Trial Outcomes & Findings for The Purpose of the Study is to Evaluate the Effect of Ruxolitinib Cream on Itch in Participants With Atopic Dermatitis (NCT NCT04839380)
NCT ID: NCT04839380
Last Updated: 2023-10-31
Results Overview
The intensity of pruritus (itch) was recorded daily using the PP-NRS (24-hour recall period). Participants were asked to assign a numerical score representing their itch at the worst moment during the previous 24 hours on a scale of 0 to 10, with 0 being no itch and 10 being the worst itch imaginable. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period.
COMPLETED
PHASE2
49 participants
Baseline; Day 2
2023-10-31
Participant Flow
This study was conducted at 1 study center in Canada.
Participant milestones
| Measure |
Ruxolitinib 1.5% Cream BID
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 28 days.
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
Intent-to-Treat Population
|
46
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Ruxolitinib 1.5% Cream BID
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 28 days.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Dosed, but Did Not Complete Run-in Period
|
3
|
Baseline Characteristics
The Purpose of the Study is to Evaluate the Effect of Ruxolitinib Cream on Itch in Participants With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Ruxolitinib 1.5% Cream BID
n=49 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 28 days.
|
|---|---|
|
Age, Continuous
|
35.6 years
STANDARD_DEVIATION 14.77 • n=93 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline; Day 2Population: Modified Intent-to Treat (mITT) Population: all participants who had both a Baseline and at least 1 post-Baseline PP-NRS or modified PP-NRS (mPP-NRS) assessment within the treatment period. Only participants with available data were analyzed.
The intensity of pruritus (itch) was recorded daily using the PP-NRS (24-hour recall period). Participants were asked to assign a numerical score representing their itch at the worst moment during the previous 24 hours on a scale of 0 to 10, with 0 being no itch and 10 being the worst itch imaginable. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=46 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 28 days.
|
|---|---|
|
Change From Baseline in the Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Day 2 (24-hour Recall Period After First Application)
Baseline
|
6.72 scores on a scale
Standard Deviation 1.363
|
|
Change From Baseline in the Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Day 2 (24-hour Recall Period After First Application)
Change from Baseline at Day 2
|
-3.37 scores on a scale
Standard Deviation 1.847
|
SECONDARY outcome
Timeframe: Baseline; Day 1 (15 and 30 minutes postdose; 1, 2, 4, 6, and 12 hours postdose)Population: mITT Population. Only participants with available data were analyzed.
On Day 1, participants were asked to evaluate the current intensity of their itch at the time of assessment (i.e., prior to the morning study drug application, and 15 and 30 minutes and 1, 2, 4, 6, and 12 hours after the morning study drug application; the 12-hour evaluation occurred prior to the second daily study drug application) on a scale from 0 to 10, with 0 indicating no itch and 10 indicating the worst imaginable itch. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last non-missing assessment before or on Day 1 and prior to the first application of study drug (including unscheduled assessments).
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=46 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 28 days.
|
|---|---|
|
Change From Baseline in the Modified Peak-Pruritus Numerical Rating Scale (mPP-NRS) Score (Current Itch Intensity) at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
Baseline
|
6.4 scores on a scale
Standard Deviation 1.72
|
|
Change From Baseline in the Modified Peak-Pruritus Numerical Rating Scale (mPP-NRS) Score (Current Itch Intensity) at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
Change from Baseline at 15 minutes postdose
|
-2.3 scores on a scale
Standard Deviation 2.34
|
|
Change From Baseline in the Modified Peak-Pruritus Numerical Rating Scale (mPP-NRS) Score (Current Itch Intensity) at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
Change from Baseline at 30 minutes postdose
|
-3.0 scores on a scale
Standard Deviation 2.38
|
|
Change From Baseline in the Modified Peak-Pruritus Numerical Rating Scale (mPP-NRS) Score (Current Itch Intensity) at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
Change from Baseline at 1 hour postdose
|
-3.3 scores on a scale
Standard Deviation 2.45
|
|
Change From Baseline in the Modified Peak-Pruritus Numerical Rating Scale (mPP-NRS) Score (Current Itch Intensity) at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
Change from Baseline at 2 hours postdose
|
-3.8 scores on a scale
Standard Deviation 2.16
|
|
Change From Baseline in the Modified Peak-Pruritus Numerical Rating Scale (mPP-NRS) Score (Current Itch Intensity) at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
Change from Baseline at 4 hours postdose
|
-4.2 scores on a scale
Standard Deviation 2.12
|
|
Change From Baseline in the Modified Peak-Pruritus Numerical Rating Scale (mPP-NRS) Score (Current Itch Intensity) at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
Change from Baseline at 6 hours postdose
|
-4.2 scores on a scale
Standard Deviation 2.04
|
|
Change From Baseline in the Modified Peak-Pruritus Numerical Rating Scale (mPP-NRS) Score (Current Itch Intensity) at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
Change from Baseline at 12 hours postdose
|
-3.1 scores on a scale
Standard Deviation 2.00
|
SECONDARY outcome
Timeframe: Baseline; Day 3 through Day 29Population: mITT Population. Only participants with available data were analyzed.
