Trial Outcomes & Findings for To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa (NCT NCT04476043)
NCT ID: NCT04476043
Last Updated: 2025-08-12
Results Overview
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The mixed model repeated measure (MMRM) included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity \[Hurley Stage I, II, and III\] and geographical region \[North America and outside of North America\]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
209 participants
Primary outcome timeframe
Baseline; Week 16
Results posted on
2025-08-12
Participant Flow
A total of 209 participants were enrolled at 36 study centers: 26 in North America and 10 in Europe. Data are reported through the cut-off date of 15 December 2021.
Participant milestones
| Measure |
Placebo
Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 15 mg
Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 45 mg
Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 75 mg
Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
52
|
52
|
52
|
53
|
|
Overall Study
COMPLETED
|
48
|
47
|
45
|
51
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
7
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 15 mg
Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 45 mg
Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 75 mg
Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
1
|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
Baseline Characteristics
To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Baseline characteristics by cohort
| Measure |
Placebo
n=52 Participants
Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 15 mg
n=52 Participants
Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 45 mg
n=52 Participants
Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 75 mg
n=53 Participants
Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
Total
n=209 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.2 years
STANDARD_DEVIATION 9.96 • n=5 Participants
|
38.2 years
STANDARD_DEVIATION 10.85 • n=7 Participants
|
37.3 years
STANDARD_DEVIATION 12.51 • n=5 Participants
|
37.5 years
STANDARD_DEVIATION 10.83 • n=4 Participants
|
37.1 years
STANDARD_DEVIATION 11.05 • n=21 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
158 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
40 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
147 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Captured as Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
179 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
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
|
|
Mean abscess and inflammatory nodule (AN) count
|
11.2 abscesses and inflammatory nodules
STANDARD_DEVIATION 5.85 • n=5 Participants
|
11.8 abscesses and inflammatory nodules
STANDARD_DEVIATION 7.10 • n=7 Participants
|
12.9 abscesses and inflammatory nodules
STANDARD_DEVIATION 12.34 • n=5 Participants
|
10.6 abscesses and inflammatory nodules
STANDARD_DEVIATION 7.24 • n=4 Participants
|
11.6 abscesses and inflammatory nodules
STANDARD_DEVIATION 8.48 • n=21 Participants
|
|
Mean International Hidradenitis Suppurativa Severity Score System (IHS4) score
|
22.9 scores on a scale
STANDARD_DEVIATION 17.02 • n=5 Participants
|
22.4 scores on a scale
STANDARD_DEVIATION 23.24 • n=7 Participants
|
23.5 scores on a scale
STANDARD_DEVIATION 22.79 • n=5 Participants
|
18.9 scores on a scale
STANDARD_DEVIATION 17.25 • n=4 Participants
|
21.9 scores on a scale
STANDARD_DEVIATION 20.21 • n=21 Participants
|
|
Mean abscess, inflammatory nodule (IN), and draining fistula (DF) (ANF) count
|
13.6 abscesses, INs, and DFs
STANDARD_DEVIATION 6.36 • n=5 Participants
|
14.1 abscesses, INs, and DFs
STANDARD_DEVIATION 10.08 • n=7 Participants
|
15.1 abscesses, INs, and DFs
STANDARD_DEVIATION 13.51 • n=5 Participants
|
12.2 abscesses, INs, and DFs
STANDARD_DEVIATION 8.94 • n=4 Participants
|
13.7 abscesses, INs, and DFs
STANDARD_DEVIATION 10.03 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 16Population: Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups for this population were defined according to the treatment assignment at randomization. Only participants with available data were analyzed.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The mixed model repeated measure (MMRM) included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity \[Hurley Stage I, II, and III\] and geographical region \[North America and outside of North America\]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 15 mg
n=45 Participants
Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 45 mg
n=43 Participants
Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 75 mg
n=46 Participants
Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16
|
-2.5 abscesses and inflammatory nodules
Standard Error 0.88
|
-5.2 abscesses and inflammatory nodules
Standard Error 0.86
|
-6.9 abscesses and inflammatory nodules
Standard Error 0.88
|
-6.3 abscesses and inflammatory nodules
Standard Error 0.85
|
SECONDARY outcome
Timeframe: Baseline; Week 16Population: ITT Population. 95% confidence interval (CI) was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders.
