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A Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03607487
Recruitment Status : Completed
First Posted : July 31, 2018
Results First Posted : September 21, 2020
Last Update Posted : September 26, 2022
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hidradenitis Suppurativa
Interventions Drug: INCB054707
Drug: Placebo
Enrollment 35
Recruitment Details The study was conducted at 9 different sites in Canada, 2 different sites in Germany and 1 site in Denmark
Pre-assignment 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.
Arm/Group Title Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg
Hide Arm/Group Description Placebo was administered QD over an 8 week treatment period. INCB054707 was administered at 30 mg QD over an 8 week treatment period. INCB054707 was administered at 60 mg QD over an 8 week treatment period. INCB054707 was administered at 90 mg QD over an 8 week treatment period.
Period Title: Overall Study
Started 9 9 9 8
Completed 7 9 9 7
Not Completed 2 0 0 1
Reason Not Completed
Withdrawal by Subject             2             0             0             1
Arm/Group Title Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg Total
Hide Arm/Group Description Placebo was administered QD over an 8 week treatment period. INCB054707 was administered at 30 mg QD over an 8 week treatment period. INCB054707 was administered at 60 mg QD over an 8 week treatment period. INCB054707 was administered at 90 mg QD over an 8 week treatment period. Total of all reporting groups
Overall Number of Baseline Participants 9 9 9 8 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 9 participants 9 participants 8 participants 35 participants
40.3  (16.70) 41.0  (11.53) 42.2  (11.96) 42.8  (14.62) 41.5  (13.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 9 participants 8 participants 35 participants
Female
8
  88.9%
7
  77.8%
8
  88.9%
5
  62.5%
28
  80.0%
Male
1
  11.1%
2
  22.2%
1
  11.1%
3
  37.5%
7
  20.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 9 participants 8 participants 35 participants
White/Caucasian
8
  88.9%
7
  77.8%
9
 100.0%
7
  87.5%
31
  88.6%
Black/African-American
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
1
   2.9%
American-Indian/Alaska Native
0
   0.0%
2
  22.2%
0
   0.0%
0
   0.0%
2
   5.7%
Other
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 9 participants 8 participants 35 participants
Hispanic or Latino
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
1
   2.9%
Not Hispanic or Latino
9
 100.0%
7
  77.8%
9
 100.0%
8
 100.0%
33
  94.3%
Not Reported
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
1
   2.9%
1.Primary Outcome
Title Number of Treatment-emergent Adverse Events (TEAEs)
Hide 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. Grading was performed using guidance from the CTCAE v 4.03. A grade 3 and above would constitute as "severe".
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set Population
Arm/Group Title Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg
Hide Arm/Group Description:
Placebo was administered QD over an 8 week treatment period.
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
Overall Number of Participants Analyzed 9 9 9 8
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
2
  22.2%
6
  66.7%
4
  44.4%
1
  12.5%
Grade 2
2
  22.2%
2
  22.2%
2
  22.2%
3
  37.5%
Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
3
  37.5%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Apparent Oral Clearance of INCB054707
Hide Description To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707.
Time Frame Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707
Arm/Group Title INCB54707
Hide Arm/Group Description:
INCB54707 was administered at either 30,60, or 90 mg. All samples from different dose groups were combined for this analysis.
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: L/hr
5.27  (2.89)
3.Secondary Outcome
Title Apparent Oral Volume of Distribution of INCB054707
Hide Description To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707.
Time Frame Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707
Arm/Group Title INCB54707
Hide Arm/Group Description:
INCB54707 was administered at either 30,60, or 90 mg. All samples from different dose groups were combined for this analysis.
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: L
239  (85.7)
4.Secondary Outcome
Title Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Hide 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.
Time Frame Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set Population. Full Analysis Set Population In placebo group 1 participant discontinued the study before week 1, second participant missed all the visits and only had early termination visit. In the 90mg group 1 participant missed week 1 visit and a second participant discontinued before the follow up visit
Arm/Group Title Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg
Hide Arm/Group Description:
Placebo was administered QD over an 8 week treatment period.
