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Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (TRuE AD1) - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03745638
Recruitment Status : Completed
First Posted : November 19, 2018
Results First Posted : December 17, 2021
Last Update Posted : December 17, 2021
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Interventions Drug: Ruxolitinib Cream
Drug: Vehicle Cream
Enrollment 631
Recruitment Details A total of 631 participants took part in the study at 78 sites, 48 in North America and 30 in Europe from December 20, 2018 to December 01, 2020.
Pre-assignment Details Participants who completed Week 8 assessments of the Vehicle Control (VC) Period with no safety concerns continued in the 44-week Long Term Safety (LTS) Period. Participants who were on active treatment during the VC Period continued with the same treatment regimen in the LTS Period and those who applied vehicle cream during the VC Period were equally randomized into 1 of the 2 active treatment groups: ruxolitinib 0.75%, ruxolitinib 1.5% cream during the LTS Period.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID LTS Period: Ruxolitinib 0.75% Cream LTS Period: Ruxolitinib 1.5% Cream
Hide Arm/Group Description Participants received vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Period Title: Vehicle Control Period (Day 1 to Week 8)
Started 126 252 253 0 0 0 0
Completed 95 222 225 0 0 0 0
Not Completed 31 30 28 0 0 0 0
Reason Not Completed
Adverse Event             4             2             1             0             0             0             0
Lack of Efficacy             1             0             0             0             0             0             0
Lost to Follow-up             5             12             8             0             0             0             0
Physician Decision             1             1             0             0             0             0             0
Pregnancy             1             0             0             0             0             0             0
Protocol Violation             0             3             0             0             0             0             0
Withdrawal by Subject             17             11             19             0             0             0             0
Reason Not Specified             2             1             0             0             0             0             0
Period Title: Long-Term Safety Period (Weeks 8 to 52)
Started 0 0 0 48 47 222 225
Completed 0 0 0 37 38 176 174
Not Completed 0 0 0 11 9 46 51
Reason Not Completed
Adverse Event             0             0             0             0             0             6             1
Lack of Efficacy             0             0             0             1             0             2             2
Lost to Follow-up             0             0             0             3             5             13             24
Physician Decision             0             0             0             0             1             3             0
Protocol Violation             0             0             0             0             0             1             0
Withdrawal by Subject             0             0             0             7             3             17             21
Reason Not Specified             0             0             0             0             0             4             3
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID Total
Hide Arm/Group Description Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. Total of all reporting groups
Overall Number of Baseline Participants 126 252 253 631
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all participants who were randomized to the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 126 participants 252 participants 253 participants 631 participants
35.2  (18.11) 36.8  (19.06) 33.7  (17.15) 35.2  (18.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 252 participants 253 participants 631 participants
Female
79
  62.7%
154
  61.1%
158
  62.5%
391
  62.0%
Male
47
  37.3%
98
  38.9%
95
  37.5%
240
  38.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 252 participants 253 participants 631 participants
Hispanic or Latino
21
  16.7%
30
  11.9%
37
  14.6%
88
  13.9%
Not Hispanic or Latino
104
  82.5%
218
  86.5%
212
  83.8%
534
  84.6%
Unknown or Not Reported
1
   0.8%
4
   1.6%
4
   1.6%
9
   1.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 252 participants 253 participants 631 participants
American Indian or Alaska Native
0
   0.0%
2
   0.8%
0
   0.0%
2
   0.3%
Asian
8
   6.3%
10
   4.0%
14
   5.5%
32
   5.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
3
   1.2%
0
   0.0%
3
   0.5%
Black or African American
29
  23.0%
55
  21.8%
56
  22.1%
140
  22.2%
White
85
  67.5%
173
  68.7%
177
  70.0%
435
  68.9%
Other
4
   3.2%
9
   3.6%
6
   2.4%
19
   3.0%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilograms per square metre (kg/m^2)
Number Analyzed 126 participants 252 participants 253 participants 631 participants
26.92  (6.245) 27.33  (6.745) 27.47  (8.077) 27.30  (7.212)
1.Primary Outcome
Title Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8
Hide Description The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥ 2 grade improvement from Baseline.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 126 252 253
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
15.1
(9.3 to 22.5)
50.0
(43.7 to 56.3)
53.8
(47.4 to 60.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.
Method Exact Logistic Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.38
Confidence Interval (2-Sided) 95%
3.556 to 11.923
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.
Method Exact Logistic Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.50
Confidence Interval (2-Sided) 95%
4.178 to 14.040
Estimation Comments [Not Specified]
2.Secondary Outcome
Title VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75)
Hide Description EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 126 252 253
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24.6
(17.4 to 33.1)
56.0
(49.6 to 62.2)
62.1
(55.8 to 68.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.
Method Exact Logistic Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.04
Confidence Interval (2-Sided) 95%
2.441 to 6.808
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.
Method Exact Logistic Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.22
Confidence Interval (2-Sided) 95%
3.145 to 8.831
Estimation Comments [Not Specified]
3.Secondary Outcome
Title VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch Numerical Rating Scale (NRS) Score
Hide Description The Itch NRS is a daily participant-reported measure (24-hour recall), using a diary, of the worst level of itch intensity. Participants were asked to rate the itching severity because of their AD in the daily diary by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study. Number analyzed included participants in the ITT population with a Baseline Itch NRS score ≥ 4.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 78 156 161
Measure Type: Number
Unit of Measure: percentage of participants
15.4 40.4 52.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.
Method Exact Logistic Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.66
Confidence Interval (2-Sided) 95%
1.773 to 8.083
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.
Method Exact Logistic Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.01
Confidence Interval (2-Sided) 95%
2.931 to 13.220
Estimation Comments [Not Specified]
4.Secondary Outcome
Title VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form - Sleep Disturbance (8b - 24-Hour Recall) Score
Hide Description The PROMIS Short Form - Sleep Disturbance (8b) questionnaire assesses participant's self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance. Each item asks the participant to rate the severity of the participant's sleep disturbance.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study. Number analyzed included participants in the ITT population with a Baseline score ≥ 6.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 116 233 238
Measure Type: Number
Unit of Measure: percentage of participants
9.5 21.0 22.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0081
Comments The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.
