From 65 to 84 years
    35
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in the study at 45 investigative sites in the United States (US), Germany, Poland, and the Czech Republic from 6 January 2022 to 2 June 2023.

    Pre-assignment
    Screening details
    		 A total of 305 participants with a diagnosis of psoriatic arthritis were enrolled in a 1:1:1:1 ratio to receive either one of the 3 doses of NDI-034858 or placebo.

    Pre-assignment period milestones
    Number of subjects started
    		 305 [1]
    Number of subjects completed
    		 290

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Withdrawal by Subject: 8
    Reason: Number of subjects
    		 Other: 3
    Reason: Number of subjects
    		 Randomized Without Dosing due to Ineligibility: 2
    Reason: Number of subjects
    		 Lost to Follow-up: 1
    Reason: Number of subjects
    		 Coronavirus Disease 2019 (COVID-19): 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Of the 305 subjects, only 290 were randomized and received at least one dose of the study drug.
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo capsules, orally, once daily (QD) for 12 weeks.
    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
    NDI-034858 placebo-matching oral capsules

    Arm title
    		 NDI-034858 Low Dose
    Arm description
    		 Participants received low dose of NDI-034858, capsules, orally, QD for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    NDI-034858
    Investigational medicinal product code
    Other name
    TAK-279
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    NDI-034858 oral capsules

    Arm title
    		 NDI-034858 Medium Dose
    Arm description
    		 Participants received medium dose of NDI-034858, capsules, orally, QD for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    NDI-034858
    Investigational medicinal product code
    Other name
    TAK-279
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    NDI-034858 oral capsules

    Arm title
    		 NDI-034858 High Dose
    Arm description
    		 Participants received high dose of NDI-034858, capsules, orally, QD for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    NDI-034858
    Investigational medicinal product code
    Other name
    TAK-279
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    NDI-034858 oral capsules

    Number of subjects in period 1
    		Placebo NDI-034858 Low Dose NDI-034858 Medium Dose NDI-034858 High Dose
    Started
    72
    71
    75
    72
    Completed
    64
    61
    62
    58
    Not completed
    8
    10
    13
    14
         Adverse Event
    4
    6
    7
    9
         Other
    -
    -
    -
    1
         Withdrawal by Subject
    3
    4
    4
    4
         Lost to follow-up
    1
    -
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo capsules, orally, once daily (QD) for 12 weeks.

    Reporting group title
    NDI-034858 Low Dose
    Reporting group description
    		 Participants received low dose of NDI-034858, capsules, orally, QD for 12 weeks.

    Reporting group title
    NDI-034858 Medium Dose
    Reporting group description
    		 Participants received medium dose of NDI-034858, capsules, orally, QD for 12 weeks.

    Reporting group title
    NDI-034858 High Dose
    Reporting group description
    		 Participants received high dose of NDI-034858, capsules, orally, QD for 12 weeks.

    Reporting group values
    		 Placebo NDI-034858 Low Dose NDI-034858 Medium Dose NDI-034858 High Dose Total
    Number of subjects
    		 72 71 75 72
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.7 ( 11.83 ) 48.3 ( 10.43 ) 52.5 ( 12.15 ) 49.0 ( 11.51 ) -
    Gender categorical
    Units: Subjects
        Female
    		 37 40 46 43 166
        Male
    		 35 31 29 29 124
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 1 4 2 9
        Not Hispanic or Latino
    		 70 69 71 70 280
        Unknown or Not Reported
    		 0 1 0 0 1
    Race/Ethnicity, Customized
    Units: Subjects
        White White
    		 69 66 71 69 275
        Non-white Non-white
    		 1 3 4 3 11
        Missing Missing
    		 2 2 0 0 4
    Height
    Units: centimeters (cm)
        arithmetic mean (standard deviation)
    		 170.3 ( 10.65 ) 170.1 ( 8.67 ) 169.0 ( 9.04 ) 170.4 ( 9.06 ) -
    Body Mass Index (BMI)
    BMI = weight (kg)/[height (m)^2]
    Units: kilograms per meter square (kg/m^2)
        arithmetic mean (standard deviation)
    		 29.48 ( 6.865 ) 29.78 ( 8.153 ) 30.04 ( 7.937 ) 30.15 ( 6.610 ) -
    Weight
    Units: kilograms (kg)
        arithmetic mean (standard deviation)
    		 86.26 ( 25.307 ) 86.97 ( 26.611 ) 85.85 ( 22.048 ) 87.74 ( 20.152 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo capsules, orally, once daily (QD) for 12 weeks.

    Reporting group title
    NDI-034858 Low Dose
    Reporting group description
    		 Participants received low dose of NDI-034858, capsules, orally, QD for 12 weeks.

