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    Clinical Trial Results:
    A Phase 2, Dose-Escalation, Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa

    Summary
    EudraCT number
    		 2018-000827-15
    Trial protocol
    		 DK  
    Global end of trial date
    13 Aug 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Aug 2020
    First version publication date
    28 Aug 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    INCB 54707-203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03607487
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Incyte Corporation
    Sponsor organisation address
    1801 Augustine Cutoff, Wilmington, United States, 19803
    Public contact
    Incyte Corporation Call Center, Incyte Corporation, +44 18554633463, medinfo@incyte.com
    Scientific contact
    Incyte Corporation Call Center, Incyte Corporation, +44 18554633463, 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
    13 Aug 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the safety of INCB054707 over an 8-week treatment period in men and women with moderate to severe hidradenitis suppurativa.
    Protection of trial subjects
    The study was conducted in compliance with the ethical principles derived from the Declaration of Helsinki and the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of study participants were also followed during the conduct of the trial
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Sep 2018
    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: 33
    Country: Number of subjects enrolled
    Germany: 2
    Worldwide total number of subjects
    35
    EEA total number of subjects
    2
    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)
    35
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 9 different sites in Canada, 2 different sites in Germany and 1 site in Denmark.

    Pre-assignment
    Screening details
    		 A total of 43 participants were screened for enrollment in the study, 8 did not meet the eligibility criteria. A total of 35 participants were randomized to one of the treatment groups.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo was administered QD over an 8 week treatment period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo was administered QD over an 8 week treatment period.

    Arm title
    		 INCB054707 at 30 mg
    Arm description
    		 INCB054707 was administered at 30 mg QD over an 8 week treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCB054707
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    INCB054707 was administered at 30 mg QD over an 8 week treatment period.

    Arm title
    		 INCB054707 at 60 mg
    Arm description
    		 INCB054707 was administered at 60 mg QD over an 8 week treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCB054707
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    INCB054707 was administered at 60 mg QD over an 8 week treatment period.

    Arm title
    		 INCB054707 at 90 mg
    Arm description
    		 INCB054707 was administered at 90 mg QD over an 8 week treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCB054707
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    INCB054707 was administered at 90 mg QD over an 8 week treatment period.

    Number of subjects in period 1
    		Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg
    Started
    9
    9
    9
    8
    Completed
    7
    9
    9
    7
    Not completed
    2
    0
    0
    1
         Consent withdrawn by subject
    2
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo was administered QD over an 8 week treatment period.

    Reporting group title
    INCB054707 at 30 mg
    Reporting group description
    		 INCB054707 was administered at 30 mg QD over an 8 week treatment period.

    Reporting group title
    INCB054707 at 60 mg
    Reporting group description
    		 INCB054707 was administered at 60 mg QD over an 8 week treatment period.

    Reporting group title
    INCB054707 at 90 mg
    Reporting group description
    		 INCB054707 was administered at 90 mg QD over an 8 week treatment period.

    Reporting group values
    		 Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg Total
    Number of subjects
    		 9 9 9 8 35
    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)
    		 9 9 9 8 35
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.3 ( 16.70 ) 41.0 ( 11.53 ) 42.2 ( 11.96 ) 42.8 ( 14.62 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 8 7 8 5 28
        Male
    		 1 2 1 3 7
    Race/Ethnicity, Customized
    Units: Subjects
        White/Caucasian
    		 8 7 9 7 31
        Black/African-American
    		 0 0 0 1 1
        American-Indian/Alaska Native
    		 0 2 0 0 2
        Other
    		 1 0 0 0 1
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    		 0 1 0 0 1
        Not Hispanic or Latino
    		 9 7 9 8 33
        Not Reported
    		 0 1 0 0 1

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo was administered QD over an 8 week treatment period.

    Reporting group title
    INCB054707 at 30 mg
    Reporting group description
    		 INCB054707 was administered at 30 mg QD over an 8 week treatment period.

    Reporting group title
    INCB054707 at 60 mg
    Reporting group description
    		 INCB054707 was administered at 60 mg QD over an 8 week treatment period.