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
Overall Number of Participants Analyzed 9 9 9 8
Measure Type: Count of Participants
Unit of Measure: Participants
Week 1 Number Analyzed 7 participants 9 participants 9 participants 7 participants
Yes
1
  14.3%
1
  11.1%
4
  44.4%
2
  28.6%
No
6
  85.7%
8
  88.9%
5
  55.6%
5
  71.4%
Week 2 Number Analyzed 7 participants 9 participants 9 participants 8 participants
Yes
1
  14.3%
6
  66.7%
5
  55.6%
4
  50.0%
No
6
  85.7%
3
  33.3%
4
  44.4%
4
  50.0%
Week 4 Number Analyzed 7 participants 9 participants 9 participants 8 participants
Yes
3
  42.9%
5
  55.6%
5
  55.6%
5
  62.5%
No
4
  57.1%
4
  44.4%
4
  44.4%
3
  37.5%
Week 6 Number Analyzed 7 participants 9 participants 9 participants 8 participants
Yes
3
  42.9%
3
  33.3%
6
  66.7%
6
  75.0%
No
4
  57.1%
6
  66.7%
3
  33.3%
2
  25.0%
Week 8 Number Analyzed 7 participants 9 participants 9 participants 8 participants
Yes
4
  57.1%
5
  55.6%
5
  55.6%
7
  87.5%
No
3
  42.9%
4
  44.4%
4
  44.4%
1
  12.5%
Follow Up Number Analyzed 7 participants 9 participants 9 participants 7 participants
Yes
3
  42.9%
3
  33.3%
1
  11.1%
4
  57.1%
No
4
  57.1%
6
  66.7%
8
  88.9%
3
  42.9%
Early Termination Number Analyzed 1 participants 0 participants 0 participants 0 participants
Yes
0
   0.0%
 0 0 0
No
1
 100.0%
 0 0 0
5.Secondary Outcome
Title Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Hide Description AN defined as abscess and inflammatory nodule count.
Time Frame Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set Population In placebo group 1 participant discontinued the study before week 1, second participant missed all the visits and only had early termination visit. In the 90mg group 1 participant missed week 1 visit and a second participant discontinued before the follow up visit
Arm/Group Title Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg
Hide Arm/Group Description:
Placebo was administered QD over an 8 week treatment period.
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
Overall Number of Participants Analyzed 9 9 9 8
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 9 participants 9 participants 9 participants 8 participants
Yes
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
No
9
 100.0%
9
 100.0%
9
 100.0%
7
  87.5%
Week 1 Number Analyzed 7 participants 9 participants 9 participants 7 participants
Yes
0
   0.0%
0
   0.0%
2
  22.2%
2
  28.6%
No
7
 100.0%
9
 100.0%
7
  77.8%
5
  71.4%
Week 2 Number Analyzed 7 participants 9 participants 9 participants 8 participants
Yes
0
   0.0%
3
  33.3%
5
  55.6%
4
  50.0%
No
7
 100.0%
6
  66.7%
4
  44.4%
4
  50.0%
Week 4 Number Analyzed 7 participants 9 participants 9 participants 8 participants
Yes
2
  28.6%
3
  33.3%
6
  66.7%
5
  62.5%
No
5
  71.4%
6
  66.7%
3
  33.3%
3
  37.5%
Week 6 Number Analyzed 7 participants 9 participants 9 participants 8 participants
Yes
3
  42.9%
2
  22.2%
5
  55.6%
5
  62.5%
No
4
  57.1%
7
  77.8%
4
  44.4%
3
  37.5%
Week 8 Number Analyzed 7 participants 9 participants 9 participants 8 participants
Yes
4
  57.1%
4
  44.4%
4
  44.4%
5
  62.5%
No
3
  42.9%
5
  55.6%
5
  55.6%
3
  37.5%
Follow Up Number Analyzed 7 participants 9 participants 9 participants 7 participants
Yes
1
  14.3%
3
  33.3%
0
   0.0%
4
  57.1%
No
6
  85.7%
6
  66.7%
9
 100.0%
3
  42.9%
Early Termination Number Analyzed 1 participants 0 participants 0 participants 0 participants
Yes
0
   0.0%
 0 0 0
No
1
 100.0%
 0 0 0
6.Secondary Outcome
Title Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit
Hide Description An 11-point scale used to assess the worst skin pain and the average skin pain due to HS. Skin pain ranges from 0 ("no skin pain") to 10 ("skin pain as bad as you can imagine").
Time Frame Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set Population
Arm/Group Title Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg
Hide Arm/Group Description:
Placebo was administered QD over an 8 week treatment period.