    Reporting group title
    NDI-034858 Medium Dose
    Reporting group description
    		 Participants received medium dose of NDI-034858, capsules, orally, QD for 12 weeks.

    Reporting group title
    NDI-034858 High Dose
    Reporting group description
    		 Participants received high dose of NDI-034858, capsules, orally, QD for 12 weeks.

    Primary: Percentage of Participants who Achieved at Least an American College of Rheumatology 20 (ACR20) Response at Week 12

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    End point title
    		 Percentage of Participants who Achieved at Least an American College of Rheumatology 20 (ACR20) Response at Week 12
    End point description
    ACR20 is composite measure defined as improvement of 20 percent(%) from baseline in both number of tender (68) & number of swollen (66) joints & a 20% improvement in at least 3 of following 5 criteria: patient global assessment of psoriatic arthritis (PGA-PsA) [visual analog scale (VAS) where, 0=very good, no symptoms & 100=very poor, severe symptoms], physician global assessment of psoriatic arthritis (PhGA-PsA) [(VAS) where 0=no disease activity & 100=maximum disease activity], patient global assessment of psoriatic arthritis pain (PGAAP) [(VAS) where 0=no pain & 100=most severe pain], disability history questionnaire i.e., Health Assessment Questionnaire-Disability Index [HAQ-DI] (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip & activities, 0=without difficulty to 3=unable to do) & acute phase reactant like high sensitivity C-reactive protein [hsCRP]). Percentages are rounded off to the nearest decimal.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Placebo NDI-034858 Low Dose NDI-034858 Medium Dose NDI-034858 High Dose
    Number of subjects analysed
    72
    71
    75
    72
    Units: percentage of participants
        number (confidence interval 95%)
    29.2 (18.7 to 39.7)
    35.2 (24.1 to 46.3)
    53.3 (42.0 to 64.6)
    54.2 (42.7 to 65.7)
    Statistical analysis title
    		 NDI-034858 Low Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Low Dose
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.446
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    5.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.3
         upper limit
    		 21.1
    Statistical analysis title
    		 NDI-034858 High Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 High Dose
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    24.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9
         upper limit
    		 39.9
    Statistical analysis title
    		 NDI-034858 Medium Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Medium Dose
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    24.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.6
         upper limit
    		 39.6

    Secondary: Percentage of Participants who Achieved at Least an ACR-50 Response at Week 12

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    End point title
    		 Percentage of Participants who Achieved at Least an ACR-50 Response at Week 12
    End point description
    The ACR-50 is a composite measure defined as improvement of 50% from baseline in both the number of tender (68) and number of swollen (66) joints, and a 50% improvement in at least three of the following five criteria: PGA-PsA (VAS where, 0 is ‘very good, no symptoms’ and 100 is ‘very poor, severe symptoms’), PhGA-PsA [(VAS) where 0=no disease activity and 100=maximum disease activity], PGAAP [(VAS) where 0=no pain & 100=most severe pain], disability history questionnaire (i.e., HAQ-DI) [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do] and an acute phase reactant [i.e., erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)]. Percentages are rounded off to the nearest decimal. Full Analysis Set included all randomised participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo NDI-034858 Low Dose NDI-034858 Medium Dose NDI-034858 High Dose
    Number of subjects analysed
    72
    71
    75
    72
    Units: percentage of participants
        number (confidence interval 95%)
    9.7 (2.9 to 16.6)
    15.5 (7.1 to 23.9)
    26.7 (16.7 to 36.7)
    26.4 (16.2 to 36.6)
    Statistical analysis title
    		 NDI-034858 Low Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Low Dose
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.312
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    5.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.3
         upper limit
    		 16.6
    Statistical analysis title
    		 NDI-034858 High Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 High Dose
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    16.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.2
         upper limit
    		 28.6
    Statistical analysis title
    		 NDI-034858 Medium Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Medium Dose
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5
         upper limit
    		 29.1

    Secondary: Percentage of Participants who Achieved at Least an ACR-70 Response at Week 12

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    End point title
    		 Percentage of Participants who Achieved at Least an ACR-70 Response at Week 12
    End point description
    The ACR-70 is a composite measure defined as improvement of 70% from baseline in both the number of tender (68) and number of swollen (66) joints, and a 70% improvement in at least three of the following five criteria: PGA-PsA (VAS where, 0 is ‘very good, no symptoms’ and 100 is ‘very poor, severe symptoms’), PhGA-PsA [(VAS) where 0=no disease activity and 100=maximum disease activity], PGAAP [(VAS) where 0=no pain & 100=most severe pain], disability history questionnaire (i.e., HAQ-DI) [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do] and an acute phase reactant (i.e., ESR or CRP). Percentages are rounded off to the nearest decimal. Full Analysis Set included all randomised participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo NDI-034858 Low Dose NDI-034858 Medium Dose NDI-034858 High Dose
    Number of subjects analysed
    72
    71
    75
    72
    Units: percentage of participants
        number (confidence interval 95%)
    5.6 (1.5 to 13.6)
    8.5 (2.0 to 14.9)
    14.7 (6.7 to 22.7)
    13.9 (5.9 to 21.9)
    Statistical analysis title
    		 NDI-034858 Low Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Low Dose
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.532
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.6
         upper limit
    		 12.7
    Statistical analysis title
    		 NDI-034858 High Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 High Dose
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.158
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    8.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 19.4
    Statistical analysis title
    		 NDI-034858 Medium Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Medium Dose
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.101
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    9.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 20.1