HiSCR, the key secondary endpoint, was defined as at least a 50% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas.
Outcome measures
| Measure |
Placebo
n=52 Participants
Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 15 mg
n=52 Participants
Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 45 mg
n=52 Participants
Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 75 mg
n=53 Participants
Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
|
28.8 percentage of participants
Interval 17.1 to 43.1
|
48.1 percentage of participants
Interval 34.0 to 62.4
|
44.2 percentage of participants
Interval 30.5 to 58.7
|
45.3 percentage of participants
Interval 31.6 to 59.6
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 6, 8, and 12Population: ITT Population. 95% CI was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders.
HiSCR was defined as at least a 50% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas.
Outcome measures
| Measure |
Placebo
n=52 Participants
Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 15 mg
n=52 Participants
Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 45 mg
n=52 Participants
Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 75 mg
n=53 Participants
Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12
Week 2
|
15.4 percentage of participants
Interval 6.9 to 28.1
|
25.0 percentage of participants
Interval 14.0 to 38.9
|
34.6 percentage of participants
Interval 22.0 to 49.1
|
34.0 percentage of participants
Interval 21.5 to 48.3
|
|
Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12
Week 4
|
25.0 percentage of participants
Interval 14.0 to 38.9
|
36.5 percentage of participants
Interval 23.6 to 51.0
|
44.2 percentage of participants
Interval 30.5 to 58.7
|
49.1 percentage of participants
Interval 35.1 to 63.2
|
|
Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12
Week 6
|
17.3 percentage of participants
Interval 8.2 to 30.3
|
32.7 percentage of participants
Interval 20.3 to 47.1
|
48.1 percentage of participants
Interval 34.0 to 62.4
|
52.8 percentage of participants
Interval 38.6 to 66.7
|
|
Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12
Week 8
|
28.8 percentage of participants
Interval 17.1 to 43.1
|
36.5 percentage of participants
Interval 23.6 to 51.0
|
44.2 percentage of participants
Interval 30.5 to 58.7
|
52.8 percentage of participants
Interval 38.6 to 66.7
|
|
Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12
Week 12
|
30.8 percentage of participants
Interval 18.7 to 45.1
|
42.3 percentage of participants
Interval 28.7 to 56.8
|
48.1 percentage of participants
Interval 34.0 to 62.4
|
58.5 percentage of participants
Interval 44.1 to 71.9
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 6, 8, 12, and 16Population: ITT Population. 95% CI was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders.
HiSCR75 was defined as at least a 75% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas.
