Trial Outcomes & Findings for Open Label, Safety and Efficacy Study of Topical Investigational Drug to Treat Patients With Psoriasis (NCT NCT00617994)
NCT ID: NCT00617994
Last Updated: 2022-02-08
Results Overview
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Approximately 3 months
Results posted on
2022-02-08
Participant Flow
The study was conducted at 6 study centers in the United States from 08 November 2007 to 13 April 2009. This study is completed.
A total of 25 participants with active but stable plaque psoriasis were enrolled in the dose-escalation study.
Participant milestones
| Measure |
Cohort A
2% to 7% of BSA treated BID with INCB018424 1.5% cream
|
Cohort B
8% to 13% of BSA treated BID with INCB018424 1.5% cream
|
Cohort C
14% to 20% of BSA treated QD with INCB018424 1.5% cream
|
Cohort D
14% to 20% of BSA treated BID with INCB018424 1.0% cream
|
Cohort E
14% to 20% of BSA treated BID with INCB018424 1.5% cream
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open Label, Safety and Efficacy Study of Topical Investigational Drug to Treat Patients With Psoriasis
Baseline characteristics by cohort
| Measure |
Cohort A
n=5 Participants
2% to 7% of BSA treated BID with INCB018424 1.5% cream
|
Cohort B
n=5 Participants
8% to 13% of BSA treated BID with INCB018424 1.5% cream
|
Cohort C
n=5 Participants
14% to 20% of BSA treated QD with INCB018424 1.5% cream
|
Cohort D
n=5 Participants
14% to 20% of BSA treated BID with INCB018424 1.0% cream
|
Cohort E
n=5 Participants
14% to 20% of BSA treated BID with INCB018424 1.5% cream
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
37.8 Years
STANDARD_DEVIATION 6.22 • n=5 Participants
|
32.4 Years
STANDARD_DEVIATION 7.57 • n=7 Participants
|
43.2 Years
STANDARD_DEVIATION 13.94 • n=5 Participants
|
46.2 Years
STANDARD_DEVIATION 12.21 • n=4 Participants
|
42.8 Years
STANDARD_DEVIATION 18.16 • n=21 Participants
|
40.5 Years
STANDARD_DEVIATION 12.36 • n=10 Participants
|
|
Sex/Gender, Customized
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
|
Sex/Gender, Customized
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
22 Participants
n=10 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
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Approximately 3 monthsAdverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Outcome measures
| Measure |
Cohort A
n=5 Participants
2% to 7% of BSA treated BID with INCB018424 1.5% cream
|
Cohort B
n=5 Participants
8% to 13% of BSA treated BID with INCB018424 1.5% cream
|
Cohort C
n=5 Participants
14% to 20% of BSA treated QD with INCB018424 1.5% cream
|
Cohort D
n=5 Participants
14% to 20% of BSA treated BID with INCB018424 1.0% cream
|
Cohort E
n=5 Participants
14% to 20% of BSA treated BID with INCB018424 1.5% cream
|
Cohort C
14% to 20% of BSA treated QD with INCB018424 1.5% cream
|
Cohort D: Control Lesion
Control Lesions were not treated.
|
Cohort D
14% to 20% of BSA treated BID with INCB018424 1.0% cream
|
Cohort E: Control Lesion
Control Lesions were not treated.
|
Cohort E
14% to 20% of BSA treated BID with INCB018424 1.5% cream
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Treatment of Emergent Adverse Events
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 4, 8, 15, 22, and 28-30The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study.
Outcome measures
| Measure |
Cohort A
n=5 Participants
2% to 7% of BSA treated BID with INCB018424 1.5% cream
|
Cohort B
n=5 Participants
8% to 13% of BSA treated BID with INCB018424 1.5% cream
|
Cohort C
n=5 Participants
14% to 20% of BSA treated QD with INCB018424 1.5% cream
|
Cohort D
n=5 Participants
14% to 20% of BSA treated BID with INCB018424 1.0% cream
|
Cohort E
n=5 Participants
14% to 20% of BSA treated BID with INCB018424 1.5% cream
|
Cohort C
14% to 20% of BSA treated QD with INCB018424 1.5% cream
|
Cohort D: Control Lesion
Control Lesions were not treated.