    Secondary: Change From Baseline in Tender Joint Count (TJC) at Week 12

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    End point title
    		 Change From Baseline in Tender Joint Count (TJC) at Week 12
    End point description
    The TJC 68 is a total score of points assigned for the presence of tenderness in the 68 joints in the upper body and upper/lower extremity. The response to tenderness for each joint was evaluated using the following scale: ‘Present’ was assigned a score of 1 whereas, ‘Absent’, ‘Not Done’, ‘Not Applicable’, or joints with missing response were assigned a score of 0. The sum of all tender joints was derived. The overall tender joint count ranged from 0 to 68, with a higher score indicating a greater degree of tenderness. A negative change from baseline indicates improvement. Full Analysis Set included all randomised participants who received at least one dose of study drug. Number of subjects analysed is the number of participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo NDI-034858 Low Dose NDI-034858 Medium Dose NDI-034858 High Dose
    Number of subjects analysed
    66
    66
    64
    63
    Units: tender joints
        least squares mean (standard error)
    -5.9 ( 1.12 )
    -7.6 ( 1.12 )
    -8.9 ( 1.12 )
    -8.3 ( 1.15 )
    Statistical analysis title
    		 NDI-034858 Low Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Low Dose
    Number of subjects included in analysis
    132
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.268
    Method
    		 Mixed Model Repeated Measure (MMRM)
    Parameter type
    		 Treatment Difference
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 1.3
    Statistical analysis title
    		 NDI-034858 High Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 High Dose
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.112
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.6
         upper limit
    		 0.6
    Statistical analysis title
    		 NDI-034858 Medium Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Medium Dose
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.051
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.1
         upper limit
    		 0

    Secondary: Change From Baseline in Swollen Joint Count (SJC) at Week 12

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    End point title
    		 Change From Baseline in Swollen Joint Count (SJC) at Week 12
    End point description
    The SJC 66 (TJC 68 joint assessment minus hip joints, which cannot be assessed for swelling) is a total score of points assigned for presence of swelling in the 66 joints in the upper body and upper/lower extremity. The response to swelling for each joint was evaluated using the following scale: ‘Present’ was assigned a score of 1 whereas, ‘Absent’, ‘Not Done’, ‘Not Applicable’, or joints with missing response were assigned a score of 0. The sum of all swollen joints was derived. The overall swollen joint count ranged from 0 to 66, with a higher score indicating a greater degree of swelling. A negative change from baseline indicates improvement. Full Analysis Set included all randomised participants who received at least one dose of study drug. Number of subjects analysed is the number of participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo NDI-034858 Low Dose NDI-034858 Medium Dose NDI-034858 High Dose
    Number of subjects analysed
    66
    66
    64
    63
    Units: swollen joints
        least squares mean (standard error)
    -3.9 ( 0.57 )
    -4.8 ( 0.58 )
    -5.0 ( 0.58 )
    -5.0 ( 0.59 )
    Statistical analysis title
    		 NDI-034858 Low Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Low Dose
    Number of subjects included in analysis
    132
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.28
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 0.7
    Statistical analysis title
    		 NDI-034858 Medium Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Medium Dose
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.177
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.6
         upper limit
    		 0.5
    Statistical analysis title
    		 NDI-034858 High Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 High Dose
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.196
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.6
         upper limit
    		 0.5

    Secondary: Change From Baseline in PGA-PsA at Week 12

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    End point title
    		 Change From Baseline in PGA-PsA at Week 12
    End point description
    Participants assessed their overall disease status based on symptoms of psoriasis and psoriatic arthritis at the time of the visit using the PGA-PsA VAS of 100 millimeters (mm) which ranges from 0 (very good, no symptoms) to 100 (very poor, severe symptoms). A negative change from Baseline indicates improvement in symptoms. Full Analysis Set included all randomised participants who received at least one dose of study drug. Number of subjects analysed is the number of participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo NDI-034858 Low Dose NDI-034858 Medium Dose NDI-034858 High Dose
    Number of subjects analysed
    64
    65
    63
    62
    Units: mm
        least squares mean (standard error)
    -11.1 ( 2.85 )
    -12.9 ( 2.84 )
    -20.2 ( 2.85 )
    -19.8 ( 2.92 )
    Statistical analysis title
    		 NDI-034858 Low Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Low Dose
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.637
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.6
         upper limit
    		 5.9
    Statistical analysis title
    		 NDI-034858 High Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 High Dose
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.03
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -8.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.5
         upper limit
    		 -0.9
    Statistical analysis title
    		 NDI-034858 Medium Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Medium Dose
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.021
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -9.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17
         upper limit
    		 -1.4