The intensity of pruritus (itch) was recorded daily using the PP-NRS (24-hour recall period). Participants were asked to assign a numerical score representing their itch at the worst moment during the previous 24 hours on a scale of 0 to 10, with 0 being no itch and 10 being the worst itch imaginable. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=46 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 28 days.
|
|---|---|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Baseline
|
6.72 scores on a scale
Standard Deviation 1.363
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 3
|
-3.78 scores on a scale
Standard Deviation 1.775
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 4
|
-4.00 scores on a scale
Standard Deviation 1.760
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 5
|
-4.20 scores on a scale
Standard Deviation 1.875
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 6
|
-4.58 scores on a scale
Standard Deviation 1.935
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 7
|
-4.78 scores on a scale
Standard Deviation 1.755
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 8
|
-4.91 scores on a scale
Standard Deviation 1.832
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 9
|
-4.92 scores on a scale
Standard Deviation 1.890
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 10
|
-5.00 scores on a scale
Standard Deviation 1.762
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 11
|
-5.19 scores on a scale
Standard Deviation 1.606
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 12
|
-5.19 scores on a scale
Standard Deviation 1.722
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 13
|
-5.03 scores on a scale
Standard Deviation 1.907
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 14
|
-5.10 scores on a scale
Standard Deviation 1.745
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 15
|
-5.03 scores on a scale
Standard Deviation 1.805
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 16
|
-5.30 scores on a scale
Standard Deviation 1.680
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 17
|
-5.28 scores on a scale
Standard Deviation 1.510
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 18
|
-5.34 scores on a scale
Standard Deviation 1.826
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 19
|
-5.37 scores on a scale
Standard Deviation 1.739
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 20
|
-5.40 scores on a scale
Standard Deviation 1.759
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 21
|
-5.52 scores on a scale
Standard Deviation 1.692
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 22
|
-5.56 scores on a scale
Standard Deviation 1.726
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 23
|
-5.50 scores on a scale
Standard Deviation 1.598
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 24
|
-5.28 scores on a scale
Standard Deviation 1.773
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 25
|
-5.65 scores on a scale
Standard Deviation 1.629
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 26
|
-5.68 scores on a scale
Standard Deviation 1.585
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 27
|
-5.69 scores on a scale
Standard Deviation 1.689
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 28
|
-5.39 scores on a scale
Standard Deviation 1.845
|
|
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
Change from Baseline at Day 29
|
-5.68 scores on a scale
Standard Deviation 1.595
|
SECONDARY outcome
Timeframe: Baseline; Day 1 (15 and 30 minutes postdose; 1, 2, 4, 6, and 12 hours postdose)Population: mITT Population. Only participants with available data were analyzed.
On Day 1, participants were asked to evaluate the current intensity of their itch at the time of assessment (i.e., prior to the morning study drug application, and 15 and 30 minutes and 1, 2, 4, 6, and 12 hours after the morning study drug application; the 12-hour evaluation occurred prior to the second daily study drug application) on a scale from 0 to 10, with 0 indicating no itch and 10 indicating the worst imaginable itch. Baseline was defined as the last non-missing assessment before or on Day 1 and prior to the first application of study drug (including unscheduled assessments). Confidence intervals were calculated using the Clopper-Pearson method.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=46 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 28 days.