Method Exact Logistic Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.56
Confidence Interval (2-Sided) 95%
1.242 to 5.723
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0039
Comments The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.
Method Exact Logistic Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.74
Confidence Interval (2-Sided) 95%
1.334 to 6.083
Estimation Comments [Not Specified]
5.Secondary Outcome
Title VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep-Related Impairment (8a - 24-Hour Recall)
Hide Description The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. Each item asks the participant to rate the severity of the participant's sleep impairment.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study. Number analyzed included participants in the ITT population with a Baseline score ≥ 6.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 114 233 245
Measure Type: Number
Unit of Measure: percentage of participants
13.2 20.2 21.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1421
Comments The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.
Method Exact Logistic Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.67
Confidence Interval (2-Sided) 95%
0.862 to 3.391
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0746
Comments The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.
Method Exact Logistic Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.82
Confidence Interval (2-Sided) 95%
0.949 to 3.665
Estimation Comments [Not Specified]
6.Secondary Outcome
Title VC Period: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (SAE)
Hide Description An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or an important medical event may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. A TEAE or treatment emergent SAE is any AE or SAE either reported for first time or worsening of a pre-existing event after first dose of study drug.
Time Frame From first dose up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who applied at least 1 application of ruxolitinib cream or vehicle cream.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 126 252 253
Measure Type: Number
Unit of Measure: percentage of participants
TEAE 34.9 29.0 29.2
Treatment Emergent SAE 1.6 0.4 0.8
7.Secondary Outcome
Title LTS Period: Percentage of Participants With at Least One TEAE and Treatment Emergent SAE
Hide Description An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or an important medical event may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. A TEAE or treatment emergent SAE is any AE or SAE either reported for first time or worsening of a pre-existing event after first dose of study drug.
Time Frame From first dose date in LTS Period (Week 8) until last follow-up visit (up to 52 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period.
Arm/Group Title LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID LTS Period: Ruxolitinib 0.75% Cream LTS Period: Ruxolitinib 1.5% Cream
Hide Arm/Group Description:
Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Overall Number of Participants Analyzed 48 47 222 225
Measure Type: Number
Unit of Measure: percentage of participants
TEAE 47.9 48.9 54.5 53.3
Treatment Emergent SAE 6.3 2.1 2.3 1.3
8.Secondary Outcome
Title VC Period: Percentage of Participants Who Achieved an IGA-TS at Weeks 2 and 4
Hide Description The IGA is an overall eczema severity rating on a 0 (clear skin) to 4 (severe disease) scale. The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥ 2 grade improvement from Baseline.
Time Frame Baseline to Weeks 2 and 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 126 252 253
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 3.2 22.2 27.3
Week 4 6.3 42.5 46.6
9.Secondary Outcome
Title VC Period: Percentage of Participants Achieving IGA Scores of 0 or 1
Hide Description The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. IGA score signifies 0 (clear skin) and 1 (almost clear skin).
Time Frame Weeks 2, 4 and 8
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Hide Analysis Population Description
ITT population included all participants who were randomized to the study.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period.
Overall Number of Participants Analyzed 126 252 253
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 6.3 32.5 34.8
Week 4 15.1 53.2 54.9
Week 8 23.8 58.7 62.8
10.Secondary Outcome
Title LTS Period: Percentage of Participants Achieving IGA Scores of 0 or 1
Hide Description The IGA is an overall eczema severity rating on a 0 (clear skin) to 4 (severe disease) scale. The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. IGA score signifies 0 (clear skin) and 1 (almost clear skin).
Time Frame Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Number analyzed is the number of participants with data available for analyses at the specified time point.
Arm/Group Title LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID LTS Period: Ruxolitinib 0.75% Cream LTS Period: Ruxolitinib 1.5% Cream
Hide Arm/Group Description:
Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Overall Number of Participants Analyzed 48 47 222 225
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 Number Analyzed 48 participants 47 participants 222 participants 225 participants
18.8 38.3 65.3 68.4
Week 12 Number Analyzed 45 participants 46 participants 212 participants 212 participants
55.6 65.2 62.7 66.5
Week 16 Number Analyzed 43 participants 45 participants 206 participants 206 participants
60.5 62.2 66.5 68.9
Week 20 Number Analyzed 44 participants 46 participants 197 participants 204 participants
63.6 67.4 62.4 73.5
Week 24 Number Analyzed 42 participants 42 participants 176 participants 189 participants
71.4 78.6 67.0 76.7
Week 28 Number Analyzed 37 participants 43 participants 171 participants 172 participants
64.9 74.4 67.3 77.3
Week 32 Number Analyzed 35 participants 43 participants 165 participants 170 participants
77.1 81.4 71.5 75.9
Week 36 Number Analyzed 34 participants 39 participants 161 participants 173 participants
73.5 82.1 74.5 71.7
Week 40 Number Analyzed 32 participants 39 participants 162 participants 163 participants
81.3 79.5 73.5 75.5
Week 44 Number Analyzed 33 participants 37 participants 167 participants 172 participants
84.8 86.5 74.3 76.2
Week 48 Number Analyzed 36 participants 38 participants 167 participants 160 participants
72.2 76.3 74.3 73.8
Week 52 Number Analyzed 38 participants 38 participants 173 participants 171 participants
76.3 73.7 76.9 75.4
11.Secondary Outcome
Title VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch NRS Score From Baseline to Weeks 2 and 4
Hide Description The Itch NRS is a daily participant-reported measure (24-hour recall), using a diary, of the worst level of itch intensity. Participants are asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours.
Time Frame Baseline to Weeks 2 and 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study. Number analyzed includes participants in the ITT population with a Baseline Itch NRS score ≥ 4.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 78 156 161
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 5.1 26.3 33.5
Week 4 11.5 38.5 51.6
12.Secondary Outcome
Title VC Period: Percentage of Participants Achieving EASI50
Hide Description EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI50 responder was defined as a participant achieving 50% or greater improvement from Baseline in EASI score.
Time Frame Weeks 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 126 252 253
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 19.8 53.2 62.5
Week 4 27.8 68.7 75.5
Week 8 43.7 69.4 77.9
13.Secondary Outcome
Title VC Period: Percentage of Participants Achieving EASI75
Hide Description EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.
