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    Clinical Trial Results:
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis

    Summary
    EudraCT number
    		 2021-006329-23
    Trial protocol
    		 ES  
    Global end of trial date
    28 Feb 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Feb 2025
    First version publication date
    20 Feb 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    INCB 54707-206
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Incyte Corporation
    Sponsor organisation address
    1801 Augustine Cutoff Drive, Wilmington, United States, 19803
    Public contact
    Study Director, Incyte Corporation, 1 8554633463, medinfo@incyte.com
    Scientific contact
    Study Director, Incyte Corporation, 1 8554633463, medinfo@incyte.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
    28 Feb 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to evaluate the efficacy and safety of povorcitinib in participants with prurigo nodularis over a 16-week double-blind, placebo-controlled treatment period, followed by a 24-week, single-blind extension period.
    Protection of trial subjects
    This study was performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and was conducted in adherence to the study Protocol, applicable Good Clinical Practices, and applicable laws and country-specific regulations in which the study was conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Nov 2021
    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
    Canada: 15
    Country: Number of subjects enrolled
    Germany: 31
    Country: Number of subjects enrolled
    Spain: 13
    Country: Number of subjects enrolled
    Poland: 11
    Country: Number of subjects enrolled
    Puerto Rico: 1
    Country: Number of subjects enrolled
    United States: 75
    Worldwide total number of subjects
    146
    EEA total number of subjects
    55
    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)
    108
    From 65 to 84 years
    38
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study was conducted across 40 sites in Canada, Germany, Spain, Poland, Puerto Rico, and the United States.

    Period 1
    Period 1 title
    16-week Placebo-controlled (PC) Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator’s Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo tablets administered orally once daily

    Arm title
    		 Povorcitinib 15 mg
    Arm description
    		 On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
    Arm type
    		 Experimental

    Investigational medicinal product name
    povorcitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15 mg tablets administered orally once daily

    Arm title
    		 Povorcitinib 45 mg
    Arm description
    		 On Day 1, participants were randomized to receive povorcitinib 45 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
    Arm type
    		 Experimental

    Investigational medicinal product name
    povorcitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15 mg tablets administered orally once daily

    Arm title
    		 Povorcitinib 75 mg
    Arm description
    		 On Day 1, participants were randomized to receive povorcitinib 75 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
    Arm type
    		 Experimental

    Investigational medicinal product name
    povorcitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15 mg tablets administered orally once daily

    Number of subjects in period 1
    		Placebo Povorcitinib 15 mg Povorcitinib 45 mg Povorcitinib 75 mg
    Started
    37
    36
    36
    37
    Completed
    32
    29
    31
    33
    Not completed
    5
    7
    5
    4
         Adverse event, serious fatal
    -
    1
    -
    -
         Consent withdrawn by subject
    2
    4
    2
    2
         Adverse event, non-fatal
    1
    1
    1
    -
         Sponsor Decision
    -
    -
    -
    1
         Lost to follow-up
    -
    -
    1
    -
         Lack of efficacy
    1
    -
    -
    -
         Protocol deviation
    1
    1
    1
    1
    Period 2
    Period 2 title
    24-week Extension Period
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo to povorcitinib 45 mg
    Arm description
    		 Participants who received placebo during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch Numerical Rating Scale (NRS) score and Investigator's Global Assessment-Treatment Success (IGA-TS) who did not receive rescue therapy during the placebo-controlled period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    povorcitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15 mg tablets administered orally once daily

    Arm title
    		 Povorcitinib 15 mg to 45 mg
    Arm description
    		 Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    povorcitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15 mg tablets administered orally once daily

    Arm title
    		 Povorcitinib 45 mg
    Arm description
    		 Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for an additional 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    povorcitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15 mg tablets administered orally once daily

    Arm title
    		 Povorcitinib 75 mg to 45 mg
    Arm description
    		 Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    povorcitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15 mg tablets administered orally once daily