|
|---|---|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
15 minutes postdose
|
82.6 percentage of participants
Interval 68.6 to 92.2
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
30 minutes postdose
|
89.1 percentage of participants
Interval 76.4 to 96.4
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
1 hour postdose
|
89.1 percentage of participants
Interval 76.4 to 96.4
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
2 hours postdose
|
97.8 percentage of participants
Interval 88.5 to 99.9
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
4 hours postdose
|
100.0 percentage of participants
Interval 92.3 to 100.0
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
6 hours postdose
|
97.8 percentage of participants
Interval 88.5 to 99.9
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
12 hours postdose
|
90.7 percentage of participants
Interval 77.9 to 97.4
|
SECONDARY outcome
Timeframe: Baseline; Day 2 through Day 29Population: mITT Population. Only participants with available data were analyzed.
The intensity of pruritus (itch) was recorded daily using the PP-NRS (24-hour recall period). Participants were asked to assign a numerical score representing their itch at the worst moment during the previous 24 hours on a scale of 0 to 10, with 0 being no itch and 10 being the worst itch imaginable. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=46 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 28 days.
|
|---|---|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 2
|
93.3 percentage of participants
Interval 81.7 to 98.6
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 3
|
95.6 percentage of participants
Interval 84.9 to 99.5
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 4
|
97.8 percentage of participants
Interval 88.2 to 99.9
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 5
|
97.8 percentage of participants
Interval 88.5 to 99.9
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 6
|
97.8 percentage of participants
Interval 88.2 to 99.9
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 7
|
97.8 percentage of participants
Interval 88.5 to 99.9
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 8
|
97.8 percentage of participants
Interval 88.2 to 99.9
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 9
|
97.8 percentage of participants
Interval 88.2 to 99.9
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 10
|
97.7 percentage of participants
Interval 88.0 to 99.9
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 11
|
100.0 percentage of participants
Interval 92.1 to 100.0
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 12
|
100.0 percentage of participants
Interval 92.1 to 100.0
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 13
|
100.0 percentage of participants
Interval 92.1 to 100.0
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 14
|
97.8 percentage of participants
Interval 88.2 to 99.9
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 15
|
100.0 percentage of participants
Interval 92.1 to 100.0
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 16
|
100.0 percentage of participants
Interval 92.1 to 100.0
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 17
|
100.0 percentage of participants
Interval 92.1 to 100.0
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 18
|
100.0 percentage of participants
Interval 92.1 to 100.0
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 19
|
97.8 percentage of participants
Interval 88.2 to 99.9
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 20
|
97.7 percentage of participants
Interval 87.7 to 99.9
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 21
|
100.0 percentage of participants
Interval 92.1 to 100.0
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 22
|
100.0 percentage of participants
Interval 92.0 to 100.0
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 23
|
100.0 percentage of participants
Interval 92.1 to 100.0
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 24
|
97.8 percentage of participants
Interval 88.2 to 99.9
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 25
|
100.0 percentage of participants
Interval 92.1 to 100.0
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 26
|
100.0 percentage of participants
Interval 92.1 to 100.0
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 27
|
100.0 percentage of participants
Interval 92.0 to 100.0
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 28
|
97.7 percentage of participants
Interval 88.0 to 99.9
|
|
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 29
|
100.0 percentage of participants
Interval 91.6 to 100.0
|
SECONDARY outcome
Timeframe: Baseline; Day 1 (15 and 30 minutes postdose; 1, 2, 4, 6, and 12 hours postdose)Population: mITT Population. Only participants with available data were analyzed.
On Day 1, participants were asked to evaluate the current intensity of their itch at the time of assessment (i.e., prior to the morning study drug application, and 15 and 30 minutes and 1, 2, 4, 6, and 12 hours after the morning study drug application; the 12-hour evaluation occurred prior to the second daily study drug application) on a scale from 0 to 10, with 0 indicating no itch and 10 indicating the worst imaginable itch. Baseline was defined as the last non-missing assessment before or on Day 1 and prior to the first application of study drug (including unscheduled assessments).