Time Frame Weeks 2 and 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 126 252 253
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 5.6 30.2 36.0
Week 4 14.3 51.6 58.5
14.Secondary Outcome
Title VC Period: Percentage of Participants Achieving EASI90
Hide Description EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI90 responder was defined as a participant achieving 90% or greater improvement from Baseline in EASI score.
Time Frame Weeks 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 126 252 253
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 2.4 12.7 19.8
Week 4 4.0 30.6 36.4
Week 8 9.5 38.1 44.3
15.Secondary Outcome
Title VC Period: Percent Change From Baseline in EASI Score
Hide Description EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. A negative change from Baseline indicates improvement.
Time Frame Baseline, Weeks 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 126 252 253
Least Squares Mean (Standard Error)
Unit of Measure: percent change
Percent Change From Baseline at Week 2 Number Analyzed 115 participants 239 participants 242 participants
-16.34  (3.42) -51.82  (2.36) -56.62  (2.35)
Percent Change From Baseline at Week 4 Number Analyzed 108 participants 237 participants 242 participants
-23.03  (3.90) -68.04  (2.66) -71.08  (2.64)
Percent Change From Baseline at Week 8 Number Analyzed 101 participants 225 participants 232 participants
-37.88  (3.72) -71.01  (2.52) -77.40  (2.49)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments Percent change from Baseline in EASI score at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -35.48
Confidence Interval (2-Sided) 95%
-43.64 to -27.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments Percent change from Baseline in EASI score at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Method of Mean Difference]
Estimated Value -40.29
Confidence Interval (2-Sided) 95%
-48.44 to -32.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments Percent change from Baseline in EASI score at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -45.01
Confidence Interval (2-Sided) 95%
-54.28 to -35.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments Percent change from Baseline in EASI score at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -48.05
Confidence Interval (2-Sided) 95%
-57.30 to -38.79
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.71
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments Percent change from Baseline in EASI score at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method Mixed-Model with Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -33.13
Confidence Interval (2-Sided) 95%
-41.95 to -24.30
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments Percent change from Baseline in EASI score at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -39.52
Confidence Interval (2-Sided) 95%
-48.32 to -30.72
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.48
Estimation Comments [Not Specified]
16.Secondary Outcome
Title VC Period: Percent Change From Baseline In SCORing Atopic Dermatitis (SCORAD) Score
Hide Description The SCORAD is a tool to assess extent and severity of eczema. To determine the extent, the rule of nines or handprint method is used to assess eczema affected area (A). To determine disease severity (B) it evaluates 6 clinical characteristics: 1. redness, 2. swelling, 3. oozing/crusting, 4. scratch marks, 5. lichenification, and 6. dryness on a 4-point scale of 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), added to give B with maximum score of 18. Subjective symptoms (C) of itch and sleeplessness are assessed using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), added to give C with maximum score of 20. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combined using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. A negative change from Baseline indicates improvement.
Time Frame Baseline, Weeks 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 126 252 253
Mean (Standard Deviation)
Unit of Measure: percent change
Percent Change From Baseline at Week 2 Number Analyzed 115 participants 239 participants 242 participants
-16.67  (34.152) -43.96  (28.548) -49.32  (31.878)
Percent Change From Baseline at Week 4 Number Analyzed 107 participants 237 participants 241 participants
-27.68  (34.518) -57.80  (28.635) -61.33  (30.113)
Percent Change From Baseline at Week 8 Number Analyzed 101 participants 225 participants 230 participants
-37.00  (36.392) -62.14  (31.108) -67.24  (28.711)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments Percent change from Baseline in SCORAD score at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -25.3
Confidence Interval (2-Sided) 95%
-32.62 to -17.95
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments Percent change from Baseline in SCORAD score at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -30.4
Confidence Interval (2-Sided) 95%
-37.68 to -23.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.72
Estimation Comments [Not Specified]
17.Secondary Outcome
Title VC Period: Change From Baseline in Itch NRS Score
Hide Description The Itch NRS is a daily participant-reported measure (24-hour recall), using a diary, of the worst level of itch intensity. Participants are asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. A negative change from Baseline indicates improvement.
Time Frame Baseline, Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 126 252 253
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Change From Baseline at Week 2 Number Analyzed 98 participants 210 participants 220 participants
-0.89  (0.20) -2.28  (0.14) -2.53  (0.13)
Change From Baseline at Week 4 Number Analyzed 94 participants 214 participants 219 participants
-1.08  (0.23) -2.79  (0.16) -3.16  (0.15)
Change From Baseline at Week 8 Number Analyzed 80 participants 185 participants 203 participants
-1.54  (0.25) -3.14  (0.17) -3.53  (0.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments Change from Baseline in Itch NRS score at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.39
Confidence Interval (2-Sided) 95%
-1.87 to -0.91
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments Change from Baseline in Itch NRS score at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.64
Confidence Interval (2-Sided) 95%
-2.11 to -1.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments Change from Baseline in Itch NRS score at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.70
Confidence Interval (2-Sided) 95%
-2.25 to -1.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments Change from Baseline in Itch NRS score at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.08
Confidence Interval (2-Sided) 95%
-2.63 to -1.53
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments Change from Baseline in Itch NRS score at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.60
Confidence Interval (2-Sided) 95%
-2.20 to -1.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments Change from Baseline in Itch NRS score at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.99
Confidence Interval (2-Sided) 95%
-2.58 to -1.40
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.30
Estimation Comments [Not Specified]
18.Secondary Outcome
Title VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2, 3, or 4 Points
Hide Description The Itch NRS is a daily participant-reported measure (24-hour recall), using a diary, of the worst level of itch intensity. Participants were asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. Kaplan-Meier estimation method was used for analyses.