|
Cohort D
14% to 20% of BSA treated BID with INCB018424 1.0% cream
|
Cohort E: Control Lesion
Control Lesions were not treated.
|
Cohort E
14% to 20% of BSA treated BID with INCB018424 1.5% cream
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics Parameter : Skin Flux of INCB018424
|
180 ng/cm^2/h
Standard Deviation 126
|
131 ng/cm^2/h
Standard Deviation 92
|
60 ng/cm^2/h
Standard Deviation 43
|
151 ng/cm^2/h
Standard Deviation 126
|
152 ng/cm^2/h
Standard Deviation 74
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Approximately one month: Days 1, 4, 8, 15, 22, and 28The INCB018424 bioavailability was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study.
Outcome measures
| Measure |
Cohort A
n=5 Participants
2% to 7% of BSA treated BID with INCB018424 1.5% cream
|
Cohort B
n=5 Participants
8% to 13% of BSA treated BID with INCB018424 1.5% cream
|
Cohort C
n=5 Participants
14% to 20% of BSA treated QD with INCB018424 1.5% cream
|
Cohort D
n=5 Participants
14% to 20% of BSA treated BID with INCB018424 1.0% cream
|
Cohort E
n=5 Participants
14% to 20% of BSA treated BID with INCB018424 1.5% cream
|
Cohort C
14% to 20% of BSA treated QD with INCB018424 1.5% cream
|
Cohort D: Control Lesion
Control Lesions were not treated.
|
Cohort D
14% to 20% of BSA treated BID with INCB018424 1.0% cream
|
Cohort E: Control Lesion
Control Lesions were not treated.
|
Cohort E
14% to 20% of BSA treated BID with INCB018424 1.5% cream
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics Parameter: Bioavailability of INCB018424
|
3.8 percentage
Standard Deviation 2.5
|
4.1 percentage
Standard Deviation 3.4
|
3.4 percentage
Standard Deviation 1.9
|
3.9 percentage
Standard Deviation 1.3
|
5.2 percentage
Standard Deviation 1.9
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Approximately one month: Days 1, 4, 8, 15, 22, and 28All observed INCB018424 plasma concentrations from Days 8, 15, 22, and 28 were averaged to obtain an overall mean exposure for each subject. Samples were taken pre-dose and approximately one hour post-dose.
Outcome measures
| Measure |
Cohort A
n=5 Participants
2% to 7% of BSA treated BID with INCB018424 1.5% cream
|
Cohort B
n=5 Participants
8% to 13% of BSA treated BID with INCB018424 1.5% cream
|
Cohort C
n=5 Participants
14% to 20% of BSA treated QD with INCB018424 1.5% cream
|
Cohort D
n=5 Participants
14% to 20% of BSA treated BID with INCB018424 1.0% cream
|
Cohort E
n=5 Participants
14% to 20% of BSA treated BID with INCB018424 1.5% cream
|
Cohort C
14% to 20% of BSA treated QD with INCB018424 1.5% cream
|
Cohort D: Control Lesion
Control Lesions were not treated.
|
Cohort D
14% to 20% of BSA treated BID with INCB018424 1.0% cream
|
Cohort E: Control Lesion
Control Lesions were not treated.
|
Cohort E
14% to 20% of BSA treated BID with INCB018424 1.5% cream
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424
|
7.00 nM
Standard Deviation 2.10
|
28.38 nM
Standard Deviation 13.10
|
24.41 nM
Standard Deviation 10.07
|
34.97 nM
Standard Deviation 20.44
|
60.98 nM
Standard Deviation 73.85
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 2 months (Days 1, 8, 15, 22, 28 and up to an additional 28 day Follow-Up)Changes in total lesion scores were compared to baseline score. Lesions were compared between active treated areas INCB018424 and control areas of the same subject (within-subject comparisons) using one sample t-test. Total lesion score was calculated as the sum of the scores for Thickness (T), erythema (E), and scaling (S) for the target and control lesions. All individual scores use a 5-point scale ranging from 0 (none) to 4 (severe) with increasing score reflecting increased lesion severity. These ratings are then added to create a total score ranging from 0 to 12.