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=46 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 28 days.
|
|---|---|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
15 minutes postdose
|
58.7 percentage of participants
Interval 43.2 to 73.0
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
30 minutes postdose
|
67.4 percentage of participants
Interval 52.0 to 80.5
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
1 hour postdose
|
71.7 percentage of participants
Interval 56.5 to 84.0
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
2 hours postdose
|
91.3 percentage of participants
Interval 79.2 to 97.6
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
4 hours postdose
|
95.7 percentage of participants
Interval 85.2 to 99.5
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
6 hours postdose
|
93.5 percentage of participants
Interval 82.1 to 98.6
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
12 hours postdose
|
76.7 percentage of participants
Interval 61.4 to 88.2
|
SECONDARY outcome
Timeframe: Baseline; Day 2 through Day 29Population: mITT Population. Only participants with available data were analyzed.
The intensity of pruritus (itch) was recorded daily using the PP-NRS (24-hour recall period). Participants were asked to assign a numerical score representing their itch at the worst moment during the previous 24 hours on a scale of 0 to 10, with 0 being no itch and 10 being the worst itch imaginable. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=46 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 28 days.
|
|---|---|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 2
|
71.1 percentage of participants
Interval 55.7 to 83.6
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 3
|
82.2 percentage of participants
Interval 67.9 to 92.0
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 4
|
84.4 percentage of participants
Interval 70.5 to 93.5
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 5
|
87.0 percentage of participants
Interval 73.7 to 95.1
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 6
|
91.1 percentage of participants
Interval 78.8 to 97.5
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 7
|
95.7 percentage of participants
Interval 85.2 to 99.5
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 8
|
93.3 percentage of participants
Interval 81.7 to 98.6
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 9
|
95.6 percentage of participants
Interval 84.9 to 99.5
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 10
|
95.5 percentage of participants
Interval 84.5 to 99.4
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 11
|
97.8 percentage of participants
Interval 88.2 to 99.9
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 12
|
97.8 percentage of participants
Interval 88.2 to 99.9
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 13
|
95.6 percentage of participants
Interval 84.9 to 99.5
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 14
|
97.8 percentage of participants
Interval 88.2 to 99.9
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 15
|
97.8 percentage of participants
Interval 88.2 to 99.9
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 16
|
100.0 percentage of participants
Interval 92.1 to 100.0
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 17
|
97.8 percentage of participants
Interval 88.2 to 99.9
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 18
|
95.6 percentage of participants
Interval 84.9 to 99.5
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 19
|
95.6 percentage of participants
Interval 84.9 to 99.5
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 20
|
97.7 percentage of participants
Interval 87.7 to 99.9
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 21
|
97.8 percentage of participants
Interval 88.2 to 99.9
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 22
|
97.7 percentage of participants
Interval 88.0 to 99.9
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 23
|
100.0 percentage of participants
Interval 92.1 to 100.0
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 24
|
95.6 percentage of participants
Interval 84.9 to 99.5
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 25
|
100.0 percentage of participants
Interval 92.1 to 100.0
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 26
|
100.0 percentage of participants
Interval 92.1 to 100.0
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 27
|
97.7 percentage of participants
Interval 88.0 to 99.9
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 28
|
95.5 percentage of participants
Interval 84.5 to 99.4
|
|
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
Day 29
|
97.6 percentage of participants
Interval 87.4 to 99.9
|
SECONDARY outcome
Timeframe: from Baseline up to Day 29Population: mITT Population
The MCID corresponds to an achievement of a ≥2-grade reduction in PP-NRS from Baseline. The time to MCID was defined as the time from the date (time) of the first dose to the date (time) of the first occurrence of MCID. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=46 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 28 days.
|
|---|---|
|
Time to Minimal Clinically Important Difference (MCID) for PP-NRS (≥2-grade Reduction in PP-NRS From Baseline )
|
1.6 days
Standard Deviation 1.42
|
SECONDARY outcome
Timeframe: Baseline; Day 1Population: mITT Population. Only participants with available data were analyzed.
The MCID corresponds to an achievement of a ≥2-grade reduction in mPP-NRS from Baseline. The time to MCID was defined as the time from the date (time) of the first dose to the date (time) of the first occurrence of MCID. Baseline was defined as the last non-missing assessment before or on Day 1 and prior to the first application of study drug (including unscheduled assessments).
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=45 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 28 days.
|
|---|---|
|
Time to MCID for mPP-NRS (≥2-grade Reduction in mPP-NRS From Baseline)
|
0.817 hours
Standard Deviation 0.9788
|
SECONDARY outcome
Timeframe: Baseline; Days 8, 15, and 29Population: mITT Population. Only participants with available data were analyzed.