Time Frame Up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study. Number analyzed included participants in the ITT population with a Baseline Itch NRS score ≥ 2, ≥ 3 or ≥ 4 and a daily Itch NRS assessment during the VC Period.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 126 252 253
Median (95% Confidence Interval)
Unit of Measure: days
≥ 2-Point Improvement in Itch NRS Score Number Analyzed 105 participants 212 participants 220 participants
15.0
(10.0 to 22.0)
4.0
(3.0 to 5.0)
3.0
(3.0 to 4.0)
≥ 3-Point Improvement in Itch NRS Score Number Analyzed 87 participants 191 participants 186 participants
27.0
(13.0 to 69.0)
8.0
(7.0 to 11.0)
6.0
(5.0 to 9.0)
≥ 4-Point Improvement in Itch NRS Score Number Analyzed 78 participants 156 participants 161 participants
NA [1] 
(28.0 to NA)
14.0
(9.0 to 19.0)
13.0
(9.0 to 15.0)
[1]
The median time and upper limit of CI was not estimable due to low number of participants with data.
19.Secondary Outcome
Title VC Period: Change From Baseline in Skin Pain NRS Score
Hide Description The Skin Pain NRS is a daily patient-reported measure (24-hour recall), using a diary, of the worst level of pain intensity from 0 (no pain) to 10 (worst imaginable pain). Participants will be asked, "Rate the pain severity from your atopic dermatitis skin changes by selecting a number that best describes your worst level of pain in the past 24 hours." A negative change from Baseline indicates improvement.
Time Frame Baseline, Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 126 252 253
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change From Baseline at Week 2 Number Analyzed 97 participants 210 participants 219 participants
-0.70  (1.746) -1.90  (1.950) -2.07  (2.164)
Change From Baseline at Week 4 Number Analyzed 94 participants 213 participants 219 participants
-0.84  (2.307) -2.36  (2.217) -2.72  (2.513)
Change From Baseline at Week 8 Number Analyzed 80 participants 185 participants 201 participants
-1.16  (2.610) -2.55  (2.360) -2.84  (2.743)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments Change from Baseline in Skin Pain NRS score at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-1.74 to -0.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments Change from Baseline in Skin Pain NRS score at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-2.11 to -1.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.25
Estimation Comments [Not Specified]
20.Secondary Outcome
Title VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score
Hide Description The PROMIS Short Form - Sleep Disturbance (8b) questionnaire assesses participant's self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This questionnaire is completed in the morning by the participant where each item asks the participant to rate the severity of the participant's sleep disturbance. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance.
Time Frame Weeks 2 and 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study. Number analyzed included participants in the ITT population with a Baseline score ≥ 6.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 116 233 238
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 5.2 13.7 14.7
Week 4 6.9 19.3 21.0
21.Secondary Outcome
Title VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score
Hide Description The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment.
Time Frame Weeks 2 and 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study. Number analyzed included participants in the ITT population with a Baseline score ≥ 6.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 114 233 245
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 8.8 16.3 13.5
Week 4 13.2 20.6 19.2
22.Secondary Outcome
Title VC Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score
Hide Description The PROMIS Short Form - Sleep Disturbance (8b) questionnaire assesses participant's self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This questionnaire is completed in the morning by the participant where each item asks the participant to rate the severity of the participant's sleep disturbance. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance. A negative change from Baseline indicates improvement.
Time Frame Baseline, Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 126 252 253
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Change From Baseline at Week 2 Number Analyzed 97 participants 205 participants 217 participants
-0.18  (0.45) -1.72  (0.31) -2.49  (0.30)
Change From Baseline at Week 4 Number Analyzed 95 participants 212 participants 217 participants
-0.25  (0.50) -2.58  (0.34) -3.10  (0.33)
Change From Baseline at Week 8 Number Analyzed 78 participants 190 participants 194 participants
-0.43  (0.59) -2.97  (0.39) -3.62  (0.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0049
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.53
Confidence Interval (2-Sided) 95%
-2.60 to -0.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.31
Confidence Interval (2-Sided) 95%
-3.37 to -1.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.33
Confidence Interval (2-Sided) 95%
-3.52 to -1.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.60
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.85
Confidence Interval (2-Sided) 95%
-4.03 to -1.67
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.60
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.54
Confidence Interval (2-Sided) 95%
-3.93 to -1.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.71
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -3.18
Confidence Interval (2-Sided) 95%
-4.57 to -1.79
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.71
Estimation Comments [Not Specified]
23.Secondary Outcome
Title VC Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score
Hide Description The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. A negative change from Baseline indicates improvement.
Time Frame Baseline, Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 126 252 253
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Change From Baseline at Week 2 Number Analyzed 98 participants 211 participants 220 participants
-0.58  (0.49) -1.76  (0.33) -2.25  (0.33)
Change From Baseline at Week 4 Number Analyzed 94 participants 212 participants 220 participants
-1.06  (0.55) -2.71  (0.37) -2.97  (0.36)
Change From Baseline at Week 8 Number Analyzed 80 participants 185 participants 203 participants
-1.22  (0.62) -3.34  (0.41) -3.52  (0.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0487
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.18
Confidence Interval (2-Sided) 95%
-2.35 to -0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.60
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0049
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.68
Confidence Interval (2-Sided) 95%
-2.84 to -0.51
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0128
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.64
Confidence Interval (2-Sided) 95%
-2.94 to -0.35
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0037
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.91
Confidence Interval (2-Sided) 95%
-3.20 to -0.62
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0048
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.11
Confidence Interval (2-Sided) 95%
-3.58 to -0.65
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0020
Comments [Not Specified]
Method Mixed-Model with Repeated Measures
Comments The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.30
Confidence Interval (2-Sided) 95%
-3.75 to -0.84
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.74
Estimation Comments [Not Specified]
24.Secondary Outcome
Title LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score
Hide Description The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. A negative change from Baseline indicates improvement.
Time Frame Baseline, Weeks 12, 24, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Number analyzed is the number of participants with data available for analyses at the specified time point.
Arm/Group Title LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID LTS Period: Ruxolitinib 0.75% Cream LTS Period: Ruxolitinib 1.5% Cream
Hide Arm/Group Description:
Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Overall Number of Participants Analyzed 48 47 222 225
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change From Baseline at Week 12 Number Analyzed 41 participants 45 participants 198 participants 198 participants
-1.51  (4.739) -2.22  (7.305) -0.39  (3.984) -0.39  (3.907)
Change From Baseline at Week 24 Number Analyzed 41 participants 41 participants 168 participants 179 participants
-0.54  (5.211) -2.66  (7.268) 0.11  (4.929) 0.02  (5.584)
Change From Baseline at Week 52 Number Analyzed 37 participants 36 participants 168 participants 167 participants
-0.97  (5.085) -2.81  (7.005) -0.37  (5.775) -0.54  (5.511)
25.Secondary Outcome
Title LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score
Hide Description The PROMIS Short Form - Sleep Disturbance (8b) questionnaire assesses participant's self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This questionnaire is completed in the morning by the participant where each item asks the participant to rate the severity of the participant's sleep disturbance. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance. A negative change from Baseline indicates improvement.