    Reporting group title
    INCB054707 at 90 mg
    Reporting group description
    		 INCB054707 was administered at 90 mg QD over an 8 week treatment period.

    Subject analysis set title
    INCB54707
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    INCB54707 was administered at either 30,60, or 90 mg. All samples from different dose groups were combined for this analysis.

    Primary: Number of treatment-emergent adverse events (TEAEs)

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    End point title
    		 Number of treatment-emergent adverse events (TEAEs) [1]
    End point description
    TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
    End point type
    Primary
    End point timeframe
    Up to 12 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There is no hypothesis testing for this endpoint , descriptive analysis is provided.
    End point values
    		 Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg
    Number of subjects analysed
    9
    9
    9
    8
    Units: Participants
        No TEAE
    5
    1
    3
    1
        Grade 1 TEAE
    2
    6
    4
    1
        Grade 2 TEAE
    2
    2
    2
    3
        Grade 3 TEAE
    0
    0
    0
    3
        Grade 4 TEAE
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Apparent oral clearance of INCB054707

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    End point title
    		 Apparent oral clearance of INCB054707
    End point description
    To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707.
    End point type
    Secondary
    End point timeframe
    Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8
    End point values
    		 INCB54707
    Number of subjects analysed
    26
    Units: L/hr
        arithmetic mean (standard deviation)
    5.27 ( 2.89 )
    No statistical analyses for this end point

    Secondary: Apparent oral volume of distribution of INCB054707

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    End point title
    		 Apparent oral volume of distribution of INCB054707
    End point description
    To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707.
    End point type
    Secondary
    End point timeframe
    Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8
    End point values
    		 INCB54707
    Number of subjects analysed
    26
    Units: Liters
        arithmetic mean (standard deviation)
    239 ( 85.7 )
    No statistical analyses for this end point

    Secondary: Proportion of participants achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at each visit

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    End point title
    		 Proportion of participants achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at each visit
    End point description
    HiSCR defined as at least 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline.
    End point type
    Secondary
    End point timeframe
    From screening up to 12 weeks
    End point values
    		 Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg
    Number of subjects analysed
    9
    9
    9
    8
    Units: Participants
        Week 1|Yes
    1
    1
    4
    2
        Week 1|No
    6
    8
    5
    5
        Week 2|Yes
    1
    6
    5
    4
        Week 2|No
    6
    3
    4
    4
        Week 4|Yes
    3
    5
    5
    5
        Week 4|No
    4
    4
    4
    3
        Week 6|Yes
    3
    3
    6
    6
        Week 6|No
    4
    6
    3
    2
        Week 8|Yes
    4
    5
    5
    7
        Week 8|No
    3
    4
    4
    1
        Early Termination|Yes
    0
    0
    0
    0
        Early Termination|No
    1
    0
    0
    0
        Follow Up|Yes
    3
    3
    1
    4
        Follow Up|No
    4
    6
    8
    3
    No statistical analyses for this end point

    Secondary: Proportion of participants achieving an AN count of 0 to 2 at each visit

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    End point title
    		 Proportion of participants achieving an AN count of 0 to 2 at each visit
    End point description
    AN defined as abscess and inflammatory nodule count.
    End point type
    Secondary
    End point timeframe
    Up to 12 weeks
    End point values
    		 Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg
    Number of subjects analysed
    9
    9
    9
    8
    Units: Participants
        Baseline|Yes
    0
    0
    0
    1
        Baseline|No
    9
    9
    9
    7
        Week 1|Yes
    0
    0
    2
    2
        Week 1|No
    7
    9
    7
    5
        Week 2|Yes
    0
    3
    5
    4
        Week 2|No
    7
    6
    4
    4
        Week 4|Yes
    2
    3
    6
    5
        Week 4|No
    5
    6
    3
    3
        Week 6|Yes
    3
    2
    5
    5
        Week 6|No
    4
    7
    4
    3
        Week 8|Yes
    4
    4
    4
    5
        Week 8|No
    3
    5
    5
    3
        Early Termination|Yes
    0
    0
    0
    0
        Early Termination|No
    1
    0
    0
    0
        Follow Up|Yes
    1
    3
    0
    4
        Follow Up|No
    6
    6
    9
    3
    No statistical analyses for this end point