Outcome measures
| Measure |
Placebo
n=52 Participants
Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 15 mg
n=52 Participants
Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 45 mg
n=52 Participants
Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 75 mg
n=53 Participants
Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16
Week 16
|
17.3 percentage of participants
Interval 8.2 to 30.3
|
30.8 percentage of participants
Interval 18.7 to 45.1
|
28.8 percentage of participants
Interval 17.1 to 43.1
|
30.2 percentage of participants
Interval 18.3 to 44.3
|
|
Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16
Week 2
|
1.9 percentage of participants
Interval 0.0 to 10.3
|
9.6 percentage of participants
Interval 3.2 to 21.0
|
13.5 percentage of participants
Interval 5.6 to 25.8
|
18.9 percentage of participants
Interval 9.4 to 32.0
|
|
Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16
Week 4
|
7.7 percentage of participants
Interval 2.1 to 18.5
|
15.4 percentage of participants
Interval 6.9 to 28.1
|
21.2 percentage of participants
Interval 11.1 to 34.7
|
15.1 percentage of participants
Interval 6.7 to 27.6
|
|
Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16
Week 6
|
9.6 percentage of participants
Interval 3.2 to 21.0
|
17.3 percentage of participants
Interval 8.2 to 30.3
|
28.8 percentage of participants
Interval 17.1 to 43.1
|
24.5 percentage of participants
Interval 13.8 to 38.3
|
|
Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16
Week 8
|
19.2 percentage of participants
Interval 9.6 to 32.5
|
23.1 percentage of participants
Interval 12.5 to 36.8
|
30.8 percentage of participants
Interval 18.7 to 45.1
|
35.8 percentage of participants
Interval 23.1 to 50.2
|
|
Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16
Week 12
|
19.2 percentage of participants
Interval 9.6 to 32.5
|
26.9 percentage of participants
Interval 15.6 to 41.0
|
32.7 percentage of participants
Interval 20.3 to 47.1
|
39.6 percentage of participants
Interval 26.5 to 54.0
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 6, 8, 12, and 16Population: ITT Population. Only participants with available data were analyzed.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The IHS4 is a composite, dynamic score and validated tool used to determine Hidradenitis Suppurativa severity. It employs a weighted scale using the number of inflammatory nodules, the number of abscesses, and the number of draining tunnels (fistulas or sinuses), with respective weight factors of 1, 2, and 4. Scores: mild=0-3; moderate=4-10; severe ≥11. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity \[Hurley Stage I, II, and III\] and geographical region \[North America and outside of North America\]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.
Outcome measures
| Measure |
Placebo
n=52 Participants
Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 15 mg
n=52 Participants
Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 45 mg
n=52 Participants
Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 75 mg
n=53 Participants
Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
|---|---|---|---|---|
|
Mean Change From Baseline in the Severity of the Disease, as Assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4) Score, From Weeks 2 to 16
Week 2
|
-2.4 scores on a scale
Standard Error 1.17
|
-3.8 scores on a scale
Standard Error 1.13
|
-6.7 scores on a scale
Standard Error 1.16
|
-6.1 scores on a scale
Standard Error 1.12
|
|
Mean Change From Baseline in the Severity of the Disease, as Assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4) Score, From Weeks 2 to 16
Week 4
|
-2.1 scores on a scale
Standard Error 1.52
|
-3.9 scores on a scale
Standard Error 1.49
|
-9.3 scores on a scale
Standard Error 1.51
|
-9.3 scores on a scale
Standard Error 1.47
|
|
Mean Change From Baseline in the Severity of the Disease, as Assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4) Score, From Weeks 2 to 16
Week 6
|
-3.1 scores on a scale
Standard Error 1.77
|
-4.7 scores on a scale
Standard Error 1.73
|
-10.7 scores on a scale
Standard Error 1.75
|
-10.6 scores on a scale
Standard Error 1.71
|
|
Mean Change From Baseline in the Severity of the Disease, as Assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4) Score, From Weeks 2 to 16
Week 8
|
-3.0 scores on a scale
Standard Error 1.85
|
-4.0 scores on a scale
Standard Error 1.79
|
-11.8 scores on a scale
Standard Error 1.83
|
-10.7 scores on a scale
Standard Error 1.78
|
|
Mean Change From Baseline in the Severity of the Disease, as Assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4) Score, From Weeks 2 to 16
Week 12
|
-3.1 scores on a scale
Standard Error 1.80
|
-5.5 scores on a scale
Standard Error 1.76
|
-11.8 scores on a scale
Standard Error 1.79
|
-11.9 scores on a scale
Standard Error 1.73
|
|
Mean Change From Baseline in the Severity of the Disease, as Assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4) Score, From Weeks 2 to 16
Week 16
|
-3.1 scores on a scale
Standard Error 1.96
|
-5.6 scores on a scale
Standard Error 1.92
|
-11.0 scores on a scale
Standard Error 1.96
|
-12.1 scores on a scale
Standard Error 1.90
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 6, 8, 12, and 16Population: ITT Population. 95% CI was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders.