    Secondary: Change From Baseline in PGAAP at Week 12

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    End point title
    		 Change From Baseline in PGAAP at Week 12
    End point description
    Participants assessed their overall psoriatic arthritis-related pain at the time of the visit using the PGAAP VAS of 100 mm which ranges from 0 (no pain) to 100 (most severe pain). A negative change from Baseline indicates improvement in pain. Full Analysis Set included all randomised participants who received at least one dose of study drug. Number of subjects analysed is the number of participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo NDI-034858 Low Dose NDI-034858 Medium Dose NDI-034858 High Dose
    Number of subjects analysed
    64
    65
    63
    62
    Units: mm
        least squares mean (standard error)
    -12.1 ( 2.75 )
    -13.0 ( 2.74 )
    -18.8 ( 2.75 )
    -18.4 ( 2.82 )
    Statistical analysis title
    		 NDI-034858 Low Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Low Dose
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.812
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.4
         upper limit
    		 6.6
    Statistical analysis title
    		 NDI-034858 High Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 High Dose
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.102
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -6.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.9
         upper limit
    		 1.3
    Statistical analysis title
    		 NDI-034858 Medium Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Medium Dose
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.079
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -6.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.2
         upper limit
    		 0.8

    Secondary: Change From Baseline in PhGA-PsA at Week 12

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    End point title
    		 Change From Baseline in PhGA-PsA at Week 12
    End point description
    The participants’ overall disease status was assessed, taking into account signs, symptoms, and function, of all components of joint and skin affected at the time of the visit and this overall status was rated by the investigator using the PhGA-PsA VAS of 100 mm where 0 is ‘very good, asymptomatic, and no limitation of normal activities’ and 100 is ‘very poor, very severe symptoms which are intolerable, and inability to carry out all normal activities’. A negative change from Baseline indicates improvement in symptoms. Full Analysis Set included all randomised participants who received at least one dose of study drug. Number of subjects analysed is the number of participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo NDI-034858 Low Dose NDI-034858 Medium Dose NDI-034858 High Dose
    Number of subjects analysed
    65
    66
    64
    63
    Units: mm
        least squares mean (standard error)
    -20.7 ( 2.66 )
    -29.6 ( 2.65 )
    -31.3 ( 2.65 )
    -31.6 ( 2.73 )
    Statistical analysis title
    		 NDI-034858 Low Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Low Dose
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.016
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -8.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.2
         upper limit
    		 -1.7
    Statistical analysis title
    		 NDI-034858 High Dose vs Placebo
    Comparison groups
    Placebo v NDI-034858 High Dose
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -10.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.2
         upper limit
    		 -3.6
    Statistical analysis title
    		 NDI-034858 Medium Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Medium Dose
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -10.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.8
         upper limit
    		 -3.4

    Secondary: Change From Baseline in HAQ-DI Total Score at Week 12

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    End point title
    		 Change From Baseline in HAQ-DI Total Score at Week 12
    End point description
    The HAQ-DI consists of 20 questions referring to 8 domains consisting of dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each item is scored from 0 (without any difficulty) to 3 (unable to do). The worst score within each domain will be used as domain score (i.e., if score for 1 question is 1 and 2 for other, then worst score for the domain is 2). The HAQ-DI total score is calculated by dividing the sum of the domain scores by the number of non-missing domains. The total score indicates the patient’s self-assessed level of functional ability and higher scores indicate worse functional ability. The HAQ-DI total score ranges from 0 to 3. A higher score indicates worse function and greater disability. A negative change from Baseline indicates improved function. Full Analysis Set included all randomised participants who received at least one dose of study drug. Number of subjects analysed is the number of participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo NDI-034858 Low Dose NDI-034858 Medium Dose NDI-034858 High Dose
    Number of subjects analysed
    66
    66
    64
    63
    Units: score on a scale
        least squares mean (standard error)
    -0.22 ( 0.053 )
    -0.29 ( 0.053 )
    -0.32 ( 0.053 )
    -0.28 ( 0.055 )
    Statistical analysis title
    		 NDI-034858 Low Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Low Dose
    Number of subjects included in analysis
    132
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.357
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.21
         upper limit
    		 0.08
    Statistical analysis title
    		 NDI-034858 High Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 High Dose
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.467
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.09
    Statistical analysis title
    		 NDI-034858 Medium Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Medium Dose
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.195
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.24
         upper limit
    		 0.05