Time Frame Baseline, Weeks 12, 24, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Number analyzed is the number of participants with data available for analyses at the specified time point.
Arm/Group Title LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID LTS Period: Ruxolitinib 0.75% Cream LTS Period: Ruxolitinib 1.5% Cream
Hide Arm/Group Description:
Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Overall Number of Participants Analyzed 48 47 222 225
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change From Baseline at Week 12 Number Analyzed 41 participants 45 participants 198 participants 198 participants
-1.93  (5.284) -2.67  (7.160) -0.67  (4.575) -0.66  (3.865)
Change From Baseline at Week 24 Number Analyzed 41 participants 41 participants 168 participants 179 participants
-1.22  (5.681) -3.15  (8.242) 0.02  (5.536) 0.51  (5.563)
Change From Baseline at Week 52 Number Analyzed 37 participants 36 participants 168 participants 167 participants
-1.95  (4.876) -3.31  (7.082) -0.27  (6.506) -0.07  (5.918)
26.Secondary Outcome
Title VC Period: Change From Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA)
Hide Description Body surface area affected by AD was assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region was assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage was reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Used the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1*BSA head and neck + 0.3*BSA trunk + 0.2* BSA upper limbs + 0.4*BSA lower limbs. A negative change from Baseline indicates improvement.
Time Frame Baseline, Weeks 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 126 252 253
Mean (Standard Deviation)
Unit of Measure: % BSA
Change From Baseline at Week 2 Number Analyzed 115 participants 239 participants 242 participants
-0.43  (5.559) -3.69  (4.230) -3.76  (4.238)
Change From Baseline at Week 4 Number Analyzed 108 participants 237 participants 242 participants
-1.56  (4.088) -5.29  (4.969) -5.25  (5.190)
Change From Baseline at Week 8 Number Analyzed 101 participants 225 participants 232 participants
-2.51  (4.722) -6.30  (5.378) -6.54  (4.967)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments Change from Baseline in %BSA at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -3.1
Confidence Interval (2-Sided) 95%
-4.07 to -2.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments Change from Baseline in %BSA at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -3.7
Confidence Interval (2-Sided) 95%
-4.67 to -2.79
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.48
Estimation Comments [Not Specified]
27.Secondary Outcome
Title LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA
Hide Description Body surface area affected by AD was assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region was assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage was reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Used the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1*BSA head and neck + 0.3*BSA trunk + 0.2* BSA upper limbs + 0.4*BSA lower limbs. A negative change from Baseline indicates improvement.
Time Frame Baseline, Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Number analyzed is the number of participants with data available for analyses at the specified time point.
Arm/Group Title LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID LTS Period: Ruxolitinib 0.75% Cream LTS Period: Ruxolitinib 1.5% Cream
Hide Arm/Group Description:
Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Overall Number of Participants Analyzed 48 47 222 225
Mean (Standard Deviation)
Unit of Measure: % BSA
Change From Baseline at Week 12 Number Analyzed 44 participants 46 participants 212 participants 212 participants
-4.23  (4.849) -2.84  (4.907) -6.84  (4.852) -6.96  (4.989)
Change From Baseline at Week 16 Number Analyzed 42 participants 45 participants 206 participants 206 participants
-4.96  (5.194) -2.98  (5.429) -7.36  (4.875) -7.26  (5.080)
Change From Baseline at Week 20 Number Analyzed 44 participants 46 participants 197 participants 204 participants
-4.78  (5.095) -3.75  (5.321) -7.69  (4.901) -7.49  (5.012)
Change From Baseline at Week 24 Number Analyzed 42 participants 42 participants 178 participants 189 participants
-5.32  (4.964) -3.85  (5.223) -7.64  (4.998) -7.64  (4.737)
Change From Baseline at Week 28 Number Analyzed 37 participants 43 participants 171 participants 172 participants
-4.56  (5.486) -4.43  (4.995) -7.66  (5.029) -7.62  (4.913)
Change From Baseline at Week 32 Number Analyzed 35 participants 43 participants 164 participants 170 participants
-5.17  (4.472) -4.53  (5.399) -7.80  (5.011) -7.61  (5.261)
Change From Baseline at Week 36 Number Analyzed 34 participants 39 participants 161 participants 173 participants
-5.21  (4.972) -4.39  (5.509) -8.18  (5.111) -7.97  (5.010)
Change From Baseline at Week 40 Number Analyzed 32 participants 39 participants 162 participants 164 participants
-4.67  (5.519) -4.75  (5.337) -8.07  (4.899) -8.11  (4.997)
Change From Baseline at Week 44 Number Analyzed 33 participants 37 participants 168 participants 172 participants
-5.28  (5.173) -4.56  (5.609) -8.14  (4.789) -8.02  (4.939)
Change From Baseline at Week 48 Number Analyzed 36 participants 38 participants 167 participants 161 participants
-5.65  (5.128) -4.58  (5.696) -8.39  (5.023) -7.96  (4.993)
Change From Baseline at Week 52 Number Analyzed 38 participants 38 participants 173 participants 171 participants
-5.72  (5.481) -4.93  (5.771) -8.58  (5.013) -8.14  (4.906)
28.Secondary Outcome
Title VC Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score
Hide Description The POEM is a 7-question quality-of-life assessment that asks how many days the participant has been bothered by various aspects of their skin condition during the past 7 days. It assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (clear or almost clear) to 28 (very severe eczema). High scores are indicative of more severe disease and poor quality of life. A negative change from Baseline indicates improvement.
