Trial Outcomes & Findings for A Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa (NCT NCT03607487)
NCT ID: NCT03607487
Last Updated: 2025-08-21
Results Overview
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".
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Up to 12 weeks
Results posted on
2025-08-21
Participant Flow
The study was conducted at 9 different sites in Canada, 2 different sites in Germany and 1 site in Denmark
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.
Participant milestones
| Measure |
Placebo
Placebo was administered QD over an 8 week treatment period.
|
INCB054707 at 30 mg
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
|
INCB054707 at 60 mg
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
|
INCB054707 at 90 mg
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
8
|
|
Overall Study
COMPLETED
|
7
|
9
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Placebo was administered QD over an 8 week treatment period.
|
INCB054707 at 30 mg
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
|
INCB054707 at 60 mg
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
|
INCB054707 at 90 mg
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
1
|
Baseline Characteristics
A Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Baseline characteristics by cohort
| Measure |
Placebo
n=9 Participants
Placebo was administered QD over an 8 week treatment period.
|
INCB054707 at 30 mg
n=9 Participants
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
|
INCB054707 at 60 mg
n=9 Participants
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
|
INCB054707 at 90 mg
n=8 Participants
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.3 years
STANDARD_DEVIATION 16.70 • n=5 Participants
|
41.0 years
STANDARD_DEVIATION 11.53 • n=7 Participants
|
42.2 years
STANDARD_DEVIATION 11.96 • n=5 Participants
|
42.8 years
STANDARD_DEVIATION 14.62 • n=4 Participants
|
41.5 years
STANDARD_DEVIATION 13.25 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American-Indian/Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Full Analysis Set Population
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".
Outcome measures
| Measure |
INCB54707
n=9 Participants
INCB54707 was administered at either 30,60, or 90 mg. All samples from different dose groups were combined for this analysis.
|
INCB054707 at 30 mg
n=9 Participants
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
|
INCB054707 at 60 mg
n=9 Participants
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
|
INCB054707 at 90 mg
n=8 Participants
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
|
|---|---|---|---|---|
|
Number of Treatment-emergent Adverse Events (TEAEs)
Grade 1
|
2 Participants
|
6 Participants
|
4 Participants
|
1 Participants
|
|
Number of Treatment-emergent Adverse Events (TEAEs)
Grade 2
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Treatment-emergent Adverse Events (TEAEs)
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Treatment-emergent Adverse Events (TEAEs)
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8Population: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707
To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707.
Outcome measures
| Measure |
INCB54707
n=26 Participants
INCB54707 was administered at either 30,60, or 90 mg. All samples from different dose groups were combined for this analysis.
|
INCB054707 at 30 mg
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
|
INCB054707 at 60 mg
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
|
INCB054707 at 90 mg
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
|
|---|---|---|---|---|
|
Apparent Oral Clearance of INCB054707
|
5.27 L/hr
Standard Deviation 2.89
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8Population: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707
To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707.
Outcome measures
| Measure |
INCB54707
n=26 Participants
INCB54707 was administered at either 30,60, or 90 mg. All samples from different dose groups were combined for this analysis.
|
INCB054707 at 30 mg
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
|
INCB054707 at 60 mg
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
|
INCB054707 at 90 mg
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
|
|---|---|---|---|---|
|
Apparent Oral Volume of Distribution of INCB054707
|
239 L
Standard Deviation 85.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)Population: 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
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.
Outcome measures
| Measure |
INCB54707
n=9 Participants
INCB54707 was administered at either 30,60, or 90 mg. All samples from different dose groups were combined for this analysis.
|
INCB054707 at 30 mg
n=9 Participants
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
|
INCB054707 at 60 mg
n=9 Participants
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
|
INCB054707 at 90 mg
n=8 Participants
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
|
|---|---|---|---|---|
|
Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 1 · Yes
|
1 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 1 · No
|
6 Participants
|
8 Participants
|
5 Participants
|
5 Participants
|
|
Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 2 · Yes
|
1 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
|
Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 2 · No
|
6 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 4 · Yes
|
3 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
|
Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 4 · No
|
4 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
|
Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 6 · Yes
|
3 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
|
Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 6 · No
|
4 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
|
Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 8 · Yes
|
4 Participants
|
5 Participants
|
5 Participants
|
7 Participants
|
|
Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 8 · No
|
3 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
|
Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Follow Up · Yes
|
3 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Follow Up · No
|
4 Participants
|
6 Participants
|
8 Participants
|
3 Participants
|
|
Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Early Termination · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Early Termination · No
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)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
AN defined as abscess and inflammatory nodule count.