    Secondary: Change From Baseline in Dactylitis Count (DC) at Week 12

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    End point title
    		 Change From Baseline in Dactylitis Count (DC) at Week 12
    End point description
    Tender score (0 = no tenderness, 1 = tender, 2 = tender and wince, 3 = tender and withdraw) is collected for Dactylitis Assessments on the Dactylitis Score Sheet that is used for calculation of total score. DC equals the number of tender fingers and toes (tender score >0). For participants with dactylitis status absent for all the fingers and toes, the DC is set as 0. The total score range of DC is from 0 to 60, higher scores indicate greater presence of dactylitis. A negative change from baseline indicates improvement. Full Analysis Set included all randomised participants who received at least one dose of study drug. Number of subjects analysed is the number of participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo NDI-034858 Low Dose NDI-034858 Medium Dose NDI-034858 High Dose
    Number of subjects analysed
    14
    14
    12
    14
    Units: dactylitis count
        least squares mean (standard error)
    -2.1 ( 0.39 )
    -0.8 ( 0.41 )
    -2.0 ( 0.47 )
    -1.9 ( 0.41 )
    Statistical analysis title
    		 NDI-034858 Low Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Low Dose
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.031
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 2.4
    Statistical analysis title
    		 NDI-034858 Medium Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Medium Dose
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.86
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 1.3
    Statistical analysis title
    		 NDI-034858 High Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 High Dose
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.758
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 1.3

    Secondary: Change From Baseline in Leeds Enthesitis Index (LEI) at Week 12

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    End point title
    		 Change From Baseline in Leeds Enthesitis Index (LEI) at Week 12
    End point description
    Enthesitis is assessed using LEI. The enthesitis examination by LEI evaluates the presence or absence of pain by applying local pressure on 6 anatomical sites: medial femoral condyle (left and right), lateral epicondyle (left and right), and the achilles tendon insertion (left and right). Enthesitis at each site is scored as 0 (enthesitis absent) and 1 (enthesitis present). LEI is derived as the sum of the enthesitis score over the 6 sites, divided by the number of sites with non-missing score. The total score ranges from 0 to 6, higher scores indicate greater degree of enthesitis. A negative change from baseline indicates improvement. Full Analysis Set included all randomised participants who received at least one dose of study drug. Number of subjects analysed is the number of participants who had a baseline LEI score of ≥1 and with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo NDI-034858 Low Dose NDI-034858 Medium Dose NDI-034858 High Dose
    Number of subjects analysed
    32
    33
    34
    31
    Units: score on a scale
        least squares mean (standard error)
    -0.9 ( 0.24 )
    -1.4 ( 0.24 )
    -1.6 ( 0.24 )
    -1.0 ( 0.25 )
    Statistical analysis title
    		 NDI-034858 Low Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Low Dose
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.131
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 0.2
    Statistical analysis title
    		 NDI-034858 High Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 High Dose
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.687
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 0.5
    Statistical analysis title
    		 NDI-034858 Medium Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Medium Dose
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.043
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 0

    Secondary: Percentage of Participants With Minimal Disease Activity (MDA) Response at Week 12

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    End point title
    		 Percentage of Participants With Minimal Disease Activity (MDA) Response at Week 12
    End point description
    MDA is a measure to indicate a state of minimal disease activity, and is a composite score of 7 domains. A participant is considered as having achieved the MDA if the participant fulfills at least 5 of the following 7 criteria: TJC 68 ≤1; SJC 66 ≤1; Psoriasis area and severity index (PASI) score ≤1 [The total score ranges from 0 (no disease) to 72 (maximal disease)] or body surface area (BSA) ≤3%; PGAAP ≤15 [using VAS on a scale of 0 (no pain) to 100 (serious pain)]; PGA-PsA ≤20 [using VAS on a scale of 0 (very well) to 100 (very poor)]; HAQ-DI score ≤0.5; LEI score ≤1. Percentages are rounded off to the nearest decimal. Full Analysis Set included all randomised participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo NDI-034858 Low Dose NDI-034858 Medium Dose NDI-034858 High Dose
    Number of subjects analysed
    72
    71
    75
    72
    Units: percentage of participants
        number (confidence interval 95%)
    12.5 (4.9 to 20.1)
    18.3 (9.3 to 27.3)
    28.0 (17.8 to 38.2)
    29.2 (18.7 to 39.7)
    Statistical analysis title
    		 NDI-034858 Low Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Low Dose
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.349
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.1
         upper limit
    		 17.4
    Statistical analysis title
    		 NDI-034858 High Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 High Dose
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.014
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    16.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.3
         upper limit
    		 29.3
    Statistical analysis title
    		 NDI-034858 Medium Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Medium Dose
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.017
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    15.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.8
         upper limit
    		 28.3