    Secondary: Mean change from baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) scores at each visit

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    End point title
    		 Mean change from baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) scores at each visit
    End point description
    An 11-point scale used to assess the worst skin pain and the average skin pain due to HS.
    End point type
    Secondary
    End point timeframe
    From baseline up to 12 weeks
    End point values
    		 Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg
    Number of subjects analysed
    9
    9
    9
    8
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Mean change from Baseline to Week 1
    0.2 ( 1.39 )
    -0.8 ( 1.13 )
    -0.3 ( 1.06 )
    -1.5 ( 1.04 )
        Mean change from Baseline to Week 2
    -0.1 ( 1.49 )
    -1.5 ( 1.18 )
    -1.1 ( 0.91 )
    -3.3 ( 3.06 )
        Mean change from Baseline to Week 4
    -0.3 ( 2.09 )
    -2.0 ( 2.02 )
    -1.4 ( 1.56 )
    -3.6 ( 3.30 )
        Mean change from Baseline to Week 6
    0.0 ( 3.49 )
    -0.9 ( 0.90 )
    -2.0 ( 1.55 )
    -3.4 ( 3.05 )
        Mean change from Baseline to Week 8
    0.3 ( 2.77 )
    -2.2 ( 2.18 )
    -1.4 ( 1.44 )
    -3.1 ( 3.28 )
        Mean change from Baseline to Follow Up
    2.6 ( 2.62 )
    -2.7 ( 2.20 )
    -0.8 ( 0.97 )
    -1.2 ( 1.91 )
    No statistical analyses for this end point

    Secondary: Mean change from baseline in the modified Sartorius scale score

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    End point title
    		 Mean change from baseline in the modified Sartorius scale score
    End point description
    Scale measuring the severity of HS.
    End point type
    Secondary
    End point timeframe
    From baseline up to week 8
    End point values
    		 Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg
    Number of subjects analysed
    7
    9
    9
    8
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 8
    -36.4 ( 35.83 )
    -41.9 ( 36.84 )
    -59.2 ( 48.48 )
    -54.6 ( 55.42 )
    No statistical analyses for this end point

    Secondary: Mean change from baseline in the number of draining fistulas count at each visit.

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    End point title
    		 Mean change from baseline in the number of draining fistulas count at each visit.
    End point description
    Defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.
    End point type
    Secondary
    End point timeframe
    From baseline up to 12 weeks
    End point values
    		 Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg
    Number of subjects analysed
    7
    9
    9
    7
    Units: Number of Fistulas
    arithmetic mean (standard deviation)
        Week 1
    -0.1 ( 0.38 )
    -0.1 ( 1.27 )
    -0.8 ( 2.39 )
    -0.3 ( 0.49 )
        Week 2
    0.0 ( 1.53 )
    -0.9 ( 1.05 )
    -2.1 ( 3.48 )
    -0.8 ( 2.19 )
        Week 4
    -0.9 ( 2.79 )
    -0.6 ( 1.01 )
    -2.0 ( 3.57 )
    -0.9 ( 2.53 )
        Week 6
    -1.3 ( 2.69 )
    -0.4 ( 1.74 )
    -2.1 ( 3.30 )
    -0.6 ( 2.72 )
        Week 8
    -1.0 ( 3.06 )
    -0.3 ( 1.66 )
    -2.0 ( 3.35 )
    -0.6 ( 3.85 )
        Follow Up
    -0.4 ( 3.10 )
    0.1 ( 1.69 )
    -2.2 ( 3.19 )
    -1.3 ( 3.86 )
    No statistical analyses for this end point