Outcome measures
| Measure |
INCB54707
n=9 Participants
INCB54707 was administered at either 30,60, or 90 mg. All samples from different dose groups were combined for this analysis.
|
INCB054707 at 30 mg
n=9 Participants
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
|
INCB054707 at 60 mg
n=9 Participants
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
|
INCB054707 at 90 mg
n=8 Participants
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
|
|---|---|---|---|---|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Early Termination · No
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Baseline · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Baseline · No
|
9 Participants
|
9 Participants
|
9 Participants
|
7 Participants
|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Week 1 · Yes
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Week 1 · No
|
7 Participants
|
9 Participants
|
7 Participants
|
5 Participants
|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Week 2 · Yes
|
0 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Week 2 · No
|
7 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Week 4 · Yes
|
2 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Week 4 · No
|
5 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Week 6 · Yes
|
3 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Week 6 · No
|
4 Participants
|
7 Participants
|
4 Participants
|
3 Participants
|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Week 8 · Yes
|
4 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Week 8 · No
|
3 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Follow Up · Yes
|
1 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Follow Up · No
|
6 Participants
|
6 Participants
|
9 Participants
|
3 Participants
|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Early Termination · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)Population: Full Analysis Set Population
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").
Outcome measures
| Measure |
INCB54707
n=9 Participants
INCB54707 was administered at either 30,60, or 90 mg. All samples from different dose groups were combined for this analysis.
|
INCB054707 at 30 mg
n=9 Participants
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
|
INCB054707 at 60 mg
n=9 Participants
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
|
INCB054707 at 90 mg
n=8 Participants
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
|
|---|---|---|---|---|
|
Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit
Mean change from Baseline to Week 1
|
0.2 Units on a scale
Standard Deviation 1.39
|
-0.8 Units on a scale
Standard Deviation 1.13
|
-0.3 Units on a scale
Standard Deviation 1.06
|
-1.5 Units on a scale
Standard Deviation 1.04
|
|
Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit
Mean change from Baseline to Week 2
|
-0.1 Units on a scale
Standard Deviation 1.49
|
-1.5 Units on a scale
Standard Deviation 1.18
|
-1.1 Units on a scale
Standard Deviation 0.91
|
-3.3 Units on a scale
Standard Deviation 3.06
|
|
Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit
Mean change from Baseline to Week 4
|
-0.3 Units on a scale
Standard Deviation 2.09
|
-2.0 Units on a scale
Standard Deviation 2.02
|
-1.4 Units on a scale
Standard Deviation 1.56
|
-3.6 Units on a scale
Standard Deviation 3.30
|
|
Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit
Mean change from Baseline to Week 6
|
0.0 Units on a scale
Standard Deviation 3.49
|
-0.9 Units on a scale
Standard Deviation 0.90
|
-2.0 Units on a scale
Standard Deviation 1.55
|
-3.4 Units on a scale
Standard Deviation 3.05
|
|
Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit
Mean change from Baseline to Week 8
|
0.3 Units on a scale
Standard Deviation 2.77
|
-2.2 Units on a scale
Standard Deviation 2.18
|
-1.4 Units on a scale
Standard Deviation 1.44
|
-3.1 Units on a scale
Standard Deviation 3.28
|
|
Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit
Mean change from Baseline to Follow Up
|
2.6 Units on a scale
Standard Deviation 2.62
|
-2.7 Units on a scale
Standard Deviation 2.20
|
-0.8 Units on a scale
Standard Deviation 0.97
|
-1.2 Units on a scale
Standard Deviation 1.91
|
SECONDARY outcome
Timeframe: From baseline up to week 8Population: Full Analysis Set Population
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.