    Secondary: Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Week 12

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    End point title
    		 Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Week 12
    End point description
    The DAPSA score is a composite score and was calculated using: TJC68, SJC66, PGA-PsA, PGAAP, and hsCRP level (milligram per deciliter [mg/dL]). DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and >28 = high disease activity. The DAPSA score has a lower bound of 0 and has no upper bound. A higher DAPSA score indicated more active disease activity. A negative change from baseline indicates improvement. Full Analysis Set included all randomised participants who received at least one dose of study drug. Number of subjects analysed is the number of participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo NDI-034858 Low Dose NDI-034858 Medium Dose NDI-034858 High Dose
    Number of subjects analysed
    64
    64
    63
    62
    Units: score on a scale
        least squares mean (standard error)
    -11.56 ( 1.948 )
    -15.30 ( 1.946 )
    -17.99 ( 1.943 )
    -16.79 ( 1.989 )
    Statistical analysis title
    		 NDI-034858 Low Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Low Dose
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.167
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -3.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.04
         upper limit
    		 1.57
    Statistical analysis title
    		 NDI-034858 Medium Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Medium Dose
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.018
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -6.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.73
         upper limit
    		 -1.13
    Statistical analysis title
    		 NDI-034858 High Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 High Dose
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.056
    Method
    		 MMRM
    Parameter type
    		 Treatment Difference
    Point estimate
    -5.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.59
         upper limit
    		 0.13

    Secondary: Percentage of Participants Who Achieved PASI-75 Response at Week 12

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    End point title
    		 Percentage of Participants Who Achieved PASI-75 Response at Week 12
    End point description
    PASI-75 is assessed in participants with psoriasis involvement for ≥3% of BSA at Baseline & assesses extent of involvement & severity of psoriasis. To calculate PASI, the body is divided into 4 regions: head & neck, trunk, upper limbs, & lower limbs. Each of these areas are assessed separately for percentage of area involved & for erythema, induration, & scaling, which are each rated on a scale of 0-4, which translates to numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement). PASI produces numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI-75, improvement threshold from baseline in PASI score is 75%. Higher score indicates more severe disease. Percentages are rounded off to nearest decimal. Full Analysis Set included all randomised participants who received at least one dose of study drug. Number of subjects analysed is number of participants with psoriasis covering ≥ 3% of BSA at Baseline and with available data.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo NDI-034858 Low Dose NDI-034858 Medium Dose NDI-034858 High Dose
    Number of subjects analysed
    39
    39
    46
    46
    Units: percentage of participants
        number (confidence interval 95%)
    15.4 (4.1 to 26.7)
    25.6 (11.9 to 39.3)
    28.3 (15.2 to 41.3)
    45.7 (31.3 to 60.0)
    Statistical analysis title
    		 NDI-034858 Low Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Low Dose
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.186
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    11.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.7
         upper limit
    		 29.4
    Statistical analysis title
    		 NDI-034858 High Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 High Dose
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.5
         upper limit
    		 47.6
    Statistical analysis title
    		 NDI-034858 Medium Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Medium Dose
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.101
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    14.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 32.1

    Secondary: Percentage of Participants Who Achieved a Physician Global Assessment of Psoriasis (PhGA-PsO) of 0 or 1 and at Least a 2-point Improvement at Week 12

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    End point title
    		 Percentage of Participants Who Achieved a Physician Global Assessment of Psoriasis (PhGA-PsO) of 0 or 1 and at Least a 2-point Improvement at Week 12
    End point description
    PhGA-PsO responder is defined as participants 1) who had PhGA-PsO score of 0 or 1 at any given post-baseline visit; and 2) who had at least 2-point improvement from baseline. The PhGA-PsO is measured using a 0 to 4 scale with a 0 meaning clear or a 4 meaning severe. The proportion of participants achieving PhGA-PsO response at Week 12 was calculated and analyzed for participants with a score of at least 2 at baseline. Percentages are rounded off to the nearest decimal. Full Analysis Set included all randomised participants who received at least one dose of study drug. Number of subjects analyzed is the number of participants with PhGA-PSO ≥2 at Baseline.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo NDI-034858 Low Dose NDI-034858 Medium Dose NDI-034858 High Dose
    Number of subjects analysed
    57
    54
    63
    58
    Units: percentage of participants
        number (confidence interval 95%)
    15.8 (6.3 to 25.3)
    20.4 (9.6 to 31.1)
    20.6 (10.6 to 30.6)
    32.8 (20.7 to 44.8)
    Statistical analysis title
    		 NDI-034858 Low Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Low Dose
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.54
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    4.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10
         upper limit
    		 19
    Statistical analysis title
    		 NDI-034858 High Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 High Dose
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.034
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    16.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 31.3
    Statistical analysis title
    		 NDI-034858 Medium Dose vs. Placebo
    Comparison groups
    Placebo v NDI-034858 Medium Dose
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.466
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    5.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.8
         upper limit
    		 19.3

    Secondary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)

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    End point title
    		 Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
    End point description
    Adverse Event(AE)=medical occurrence that does not necessarily have a causal relationship with this drug also including clinically meaningful findings in laboratory safety tests,vital signs,weight,and electrocardiogram(ECG).TEAEs=AEs occurring at time of or post study drug dosing until study end.SAE=any medical occurrence at any dose that resulted in death,was life-threatening,required inpatient hospitalization/prolongation of existing hospitalization,resulted in persistent or significant disability/incapacity,was a congenital abnormality/birth defect,an important medical event.AESIs included Common Terminology Criteria for Adverse Events(CTCAE)Grade≥2 cytopenia,CTCAE Grade≥3 elevation of creatine phosphokinase(CPK)[clinically significant or not]defined as CPK>5xupper limit of normal(ULN),infections,adverse events of abnormal liver function tests,adverse events of renal dysfunction,major adverse cardiovascular events,thromboembolic events,gastrointestinal perforation,and malignancies.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug up to end of study (up to Week 16)
    End point values
    		 Placebo NDI-034858 Low Dose NDI-034858 Medium Dose NDI-034858 High Dose
    Number of subjects analysed
    72
    71
    75
    72
    Units: participants
        TEAEs
    39
    42
    45
    56
        SAEs
    4
    4
    3
    2
        AESIs
    19
    33
    22
    38
    No statistical analyses for this end point

    Secondary: Plasma Concentration of NDI-034858

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    End point title
    		 Plasma Concentration of NDI-034858 [1]
    End point description
    Plasma concentration of NDI-034858 was measured in participants who received low, medium, or high dose of NDI-034858. Pharmacokinetic (PK) Analysis Set included all participants in the Safety Analysis Set with at least one evaluable post-dose PK assessment. Number analysed is the number of participants with data available for analysis at the specified time point.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 1 hour post-dose on Day 1 and Week 4, 4 hours post-dose at Week 4, Pre-dose at Week 8, and anytime at Week 12
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive data was collected and analysed for NDI-034858 arms only.
    End point values
    		 NDI-034858 Low Dose NDI-034858 Medium Dose NDI-034858 High Dose
    Number of subjects analysed
    71
    75
    72
    Units: nanograms per milliliter (ng/mL)
    arithmetic mean (standard deviation)
        Day 1: Pre-dose (n=66,75,71)
    0.000 ( 0.000 )
    0.000 ( 0.000 )
    0.000 ( 0.000 )
        Day 1: 1 hour (n=71,74,72)
    5.860 ( 7.251 )
    25.43 ( 37.21 )
    38.32 ( 59.74 )
        Week 4: Pre-dose (n=67,66,65)
    25.26 ( 17.95 )
    82.11 ( 74.46 )
    187.5 ( 140.9 )
        Week 4: 1 hour (n=64,61,62)
    33.03 ( 24.05 )
    112.8 ( 81.19 )
    245.3 ( 184.6 )
        Week 4: 4 Hours (n=64,61,61)
    46.68 ( 25.85 )
    149.5 ( 90.56 )
    370.1 ( 178.4 )
        Week 8: Pre-dose (n=67,67,62)
    26.99 ( 21.00 )
    78.29 ( 69.37 )
    209.4 ( 182.0 )
        Week 12: Any Time (n=61,61,58)
    24.85 ( 20.58 )
    66.17 ( 51.81 )
    178.2 ( 149.5 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug up to end of study (up to Week 16)
    Adverse event reporting additional description
    All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo capsules, orally, QD for 12 weeks.

    Reporting group title
    NDI-034858 High Dose
    Reporting group description
    		 Participants received high dose of NDI-034858, capsules, orally, QD for 12 weeks.

    Reporting group title
    NDI-034858 Medium Dose
    Reporting group description
    		 Participants received medium dose of NDI-034858, capsules, orally, QD for 12 weeks.

    Reporting group title
    NDI-034858 Low Dose
    Reporting group description
    		 Participants received low dose of NDI-034858, capsules, orally, QD for 12 weeks.

    Serious adverse events
    		 Placebo NDI-034858 High Dose NDI-034858 Medium Dose NDI-034858 Low Dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 72 (5.56%)
    2 / 72 (2.78%)
    3 / 75 (4.00%)
    4 / 71 (5.63%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Oesophageal adenocarcinoma
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 72 (0.00%)
    0 / 75 (0.00%)
    0 / 71 (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
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 72 (0.00%)
    1 / 75 (1.33%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 72 (0.00%)
    0 / 75 (0.00%)
    1 / 71 (1.41%)
         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
    Nervous system disorders
    Bell's palsy
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 72 (1.39%)
    0 / 75 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal inflammation
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 72 (0.00%)
    1 / 75 (1.33%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Erythema nodosum
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 72 (0.00%)
    1 / 75 (1.33%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Psoriatic arthropathy
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 72 (0.00%)
    0 / 75 (0.00%)
    0 / 71 (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
    Osteoarthritis
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 72 (0.00%)
    0 / 75 (0.00%)
    0 / 71 (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
    Arthritis
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 72 (0.00%)
    0 / 75 (0.00%)
    0 / 71 (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
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 72 (0.00%)
    0 / 75 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 72 (1.39%)
    0 / 75 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 72 (0.00%)
    0 / 75 (0.00%)
    1 / 71 (1.41%)
         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
    		 Placebo NDI-034858 High Dose NDI-034858 Medium Dose NDI-034858 Low Dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 72 (18.06%)
    35 / 72 (48.61%)
    27 / 75 (36.00%)
    19 / 71 (26.76%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    3 / 72 (4.17%)
    1 / 72 (1.39%)
    4 / 75 (5.33%)
    2 / 71 (2.82%)
         occurrences all number
    3
    1
    4
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 72 (4.17%)
    4 / 72 (5.56%)
    6 / 75 (8.00%)
    2 / 71 (2.82%)
         occurrences all number
    3
    6
    6
    3
    Gastrointestinal disorders
    Aphthous ulcer
         subjects affected / exposed
    0 / 72 (0.00%)
    6 / 72 (8.33%)
    1 / 75 (1.33%)
    0 / 71 (0.00%)
         occurrences all number
    0
    7
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis acneiform
         subjects affected / exposed
    0 / 72 (0.00%)
    6 / 72 (8.33%)
    2 / 75 (2.67%)
    0 / 71 (0.00%)
         occurrences all number
    0
    7
    4
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 72 (0.00%)
    4 / 72 (5.56%)
    1 / 75 (1.33%)
    1 / 71 (1.41%)
         occurrences all number
    0
    5
    1
    1
    Rash
         subjects affected / exposed
    0 / 72 (0.00%)
    4 / 72 (5.56%)
    6 / 75 (8.00%)
    3 / 71 (4.23%)
         occurrences all number
    0
    4
    6
    4
    Rash maculo-papular
         subjects affected / exposed
    0 / 72 (0.00%)
    4 / 72 (5.56%)
    2 / 75 (2.67%)
    0 / 71 (0.00%)
         occurrences all number
    0
    5
    4
    0
    Rash papular
         subjects affected / exposed
    0 / 72 (0.00%)
    4 / 72 (5.56%)
    3 / 75 (4.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    4
    3
    1
    Musculoskeletal and connective tissue disorders
    Psoriatic arthropathy
         subjects affected / exposed
    4 / 72 (5.56%)
    1 / 72 (1.39%)
    2 / 75 (2.67%)
    0 / 71 (0.00%)
         occurrences all number
    5
    1
    2
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 72 (4.17%)
    7 / 72 (9.72%)
    7 / 75 (9.33%)
    6 / 71 (8.45%)
         occurrences all number
    4
    7
    7
    6
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 72 (2.78%)
    7 / 72 (9.72%)
    3 / 75 (4.00%)
    8 / 71 (11.27%)
         occurrences all number
    3
    7
    4
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Oct 2021
    The following changes were made as per Amendment 1: 1) Participants with SAEs or severe AEs could be discontinued from study drug regardless of relationship to drug. 2) Added homeopathic medications to the concomitant medications recorded. 3) Clarified that ESRs would be performed at the clinical sites, not the central laboratory. 4) PGA and functional assessment of chronic illness-fatigue (FACIT-F) were described for clarity. 5) Revised stopping rules for potential hepatic laboratory abnormalities.
    06 Apr 2022
    The following changes were made as per Amendment 2: 1) Revised statistical analysis methods to include estimand of interest, clarifications for definition of analysis data sets, use of the MH stratum-weighted test. 2) Clarified and defined study objectives and endpoints. 3) Updated inclusion criteria. 4) Updated exclusion criteria. 5) Added footnotes to schedule of activities clarifying the timing of each visit was based on Day 1, allowance for use of a T-Spot. tuberculosis (TB) test (TBT), and timing for AE collection based on Day 1 dosing time. 6) Added information to define the formulation of NDI-034858 used in this study.
    05 May 2023
    The following changes were made as per Amendment 3: 1) Updated the Sponsor change of address. 2) Updated that NDI-034858 is now also known as TAK-279. 3) Clarified “ACR-50 or ACR-70” secondary endpoints by separating into 2 statements.

    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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