Outcome measures
| Measure |
Cohort A
n=5 Participants
2% to 7% of BSA treated BID with INCB018424 1.5% cream
|
Cohort B
n=5 Participants
8% to 13% of BSA treated BID with INCB018424 1.5% cream
|
Cohort C
n=5 Participants
14% to 20% of BSA treated QD with INCB018424 1.5% cream
|
Cohort D
n=5 Participants
14% to 20% of BSA treated BID with INCB018424 1.0% cream
|
Cohort E
n=5 Participants
14% to 20% of BSA treated BID with INCB018424 1.5% cream
|
Cohort C
n=5 Participants
14% to 20% of BSA treated QD with INCB018424 1.5% cream
|
Cohort D: Control Lesion
n=5 Participants
Control Lesions were not treated.
|
Cohort D
n=5 Participants
14% to 20% of BSA treated BID with INCB018424 1.0% cream
|
Cohort E: Control Lesion
n=5 Participants
Control Lesions were not treated.
|
Cohort E
n=5 Participants
14% to 20% of BSA treated BID with INCB018424 1.5% cream
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline
Day 8
|
.4 Change in Total Score
Interval 0.0 to 2.0
|
-1.4 Change in Total Score
Interval -4.0 to 1.0
|
-0.8 Change in Total Score
Interval -3.0 to 0.0
|
-4.0 Change in Total Score
Interval -6.0 to -2.0
|
-0.2 Change in Total Score
Interval -1.0 to 0.0
|
-1.2 Change in Total Score
Interval -5.0 to 1.0
|
-0.2 Change in Total Score
Interval -2.0 to 1.0
|
-1.2 Change in Total Score
Interval -2.0 to 0.0
|
0.2 Change in Total Score
Interval 0.0 to 1.0
|
-2.8 Change in Total Score
Interval -5.0 to 2.0
|
|
Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline
Day 15
|
0.2 Change in Total Score
Interval -1.0 to 2.0
|
-3.2 Change in Total Score
Interval -5.0 to -2.0
|
-2.00 Change in Total Score
Interval -4.0 to -1.0
|
-4.2 Change in Total Score
Interval -7.0 to -2.0
|
-0.6 Change in Total Score
Interval -2.0 to 0.0
|
-2.6 Change in Total Score
Interval -7.0 to 0.0
|
0.8 Change in Total Score
Interval 0.0 to 2.0
|
-0.8 Change in Total Score
Interval -4.0 to 0.0
|
-0.8 Change in Total Score
Interval -4.0 to 0.0
|
-3.6 Change in Total Score
Interval -6.0 to -2.0
|
|
Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline
Day 22
|
1.0 Change in Total Score
Interval 0.0 to 2.0
|
-2.8 Change in Total Score
Interval -6.0 to 0.0
|
-1.8 Change in Total Score
Interval -4.0 to -1.0
|
-5.0 Change in Total Score
Interval -7.0 to -2.0
|
-2.8 Change in Total Score
Interval -6.0 to 0.0
|
-3.6 Change in Total Score
Interval -7.0 to -1.0
|
1.0 Change in Total Score
Interval 0.0 to 3.0
|
-2.8 Change in Total Score
Interval -6.0 to -1.0
|
-0.4 Change in Total Score
Interval -3.0 to 1.0
|
-3.6 Change in Total Score
Interval -7.0 to -2.0
|
|
Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline
Day 28
|
0.8 Change in Total Score
Interval -1.0 to 2.0
|
-3.4 Change in Total Score
Interval -6.0 to -2.0
|
-2.0 Change in Total Score
Interval -4.0 to 0.0
|
-5.4 Change in Total Score
Interval -7.0 to -3.0
|
-3.6 Change in Total Score
Interval -8.0 to 0.0
|
-4.4 Change in Total Score
Interval -8.0 to -2.0
|
0.6 Change in Total Score
Interval 0.0 to 1.0
|
-3.6 Change in Total Score
Interval -5.0 to -2.0
|
-1.2 Change in Total Score
Interval -6.0 to 0.0
|
-3.8 Change in Total Score
Interval -7.0 to -2.0
|
|
Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline
Follow-up
|
1.2 Change in Total Score
Interval 0.0 to 2.0
|
-1.2 Change in Total Score
Interval -4.0 to 1.0
|
1.0 Change in Total Score
Interval -3.0 to 1.0
|
-3.6 Change in Total Score
Interval -6.0 to 0.0
|
-4.2 Change in Total Score
Interval -9.0 to 0.0
|
-3.2 Change in Total Score
Interval -9.0 to 1.0
|
0.6 Change in Total Score
Interval -1.0 to 2.0
|
-1.0 Change in Total Score
Interval -3.0 to 0.0
|
-2.0 Change in Total Score
Interval -6.0 to 0.0
|
-2.8 Change in Total Score
Interval -7.0 to 0.0
|
SECONDARY outcome
Timeframe: Days 1 and 28The target and control lesion areas were determined in an objective manner on Day 1 and Day 28 based on a tracing of the perimeter of the lesions on transparency film and measurement of the area.