The IGA of the current state of the disease is a 5-point morphological assessment of overall disease severity. 0, clear: no erythema or induration/papulation, no oozing/crusting; there may be minor residual discoloration. 1, almost clear: there may be trace faint pink erythema with almost no induration/papulation and no oozing/crusting. 2, mild: there may be faint pink erythema with mild induration/papulation and no oozing/crusting. 3, moderate: there may be pink-red erythema with moderate induration/papulation, and there may be some oozing/crusting. 4, severe: there may be deep or bright red erythema with severe induration/papulation and with oozing/crusting.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=46 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 28 days.
|
|---|---|
|
Change From Baseline in Investigator Global Assessment (IGA) at Day 8, Day 15, and Day 29
Baseline
|
2.9 scores on a scale
Standard Deviation 0.31
|
|
Change From Baseline in Investigator Global Assessment (IGA) at Day 8, Day 15, and Day 29
Change from Baseline a Day 8
|
-1.4 scores on a scale
Standard Deviation 0.73
|
|
Change From Baseline in Investigator Global Assessment (IGA) at Day 8, Day 15, and Day 29
Change from Baseline at Day 15
|
-2.0 scores on a scale
Standard Deviation 0.87
|
|
Change From Baseline in Investigator Global Assessment (IGA) at Day 8, Day 15, and Day 29
Change from Baseline at Day 29
|
-2.2 scores on a scale
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Baseline; Days 8, 15, and 29Population: mITT Population. Only participants with available data were analyzed.
The IGA-TS is defined as an IGA score of 0 or 1 with a ≥2-grade reduction from Baseline. The IGA of the current state of the disease is a 5-point morphological assessment of overall disease severity. 0, clear: no erythema or induration/papulation, no oozing/crusting; there may be minor residual discoloration. 1, almost clear: there may be trace faint pink erythema with almost no induration/papulation and no oozing/crusting. 2, mild: there may be faint pink erythema with mild induration/papulation and no oozing/crusting. 3, moderate: there may be pink-red erythema with moderate induration/papulation, and there may be some oozing/crusting. 4, severe: there may be deep or bright red erythema with severe induration/papulation and with oozing/crusting.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=46 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 28 days.
|
|---|---|
|
Percentage of Participants Achieving Investigator Global Assessment-Treatment Success (IGA-TS) (Score of 0 or 1 in IGA With a ≥2-grade Reduction From Baseline) at Day 8, Day 15, and Day 29
Day 8
|
45.5 percentage of participants
Interval 30.4 to 61.2
|
|
Percentage of Participants Achieving Investigator Global Assessment-Treatment Success (IGA-TS) (Score of 0 or 1 in IGA With a ≥2-grade Reduction From Baseline) at Day 8, Day 15, and Day 29
Day 15
|
71.1 percentage of participants
Interval 55.7 to 83.6
|
|
Percentage of Participants Achieving Investigator Global Assessment-Treatment Success (IGA-TS) (Score of 0 or 1 in IGA With a ≥2-grade Reduction From Baseline) at Day 8, Day 15, and Day 29
Day 29
|
77.3 percentage of participants
Interval 62.2 to 88.5
|
SECONDARY outcome
Timeframe: up to Day 43Population: Safety Analysis Set: all enrolled participants who received at least 1 application of ruxolitinib 1.5% cream.
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. TEAEs were defined as any AEs with an onset date during or after the first study treatment dose.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=49 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 28 days.
|
|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
|
15 participants
|
SECONDARY outcome
Timeframe: up to Day 43Population: Safety Analysis Set
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. TEAEs were defined as any AEs with an onset date during or after the first study treatment dose. The severity of AEs were assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=49 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 28 days.