    Secondary: Proportion of participants at each category of Hurley Stage

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    End point title
    		 Proportion of participants at each category of Hurley Stage
    End point description
    The Hurley classification is a static score and was originally designed for selection of the appropriate treatment modality in a certain body region. The assessor determines the Hurley stage in each affected anatomical region. If more than 1 stage is present in the same region, the worst stage in that region is documented. The participant will be assigned an overall Hurley stage classification corresponding to the stage of the worst involved anatomical region. The definition of each Hurley stage is as follows: Stage I : Abscess formation, single or multiple, without sinus tracts and cicatrization (scarring). Stage II : One or more widely separated recurrent abscesses with tract formation and cicatrization (scarring). Stage III : Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 8
    End point values
    		 Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg
    Number of subjects analysed
    9
    9
    9
    8
    Units: Participants
        Baseline|Stage I
    0
    0
    0
    0
        Week 8|Stage I
    1
    3
    3
    0
        Baseline|Stage II
    4
    9
    5
    7
        Week 8|Stage II
    3
    6
    5
    7
        Baseline|Stage III
    5
    0
    4
    1
        Week 8|Stage III
    3
    0
    0
    0
        Baseline|No HS
    0
    0
    0
    0
        Week 8|No HS
    0
    0
    1
    1
    No statistical analyses for this end point

    Secondary: Proportions of participants in each HS Patient Global Impression of Change (PGIC) category during the treatment period

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    End point title
    		 Proportions of participants in each HS Patient Global Impression of Change (PGIC) category during the treatment period
    End point description
    The HS-PGIC consists of 1 self-administered item that assesses change in the severity of skin in the HS area. The participant will answer the following: Since your last visit, your HS is: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse, or (7) very much worse.
    End point type
    Secondary
    End point timeframe
    Up to 12 weeks
    End point values
    		 Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg
    Number of subjects analysed
    9
    9
    9
    8
    Units: participants
        Week 1|1
    0
    0
    0
    0
        Week 2|1
    0
    1
    0
    0
        Week 4|1
    0
    1
    2
    0
        Week 6|1
    0
    0
    1
    0
        Week 8|1
    0
    0
    0
    1
        Early Termination|1
    0
    0
    0
    0
        Follow Up|1
    0
    0
    0
    0
        Week 1|2
    0
    1
    0
    0
        Week 2|2
    0
    1
    2
    3
        Week 4|2
    0
    1
    1
    3
        Week 6|2
    1
    1
    1
    2
        Week 8|2
    0
    3
    1
    0
        Early Termination|2
    0
    0
    0
    0
        Follow Up|2
    0
    1
    0
    0
        Week 1|3
    0
    3
    3
    3
        Week 2|3
    3
    4
    3
    1
        Week 4|3
    3
    2
    1
    1
        Week 6|3
    3
    2
    3
    2
        Week 8|3
    1
    1
    3
    1
        Early Termination|3
    0
    0
    0
    0
        Follow Up|3
    1
    1
    0
    0
        Week 1|4
    4
    2
    4
    2
        Week 2|4
    1
    2
    3
    3
        Week 4|4
    2
    2
    2
    2
        Week 6|4
    1
    4
    1
    4
        Week 8|4
    5
    3
    4
    2
        Early Termination|4
    1
    0
    0
    0
        Follow Up|4
    1
    2
    2
    1
        Week 1|5
    3
    3
    1
    2
        Week 2|5
    3
    1
    1
    1
        Week 4|5
    2
    1
    2
    2
        Week 6|5
    2
    1
    3
    0
        Week 8|5
    1
    1
    1
    3
        Early Termination|5
    0
    0
    0
    0
        Follow Up|5
    3
    2
    2
    3
        Week 1|6
    0
    0
    1
    0
        Week 2|6
    0
    0
    0
    0
        Week 4|6
    0
    1
    1
    0
        Week 6|6
    0
    1
    0
    0
        Week 8|6
    0
    1
    0
    1
        Early Termination|6
    0
    0
    0
    0
        Follow Up|6
    2
    3
    4
    0
        Week 1|7
    0
    0
    0
    0
        Week 2|7
    0
    0
    0
    0
        Week 4|7
    0
    1
    0
    0
        Week 6|7
    0
    0
    0
    0
        Week 8|7
    0
    0
    0
    0
        Early Termination|7
    0
    0
    0
    0
        Follow Up|7
    0
    0
    1
    3
    No statistical analyses for this end point