Outcome measures
| Measure |
Cohort A
n=5 Participants
2% to 7% of BSA treated BID with INCB018424 1.5% cream
|
Cohort B
n=5 Participants
8% to 13% of BSA treated BID with INCB018424 1.5% cream
|
Cohort C
n=5 Participants
14% to 20% of BSA treated QD with INCB018424 1.5% cream
|
Cohort D
n=5 Participants
14% to 20% of BSA treated BID with INCB018424 1.0% cream
|
Cohort E
n=5 Participants
14% to 20% of BSA treated BID with INCB018424 1.5% cream
|
Cohort C
n=5 Participants
14% to 20% of BSA treated QD with INCB018424 1.5% cream
|
Cohort D: Control Lesion
n=5 Participants
Control Lesions were not treated.
|
Cohort D
n=5 Participants
14% to 20% of BSA treated BID with INCB018424 1.0% cream
|
Cohort E: Control Lesion
n=5 Participants
Control Lesions were not treated.
|
Cohort E
n=5 Participants
14% to 20% of BSA treated BID with INCB018424 1.5% cream
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Change in Psoriatic Lesion Area
|
-2.20 cm^2
Standard Deviation 23.993
|
-237.76 cm^2
Standard Deviation 240.500
|
-15.94 cm^2
Standard Deviation 38.247
|
-620.56 cm^2
Standard Deviation 714.829
|
0.40 cm^2
Standard Deviation 11.336
|
-1267.78 cm^2
Standard Deviation 1009.159
|
-9.02 cm^2
Standard Deviation 10.346
|
-871.12 cm^2
Standard Deviation 1062.346
|
-12.32 cm^2
Standard Deviation 23.283
|
-823.78 cm^2
Standard Deviation 313.733
|
SECONDARY outcome
Timeframe: Approximately 2 months: Days 1, 8, 15, 22, 28 and follow-up approximately one month laterThe PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a scale that ranged from 0 (clear) to 6 (most severe) in whole-unit increments. Note that, for analysis purposes, the scale was adjusted to range from 1 (clear) to 7 (most severe) to allow for the evaluation of mean scores.
Outcome measures
| Measure |
Cohort A
n=5 Participants
2% to 7% of BSA treated BID with INCB018424 1.5% cream
|
Cohort B
n=5 Participants
8% to 13% of BSA treated BID with INCB018424 1.5% cream
|
Cohort C
n=5 Participants
14% to 20% of BSA treated QD with INCB018424 1.5% cream
|
Cohort D
n=5 Participants
14% to 20% of BSA treated BID with INCB018424 1.0% cream
|
Cohort E
n=5 Participants
14% to 20% of BSA treated BID with INCB018424 1.5% cream
|
Cohort C
14% to 20% of BSA treated QD with INCB018424 1.5% cream
|
Cohort D: Control Lesion
Control Lesions were not treated.
|
Cohort D
14% to 20% of BSA treated BID with INCB018424 1.0% cream
|
Cohort E: Control Lesion
Control Lesions were not treated.