    Arm title
    		 Placebo to povorcitinib 75 mg
    Arm description
    		 Participants who received placebo during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
    Arm type
    		 Experimental

    Investigational medicinal product name
    povorcitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15 mg tablets administered orally once daily

    Arm title
    		 Povorcitinib 15 mg to 75 mg
    Arm description
    		 Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
    Arm type
    		 Experimental

    Investigational medicinal product name
    povorcitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15 mg tablets administered orally once daily

    Arm title
    		 Povorcitinib 45 mg to 75 mg
    Arm description
    		 Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
    Arm type
    		 Experimental

    Investigational medicinal product name
    povorcitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15 mg tablets administered orally once daily

    Arm title
    		 Povorcitinib 75 mg
    Arm description
    		 Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for an additional 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
    Arm type
    		 Experimental

    Investigational medicinal product name
    povorcitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15 mg tablets administered orally once daily

    Number of subjects in period 2 [1]
    		Placebo to povorcitinib 45 mg Povorcitinib 15 mg to 45 mg Povorcitinib 45 mg Povorcitinib 75 mg to 45 mg Placebo to povorcitinib 75 mg Povorcitinib 15 mg to 75 mg Povorcitinib 45 mg to 75 mg Povorcitinib 75 mg
    Started
    1
    4
    8
    15
    30
    25
    23
    18
    Completed
    1
    4
    7
    12
    25
    22
    18
    13
    Not completed
    0
    0
    1
    3
    5
    3
    5
    5
         Site Closure
    -
    -
    -
    -
    1
    -
    -
    1
         Consent withdrawn by subject
    -
    -
    -
    -
    1
    2
    2
    1
         Adverse event, non-fatal
    -
    -
    -
    2
    2
    -
    1
    3
         Sponsor Decision
    -
    -
    -
    1
    -
    -
    -
    -
         Lost to follow-up
    -
    -
    1
    -
    1
    1
    -
    -
         Lack of efficacy
    -
    -
    -
    -
    -
    -
    2
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all participants who completed the Placebo-controlled Period started the Extension Period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator’s Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.

    Reporting group title
    Povorcitinib 15 mg
    Reporting group description
    		 On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.

    Reporting group title
    Povorcitinib 45 mg
    Reporting group description
    		 On Day 1, participants were randomized to receive povorcitinib 45 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.

    Reporting group title
    Povorcitinib 75 mg
    Reporting group description
    		 On Day 1, participants were randomized to receive povorcitinib 75 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.

    Reporting group values
    		 Placebo Povorcitinib 15 mg Povorcitinib 45 mg Povorcitinib 75 mg Total
    Number of subjects
    		 37 36 36 37 146
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 29 27 23 29 108
        From 65-84 years
    		 8 9 13 8 38
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52.9 ( 12.32 ) 56.0 ( 12.92 ) 55.6 ( 15.25 ) 55.9 ( 10.18 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 22 24 27 23 96
        Male
    		 15 12 9 14 50
    Race/Ethnicity, Customized
    Units: Subjects
        White/Caucasian
    		 33 31 27 30 121
        Black/African-American
    		 3 3 5 5 16
        Asian
    		 0 2 4 1 7
        American-Indian/Alaska Native
    		 0 0 0 1 1
        Unknown
    		 1 0 0 0 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 7 3 3 3 16
        Not Hispanic or Latino
    		 30 32 33 33 128
        Unknown or Not Reported
    		 0 1 0 1 2

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator’s Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.

    Reporting group title
    Povorcitinib 15 mg
    Reporting group description
    		 On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.

    Reporting group title
    Povorcitinib 45 mg
    Reporting group description
    		 On Day 1, participants were randomized to receive povorcitinib 45 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.

    Reporting group title
    Povorcitinib 75 mg
    Reporting group description
    		 On Day 1, participants were randomized to receive povorcitinib 75 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
    Reporting group title
    Placebo to povorcitinib 45 mg
    Reporting group description
    		 Participants who received placebo during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch Numerical Rating Scale (NRS) score and Investigator's Global Assessment-Treatment Success (IGA-TS) who did not receive rescue therapy during the placebo-controlled period.