    Secondary: Actual measurements in HS-PGIC at each visit

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    End point title
    		 Actual measurements in HS-PGIC at each visit
    End point description
    The HS-PGIC consists of 1 self-administered item that assesses change in the severity of skin in the HS area. The participant will answer the following: Since your last visit, your HS is: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse, or (7) very much worse.
    End point type
    Secondary
    End point timeframe
    Up to 12 weeks
    End point values
    		 Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg
    Number of subjects analysed
    9
    9
    9
    8
    Units: participants
        Week 1|1
    0
    0
    0
    0
        Week 2|1
    0
    1
    0
    0
        Week 4|1
    0
    1
    2
    0
        Week 6|1
    0
    0
    1
    0
        Week 8|1
    0
    0
    0
    1
        Early Termination|1
    0
    0
    0
    0
        Follow Up|1
    0
    0
    0
    0
        Week 1|2
    0
    1
    0
    0
        Week 2|2
    0
    1
    2
    3
        Week 4|2
    0
    1
    1
    3
        Week 6|2
    1
    1
    1
    2
        Week 8|2
    0
    3
    1
    0
        Early Termination|2
    0
    0
    0
    0
        Follow Up|2
    0
    1
    0
    0
        Week 1|3
    0
    3
    3
    3
        Week 2|3
    3
    4
    3
    1
        Week 4|3
    3
    2
    1
    1
        Week 6|3
    3
    2
    3
    2
        Week 8|3
    1
    1
    3
    1
        Early Termination|3
    0
    0
    0
    0
        Follow Up|3
    1
    1
    0
    0
        Week 1|4
    4
    2
    4
    2
        Week 2|4
    1
    2
    3
    3
        Week 4|4
    2
    2
    2
    2
        Week 6|4
    1
    4
    1
    4
        Week 8|4
    5
    3
    4
    2
        Early Termination|4
    1
    0
    0
    0
        Follow Up|4
    1
    2
    2
    1
        Week 1|5
    3
    3
    1
    2
        Week 2|5
    3
    1
    1
    1
        Week 4|5
    2
    1
    2
    2
        Week 6|5
    2
    1
    3
    0
        Week 8|5
    1
    1
    1
    3
        Early Termination|5
    0
    0
    0
    0
        Follow Up|5
    3
    2
    2
    3
        Week 1|6
    0
    0
    1
    0
        Week 2|6
    0
    0
    0
    0
        Week 4|6
    0
    1
    1
    0
        Week 6|6
    0
    1
    0
    0
        Week 8|6
    0
    1
    0
    1
        Early Termination|6
    0
    0
    0
    0
        Follow Up|6
    2
    3
    4
    0
        Week 1|7
    0
    0
    0
    0
        Week 2|7
    0
    0
    0
    0
        Week 4|7
    0
    1
    0
    0
        Week 6|7
    0
    0
    0
    0
        Week 8|7
    0
    0
    0
    0
        Early Termination|7
    0
    0
    0
    0
        Follow Up|7
    0
    0
    1
    3
    No statistical analyses for this end point