AN50, AN75, AN90, and AN100 were defined as at least a 50%, 75%, 90%, and 100% decrease, respectively, from Baseline in AN count.
Outcome measures
| Measure |
Placebo
n=52 Participants
Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 15 mg
n=52 Participants
Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 45 mg
n=52 Participants
Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 75 mg
n=53 Participants
Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN50, Week 2
|
15.4 percentage of participants
Interval 6.9 to 28.1
|
25.0 percentage of participants
Interval 14.0 to 38.9
|
34.6 percentage of participants
Interval 22.0 to 49.1
|
39.6 percentage of participants
Interval 26.5 to 54.0
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN50, Week 4
|
30.8 percentage of participants
Interval 18.7 to 45.1
|
44.2 percentage of participants
Interval 30.5 to 58.7
|
46.2 percentage of participants
Interval 32.2 to 60.5
|
58.5 percentage of participants
Interval 44.1 to 71.9
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN50, Week 6
|
32.7 percentage of participants
Interval 20.3 to 47.1
|
46.2 percentage of participants
Interval 32.2 to 60.5
|
51.9 percentage of participants
Interval 37.6 to 66.0
|
56.6 percentage of participants
Interval 42.3 to 70.2
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN50, Week 8
|
36.5 percentage of participants
Interval 23.6 to 51.0
|
55.8 percentage of participants
Interval 41.3 to 69.5
|
53.8 percentage of participants
Interval 39.5 to 67.8
|
54.7 percentage of participants
Interval 40.4 to 68.4
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN50, Week 12
|
44.2 percentage of participants
Interval 30.5 to 58.7
|
51.9 percentage of participants
Interval 37.6 to 66.0
|
55.8 percentage of participants
Interval 41.3 to 69.5
|
62.3 percentage of participants
Interval 47.9 to 75.2
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN50, Week 16
|
36.5 percentage of participants
Interval 23.6 to 51.0
|
55.8 percentage of participants
Interval 41.3 to 69.5
|
57.7 percentage of participants
Interval 43.2 to 71.3
|
52.8 percentage of participants
Interval 38.6 to 66.7
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN75, Week 2
|
1.9 percentage of participants
Interval 0.0 to 10.3
|
9.6 percentage of participants
Interval 3.2 to 21.0
|
13.5 percentage of participants
Interval 5.6 to 25.8
|
20.8 percentage of participants
Interval 10.8 to 34.1
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN75, Week 4
|
7.7 percentage of participants
Interval 2.1 to 18.5
|
15.4 percentage of participants
Interval 6.9 to 28.1
|
23.1 percentage of participants
Interval 12.5 to 36.8
|
18.9 percentage of participants
Interval 9.4 to 32.0
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN75, Week 6
|
13.5 percentage of participants
Interval 5.6 to 25.8
|
25.0 percentage of participants
Interval 14.0 to 38.9
|
32.7 percentage of participants
Interval 20.3 to 47.1
|
26.4 percentage of participants
Interval 15.3 to 40.3
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN75, Week 8
|
21.2 percentage of participants
Interval 11.1 to 34.7
|
28.8 percentage of participants
Interval 17.1 to 43.1
|
32.7 percentage of participants
Interval 20.3 to 47.1
|
37.7 percentage of participants
Interval 24.8 to 52.1
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN75, Week 12
|
23.1 percentage of participants
Interval 12.5 to 36.8
|
32.7 percentage of participants
Interval 20.3 to 47.1
|
36.5 percentage of participants
Interval 23.6 to 51.0
|
39.6 percentage of participants
Interval 26.5 to 54.0
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN75, Week 16
|
17.3 percentage of participants
Interval 8.2 to 30.3
|
36.5 percentage of participants
Interval 23.6 to 51.0
|
36.5 percentage of participants
Interval 23.6 to 51.0
