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

• 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: Incyte Corporation
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID	Total
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
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)

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8
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

Outcome Measure Data

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
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)

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]

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)
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

Outcome Measure Data

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
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)

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]

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
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

Outcome Measure Data

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
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

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]

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
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

Outcome Measure Data

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
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

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]

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)
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

Outcome Measure Data

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
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

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]

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)
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

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

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]

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]

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]

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]

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]

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
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

Outcome Measure Data

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
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)

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]

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
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

Outcome Measure Data

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
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)

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]

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]

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]

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]

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]

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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

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]

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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

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]

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]

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]

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]

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]

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
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

Outcome Measure Data

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
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)

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]

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]

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]

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]

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]

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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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)

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]

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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

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]

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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

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]

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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

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]

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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

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]

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
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

Outcome Measure Data

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
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)

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]

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)
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

Outcome Measure Data

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
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)

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]

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%