    Secondary: Proportion of participants with change from baseline Hurley Stage

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    End point title
    		 Proportion of participants with change from baseline Hurley Stage
    End point description
    The Hurley classification is a static score and was originally designed for selection of the appropriate treatment modality in a certain body region. The assessor determines the Hurley stage in each affected anatomical region. If more than 1 stage is present in the same region, the worst stage in that region is documented. The participant will be assigned an overall Hurley stage classification corresponding to the stage of the worst involved anatomical region. The definition of each Hurley stage is as follows: Stage I : Abscess formation, single or multiple, without sinus tracts and cicatrization (scarring). Stage II : One or more widely separated recurrent abscesses with tract formation and cicatrization (scarring). Stage III : Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 8
    End point values
    		 Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg
    Number of subjects analysed
    9
    9
    9
    8
    Units: Participants
        Baseline|Stage I
    0
    0
    0
    0
        Week 8|Stage I
    1
    3
    3
    0
        Baseline|Stage II
    4
    9
    5
    7
        Week 8|Stage II
    3
    6
    5
    7
        Baseline|Stage III
    5
    0
    4
    1
        Week 8|Stage III
    3
    0
    0
    0
        Baseline|No HS
    0
    0
    0
    0
        Week 8|No HS
    0
    0
    1
    1
        Baseline|Missing
    0
    0
    0
    0
        Week 8|Missing
    2
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 12 weeks
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    INCB054707 30 mg
    Reporting group description
    		 INCB054707 30 mg

    Reporting group title
    INCB054707 60 mg
    Reporting group description
    		 INCB054707 60 mg

    Reporting group title
    INCB054707 90 mg
    Reporting group description
    		 INCB054707 90 mg

    Reporting group title
    Total
    Reporting group description
    		 Total

    Serious adverse events
    		 Placebo INCB054707 30 mg INCB054707 60 mg INCB054707 90 mg Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 35 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo INCB054707 30 mg INCB054707 60 mg INCB054707 90 mg Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 9 (44.44%)
    8 / 9 (88.89%)
    6 / 9 (66.67%)
    7 / 8 (87.50%)
    25 / 35 (71.43%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    0
    1
    Surgical and medical procedures
    Endodontic procedure
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    0
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    1
    Exercise tolerance decreased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    0
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    2 / 9 (22.22%)
    3 / 8 (37.50%)
    7 / 35 (20.00%)
         occurrences all number
    1
    1
    2
    3
    7
    Oedema peripheral
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    0
    0
    1
    Pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    1
    Pyrexia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    1
    Vessel puncture site haemorrhage
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    1
    1
    0
    0
    2
    Reproductive system and breast disorders
    Polymenorrhoea
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    0
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    0
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    0
    0
    1
    Restlessness
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    2
    2
    Sleep disorder
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    0
    0
    1
    Fall
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    0
    0
    1
    Rib fracture
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    0
    0
    1
    Nervous system disorders
    Disturbance in attention
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    2 / 35 (5.71%)
         occurrences all number
    0
    0
    1
    2
    3
    Dizziness
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    2 / 8 (25.00%)
    6 / 35 (17.14%)
         occurrences all number
    2
    0
    3
    4
    9
    Hypoaesthesia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    0
    0
    1
    Migraine
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    2
    0
    2
    Sinus headache
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    0
    1
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    4 / 8 (50.00%)
    4 / 35 (11.43%)
         occurrences all number
    0
    0
    0
    4
    4
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    0
    1
    Abdominal pain
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    1
    1
    0
    0
    2
    Abdominal pain upper
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    0
    0
    1
    Constipation
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    1
    0
    2
    0
    3
    Diarrhoea
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    3 / 35 (8.57%)
         occurrences all number
    2
    1
    0
    0
    3
    Dyspepsia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    0
    0
    1
    Food poisoning
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    1
    Rectal haemorrhage
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    1
    Acne cystic
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    0
    0
    1
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    0
    0
    1
    Telangiectasia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    2 / 35 (5.71%)
         occurrences all number
    0
    1
    0
    1
    2
    Back pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    0
    1
    Torticollis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    0
    0
    1
    Infections and infestations
    Folliculitis
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 9 (22.22%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    4 / 35 (11.43%)
         occurrences all number
    1
    2
    1
    0
    4
    Gastroenteritis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    0 / 8 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    0
    2
    0
    2
    Influenza
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    2 / 9 (22.22%)
    0 / 8 (0.00%)
    4 / 35 (11.43%)
         occurrences all number
    1
    1
    2
    0
    4
    Oral herpes
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    1
    1
    0
    0
    2
    Sinusitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    1
    Tinea pedis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    0
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    0
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    0
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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