|
34.0 percentage of participants
Interval 21.5 to 48.3
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN90, Week 2
|
0.0 percentage of participants
Interval 0.0 to 6.8
|
3.8 percentage of participants
Interval 0.5 to 13.2
|
1.9 percentage of participants
Interval 0.0 to 10.3
|
11.3 percentage of participants
Interval 4.3 to 23.0
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN90, Week 4
|
0.0 percentage of participants
Interval 0.0 to 6.8
|
5.8 percentage of participants
Interval 1.2 to 15.9
|
7.7 percentage of participants
Interval 2.1 to 18.5
|
5.7 percentage of participants
Interval 1.2 to 15.7
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN90, Week 6
|
5.8 percentage of participants
Interval 1.2 to 15.9
|
5.8 percentage of participants
Interval 1.2 to 15.9
|
11.5 percentage of participants
Interval 4.4 to 23.4
|
9.4 percentage of participants
Interval 3.1 to 20.7
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN90, Week 8
|
5.8 percentage of participants
Interval 1.2 to 15.9
|
15.4 percentage of participants
Interval 6.9 to 28.1
|
19.2 percentage of participants
Interval 9.6 to 32.5
|
18.9 percentage of participants
Interval 9.4 to 32.0
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN90, Week 12
|
5.8 percentage of participants
Interval 1.2 to 15.9
|
17.3 percentage of participants
Interval 8.2 to 30.3
|
13.5 percentage of participants
Interval 5.6 to 25.8
|
20.8 percentage of participants
Interval 10.8 to 34.1
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN90, Week 16
|
3.8 percentage of participants
Interval 0.5 to 13.2
|
17.3 percentage of participants
Interval 8.2 to 30.3
|
19.2 percentage of participants
Interval 9.6 to 32.5
|
18.9 percentage of participants
Interval 9.4 to 32.0
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN100, Week 2
|
0.0 percentage of participants
Interval 0.0 to 6.8
|
3.8 percentage of participants
Interval 0.5 to 13.2
|
1.9 percentage of participants
Interval 0.0 to 10.3
|
7.5 percentage of participants
Interval 2.1 to 18.2
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN100, Week 4
|
0.0 percentage of participants
Interval 0.0 to 6.8
|
3.8 percentage of participants
Interval 0.5 to 13.2
|
5.8 percentage of participants
Interval 1.2 to 15.9
|
5.7 percentage of participants
Interval 1.2 to 15.7
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN100, Week 6
|
0.0 percentage of participants
Interval 0.0 to 6.8
|
3.8 percentage of participants
Interval 0.5 to 13.2
|
7.7 percentage of participants
Interval 2.1 to 18.5
|
9.4 percentage of participants
Interval 3.1 to 20.7
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN100, Week 8
|
3.8 percentage of participants
Interval 0.5 to 13.2
|
13.5 percentage of participants
Interval 5.6 to 25.8
|
11.5 percentage of participants
Interval 4.4 to 23.4
|
17.0 percentage of participants
Interval 8.1 to 29.8
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN100, Week 12
|
3.8 percentage of participants
Interval 0.5 to 13.2
|
13.5 percentage of participants
Interval 5.6 to 25.8
|
11.5 percentage of participants
Interval 4.4 to 23.4
|
18.9 percentage of participants
Interval 9.4 to 32.0
|
|
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN100, Week 16
|
3.8 percentage of participants
Interval 0.5 to 13.2
|
15.4 percentage of participants
Interval 6.9 to 28.1
|
11.5 percentage of participants
Interval 4.4 to 23.4
|
17.0 percentage of participants
Interval 8.1 to 29.8
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 6, 8, and 12Population: ITT Population. Only participants with available data were analyzed.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity \[Hurley Stage I, II, and III\] and geographical region \[North America and outside of North America\]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.