Time Frame Baseline, Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 126 252 253
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change From Baseline at Week 2 Number Analyzed 112 participants 236 participants 237 participants
-2.25  (5.779) -9.47  (7.212) -10.60  (6.670)
Change From Baseline at Week 4 Number Analyzed 106 participants 234 participants 240 participants
-3.38  (6.685) -10.12  (7.380) -11.53  (6.891)
Change From Baseline at Week 8 Number Analyzed 99 participants 222 participants 228 participants
-4.30  (7.044) -10.60  (7.262) -11.82  (6.931)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments Change from Baseline in POEM score at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -5.1
Confidence Interval (2-Sided) 95%
-6.43 to -3.80
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.67
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments Change from Baseline in POEM score at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -6.3
Confidence Interval (2-Sided) 95%
-7.62 to -5.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.67
Estimation Comments [Not Specified]
29.Secondary Outcome
Title LTS Period: Change From Baseline in POEM Score
Hide Description The POEM is a 7-question quality-of-life assessment that asks how many days the participant has been bothered by various aspects of their skin condition during the past 7 days. It assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life. A negative change from Baseline indicates improvement.
Time Frame Baseline, Weeks 12, 24, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Number analyzed is the number of participants with data available for analyses at the specified time point.
Arm/Group Title LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID LTS Period: Ruxolitinib 0.75% Cream LTS Period: Ruxolitinib 1.5% Cream
Hide Arm/Group Description:
Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Overall Number of Participants Analyzed 48 47 222 225
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change From Baseline at Week 12 Number Analyzed 41 participants 46 participants 206 participants 206 participants
-5.95  (6.607) -6.89  (9.730) -10.74  (6.653) -11.38  (6.710)
Change From Baseline at Week 24 Number Analyzed 41 participants 42 participants 173 participants 185 participants
-4.46  (6.185) -7.26  (9.189) -10.46  (6.655) -11.44  (6.689)
Change From Baseline at Week 52 Number Analyzed 38 participants 38 participants 174 participants 170 participants
-4.61  (6.868) -7.00  (8.752) -10.51  (7.396) -10.61  (7.057)
30.Secondary Outcome
Title VC Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Hide Description The DLQI is a simple, 10 question (Q) validated quality-of-life questionnaire to measure how much the skin problem has affected the participant. It covers 6 domains including symptoms and feelings (Q1 and Q2), daily activities (Q3 and Q4), leisure (Q5 and Q6), work and school (Q7), personal relationships (Q8 and Q9), and treatment(Q10). The recall Period of this scale is over the last week. Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. Scores range from 0 ("no impact on participant's life") to 30 ("extremely large effect on participant's life"), and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant's life.
Time Frame Baseline, Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study. Participants in the ITT population with age >= 16 were included. Number analyzed is the number of participants with data available for analyses at the specified time point.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 107 215 223
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change From Baseline at Week 2 Number Analyzed 94 participants 200 participants 209 participants
-1.54  (4.618) -6.18  (5.740) -6.90  (5.980)
Change From Baseline at Week 4 Number Analyzed 88 participants 198 participants 211 participants
-2.50  (6.101) -6.88  (5.867) -7.15  (6.565)
Change From Baseline at Week 8 Number Analyzed 82 participants 188 participants 201 participants
-2.83  (6.722) -7.28  (5.907) -7.72  (6.152)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments Change from Baseline in total DLQI score at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -3.8
Confidence Interval (2-Sided) 95%
-4.85 to -2.68
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments Change from Baseline in total DLQI score at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -4.5
Confidence Interval (2-Sided) 95%
-5.56 to -3.42
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.55
Estimation Comments [Not Specified]
31.Secondary Outcome
Title LTS Period: Change From Baseline in DLQI Score
Hide Description The DLQI is a simple, 10 question (Q) validated quality-of-life questionnaire to measure how much the skin problem has affected the participant. It covers 6 domains including symptoms and feelings (Q1 and Q2), daily activities (Q3 and Q4), leisure (Q5 and Q6), work and school (Q7), personal relationships (Q8 and Q9), and treatment(Q10). The recall Period of this scale is over the last week. Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. Scores range from 0 ("no impact on participant's life") to 30 ("extremely large effect on participant's life"), and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant's life.
Time Frame Baseline, Weeks 12, 24, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Participants in the LTS evaluable population with age >= 16 were included. Number analyzed is the number of participants with data available for analyses at the specified time point.
Arm/Group Title LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID LTS Period: Ruxolitinib 0.75% Cream LTS Period: Ruxolitinib 1.5% Cream
Hide Arm/Group Description:
Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Overall Number of Participants Analyzed 40 38 189 200
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change From Baseline at Week 12 Number Analyzed 34 participants 38 participants 175 participants 185 participants
-3.65  (5.602) -4.53  (6.246) -7.67  (5.855) -7.79  (6.240)
Change From Baseline at Week 24 Number Analyzed 33 participants 34 participants 148 participants 167 participants
-3.21  (4.814) -5.32  (6.304) -7.87  (6.080) -7.75  (6.277)
Change From Baseline at Week 52 Number Analyzed 31 participants 31 participants 151 participants 149 participants
-3.35  (5.438) -4.81  (6.720) -7.95  (6.589) -7.70  (6.443)
32.Secondary Outcome
Title VC Period: Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score
Hide Description CDLQI is the youth/children's version of the DLQI. The CDLQI is a simple 10 question (Q) validated quality-of-life questionnaire. It covers 6 domains including symptoms and feelings (Q1 and Q2), leisure (Q4, Q5, and Q6), school or holidays (Q7), personal relationships (Q3 and Q8), sleep (Q9) and treatment (Q10). Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. The total DLQI score is calculated by adding the score of each question resulting in a maximum score of 30 (extremely large effect on participant's life) and a minimum score of 0 (no impact on participant's life) and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant's life.