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
Overall Number of Participants Analyzed 9 9 9 8
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Mean change from Baseline to Week 1 Number Analyzed 6 participants 5 participants 8 participants 6 participants
0.2  (1.39) -0.8  (1.13) -0.3  (1.06) -1.5  (1.04)
Mean change from Baseline to Week 2 Number Analyzed 6 participants 5 participants 8 participants 7 participants
-0.1  (1.49) -1.5  (1.18) -1.1  (0.91) -3.3  (3.06)
Mean change from Baseline to Week 4 Number Analyzed 6 participants 5 participants 8 participants 7 participants
-0.3  (2.09) -2.0  (2.02) -1.4  (1.56) -3.6  (3.30)
Mean change from Baseline to Week 6 Number Analyzed 6 participants 4 participants 8 participants 7 participants
0.0  (3.49) -0.9  (0.90) -2.0  (1.55) -3.4  (3.05)
Mean change from Baseline to Week 8 Number Analyzed 6 participants 4 participants 8 participants 7 participants
0.3  (2.77) -2.2  (2.18) -1.4  (1.44) -3.1  (3.28)
Mean change from Baseline to Follow Up Number Analyzed 3 participants 3 participants 8 participants 4 participants
2.6  (2.62) -2.7  (2.20) -0.8  (0.97) -1.2  (1.91)
7.Secondary Outcome
Title Mean Change From Baseline in the Modified Sartorius Scale Score
Hide Description The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other). For each area, points are awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated buy normal skin (yes-0 point; no-6 points). The total Sartorius Scale score is the sum of the 12 regional scores. Scale scores range from 0 to infinite, with larger scores representing higher severity of HS.
Time Frame From baseline up to week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set Population
Arm/Group Title Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg
Hide Arm/Group Description:
Placebo was administered QD over an 8 week treatment period.
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
Overall Number of Participants Analyzed 9 9 9 8
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-36.4  (35.83) -41.9  (36.84) -59.2  (48.48) -54.6  (55.42)
8.Secondary Outcome
Title Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit.
Hide Description Defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.
Time Frame Baseline,Weeks 1, 2, 4, 6, 8 and Follow-up (Up to 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set Population
Arm/Group Title Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg
Hide Arm/Group Description:
Placebo was administered QD over an 8 week treatment period.
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
Overall Number of Participants Analyzed 9 9 9 8
Mean (Standard Deviation)
Unit of Measure: Number of Fistulas
Week 1 Number Analyzed 7 participants 9 participants 9 participants 7 participants
-0.1  (0.38) -0.1  (1.27) -0.8  (2.39) -0.3  (0.49)
Week 2 Number Analyzed 7 participants 9 participants 9 participants 8 participants
0.0  (1.53) -0.9  (1.05) -2.1  (3.48) -0.8  (2.19)
Week 4 Number Analyzed 7 participants 9 participants 9 participants 8 participants
-0.9  (2.79) -0.6  (1.01) -2.0  (3.57) -0.9  (2.53)
Week 6 Number Analyzed 7 participants 9 participants 9 participants 8 participants
-1.3  (2.69) -0.4  (1.74) -2.1  (3.30) -0.6  (2.72)
Week 8 Number Analyzed 7 participants 9 participants 9 participants 8 participants
-1.0  (3.06) -0.3  (1.66) -2.0  (3.35) -0.6  (3.85)
Follow Up Number Analyzed 7 participants 9 participants 9 participants 7 participants
-0.4  (3.10) 0.1  (1.69) -2.2  (3.19) -1.3  (3.86)
9.Secondary Outcome
Title Proportion of Participants at Each Category of Hurley Stage
Hide 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.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set Population
Arm/Group Title Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg
Hide Arm/Group Description:
Placebo was administered QD over an 8 week treatment period.
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
Overall Number of Participants Analyzed 9 9 9 8
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 9 participants 9 participants 9 participants 8 participants
Stage I
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Stage II
4
  44.4%
9
 100.0%
5
  55.6%
7
  87.5%
Stage III
5
  55.6%
0
   0.0%
4
  44.4%
1
  12.5%
No HS
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 8 Number Analyzed 7 participants 9 participants 9 participants 8 participants
Stage I
1
  14.3%
3
  33.3%
3
  33.3%
0
   0.0%
Stage II
3
  42.9%
6
  66.7%
5
  55.6%
7
  87.5%
Stage III
3
  42.9%
0
   0.0%
0
   0.0%
0
   0.0%
No HS
0
   0.0%
0
   0.0%
1
  11.1%
1
  12.5%
10.Secondary Outcome
Title Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Hide 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.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set Population
Arm/Group Title Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg
Hide Arm/Group Description:
Placebo was administered QD over an 8 week treatment period.