Outcome measures
| Measure |
Placebo
n=52 Participants
Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 15 mg
n=52 Participants
Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 45 mg
n=52 Participants
Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 75 mg
n=53 Participants
Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
|---|---|---|---|---|
|
Mean Change From Baseline in AN Count at Weeks 2 to 12
Week 2
|
-1.7 abscesses and inflammatory nodules
Standard Error 0.69
|
-2.7 abscesses and inflammatory nodules
Standard Error 0.66
|
-3.4 abscesses and inflammatory nodules
Standard Error 0.69
|
-4.0 abscesses and inflammatory nodules
Standard Error 0.66
|
|
Mean Change From Baseline in AN Count at Weeks 2 to 12
Week 4
|
-3.0 abscesses and inflammatory nodules
Standard Error 0.71
|
-3.6 abscesses and inflammatory nodules
Standard Error 0.70
|
-4.8 abscesses and inflammatory nodules
Standard Error 0.71
|
-5.3 abscesses and inflammatory nodules
Standard Error 0.69
|
|
Mean Change From Baseline in AN Count at Weeks 2 to 12
Week 6
|
-2.7 abscesses and inflammatory nodules
Standard Error 0.77
|
-4.8 abscesses and inflammatory nodules
Standard Error 0.76
|
-5.3 abscesses and inflammatory nodules
Standard Error 0.77
|
-6.2 abscesses and inflammatory nodules
Standard Error 0.75
|
|
Mean Change From Baseline in AN Count at Weeks 2 to 12
Week 8
|
-2.7 abscesses and inflammatory nodules
Standard Error 0.82
|
-4.7 abscesses and inflammatory nodules
Standard Error 0.79
|
-6.4 abscesses and inflammatory nodules
Standard Error 0.82
|
-5.7 abscesses and inflammatory nodules
Standard Error 0.79
|
|
Mean Change From Baseline in AN Count at Weeks 2 to 12
Week 12
|
-2.8 abscesses and inflammatory nodules
Standard Error 0.84
|
-5.0 abscesses and inflammatory nodules
Standard Error 0.82
|
-6.7 abscesses and inflammatory nodules
Standard Error 0.84
|
-6.5 abscesses and inflammatory nodules
Standard Error 0.81
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6, 8, 12, and 16Population: ITT Population. Only participants with available data were analyzed.
Total AN count was assessed throughout the study.
Outcome measures
| Measure |
Placebo
n=52 Participants
Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 15 mg
n=52 Participants
Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 45 mg
n=52 Participants
Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 75 mg
n=53 Participants
Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
|---|---|---|---|---|
|
Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16
Week 2
|
4.3 percentage of participants
|
9.8 percentage of participants
|
16.7 percentage of participants
|
23.1 percentage of participants
|
|
Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16
Week 4
|
14.3 percentage of participants
|
20.0 percentage of participants
|
20.0 percentage of participants
|
23.1 percentage of participants
|
|
Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16
Week 6
|
13.3 percentage of participants
|
19.1 percentage of participants
|
31.3 percentage of participants
|
38.8 percentage of participants
|
|
Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16
Week 8
|
28.9 percentage of participants
|
30.0 percentage of participants
|
38.3 percentage of participants
|
41.2 percentage of participants
|
|
Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16
Week 12
|
28.9 percentage of participants
|
33.3 percentage of participants
|
46.7 percentage of participants
|
38.8 percentage of participants
|
|
Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16
Week 16
|
25.6 percentage of participants
|
44.4 percentage of participants
|
51.2 percentage of participants
|
37.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 6, 8, 12, and 16Population: ITT Population. Only participants with available data were analyzed.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Placebo
n=52 Participants
Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 15 mg
n=52 Participants
Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 45 mg
n=52 Participants
Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 75 mg
n=53 Participants
Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16
Baseline
|
2.4 draining fistulas
Standard Deviation 3.97
|