Outcome measures
| Measure |
INCB54707
n=9 Participants
INCB54707 was administered at either 30,60, or 90 mg. All samples from different dose groups were combined for this analysis.
|
INCB054707 at 30 mg
n=9 Participants
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
|
INCB054707 at 60 mg
n=9 Participants
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
|
INCB054707 at 90 mg
n=8 Participants
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
|
|---|---|---|---|---|
|
Mean Change From Baseline in the Modified Sartorius Scale Score
|
-36.4 Units on a scale
Standard Deviation 35.83
|
-41.9 Units on a scale
Standard Deviation 36.84
|
-59.2 Units on a scale
Standard Deviation 48.48
|
-54.6 Units on a scale
Standard Deviation 55.42
|
SECONDARY outcome
Timeframe: Baseline,Weeks 1, 2, 4, 6, 8 and Follow-up (Up to 3 months)Population: Full Analysis Set Population
Defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.
Outcome measures
| Measure |
INCB54707
n=9 Participants
INCB54707 was administered at either 30,60, or 90 mg. All samples from different dose groups were combined for this analysis.
|
INCB054707 at 30 mg
n=9 Participants
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
|
INCB054707 at 60 mg
n=9 Participants
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
|
INCB054707 at 90 mg
n=8 Participants
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
|
|---|---|---|---|---|
|
Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit.
Week 1
|
-0.1 Number of Fistulas
Standard Deviation 0.38
|
-0.1 Number of Fistulas
Standard Deviation 1.27
|
-0.8 Number of Fistulas
Standard Deviation 2.39
|
-0.3 Number of Fistulas
Standard Deviation 0.49
|
|
Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit.
Week 2
|
0.0 Number of Fistulas
Standard Deviation 1.53
|
-0.9 Number of Fistulas
Standard Deviation 1.05
|
-2.1 Number of Fistulas
Standard Deviation 3.48
|
-0.8 Number of Fistulas
Standard Deviation 2.19
|
|
Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit.
Week 4
|
-0.9 Number of Fistulas
Standard Deviation 2.79
|
-0.6 Number of Fistulas
Standard Deviation 1.01
|
-2.0 Number of Fistulas
Standard Deviation 3.57
|
-0.9 Number of Fistulas
Standard Deviation 2.53
|
|
Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit.
Week 6
|
-1.3 Number of Fistulas
Standard Deviation 2.69
|
-0.4 Number of Fistulas
Standard Deviation 1.74
|
-2.1 Number of Fistulas
Standard Deviation 3.30
|
-0.6 Number of Fistulas
Standard Deviation 2.72
|
|
Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit.
Week 8
|
-1.0 Number of Fistulas
Standard Deviation 3.06
|
-0.3 Number of Fistulas
Standard Deviation 1.66
|
-2.0 Number of Fistulas
Standard Deviation 3.35
|
-0.6 Number of Fistulas
Standard Deviation 3.85
|
|
Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit.
Follow Up
|
-0.4 Number of Fistulas
Standard Deviation 3.10
|
0.1 Number of Fistulas
Standard Deviation 1.69
|
-2.2 Number of Fistulas
Standard Deviation 3.19
|
-1.3 Number of Fistulas
Standard Deviation 3.86
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Full Analysis Set Population
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.
Outcome measures
| Measure |
INCB54707
n=9 Participants
INCB54707 was administered at either 30,60, or 90 mg. All samples from different dose groups were combined for this analysis.
|
INCB054707 at 30 mg
n=9 Participants
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
|
INCB054707 at 60 mg
n=9 Participants
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
|
INCB054707 at 90 mg
n=8 Participants
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
|
|---|---|---|---|---|
|
Proportion of Participants at Each Category of Hurley Stage
Baseline · Stage I
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportion of Participants at Each Category of Hurley Stage
Baseline · Stage II
|
4 Participants
|
9 Participants
|
5 Participants
|
7 Participants
|
|
Proportion of Participants at Each Category of Hurley Stage
Baseline · Stage III
|
5 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Proportion of Participants at Each Category of Hurley Stage
Baseline · No HS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportion of Participants at Each Category of Hurley Stage
Week 8 · Stage I
|
1 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Proportion of Participants at Each Category of Hurley Stage
Week 8 · Stage II
|
3 Participants
|
6 Participants
|
5 Participants
|
7 Participants
|
|
Proportion of Participants at Each Category of Hurley Stage
Week 8 · Stage III
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportion of Participants at Each Category of Hurley Stage
Week 8 · No HS
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Full Analysis Set Population
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.
Outcome measures
| Measure |
INCB54707
n=9 Participants
INCB54707 was administered at either 30,60, or 90 mg. All samples from different dose groups were combined for this analysis.
|
INCB054707 at 30 mg
n=9 Participants
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
|
INCB054707 at 60 mg
n=9 Participants
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
|
INCB054707 at 90 mg
n=8 Participants
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
|
|---|---|---|---|---|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Early Termination · 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Early Termination · 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 6 · 5
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 6 · 6
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 6 · 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 8 · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 8 · 2
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 8 · 3
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 1 · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 1 · 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 1 · 3
|
0 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 1 · 4
|
4 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 1 · 5
|
3 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 1 · 6
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 1 · 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 2 · 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 2 · 2
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 2 · 3
|
3 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 2 · 4
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 2 · 5
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 2 · 6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 2 · 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 4 · 1
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 4 · 2
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 4 · 3
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 4 · 4
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 4 · 5
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 4 · 6
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 4 · 7
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 6 · 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 6 · 2
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 6 · 3
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 6 · 4
|
1 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 8 · 4
|
5 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 8 · 5
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 8 · 6
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Week 8 · 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Early Termination · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Early Termination · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Early Termination · 4
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Early Termination · 6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Early Termination · 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Follow Up · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Follow Up · 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Follow Up · 3
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Follow Up · 4
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Follow Up · 5
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Follow Up · 6
|
2 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Follow Up · 7
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Full Analysis Set Population
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.
Outcome measures
| Measure |
INCB54707
n=9 Participants
INCB54707 was administered at either 30,60, or 90 mg. All samples from different dose groups were combined for this analysis.
|
INCB054707 at 30 mg
n=9 Participants
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
|
INCB054707 at 60 mg
n=9 Participants
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
|
INCB054707 at 90 mg
n=8 Participants
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
|
|---|---|---|---|---|
|
Actual Measurements in HS-PGIC at Each Visit
Week 1 · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 1 · 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 1 · 3
|
0 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 1 · 4
|
4 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 1 · 5
|
3 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 1 · 6
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 1 · 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 2 · 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 2 · 2
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 2 · 3
|
3 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 2 · 4
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 2 · 5
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 2 · 6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 2 · 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 4 · 1
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 4 · 2
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 4 · 3
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 4 · 4
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 4 · 5
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 4 · 6
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 4 · 7
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 6 · 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 6 · 2
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 6 · 3
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 6 · 4
|
1 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 6 · 5
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 6 · 6
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 6 · 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 8 · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 8 · 2
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 8 · 3
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 8 · 4
|
5 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 8 · 5
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 8 · 6
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Week 8 · 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Early Termination · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Early Termination · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Early Termination · 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Early Termination · 4
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Early Termination · 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Early Termination · 6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Early Termination · 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Follow Up · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Follow Up · 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Follow Up · 3
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Follow Up · 4
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Follow Up · 5
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Follow Up · 6
|
2 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Actual Measurements in HS-PGIC at Each Visit
Follow Up · 7
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Full Analysis Set Population
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.
Outcome measures
| Measure |
INCB54707
n=9 Participants
INCB54707 was administered at either 30,60, or 90 mg. All samples from different dose groups were combined for this analysis.
