Atopic Dermatitis
Conditions
Keywords
ruxolitinib, Itch, Chronic Pruritus
Brief summary
The purpose of the study is to evaluate the effect of ruxolitinib cream on itch in participants with Atopic Dermatitis.
Interventions
DRUGruxolitinib cream
ruxolitinib cream 1.5% will be applied twice daily as a thin film
Sponsors
Incyte Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participant has clinically confirmed diagnosis of active AD for at least a 6-months. * Participant has chronic pruritus related to AD for at least 3 months . * Participant has an overall BSA (excluding palms, soles, scalp, genitals, and folds) affected by AD of 1%-20% on Day 1. * Participant has an IGA score of at least 2 on Day 1. * Participant has a single PP-NRS score ≥ 4 in the 24-hour period prior to the screening visit. * Willingness to avoid pregnancy or fathering children. * Participant must be willing to comply with all study procedures and restrictions including discontinuation of all current therapies for AD and pruritus (unless otherwise specified), and must be available for the duration of the study.
Exclusion criteria
* Female participnat who is breastfeeding, pregnant, or planning to become pregnant during the study. Participant had significant flares or unstable course in AD. * Participant has clinically infected AD or has used antibiotics (systemic or topical) for their infected AD within 2 weeks prior to the run-in period. * Participant has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments. * Participant has any clinically significant medical condition or physical/laboratory/vital sign abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results. * Participant has received treatment with JAK inhibitors (systemic or topical) within 4 weeks prior to the run-in period. * Participant is unlikely, in the opinion of the investigator, to be compliant with study procedures and requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Day 2 (24-hour Recall Period After First Application) | Baseline; Day 2 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application) | Baseline; Day 3 through Day 29 | 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. |
| 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 | Baseline; Day 1 (15 and 30 minutes postdose; 1, 2, 4, 6, and 12 hours postdose) | 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. |
| Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29 | Baseline; Day 2 through Day 29 | 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. |
| 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 | Baseline; Day 1 (15 and 30 minutes postdose; 1, 2, 4, 6, and 12 hours postdose) | 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). |
| Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29 | Baseline; Day 2 through Day 29 | 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. |
| 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; Day 1 (15 and 30 minutes postdose; 1, 2, 4, 6, and 12 hours postdose) | 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). |
| Time to MCID for mPP-NRS (≥2-grade Reduction in mPP-NRS From Baseline) | Baseline; Day 1 | 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). |
| Change From Baseline in Investigator Global Assessment (IGA) at Day 8, Day 15, and Day 29 | Baseline; Days 8, 15, and 29 | 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. |
| 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 | Baseline; Days 8, 15, and 29 | 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. |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to Day 43 | 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. |
| Number of Participants With Any Grade 3 or Higher TEAE | up to Day 43 | 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. |
| Time to Minimal Clinically Important Difference (MCID) for PP-NRS (≥2-grade Reduction in PP-NRS From Baseline ) | from Baseline up to Day 29 | 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. |
Countries
Canada
Participant flow
Recruitment details
This study was conducted at 1 study center in Canada.
Participants by arm
| Arm | Count |
|---|---|
| Ruxolitinib 1.5% Cream BID Participants applied ruxolitinib 1.5% cream twice daily (BID) for 28 days. | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Dosed, but Did Not Complete Run-in Period | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Ruxolitinib 1.5% Cream BID |
|---|---|
| Age, Continuous | 35.6 years STANDARD_DEVIATION 14.77 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 42 Participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 49 |
| other Total, other adverse events | 15 / 49 |
| serious Total, serious adverse events | 0 / 49 |
Outcome results
Primary
Change From Baseline in the Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Day 2 (24-hour Recall Period After First Application)
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.
Time frame: Baseline; Day 2
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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
Change From Baseline in Investigator Global Assessment (IGA) at Day 8, Day 15, and Day 29
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.
Time frame: Baseline; Days 8, 15, and 29
Population: mITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 0.9 |
Secondary
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
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
Secondary
Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
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.
Time frame: Baseline; Day 3 through Day 29
Population: mITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | 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 1.68 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 1.76 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 1.89 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 1.51 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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
Number of Participants With Any Grade 3 or Higher TEAE
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.
Time frame: up to Day 43
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ruxolitinib 1.5% Cream BID | Number of Participants With Any Grade 3 or Higher TEAE | 0 participants |
Secondary
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
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.
Time frame: up to Day 43
Population: Safety Analysis Set: all enrolled participants who received at least 1 application of ruxolitinib 1.5% cream.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ruxolitinib 1.5% Cream BID | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 15 participants |
Secondary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
Secondary
Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
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.
Time frame: Baseline; Day 2 through Day 29
Population: mITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
Secondary
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
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
Secondary
Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
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.
Time frame: Baseline; Day 2 through Day 29
Population: mITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
Secondary
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
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.
Time frame: Baseline; Days 8, 15, and 29
Population: mITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
Secondary
Time to MCID for mPP-NRS (≥2-grade Reduction in mPP-NRS From Baseline)
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).
Time frame: Baseline; Day 1
Population: mITT Population. Only participants with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | Time to MCID for mPP-NRS (≥2-grade Reduction in mPP-NRS From Baseline) | 0.817 hours | Standard Deviation 0.9788 |
Secondary
Time to Minimal Clinically Important Difference (MCID) for PP-NRS (≥2-grade Reduction in PP-NRS From Baseline )
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.
Time frame: from Baseline up to Day 29
Population: mITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | 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 |