2.3 draining fistulas
Standard Deviation 4.44
|
2.2 draining fistulas
Standard Deviation 4.04
|
1.6 draining fistulas
Standard Deviation 2.85
|
|
Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16
Change from Baseline at Week 2
|
-0.2 draining fistulas
Standard Deviation 1.23
|
-0.2 draining fistulas
Standard Deviation 1.01
|
-0.6 draining fistulas
Standard Deviation 1.62
|
-0.2 draining fistulas
Standard Deviation 1.30
|
|
Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16
Change from Baseline at Week 4
|
0.0 draining fistulas
Standard Deviation 1.80
|
0.0 draining fistulas
Standard Deviation 1.11
|
-0.8 draining fistulas
Standard Deviation 2.59
|
-0.6 draining fistulas
Standard Deviation 2.44
|
|
Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16
Change from Baseline at Week 6
|
-0.2 draining fistulas
Standard Deviation 2.14
|
0.1 draining fistulas
Standard Deviation 1.85
|
-1.0 draining fistulas
Standard Deviation 2.95
|
-0.8 draining fistulas
Standard Deviation 2.62
|
|
Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16
Change from Baseline at Week 8
|
-0.2 draining fistulas
Standard Deviation 2.46
|
0.2 draining fistulas
Standard Deviation 2.10
|
-1.1 draining fistulas
Standard Deviation 2.82
|
-0.8 draining fistulas
Standard Deviation 2.70
|
|
Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16
Change from Baseline at Week 12
|
-0.3 draining fistulas
Standard Deviation 2.17
|
0.0 draining fistulas
Standard Deviation 2.71
|
-1.0 draining fistulas
Standard Deviation 2.87
|
-1.0 draining fistulas
Standard Deviation 2.61
|
|
Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16
Change from Baseline at Week 16
|
-0.3 draining fistulas
Standard Deviation 2.05
|
0.1 draining fistulas
Standard Deviation 3.25
|
-0.8 draining fistulas
Standard Deviation 3.20
|
-1.1 draining fistulas
Standard Deviation 2.57
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 6, 8, 12, and 16Population: ITT Population. Only participants with available data were analyzed.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity \[Hurley Stage I, II, and III\] and geographical region \[North America and outside of North America\]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.
Outcome measures
| Measure |
Placebo
n=52 Participants
Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 15 mg
n=52 Participants
Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 45 mg
n=52 Participants
Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 75 mg
n=53 Participants
Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16
Week 2
|
-1.8 abscesses, INs, and DFs
Standard Error 0.74
|
-2.9 abscesses, INs, and DFs
Standard Error 0.72
|
-4.0 abscesses, INs, and DFs
Standard Error 0.74
|
-4.4 abscesses, INs, and DFs
Standard Error 0.71
|
|
Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16
Week 4
|
-2.7 abscesses, INs, and DFs
Standard Error 0.83
|
-3.5 abscesses, INs, and DFs
Standard Error 0.82
|
-5.7 abscesses, INs, and DFs
Standard Error 0.82
|
-6.2 abscesses, INs, and DFs
Standard Error 0.80
|
|
Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16
Week 6
|
-2.6 abscesses, INs, and DFs
Standard Error 0.92
|
-4.7 abscesses, INs, and DFs
Standard Error 0.90
|
-6.4 abscesses, INs, and DFs
Standard Error 0.92
|
-7.1 abscesses, INs, and DFs
Standard Error 0.89
|
|
Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16
Week 8
|
-2.6 abscesses, INs, and DFs
Standard Error 0.96
|
-4.4 abscesses, INs, and DFs
Standard Error 0.93
|
-7.5 abscesses, INs, and DFs
Standard Error 0.96
|
-6.8 abscesses, INs, and DFs
Standard Error 0.92
|
|
Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16
Week 12
|
-2.7 abscesses, INs, and DFs
Standard Error 0.99
|
-5.0 abscesses, INs, and DFs
Standard Error 0.97
|
-7.7 abscesses, INs, and DFs
Standard Error 0.98
|
-7.6 abscesses, INs, and DFs
Standard Error 0.95
|
|
Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16
Week 16
|
-2.4 abscesses, INs, and DFs
Standard Error 1.06
|
-5.1 abscesses, INs, and DFs
Standard Error 1.03
|
-7.7 abscesses, INs, and DFs
Standard Error 1.05
|
-7.6 abscesses, INs, and DFs
Standard Error 1.02
|
SECONDARY outcome
Timeframe: up to Week 16Population: Safety Population: all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up.