|
INCB054707 at 30 mg
n=9 Participants
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
|
INCB054707 at 60 mg
n=9 Participants
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
|
INCB054707 at 90 mg
n=8 Participants
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
|
|---|---|---|---|---|
|
Proportion of Participants With Change From Baseline Hurley Stage
Week 8 · Missing
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportion of Participants With Change From Baseline Hurley Stage
Baseline · Stage I
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportion of Participants With Change From Baseline Hurley Stage
Baseline · Stage II
|
4 Participants
|
9 Participants
|
5 Participants
|
7 Participants
|
|
Proportion of Participants With Change From Baseline Hurley Stage
Baseline · Stage III
|
5 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Proportion of Participants With Change From Baseline Hurley Stage
Baseline · No HS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportion of Participants With Change From Baseline Hurley Stage
Baseline · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportion of Participants With Change From Baseline Hurley Stage
Week 8 · Stage I
|
1 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Proportion of Participants With Change From Baseline Hurley Stage
Week 8 · Stage II
|
3 Participants
|
6 Participants
|
5 Participants
|
7 Participants
|
|
Proportion of Participants With Change From Baseline Hurley Stage
Week 8 · Stage III
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportion of Participants With Change From Baseline Hurley Stage
Week 8 · No HS
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
INCB054707 at 30 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
INCB054707 at 60 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
INCB054707 at 90 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Total
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=9 participants at risk
Placebo was administered QD over an 8 week treatment period.
|
INCB054707 at 30 mg
n=9 participants at risk
INCB054707 was administered at 30 mg QD over an 8 week treatment period.
|
INCB054707 at 60 mg
n=9 participants at risk
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
|
INCB054707 at 90 mg
n=8 participants at risk
INCB054707 was administered at 90 mg QD over an 8 week treatment period.
|
Total
n=35 participants at risk
Total
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
5.7%
2/35 • Number of events 2 • up to 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
12.5%
1/8 • Number of events 1 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Acne cystic
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
12.5%
1/8 • Number of events 1 • up to 12 weeks
|
5.7%
2/35 • Number of events 2 • up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
General disorders
Chest pain
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
12.5%
1/8 • Number of events 1 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 2 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
5.7%
2/35 • Number of events 3 • up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
22.2%
2/9 • Number of events 2 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
8.6%
3/35 • Number of events 3 • up to 12 weeks
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
12.5%
1/8 • Number of events 2 • up to 12 weeks
|
5.7%
2/35 • Number of events 3 • up to 12 weeks
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Surgical and medical procedures
Endodontic procedure
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
General disorders
Exercise tolerance decreased
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
General disorders
Fatigue
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
22.2%
2/9 • Number of events 2 • up to 12 weeks
|
37.5%
3/8 • Number of events 3 • up to 12 weeks
|
20.0%
7/35 • Number of events 7 • up to 12 weeks
|
|
Infections and infestations
Folliculitis
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
22.2%
2/9 • Number of events 2 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
11.4%
4/35 • Number of events 4 • up to 12 weeks
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
22.2%
2/9 • Number of events 2 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
5.7%
2/35 • Number of events 2 • up to 12 weeks
|
|
Nervous system disorders
Headache
|
22.2%
2/9 • Number of events 2 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
22.2%
2/9 • Number of events 3 • up to 12 weeks
|
25.0%
2/8 • Number of events 4 • up to 12 weeks
|
17.1%
6/35 • Number of events 9 • up to 12 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Nervous system disorders
Migraine
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 2 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 2 • up to 12 weeks
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
22.2%
2/9 • Number of events 2 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
11.4%
4/35 • Number of events 4 • up to 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
12.5%
1/8 • Number of events 1 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Infections and infestations
Oral herpes
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
5.7%
2/35 • Number of events 2 • up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
General disorders
Pain
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
12.5%
1/8 • Number of events 1 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Cardiac disorders
Palpitations
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
12.5%
1/8 • Number of events 1 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
12.5%
1/8 • Number of events 2 • up to 12 weeks
|
2.9%
1/35 • Number of events 2 • up to 12 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
12.5%
1/8 • Number of events 1 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
12.5%
1/8 • Number of events 1 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Psychiatric disorders
Sleep disorder
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
50.0%
4/8 • Number of events 4 • up to 12 weeks
|
11.4%
4/35 • Number of events 4 • up to 12 weeks
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/9 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
12.5%
1/8 • Number of events 1 • up to 12 weeks
|
2.9%
1/35 • Number of events 1 • up to 12 weeks
|
|
General disorders
Vessel puncture site haemorrhage
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
11.1%
1/9 • Number of events 1 • up to 12 weeks
|
0.00%
0/9 • up to 12 weeks
|
0.00%
0/8 • up to 12 weeks
|
5.7%
2/35 • Number of events 2 • up to 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Study Agreement
- Publication restrictions are in place
Restriction type: OTHER