    Reporting group title
    Povorcitinib 15 mg to 45 mg
    Reporting group description
    		 Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period.

    Reporting group title
    Povorcitinib 45 mg
    Reporting group description
    		 Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for an additional 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period.

    Reporting group title
    Povorcitinib 75 mg to 45 mg
    Reporting group description
    		 Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period.

    Reporting group title
    Placebo to povorcitinib 75 mg
    Reporting group description
    		 Participants who received placebo during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.

    Reporting group title
    Povorcitinib 15 mg to 75 mg
    Reporting group description
    		 Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.

    Reporting group title
    Povorcitinib 45 mg to 75 mg
    Reporting group description
    		 Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.

    Reporting group title
    Povorcitinib 75 mg
    Reporting group description
    		 Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for an additional 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.

    Primary: Percentage of participants achieving ≥4-point improvement in Itch Numerical Rating Scale (NRS) score at Week 16

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    End point title
    		 Percentage of participants achieving ≥4-point improvement in Itch Numerical Rating Scale (NRS) score at Week 16
    End point description
    Each evening, the participants assessed their worst level of itch during the past 24 hours on a scale of 0 (no itch) to 10 (worst itch imaginable). The Baseline Itch NRS score was determined by averaging the 7 daily Itch NRS scores before Day 1 (i.e., Day −7 to Day −1). If ≥4 of the 7 days of the daily Itch NRS scores were missing prior to Day 1, then the Baseline Itch NRS score was set to "missing." The by-visit Itch NRS score for postbaseline visits was determined by averaging the 7 daily Itch NRS scores before the visit day. If 4 or more daily Itch NRS scores out of the 7 days before the visit day were missing, the Itch NRS score at the visit was set to missing. Analysis was conducted in members of the Intent-to-Treat (ITT) Population, comprised of all randomized participants. Missing post-Baseline values and rescue therapy recipients for all subsequent visits after the initiation date of rescue therapy were imputed as nonresponders.
    End point type
    Primary
    End point timeframe
    Baseline; Week 16
    End point values
    		 Placebo Povorcitinib 15 mg Povorcitinib 45 mg Povorcitinib 75 mg
    Number of subjects analysed
    37 [1]
    36 [2]
    36 [3]
    37 [4]
    Units: percentage of participants
        number (confidence interval 95%)
    8.1 (1.7 to 21.9)
    36.1 (20.8 to 53.8)
    44.4 (27.9 to 61.9)
    56.8 (39.5 to 72.9)
    Notes
    [1] - ITT Population. The 95% confidence interval was based on the Clopper-Pearson exact method.
    [2] - ITT Population. The 95% confidence interval was based on the Clopper-Pearson exact method.
    [3] - ITT Population. The 95% confidence interval was based on the Clopper-Pearson exact method.
    [4] - ITT Population. The 95% confidence interval was based on the Clopper-Pearson exact method.
    Statistical analysis title
    		 Placebo:15 mg; Exact logistic regression
    Comparison groups
    Placebo v Povorcitinib 15 mg
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0061 [5]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    7.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.6
         upper limit
    		 45.4
    Notes
    [5] - Exact Logistic regression: (response at Week 16 = treatment + stratification factor [Day 1 Investigator's Global Assessment score (3 or 4)])
    Statistical analysis title
    		 Placebo:75 mg; Exact logistic regression
    Comparison groups
    Placebo v Povorcitinib 75 mg
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001 [6]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    16.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.9
         upper limit
    		 107.5
    Notes
    [6] - Exact Logistic regression: (response at Week 16 = treatment + stratification factor [Day 1 Investigator's Global Assessment score (3 or 4)])
    Statistical analysis title
    		 Placebo:45 mg; Exact logistic regression
    Comparison groups
    Placebo v Povorcitinib 45 mg
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0005 [7]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    10.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.3
         upper limit
    		 65.6
    Notes
    [7] - Exact Logistic regression: (response at Week 16 = treatment + stratification factor [Day 1 Investigator's Global Assessment score (3 or 4)])