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
Overall Number of Participants Analyzed 9 9 9 8
Measure Type: Count of Participants
Unit of Measure: Participants
Week 1 Number Analyzed 7 participants 9 participants 9 participants 7 participants
1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
3
0
   0.0%
3
  33.3%
3
  33.3%
3
  42.9%
4
4
  57.1%
2
  22.2%
4
  44.4%
2
  28.6%
5
3
  42.9%
3
  33.3%
1
  11.1%
2
  28.6%
6
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
7
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 2 Number Analyzed 7 participants 9 participants 9 participants 8 participants
1
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
2
0
   0.0%
1
  11.1%
2
  22.2%
3
  37.5%
3
3
  42.9%
4
  44.4%
3
  33.3%
1
  12.5%
4
1
  14.3%
2
  22.2%
3
  33.3%
3
  37.5%
5
3
  42.9%
1
  11.1%
1
  11.1%
1
  12.5%
6
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 4 Number Analyzed 7 participants 9 participants 9 participants 8 participants
1
0
   0.0%
1
  11.1%
2
  22.2%
0
   0.0%
2
0
   0.0%
1
  11.1%
1
  11.1%
3
  37.5%
3
3
  42.9%
2
  22.2%
1
  11.1%
1
  12.5%
4
2
  28.6%
2
  22.2%
2
  22.2%
2
  25.0%
5
2
  28.6%
1
  11.1%
2
  22.2%
2
  25.0%
6
0
   0.0%
1
  11.1%
1
  11.1%
0
   0.0%
7
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
Week 6 Number Analyzed 7 participants 9 participants 9 participants 8 participants
1
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
2
1
  14.3%
1
  11.1%
1
  11.1%
2
  25.0%
3
3
  42.9%
2
  22.2%
3
  33.3%
2
  25.0%
4
1
  14.3%
4
  44.4%
1
  11.1%
4
  50.0%
5
2
  28.6%
1
  11.1%
3
  33.3%
0
   0.0%
6
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
7
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 8 Number Analyzed 7 participants 9 participants 9 participants 8 participants
1
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
2
0
   0.0%
3
  33.3%
1
  11.1%
0
   0.0%
3
1
  14.3%
1
  11.1%
3
  33.3%
1
  12.5%
4
5
  71.4%
3
  33.3%
4
  44.4%
2
  25.0%
5
1
  14.3%
1
  11.1%
1
  11.1%
3
  37.5%
6
0
   0.0%
1
  11.1%
0
   0.0%
1
  12.5%
7
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Early Termination Number Analyzed 1 participants 0 participants 0 participants 0 participants
1
0
   0.0%
 0 0 0
2
0
   0.0%
 0 0 0
3
0
   0.0%
 0 0 0
4
1
 100.0%
 0 0 0
5
0
   0.0%
 0 0 0
6
0
   0.0%
 0 0 0
7
0
   0.0%
 0 0 0
Follow Up Number Analyzed 7 participants 9 participants 9 participants 7 participants
1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
3
1
  14.3%
1
  11.1%
0
   0.0%
0
   0.0%
4
1
  14.3%
2
  22.2%
2
  22.2%
1
  14.3%
5
3
  42.9%
2
  22.2%
2
  22.2%
3
  42.9%
6
2
  28.6%
3
  33.3%
4
  44.4%
0
   0.0%
7
0
   0.0%
0
   0.0%
1
  11.1%
3
  42.9%
11.Secondary Outcome
Title Actual Measurements in HS-PGIC at Each Visit
Hide 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.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set Population
Arm/Group Title Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg
Hide Arm/Group Description:
Placebo was administered QD over an 8 week treatment period.