Time Frame Baseline, Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study. Participants in the ITT population with age < 16 were included. Number analyzed is the number of participants with data available for analyses at the specified time point.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 19 37 30
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change From Baseline at Week 2 Number Analyzed 18 participants 33 participants 29 participants
-1.06  (3.733) -5.06  (6.937) -6.76  (6.306)
Change From Baseline at Week 4 Number Analyzed 17 participants 34 participants 29 participants
-2.47  (6.530) -4.35  (8.683) -6.90  (5.101)
Change From Baseline at Week 8 Number Analyzed 16 participants 33 participants 28 participants
-2.31  (5.618) -5.88  (7.524) -7.61  (6.142)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments Change from Baseline in total CDLQI score at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0018
Comments [Not Specified]
Method ANCOVA
Comments P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -3.3
Confidence Interval (2-Sided) 95%
-5.29 to -1.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments Change from Baseline in total CDLQI score at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0378
Comments [Not Specified]
Method ANCOVA
Comments P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.3
Confidence Interval (2-Sided) 95%
-4.43 to -0.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.08
Estimation Comments [Not Specified]
33.Secondary Outcome
Title LTS Period: Change From Baseline in CDLQI Score
Hide Description CDLQI is the youth/children's version of the DLQI. The CDLQI is a simple 10 question (Q) validated quality-of-life questionnaire. It covers 6 domains including symptoms and feelings (Q1 and Q2), leisure (Q4, Q5, and Q6), school or holidays (Q7), personal relationships (Q3 and Q8), sleep (Q9) and treatment (Q10). Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. The total DLQI score is calculated by adding the score of each question resulting in a maximum score of 30 (extremely large effect on participant's life) and a minimum score of 0 (no impact on participant's life) and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant's life.
Time Frame Baseline, Weeks 12, 24, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Participants in the LTS evaluable population with age < 16 were included. Number analyzed is the number of participants with data available for analyses at the specified time point.
Arm/Group Title LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID LTS Period: Ruxolitinib 0.75% Cream LTS Period: Ruxolitinib 1.5% Cream
Hide Arm/Group Description:
Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Overall Number of Participants Analyzed 8 9 33 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change From Baseline at Week 12 Number Analyzed 6 participants 8 participants 30 participants 22 participants
-4.00  (5.477) -1.13  (8.097) -5.83  (7.661) -8.86  (5.532)
Change From Baseline at Week 24 Number Analyzed 7 participants 8 participants 25 participants 19 participants
-2.71  (5.155) -2.00  (3.780) -6.72  (7.640) -9.42  (7.214)
Change From Baseline at Week 52 Number Analyzed 6 participants 7 participants 23 participants 21 participants
-4.33  (8.359) -0.43  (4.928) -6.70  (7.766) -9.71  (6.262)
34.Secondary Outcome
Title VC Period: Mean Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, and 8
Hide Description The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. It is a 7-point scale where participants rate the questions as: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The lower score indicates improvement.
Time Frame Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 126 252 253
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 2 Number Analyzed 113 participants 236 participants 237 participants
3.53  (1.500) 2.06  (0.937) 1.94  (0.911)
Week 4 Number Analyzed 105 participants 237 participants 240 participants
3.30  (1.434) 1.78  (0.903) 1.68  (0.843)
Week 8 Number Analyzed 100 participants 223 participants 229 participants
3.08  (1.489) 1.76  (0.913) 1.61  (0.914)
35.Secondary Outcome
Title VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8
Hide Description The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. It is a 7-point scale where participants rate the questions as: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The lower score indicates improvement.
Time Frame Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 126 252 253
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 - Very Much Improved: 1 Number Analyzed 113 participants 236 participants 237 participants
5.3 31.4 36.7
Week 2 - Much Improved: 2 Number Analyzed 113 participants 236 participants 237 participants
18.6 38.6 40.1
Week 2 - Minimally Improved: 3 Number Analyzed 113 participants 236 participants 237 participants
37.2 25.0 16.9
Week 2 - No Change: 4 Number Analyzed 113 participants 236 participants 237 participants
13.3 4.2 5.5
Week 2 - Minimally Worse: 5 Number Analyzed 113 participants 236 participants 237 participants
11.5 0.4 0.8
Week 2 - Much Worse: 6 Number Analyzed 113 participants 236 participants 237 participants
10.6 0.0 0.0
Week 2 - Very Much Worse: 7 Number Analyzed 113 participants 236 participants 237 participants
3.5 0.4 0.0
Week 4 - Very Much Improved: 1 Number Analyzed 105 participants 237 participants 240 participants
6.7 48.5 51.7
Week 4 - Much Improved: 2 Number Analyzed 105 participants 237 participants 240 participants
22.9 29.5 32.1
Week 4 - Minimally Improved: 3 Number Analyzed 105 participants 237 participants 240 participants
38.1 18.1 13.3
Week 4 - No Change: 4 Number Analyzed 105 participants 237 participants 240 participants
11.4 3.0 2.1
Week 4 - Minimally Worse: 5 Number Analyzed 105 participants 237 participants 240 participants
11.4 0.8 0.8
Week 4 - Much Worse: 6 Number Analyzed 105 participants 237 participants 240 participants
6.7 0.0 0.0
Week 4 - Very Much Worse: 7 Number Analyzed 105 participants 237 participants 240 participants
2.9 0.0 0.0
Week 8 - Very Much Improved: 1 Number Analyzed 100 participants 223 participants 229 participants
11.0 48.4 59.8
Week 8 - Much Improved: 2 Number Analyzed 100 participants 223 participants 229 participants
30.0 33.2 25.8
Week 8 - Minimally Improved: 3 Number Analyzed 100 participants 223 participants 229 participants
29.0 14.8 10.0
Week 8 - No Change: 4 Number Analyzed 100 participants 223 participants 229 participants
12.0 1.3 2.2
Week 8 - Minimally Worse: 5 Number Analyzed 100 participants 223 participants 229 participants
7.0 2.2 2.2
Week 8 - Much Worse: 6 Number Analyzed 100 participants 223 participants 229 participants
10.0 0.0 0.0
Week 8 - Very Much Worse: 7 Number Analyzed 100 participants 223 participants 229 participants
1.0 0.0 0.0
36.Secondary Outcome
Title VC Period: Percentage of Participants With a Score of Either 1 or 2 on the PGIC at Weeks 2, 4, and 8
Hide Description The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. It is a 7-point scale where participants rate the questions as: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The lower score indicates improvement.
Time Frame Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 126 252 253
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2 Number Analyzed 113 participants 236 participants 237 participants
23.9
(16.4 to 32.8)
69.9
(63.6 to 75.7)
76.8
(70.9 to 82.0)
Week 4 Number Analyzed 105 participants 237 participants 240 participants
29.5
(21.0 to 39.2)
78.1
(72.2 to 83.2)
83.8
(78.5 to 88.2)
Week 8 Number Analyzed 100 participants 223 participants 229 participants
41.0
(31.3 to 51.3)
81.6
(75.9 to 86.5)
85.6
(80.4 to 89.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.