|
Cohort E
14% to 20% of BSA treated BID with INCB018424 1.5% cream
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Change in Physicians Global Assessment Score
Day 22
|
2.4 Score
Standard Deviation 0.55
|
3.0 Score
Standard Deviation 0.71
|
3.6 Score
Standard Deviation 0.89
|
3.2 Score
Standard Deviation 0.45
|
2.6 Score
Standard Deviation 0.55
|
—
|
—
|
—
|
—
|
—
|
|
Mean Change in Physicians Global Assessment Score
Day 28
|
2.4 Score
Standard Deviation 0.55
|
2.6 Score
Standard Deviation 0.89
|
3.4 Score
Standard Deviation 0.55
|
3.0 Score
Standard Deviation 0.71
|
2.4 Score
Standard Deviation 0.55
|
—
|
—
|
—
|
—
|
—
|
|
Mean Change in Physicians Global Assessment Score
Follow-up
|
3.4 Score
Standard Deviation 0.89
|
3.4 Score
Standard Deviation 0.89
|
3.2 Score
Standard Deviation 1.30
|
4.0 Score
Standard Deviation 0.71
|
3.2 Score
Standard Deviation 0.45
|
—
|
—
|
—
|
—
|
—
|
|
Mean Change in Physicians Global Assessment Score
Screening
|
4.4 Score
Standard Deviation 0.55
|
4.4 Score
Standard Deviation 0.89
|
4.2 Score
Standard Deviation 0.45
|
4.4 Score
Standard Deviation 0.55
|
4.0 Score
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
|
Mean Change in Physicians Global Assessment Score
Day 1
|
4.0 Score
Standard Deviation 0.00
|
4.4 Score
Standard Deviation 0.89
|
4.2 Score
Standard Deviation 0.45
|
4.4 Score
Standard Deviation 0.55
|
4.0 Score
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
|
Mean Change in Physicians Global Assessment Score
Day 8
|
3.4 Score
Standard Deviation 0.55
|
3.6 Score
Standard Deviation 0.55
|
4.0 Score
Standard Deviation 0.71
|
4.2 Score
Standard Deviation 0.45
|
3.0 Score
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
|
Mean Change in Physicians Global Assessment Score
Day 15
|
2.6 Score
Standard Deviation 0.55
|
3.2 Score
Standard Deviation 0.84
|
3.8 Score
Standard Deviation 0.84
|
3.8 Score
Standard Deviation 0.45
|
2.6 Score
Standard Deviation 0.55
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort B
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort C
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort D
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort E
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Total
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A
n=5 participants at risk
2 to 7% of BSA treated BID with INCB018424 1.5% cream
|
Cohort B
n=5 participants at risk
8 to 13% of BSA treated BID with INCB018424 1.5% cream BID
|
Cohort C
n=5 participants at risk
14 to 20% of BSA treated QD with INCB018424 1.5% cream QD
|
Cohort D
n=5 participants at risk
14-20% of BSA with INCB018424 1.0% cream BID
|
Cohort E
n=5 participants at risk
14 to 20% of BSA treated BID with INCB018424 1.5% cream BID
|
Total
n=25 participants at risk
Total
|
|---|---|---|---|---|---|---|
|
Psychiatric disorders
Schizophrenia, paranoid type
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
4.0%
1/25 • Number of events 1
|
Other adverse events
| Measure |
Cohort A
n=5 participants at risk
2 to 7% of BSA treated BID with INCB018424 1.5% cream
|
Cohort B
n=5 participants at risk
8 to 13% of BSA treated BID with INCB018424 1.5% cream BID
|
Cohort C
n=5 participants at risk
14 to 20% of BSA treated QD with INCB018424 1.5% cream QD
|
Cohort D
n=5 participants at risk
14-20% of BSA with INCB018424 1.0% cream BID
|
Cohort E
n=5 participants at risk
14 to 20% of BSA treated BID with INCB018424 1.5% cream BID
|
Total
n=25 participants at risk
Total
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Application site irritation
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
4.0%
1/25 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
12.0%
3/25 • Number of events 3
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
4.0%
1/25 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/5
|
20.0%
1/5 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
4.0%
1/25 • Number of events 2
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
4.0%
1/25 • Number of events 1
|
|
Blood and lymphatic system disorders
Reticulocytosis
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
4.0%
1/25 • Number of events 1
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
4.0%
1/25 • Number of events 1
|
|
Immune system disorders
Seasonal allergy
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
8.0%
2/25 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
4.0%
1/25 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Tension headache
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
4.0%
1/25 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Study Agreement
- Publication restrictions are in place
Restriction type: OTHER