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
Overall Number of Participants Analyzed 9 9 9 8
Measure Type: Count of Participants
Unit of Measure: Participants
Week 1 Number Analyzed 7 participants 9 participants 9 participants 7 participants
1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
3
0
   0.0%
3
  33.3%
3
  33.3%
3
  42.9%
4
4
  57.1%
2
  22.2%
4
  44.4%
2
  28.6%
5
3
  42.9%
3
  33.3%
1
  11.1%
2
  28.6%
6
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
7
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 2 Number Analyzed 7 participants 9 participants 9 participants 8 participants
1
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
2
0
   0.0%
1
  11.1%
2
  22.2%
3
  37.5%
3
3
  42.9%
4
  44.4%
3
  33.3%
1
  12.5%
4
1
  14.3%
2
  22.2%
3
  33.3%
3
  37.5%
5
3
  42.9%
1
  11.1%
1
  11.1%
1
  12.5%
6
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 4 Number Analyzed 7 participants 9 participants 9 participants 8 participants
1
0
   0.0%
1
  11.1%
2
  22.2%
0
   0.0%
2
0
   0.0%
1
  11.1%
1
  11.1%
3
  37.5%
3
3
  42.9%
2
  22.2%
1
  11.1%
1
  12.5%
4
2
  28.6%
2
  22.2%
2
  22.2%
2
  25.0%
5
2
  28.6%
1
  11.1%
2
  22.2%
2
  25.0%
6
0
   0.0%
1
  11.1%
1
  11.1%
0
   0.0%
7
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
Week 6 Number Analyzed 7 participants 9 participants 9 participants 8 participants
1
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
2
1
  14.3%
1
  11.1%
1
  11.1%
2
  25.0%
3
3
  42.9%
2
  22.2%
3
  33.3%
2
  25.0%
4
1
  14.3%
4
  44.4%
1
  11.1%
4
  50.0%
5
2
  28.6%
1
  11.1%
3
  33.3%
0
   0.0%
6
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
7
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 8 Number Analyzed 7 participants 9 participants 9 participants 8 participants
1
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
2
0
   0.0%
3
  33.3%
1
  11.1%
0
   0.0%
3
1
  14.3%
1
  11.1%
3
  33.3%
1
  12.5%
4
5
  71.4%
3
  33.3%
4
  44.4%
2
  25.0%
5
1
  14.3%
1
  11.1%
1
  11.1%
3
  37.5%
6
0
   0.0%
1
  11.1%
0
   0.0%
1
  12.5%
7
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Early Termination Number Analyzed 1 participants 0 participants 0 participants 0 participants
1
0
   0.0%
 0 0 0
2
0
   0.0%
 0 0 0
3
0
   0.0%
 0 0 0
4
1
 100.0%
 0 0 0
5
0
   0.0%
 0 0 0
6
0
   0.0%
 0 0 0
7
0
   0.0%
 0 0 0
Follow Up Number Analyzed 7 participants 9 participants 9 participants 7 participants
1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
3
1
  14.3%
1
  11.1%
0
   0.0%
0
   0.0%
4
1
  14.3%
2
  22.2%
2
  22.2%
1
  14.3%
5
3
  42.9%
2
  22.2%
2
  22.2%
3
  42.9%
6
2
  28.6%
3
  33.3%
4
  44.4%
0
   0.0%
7
0
   0.0%
0
   0.0%
1
  11.1%
3
  42.9%
12.Secondary Outcome
Title Proportion of Participants With Change From Baseline Hurley Stage
Hide 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.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set Population
Arm/Group Title Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg
Hide Arm/Group Description:
Placebo was administered QD over an 8 week treatment period.
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
Overall Number of Participants Analyzed 9 9 9 8
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Stage I
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Stage II
4
  44.4%
9
 100.0%
5
  55.6%
7
  87.5%
Stage III
5
  55.6%
0
   0.0%
4
  44.4%
1
  12.5%
No HS
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 8 Stage I
1
  11.1%
3
  33.3%
3
  33.3%
0
   0.0%
Stage II
3
  33.3%
6
  66.7%
5
  55.6%
7
  87.5%
Stage III
3
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
No HS
0
   0.0%
0
   0.0%
1
  11.1%
1
  12.5%
Missing
2
  22.2%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame up to 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg Total
Hide Arm/Group Description Placebo was administered QD over an 8 week treatment period. INCB054707 was administered at 30 mg QD over an 8 week treatment period. INCB054707 was administered at 60 mg QD over an 8 week treatment period. INCB054707 was administered at 90 mg QD over an 8 week treatment period. Total
All-Cause Mortality
Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)      0/9 (0.00%)      0/9 (0.00%)      0/8 (0.00%)      0/35 (0.00%)    
Hide Serious Adverse Events
Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/9 (0.00%)      0/9 (0.00%)      0/8 (0.00%)      0/35 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo INCB054707 at 30 mg INCB054707 at 60 mg INCB054707 at 90 mg Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/9 (44.44%)      8/9 (88.89%)      6/9 (66.67%)      7/8 (87.50%)      25/35 (71.43%)    
Blood and lymphatic system disorders           
Thrombocytopenia † 1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 4/8 (50.00%)  4 4/35 (11.43%)  4
Cardiac disorders           
Palpitations † 1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Gastrointestinal disorders           
Abdominal distension † 1  0/9 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 1/35 (2.86%)  1
Abdominal pain † 1  1/9 (11.11%)  1 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 2/35 (5.71%)  2
Abdominal pain upper † 1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Constipation † 1  1/9 (11.11%)  1 0/9 (0.00%)  0 1/9 (11.11%)  2 0/8 (0.00%)  0 2/35 (5.71%)  3
Diarrhoea † 1  2/9 (22.22%)  2 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 3/35 (8.57%)  3
Dyspepsia † 1  1/9 (11.11%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Food poisoning † 1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Nausea † 1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 1/35 (2.86%)  1
Rectal haemorrhage † 1  1/9 (11.11%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
General disorders           
Chest pain † 1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 1/35 (2.86%)  1
Exercise tolerance decreased † 1  1/9 (11.11%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Fatigue † 1  1/9 (11.11%)  1 1/9 (11.11%)  1 2/9 (22.22%)  2 3/8 (37.50%)  3 7/35 (20.00%)  7
Oedema peripheral † 1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Pain † 1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 1/35 (2.86%)  1
Pyrexia † 1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 1/35 (2.86%)  1
Vessel puncture site haemorrhage † 1  1/9 (11.11%)  1 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 2/35 (5.71%)  2
Infections and infestations           
Folliculitis † 1  1/9 (11.11%)  1 2/9 (22.22%)  2 1/9 (11.11%)  1 0/8 (0.00%)  0 4/35 (11.43%)  4
Gastroenteritis † 1  0/9 (0.00%)  0 0/9 (0.00%)  0 2/9 (22.22%)  2 0/8 (0.00%)  0 2/35 (5.71%)  2
Influenza † 1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Nasopharyngitis † 1  1/9 (11.11%)  1 1/9 (11.11%)  1 2/9 (22.22%)  2 0/8 (0.00%)  0 4/35 (11.43%)  4
Oral herpes † 1  1/9 (11.11%)  1 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 2/35 (5.71%)  2
Sinusitis † 1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 1/35 (2.86%)  1
Tinea pedis † 1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Tonsillitis † 1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Upper respiratory tract infection † 1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 1/35 (2.86%)  1
Injury, poisoning and procedural complications           
Animal bite † 1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Fall † 1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Rib fracture † 1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 1/35 (2.86%)  1
Metabolism and nutrition disorders           
Decreased appetite † 1  0/9 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 1/35 (2.86%)  1
Hypertriglyceridaemia † 1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Hypoglycaemia † 1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Musculoskeletal and connective tissue disorders           
Arthralgia † 1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 1/8 (12.50%)  1 2/35 (5.71%)  2
Back pain † 1  0/9 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 1/35 (2.86%)  1
Torticollis † 1  1/9 (11.11%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Basal cell carcinoma † 1  0/9 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 1/35 (2.86%)  1
Nervous system disorders           
Disturbance in attention † 1  0/9 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1 1/8 (12.50%)  2 2/35 (5.71%)  3
Dizziness † 1  1/9 (11.11%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Headache † 1  2/9 (22.22%)  2 0/9 (0.00%)  0 2/9 (22.22%)  3 2/8 (25.00%)  4 6/35 (17.14%)  9
Hypoaesthesia † 1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Migraine † 1  0/9 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  2 0/8 (0.00%)  0 1/35 (2.86%)  2
Sinus headache † 1  0/9 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 1/35 (2.86%)  1
Psychiatric disorders           
Insomnia † 1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Restlessness † 1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  2 1/35 (2.86%)  2
Sleep disorder † 1  1/9 (11.11%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Reproductive system and breast disorders           
Polymenorrhoea † 1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Respiratory, thoracic and mediastinal disorders           
Cough † 1  1/9 (11.11%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Oropharyngeal pain † 1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Skin and subcutaneous tissue disorders           
Acne † 1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 1/35 (2.86%)  1
Acne cystic † 1  1/9 (11.11%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Seborrhoeic dermatitis † 1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/35 (2.86%)  1
Telangiectasia † 1  0/9 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 1/35 (2.86%)  1
Surgical and medical procedures           
Endodontic procedure † 1  0/9 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 1/35 (2.86%)  1
1
Term from vocabulary, MedDRA 20.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Clinical Study Agreement
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Incyte Corporation Call Center
Organization: Incyte Corporation
Phone: 1-855-463-3463
EMail: medinfo@incyte.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03607487    
Other Study ID Numbers: INCB 54707-203
First Submitted: June 25, 2018
First Posted: July 31, 2018
Results First Submitted: August 12, 2020
Results First Posted: September 21, 2020
Last Update Posted: September 26, 2022