    Secondary: Percentage of participants achieving Investigator’s Global Assessment-Treatment Success (IGA-TS) (IGA score of 0 or 1 with a ≥2-grade improvement from Baseline) at Week 16

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    End point title
    		 Percentage of participants achieving Investigator’s Global Assessment-Treatment Success (IGA-TS) (IGA score of 0 or 1 with a ≥2-grade improvement from Baseline) at Week 16
    End point description
    The IGA for chronic prurigo considers the number of pruriginous lesions, which includes papules, nodules, plaques, umbilicated ulcers, and ulcers, and uses them as an overall severity rating on a scale of 0 to 4. 0: clear; no pruriginous lesions (0 lesions). 1: almost clear; rare palpable pruriginous lesions (approximately 1-5 lesions). 2: mild; few palpable pruriginous lesions (approximately 6-19 lesions). 3: moderate: many palpable pruriginous lesions (approximately 20-100 lesions). 4: severe; abundant palpable pruriginous lesions (over 100 lesions). The IGA-TS is defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline. Missing post-Baseline values were imputed as non-responders. The 95% confidence interval was based on the Clopper-Pearson exact method.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 16
    End point values
    		 Placebo Povorcitinib 15 mg Povorcitinib 45 mg Povorcitinib 75 mg
    Number of subjects analysed
    37 [8]
    36 [9]
    36 [10]
    37 [11]
    Units: percentage of participants
        number (confidence interval 95%)
    5.4 (0.7 to 18.2)
    13.9 (4.7 to 29.5)
    30.6 (16.3 to 48.1)
    48.6 (31.9 to 65.6)
    Notes
    [8] - ITT Population
    [9] - ITT Population
    [10] - ITT Population
    [11] - ITT Population
    No statistical analyses for this end point

    Secondary: Time to ≥4-point improvement from Baseline in Itch NRS score

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    End point title
    		 Time to ≥4-point improvement from Baseline in Itch NRS score
    End point description
    Each evening, the participants assessed their worst level of itch during the past 24 hours on a scale of 0 (no itch) to 10 (worst itch imaginable). The Baseline Itch NRS score was determined by averaging the 7 daily Itch NRS scores before Day 1. If ≥4 of the 7 days of the daily Itch NRS scores were missing prior to Day 1, then the Baseline Itch NRS score was set to "missing." The by-visit Itch NRS score for postbaseline visits was determined by averaging the 7 daily Itch NRS scores before the visit day. If 4 or more daily Itch NRS scores out of the 7 days before the visit day were missing, the Itch NRS score at the visit was set to missing. The time to a ≥4-point improvement from Baseline in itch NRS score was estimated using the Kaplan-Meier method. -9999, 9999=value was not estimable because too few participants achieved a ≥4-point improvement from Baseline in itch NRS score.
    End point type
    Secondary
    End point timeframe
    up to 122 days
    End point values
    		 Placebo Povorcitinib 15 mg Povorcitinib 45 mg Povorcitinib 75 mg
    Number of subjects analysed
    36 [12]
    35 [13]
    34 [14]
    36 [15]
    Units: days
        median (confidence interval 95%)
    9999 (-9999 to 9999)
    58.0 (16.0 to 9999)
    35.0 (21.0 to 9999)
    19.0 (13.0 to 47.0)
    Notes
    [12] - ITT Population. Only participants with available data were analyzed.
    [13] - ITT Population. Only participants with available data were analyzed.
    [14] - ITT Population. Only participants with available data were analyzed.
    [15] - ITT Population. Only participants with available data were analyzed.
    No statistical analyses for this end point

    Secondary: PC Period: Number of participants with any treatment-emergent adverse event (TEAE)

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    End point title
    		 PC Period: Number of participants with any treatment-emergent adverse event (TEAE)
    End point description
    An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug. Analysis was conducted in members of the Safety Population, comprised of all participants who received at least 1 dose of study drug. Treatment groups for this population were determined according to the actual treatment the participant received on Day 1.
    End point type
    Secondary
    End point timeframe
    up to 152 days
    End point values
    		 Placebo Povorcitinib 15 mg Povorcitinib 45 mg Povorcitinib 75 mg
    Number of subjects analysed
    37 [16]
    36 [17]
    35 [18]
    37 [19]
    Units: participants
    20
    20
    25
    28
    Notes
    [16] - Safety Population
    [17] - Safety Population
    [18] - Safety Population
    [19] - Safety Population
    No statistical analyses for this end point

    Secondary: PC Period: Number of participants with any ≥Grade 3 TEAE

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    End point title
    		 PC Period: Number of participants with any ≥Grade 3 TEAE
    End point description
    A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and serious adverse event (SAE) reported during the study and assigned it to 1 of the following categories. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
    End point type
    Secondary
    End point timeframe
    up to 152 days
    End point values
    		 Placebo Povorcitinib 15 mg Povorcitinib 45 mg Povorcitinib 75 mg
    Number of subjects analysed
    37 [20]
    36 [21]
    35 [22]
    37 [23]
    Units: participants
    0
    1
    1
    2
    Notes
    [20] - Safety Population
    [21] - Safety Population
    [22] - Safety Population
    [23] - Safety Population
    No statistical analyses for this end point

    Secondary: Extension Period: Number of participants with any TEAE

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    End point title
    		 Extension Period: Number of participants with any TEAE
    End point description
    An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug. Analysis was conducted in members of the Extension Evaluable Population, comprised of all participants who received at least 1 dose of povorcitinib during the Extension Period.
    End point type
    Secondary
    End point timeframe
    up to 215 days
    End point values
    		 Placebo to povorcitinib 45 mg Povorcitinib 15 mg to 45 mg Povorcitinib 45 mg Povorcitinib 75 mg to 45 mg Placebo to povorcitinib 75 mg Povorcitinib 15 mg to 75 mg Povorcitinib 45 mg to 75 mg Povorcitinib 75 mg
    Number of subjects analysed
    1 [24]
    4 [25]
    8 [26]
    15 [27]
    30 [28]
    25 [29]
    23 [30]
    18 [31]
    Units: participants
    0
    3
    5
    7
    20
    19
    16
    13
    Notes
    [24] - Extension Evaluable Population
    [25] - Extension Evaluable Population
    [26] - Extension Evaluable Population
    [27] - Extension Evaluable Population
    [28] - Extension Evaluable Population
    [29] - Extension Evaluable Population
    [30] - Extension Evaluable Population
    [31] - Extension Evaluable Population
    No statistical analyses for this end point

    Secondary: Extension Period: Number of participants with any ≥Grade 3 TEAE

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    End point title
    		 Extension Period: Number of participants with any ≥Grade 3 TEAE
    End point description
    A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and serious adverse event (SAE) reported during the study and assigned it to 1 of the following categories. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
    End point type
    Secondary
    End point timeframe
    up to 215 days
    End point values
    		 Placebo to povorcitinib 45 mg Povorcitinib 15 mg to 45 mg Povorcitinib 45 mg Povorcitinib 75 mg to 45 mg Placebo to povorcitinib 75 mg Povorcitinib 15 mg to 75 mg Povorcitinib 45 mg to 75 mg Povorcitinib 75 mg
    Number of subjects analysed
    1 [32]
    4 [33]
    8 [34]
    15 [35]
    30 [36]
    25 [37]
    23 [38]
    18 [39]
    Units: participants
    0
    0
    0
    1
    0
    1
    3
    3
    Notes
    [32] - Extension Evaluable Population
    [33] - Extension Evaluable Population
    [34] - Extension Evaluable Population
    [35] - Extension Evaluable Population
    [36] - Extension Evaluable Population
    [37] - Extension Evaluable Population
    [38] - Extension Evaluable Population
    [39] - Extension Evaluable Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
    Adverse event reporting additional description
    Adverse events were collected in members of the Safety Population, comprised of all participants who received at least 1 dose of study drug, and the Extension Evaluable Population, comprised of all participants who received at least 1 dose of povorcitinib during the Extension Period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator’s Global Assessment (IGA) score (3 versus 4). Participants received blinded placebo through Week 16.

    Reporting group title
    Placebo to povorcitinib 75 mg
    Reporting group description
    		 On Day 1, participants were randomized to receive placebo QD and stratified by IGA score (3 versus 4). Participants received blinded placebo through Week 16. Based on a lack of efficacy response at Week 16 (not meeting the definition of a responder), these participants received povorcitinib 75 mg QD for an additional 24 weeks in the extension period.

    Reporting group title
    Povorcitinib 15 mg
    Reporting group description
    		 On Day 1, participants were randomized to receive povorcitinib 15 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.

    Reporting group title
    Placebo to povorcitinib 45 mg
    Reporting group description
    		 On Day 1, participants were randomized to receive placebo QD and stratified by IGA score (3 versus 4). Participants received blinded placebo through Week 16. Based on their efficacy response at Week 16 (≥4-point decrease in Itch Numerical Rating Scale [NRS] score and IGA-Treatment Success and no administration of rescue therapy during the placebo-controlled period), these participants received povorcitinib 45 milligrams (mg) QD for an additional 24 weeks in the extension period.

    Reporting group title
    Povorcitinib 15 mg to 45 mg
    Reporting group description
    		 On Day 1, participants were randomized to receive povorcitinib 15 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16. Based on their efficacy response at Week 16 (≥4-point decrease in Itch NRS score and IGA-Treatment Success and no administration of rescue therapy during the placebo-controlled period), these participants received povorcitinib 45 mg QD for an additional 24 weeks in the extension period.

    Reporting group title
    Povorcitinib 45 mg to 75 mg
    Reporting group description
    		 On Day 1, participants were randomized to receive povorcitinib 45 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16. Based on a lack of efficacy response at Week 16 (not meeting the definition of a responder), these participants received povorcitinib 75 mg QD for an additional 24 weeks in the extension period.

    Reporting group title
    Povorcitinib 15 mg to 75 mg
    Reporting group description
    		 On Day 1, participants were randomized to receive povorcitinib 15 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16. Based on a lack of efficacy response at Week 16 (not meeting the definition of a responder), these participants received povorcitinib 75 mg QD for an additional 24 weeks in the extension period.

    Reporting group title
    Povorcitinib 45 mg
    Reporting group description
    		 Participants received povorcitinib 45 mg in both the placebo-controlled period and the treatment extension period. On Day 1, participants were randomized to receive povorcitinib 45 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16. Based on their efficacy response at Week 16 (≥4-point decrease in Itch NRS score and IGA-TS and no administration of rescue therapy during the placebo-controlled period), these participants received povorcitinib 45 mg QD for an additional 24 weeks in the extension period.

    Reporting group title
    Povorcitinib 75 mg to 45 mg
    Reporting group description
    		 On Day 1, participants were randomized to receive povorcitinib 75 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16. Based on their efficacy response at Week 16 (≥4-point decrease in Itch NRS score and IGA-Treatment Success and no administration of rescue therapy during the placebo-controlled period), these participants received povorcitinib 45 mg QD for an additional 24 weeks in the extension period.

    Reporting group title
    Povorcitinib 75 mg
    Reporting group description
    		 Participants received povorcitinib 75 mg in both the placebo-controlled period and he treatment extension period. On Day 1, participants were randomized to receive povorcitinib 75 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16. Based on a lack of efficacy response at Week 16 (not meeting the definition of a responder), these participants received povorcitinib 75 mg QD for an additional 24 weeks in the extension period.

    Serious adverse events
    		 Placebo Placebo to povorcitinib 75 mg Povorcitinib 15 mg Placebo to povorcitinib 45 mg Povorcitinib 15 mg to 45 mg Povorcitinib 45 mg to 75 mg Povorcitinib 15 mg to 75 mg Povorcitinib 45 mg Povorcitinib 75 mg to 45 mg Povorcitinib 75 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 30 (3.33%)
    2 / 7 (28.57%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    5 / 23 (21.74%)
    1 / 25 (4.00%)
    1 / 12 (8.33%)
    2 / 15 (13.33%)
    4 / 22 (18.18%)
         number of deaths (all causes)
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Nasal septum deviation
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 23 (4.35%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Hidradenitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neurodermatitis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 30 (3.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 23 (4.35%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myopathy
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    2 / 23 (8.70%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 23 (4.35%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mastitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    1 / 25 (4.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Placebo to povorcitinib 75 mg Povorcitinib 15 mg Placebo to povorcitinib 45 mg Povorcitinib 15 mg to 45 mg Povorcitinib 45 mg to 75 mg Povorcitinib 15 mg to 75 mg Povorcitinib 45 mg Povorcitinib 75 mg to 45 mg Povorcitinib 75 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 6 (33.33%)
    19 / 30 (63.33%)
    4 / 7 (57.14%)
    0 / 1 (0.00%)
    3 / 4 (75.00%)
    20 / 23 (86.96%)
    19 / 25 (76.00%)
    7 / 12 (58.33%)
    12 / 15 (80.00%)
    14 / 22 (63.64%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 30 (3.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    2 / 23 (8.70%)
    1 / 25 (4.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    0
    0
    1
    2
    1
    0
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Chest pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 23 (4.35%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 30 (10.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    2 / 4 (50.00%)
    3 / 23 (13.04%)
    4 / 25 (16.00%)
    0 / 12 (0.00%)
    2 / 15 (13.33%)
    1 / 22 (4.55%)
         occurrences all number
    0
    3
    1
    0
    2
    3
    6
    0
    2
    1
    Mucosal dryness
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Reproductive system and breast disorders
    Ejaculation failure
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Uterine polyp
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 23 (4.35%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    Cough
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    2 / 23 (8.70%)
    1 / 25 (4.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    1
    0
    1
    1
    Epistaxis
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 30 (6.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    0
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    2 / 25 (8.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 23 (4.35%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Investigations
    Aspergillus test positive
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 30 (6.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    4 / 23 (17.39%)
    1 / 25 (4.00%)
    1 / 12 (8.33%)
    1 / 15 (6.67%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    0
    0
    0
    4
    1
    2
    1
    2
    Haemoglobin decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    3 / 23 (13.04%)
    5 / 25 (20.00%)
    0 / 12 (0.00%)
    3 / 15 (20.00%)
    3 / 22 (13.64%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    6
    0
    3
    5
    Platelet count decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    Weight increased
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 30 (10.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    2 / 23 (8.70%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    3
    0
    0
    1
    2
    0
    1
    0
    2
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    2 / 23 (8.70%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    0
    0
    0
    2
    Joint capsule rupture
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Muscle strain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Ligament sprain
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 30 (3.33%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 23 (4.35%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    1 / 15 (6.67%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    1
    2
    Headache
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 30 (3.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    4 / 23 (17.39%)
    6 / 25 (24.00%)
    2 / 12 (16.67%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2
    7
    6
    2
    0
    0
    Intercostal neuralgia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Migraine
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 30 (3.33%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Polyneuropathy
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Presyncope
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 30 (6.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    1
    0
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Vertigo
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Eye disorders
    Blepharospasm
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Blepharitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Eye pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 30 (6.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    2 / 15 (13.33%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    2
    0
    Constipation
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 30 (3.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    2 / 23 (8.70%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0
    Dry mouth
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    2 / 23 (8.70%)
    1 / 25 (4.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    2
    1
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Dysphagia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Loose tooth
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Nausea
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 23 (4.35%)
    3 / 25 (12.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    4
    1
    0
    3
    Trichoglossia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 30 (3.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    Dermatitis contact
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    2 / 23 (8.70%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Diffuse alopecia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Dry skin
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Erythema
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Lichen myxoedematosus
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Neurodermatitis
         subjects affected / exposed
    0 / 6 (0.00%)
    4 / 30 (13.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 23 (4.35%)
    3 / 25 (12.00%)
    1 / 12 (8.33%)
    1 / 15 (6.67%)
    2 / 22 (9.09%)
         occurrences all number
    0
    4
    0
    0
    0
    1
    3
    1
    1
    2
    Perioral dermatitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    Rosacea
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    2 / 25 (8.00%)
    1 / 12 (8.33%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    1
    1
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 23 (4.35%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    Skin mass
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Trichorrhexis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 23 (4.35%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    Pollakiuria
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Urinary incontinence
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    4 / 23 (17.39%)
    4 / 25 (16.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    0
    0
    0
    4
    4
    1
    0
    2
    Myalgia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 23 (0.00%)
    1 / 25 (4.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    1 / 23 (4.35%)
    1 / 25 (4.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    Pain in jaw
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Spinal pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Infections and infestations
    Asymptomatic bacteriuria
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Cellulitis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 30 (3.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    1 / 25 (4.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    2
    1
    0
    2
    COVID-19
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 30 (10.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    2 / 23 (8.70%)
    3 / 25 (12.00%)
    2 / 12 (16.67%)
    1 / 15 (6.67%)
    2 / 22 (9.09%)
         occurrences all number
    0
    3
    1
    0
    0
    2
    3
    2
    1
    2
    Bronchitis
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 30 (6.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 23 (4.35%)
    0 / 25 (0.00%)
    2 / 12 (16.67%)
    2 / 15 (13.33%)
    0 / 22 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    1
    0
    2
    2
    0
    Cystitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Eyelid folliculitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Folliculitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    3 / 23 (13.04%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    3
    0
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 30 (10.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 23 (4.35%)
    1 / 25 (4.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    1
    1
    0
    1
    0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 23 (4.35%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    1
    0
    Herpes zoster
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Herpes simplex
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    Influenza
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 6 (0.00%)
    5 / 30 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    2 / 23 (8.70%)
    3 / 25 (12.00%)
    2 / 12 (16.67%)
    4 / 15 (26.67%)
    2 / 22 (9.09%)
         occurrences all number
    0
    7
    0
    0
    1
    4
    5
    2
    4
    2
    Otitis externa
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 30 (3.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    Oral candidiasis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 30 (3.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 23 (4.35%)
    1 / 25 (4.00%)
    1 / 12 (8.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    1
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Pulpitis dental
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    2 / 15 (13.33%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    Sinusitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Skin candida
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Skin infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    1 / 25 (4.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    Tooth infection
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 30 (6.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Tonsillitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 30 (3.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    1 / 23 (4.35%)
    1 / 25 (4.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2
    1
    1
    0
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 30 (6.67%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    1 / 25 (4.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    1
    0
    4
    2
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    2 / 25 (8.00%)
    0 / 12 (0.00%)
    2 / 15 (13.33%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    2
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Increased appetite
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 30 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jul 2021
    The primary purpose of the amendment was to change the inclusion criteria associated with the minimum number of nodules, to include a sub-study for itch and sleep monitoring assessment, and to revise the interim analysis.
    06 May 2022
    The primary purpose of the amendment was to remove the interim analysis, modify the exclusion criteria associated with estimated glomerular filtration rate; to add clarification on the types of prurigo nodularis lesions being assessed; and to add clarification on the management of creatine kinase elevations.

    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
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