|
|---|---|
|
Number of Participants With Any Grade 3 or Higher TEAE
|
0 participants
|
Adverse Events
Ruxolitinib 1.5% Cream BID
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ruxolitinib 1.5% Cream BID
n=49 participants at risk
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 28 days.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Acne
|
2.0%
1/49 • Number of events 1 • up to Day 43
Treatment-emergent adverse events (TEAEs), defined as any adverse events with an onset date during or after the first study treatment dose, have been reported for all enrolled participants who received at least 1 application of ruxolitinib 1.5% cream (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.1%
2/49 • Number of events 2 • up to Day 43
Treatment-emergent adverse events (TEAEs), defined as any adverse events with an onset date during or after the first study treatment dose, have been reported for all enrolled participants who received at least 1 application of ruxolitinib 1.5% cream (Safety Analysis Set).
|
|
Infections and infestations
COVID-19
|
6.1%
3/49 • Number of events 3 • up to Day 43
Treatment-emergent adverse events (TEAEs), defined as any adverse events with an onset date during or after the first study treatment dose, have been reported for all enrolled participants who received at least 1 application of ruxolitinib 1.5% cream (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Concussion
|
2.0%
1/49 • Number of events 1 • up to Day 43
Treatment-emergent adverse events (TEAEs), defined as any adverse events with an onset date during or after the first study treatment dose, have been reported for all enrolled participants who received at least 1 application of ruxolitinib 1.5% cream (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
1/49 • Number of events 1 • up to Day 43
Treatment-emergent adverse events (TEAEs), defined as any adverse events with an onset date during or after the first study treatment dose, have been reported for all enrolled participants who received at least 1 application of ruxolitinib 1.5% cream (Safety Analysis Set).
|
|
Eye disorders
Eye pruritus
|
2.0%
1/49 • Number of events 1 • up to Day 43
Treatment-emergent adverse events (TEAEs), defined as any adverse events with an onset date during or after the first study treatment dose, have been reported for all enrolled participants who received at least 1 application of ruxolitinib 1.5% cream (Safety Analysis Set).
|
|
Infections and infestations
Gastroenteritis
|
2.0%
1/49 • Number of events 1 • up to Day 43
Treatment-emergent adverse events (TEAEs), defined as any adverse events with an onset date during or after the first study treatment dose, have been reported for all enrolled participants who received at least 1 application of ruxolitinib 1.5% cream (Safety Analysis Set).
|
|
Nervous system disorders
Headache
|
4.1%
2/49 • Number of events 2 • up to Day 43
Treatment-emergent adverse events (TEAEs), defined as any adverse events with an onset date during or after the first study treatment dose, have been reported for all enrolled participants who received at least 1 application of ruxolitinib 1.5% cream (Safety Analysis Set).
|
|
Infections and infestations
Molluscum contagiosum
|
2.0%
1/49 • Number of events 1 • up to Day 43
Treatment-emergent adverse events (TEAEs), defined as any adverse events with an onset date during or after the first study treatment dose, have been reported for all enrolled participants who received at least 1 application of ruxolitinib 1.5% cream (Safety Analysis Set).
|
|
Infections and infestations
Nasopharyngitis
|
4.1%
2/49 • Number of events 2 • up to Day 43
Treatment-emergent adverse events (TEAEs), defined as any adverse events with an onset date during or after the first study treatment dose, have been reported for all enrolled participants who received at least 1 application of ruxolitinib 1.5% cream (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.0%
1/49 • Number of events 1 • up to Day 43
Treatment-emergent adverse events (TEAEs), defined as any adverse events with an onset date during or after the first study treatment dose, have been reported for all enrolled participants who received at least 1 application of ruxolitinib 1.5% cream (Safety Analysis Set).
|
|
Infections and infestations
Upper respiratory tract infection
|
4.1%
2/49 • Number of events 2 • up to Day 43
Treatment-emergent adverse events (TEAEs), defined as any adverse events with an onset date during or after the first study treatment dose, have been reported for all enrolled participants who received at least 1 application of ruxolitinib 1.5% cream (Safety Analysis Set).
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/49 • Number of events 1 • up to Day 43
Treatment-emergent adverse events (TEAEs), defined as any adverse events with an onset date during or after the first study treatment dose, have been reported for all enrolled participants who received at least 1 application of ruxolitinib 1.5% cream (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
2.0%
1/49 • Number of events 1 • up to Day 43
Treatment-emergent adverse events (TEAEs), defined as any adverse events with an onset date during or after the first study treatment dose, have been reported for all enrolled participants who received at least 1 application of ruxolitinib 1.5% cream (Safety Analysis Set).
|
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