Method Exact Logistic Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.28
Confidence Interval (2-Sided) 95%
3.632 to 11.018
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.
Method Exact Logistic Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 8.39
Confidence Interval (2-Sided) 95%
4.755 to 15.083
Estimation Comments [Not Specified]
37.Secondary Outcome
Title VC Period: Change From Baseline in EuroQuality of Life Five Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) Score
Hide Description EQ-5D-5L questionnaire has 2 parts: EQ-5D-5L descriptive system & EQ-VAS. EQ-5D is a validated, self-administered, generic utility questionnaire wherein participants rate their current health state based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. 5L indicates that for each dimension, there are 5 levels:1=no problems,2=slight problems,3=moderate problems,4=severe problems, and 5=extreme problems. EQ-5D-5L score is assessed using VAS that ranges from 0 to 100 millimetres (mm), where 0 indicates "worst health you can imagine" and 100 indicates "best health you can imagine". The participant was asked to indicate his/her health state over past 7 days in each of the 5 dimensions. Digits for the 5 dimensions can be combined into a 5-digit number that describes the participant's health state. In the EQ-VAS, participants had to record their health state on a scale ranging from 0 to 100. A positive change from Baseline indicates improvement.
Time Frame Baseline, Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 126 252 253
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change From Baseline at Week 2 Number Analyzed 114 participants 237 participants 237 participants
-0.94  (14.046) 6.93  (17.690) 8.21  (15.770)
Change From Baseline at Week 4 Number Analyzed 107 participants 237 participants 241 participants
1.76  (11.618) 8.73  (17.494) 7.10  (16.697)
Change From Baseline at Week 8 Number Analyzed 100 participants 223 participants 229 participants
1.74  (14.376) 9.12  (17.871) 7.98  (16.813)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments Change from Baseline in EQ VAS score at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0037
Comments [Not Specified]
Method ANCOVA
Comments P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 4.9
Confidence Interval (2-Sided) 95%
1.59 to 8.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.67
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments Change from Baseline in EQ VAS score at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method ANCOVA
Comments P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 5.7
Confidence Interval (2-Sided) 95%
2.45 to 8.96
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.66
Estimation Comments [Not Specified]
38.Secondary Outcome
Title VC Period: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Version 2.0 (v2.0)
Hide Description The WPAI-SHP is a 6-item participant questionnaire developed to measure the effect of overall health and specific symptoms on productivity at work and regular activities outside of it in the past 7 days. The WPAI-SHP consists of 6 questions as follows: 1=currently employed; 2=hours missed due to AD; 3=hours missed other reasons; 4=hours actually worked; 5=degree AD affected productivity while working; 6=degree AD affected regular activities and the computed percentage, range for each sub scale is from 0 to 100, with higher values indicating greater impairment and less productivity. A negative change from Baseline indicates improvement.
Time Frame Baseline, Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point.
Arm/Group Title VC Period: Vehicle Cream BID VC Period: Ruxolitinib 0.75% Cream BID VC Period: Ruxolitinib 1.5% Cream BID
Hide Arm/Group Description:
Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Overall Number of Participants Analyzed 126 252 253
Mean (Standard Deviation)
Unit of Measure: score on a scale
Percent Work Time Missed Due to AD: Change From Baseline at Week 2 Number Analyzed 54 participants 111 participants 121 participants
4.45  (19.542) -3.89  (24.223) 1.19  (14.954)
Percent Work Time Missed Due to AD: Change From Baseline at Week 4 Number Analyzed 48 participants 107 participants 124 participants
14.09  (30.660) 1.22  (23.898) 3.43  (17.242)
Percent Work Time Missed Due to AD: Change From Baseline at Week 8 Number Analyzed 48 participants 108 participants 119 participants
5.07  (23.253) -0.26  (23.891) 6.23  (22.211)
Percent Impairment While Working Due to AD: Change From Baseline at Week 2 Number Analyzed 53 participants 110 participants 120 participants
-7.36  (22.630) -15.00  (22.494) -16.75  (20.951)
Percent Impairment While Working Due to AD: Change From Baseline at Week 4 Number Analyzed 45 participants 105 participants 123 participants
-9.56  (25.580) -16.86  (22.417) -19.43  (20.933)
Percent Impairment While Working Due to AD: Change From Baseline at Week 8 Number Analyzed 48 participants 105 participants 118 participants
-13.54  (28.019) -19.43  (24.878) -21.61  (22.071)
Percent Overall Work Impairment Due to AD: Change From Baseline at Week 2 Number Analyzed 53 participants 110 participants 120 participants
-5.27  (21.539) -15.04  (27.812) -15.49  (23.785)
Percent Overall Work Impairment Due to AD: Change From Baseline at Week 4 Number Analyzed 45 participants 105 participants 123 participants
-2.35  (27.602) -13.82  (26.207) -15.82  (25.545)
Percent Overall Work Impairment Due to AD: Change From Baseline at Week 8 Number Analyzed 48 participants 105 participants 118 participants
-9.01  (31.735) -18.09  (27.718) -15.54  (27.119)
Percent Activity Impairment Due to AD: Change From Baseline at Week 2 Number Analyzed 114 participants 237 participants 237 participants
-6.32  (23.434) -16.58  (24.696) -21.56  (24.695)
Percent Activity Impairment Due to AD: Change From Baseline at Week 4 Number Analyzed 106 participants 237 participants 241 participants
-10.09  (26.349) -20.80  (24.107) -23.53  (25.422)
Percent Activity Impairment Due to AD: Change From Baseline at Week 8 Number Analyzed 100 participants 223 participants 229 participants
-11.70  (28.992) -21.30  (24.653) -24.06  (26.682)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID
Comments Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1417
Comments [Not Specified]
Method ANCOVA
Comments P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -4.9
Confidence Interval (2-Sided) 95%
-11.49 to 1.65
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID
Comments Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6037
Comments [Not Specified]
Method ANCOVA
Comments P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.7
Confidence Interval (2-Sided) 95%