Outcome measures
| Measure |
Placebo
n=52 Participants
Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 15 mg
n=52 Participants
Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 45 mg
n=50 Participants
Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 75 mg
n=53 Participants
Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
34 Participants
|
31 Participants
|
30 Participants
|
32 Participants
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
INCB054707 15 mg
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
INCB054707 45 mg
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
INCB054707 75 mg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=52 participants at risk
Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 15 mg
n=52 participants at risk
Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 45 mg
n=50 participants at risk
Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 75 mg
n=53 participants at risk
Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
|---|---|---|---|---|
|
Infections and infestations
Abscess limb
|
1.9%
1/52 • Number of events 1 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/52 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/50 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/53 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
1/52 • Number of events 1 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/52 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/50 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/53 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
|
Infections and infestations
Bacterial infection
|
1.9%
1/52 • Number of events 1 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/52 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/50 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/53 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
|
Hepatobiliary disorders
Cholecystitis
|
1.9%
1/52 • Number of events 1 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/52 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/50 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/53 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/52 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
1.9%
1/52 • Number of events 1 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/50 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/53 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/52 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/52 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
2.0%
1/50 • Number of events 1 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/53 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/52 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
1.9%
1/52 • Number of events 1 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/50 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/53 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/52 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
1.9%
1/52 • Number of events 1 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/50 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/53 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/52 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
1.9%
1/52 • Number of events 1 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/50 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/53 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
Other adverse events
| Measure |
Placebo
n=52 participants at risk
Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 15 mg
n=52 participants at risk
Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 45 mg
n=50 participants at risk
Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
INCB054707 75 mg
n=53 participants at risk
Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/52 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
1.9%
1/52 • Number of events 1 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
6.0%
3/50 • Number of events 3 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
5.7%
3/53 • Number of events 3 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/52 • Number of events 1 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
5.8%
3/52 • Number of events 3 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
2.0%
1/50 • Number of events 1 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/53 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
|
Gastrointestinal disorders
Constipation
|
3.8%
2/52 • Number of events 2 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
7.7%
4/52 • Number of events 5 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/50 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
1.9%
1/53 • Number of events 1 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
1/52 • Number of events 1 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
5.8%
3/52 • Number of events 3 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
4.0%
2/50 • Number of events 2 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
5.7%
3/53 • Number of events 3 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
|
General disorders
Fatigue
|
7.7%
4/52 • Number of events 4 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
9.6%
5/52 • Number of events 5 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
12.0%
6/50 • Number of events 6 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
11.3%
6/53 • Number of events 6 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
|
Nervous system disorders
Headache
|
9.6%
5/52 • Number of events 5 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
7.7%
4/52 • Number of events 5 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
6.0%
3/50 • Number of events 3 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
7.5%
4/53 • Number of events 4 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
|
Vascular disorders
Hypertension
|
3.8%
2/52 • Number of events 2 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/52 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/50 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
5.7%
3/53 • Number of events 3 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/52 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
5.8%
3/52 • Number of events 3 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
6.0%
3/50 • Number of events 3 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/53 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
|
Gastrointestinal disorders
Nausea
|
9.6%
5/52 • Number of events 6 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
5.8%
3/52 • Number of events 3 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
4.0%
2/50 • Number of events 2 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
5.7%
3/53 • Number of events 3 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
2/52 • Number of events 2 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/52 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
2.0%
1/50 • Number of events 1 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
7.5%
4/53 • Number of events 4 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/52 • Number of events 1 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
0.00%
0/52 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
2.0%
1/50 • Number of events 1 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
5.7%
3/53 • Number of events 3 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/52 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
5.8%
3/52 • Number of events 3 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
4.0%
2/50 • Number of events 2 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
1.9%
1/53 • Number of events 1 • up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER