Trial Outcomes & Findings for TRuE AD2 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis (NCT NCT03745651)

NCT ID: NCT03745651

Last Updated: 2023-09-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 618 participants
• Primary outcome timeframe: Baseline to Week 8
• Results posted on: 2023-09-28

Participant Flow

A total of 618 participants were enrolled at 65 investigative sites in North America and Europe from December 20, 2018 to November 09, 2020.

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.

Participant milestones

Measure	VC Period: Vehicle Cream BID Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.	LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.	LTS Period: Ruxolitinib 0.75% Cream BID Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Vehicle Control Period (Day 1 to Week 8) STARTED	124	248	246	0	0	0	0
Vehicle Control Period (Day 1 to Week 8) COMPLETED	105	209	224	0	0	0	0
Vehicle Control Period (Day 1 to Week 8) NOT COMPLETED	19	39	22	0	0	0	0
Long-Term Safety Period (Weeks 8 to 52) STARTED	0	0	0	53	52	204	221
Long-Term Safety Period (Weeks 8 to 52) COMPLETED	0	0	0	33	41	151	170
Long-Term Safety Period (Weeks 8 to 52) NOT COMPLETED	0	0	0	20	11	53	51

Reasons for withdrawal

Measure	VC Period: Vehicle Cream BID Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.	LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.	LTS Period: Ruxolitinib 0.75% Cream BID Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Vehicle Control Period (Day 1 to Week 8) Adverse Event	1	1	0	0	0	0	0
Vehicle Control Period (Day 1 to Week 8) Lost to Follow-up	3	13	4	0	0	0	0
Vehicle Control Period (Day 1 to Week 8) Physician Decision	3	0	1	0	0	0	0
Vehicle Control Period (Day 1 to Week 8) Protocol Violation	0	2	0	0	0	0	0
Vehicle Control Period (Day 1 to Week 8) Withdrawal by Subject	11	21	15	0	0	0	0
Vehicle Control Period (Day 1 to Week 8) Reason not Specified	1	2	2	0	0	0	0
Long-Term Safety Period (Weeks 8 to 52) Adverse Event	0	0	0	0	0	4	0
Long-Term Safety Period (Weeks 8 to 52) Lack of Efficacy	0	0	0	1	0	4	4
Long-Term Safety Period (Weeks 8 to 52) Lost to Follow-up	0	0	0	4	2	13	10
Long-Term Safety Period (Weeks 8 to 52) Physician Decision	0	0	0	1	0	4	2
Long-Term Safety Period (Weeks 8 to 52) Pregnancy	0	0	0	1	0	0	1
Long-Term Safety Period (Weeks 8 to 52) Protocol Violation	0	0	0	0	0	1	0
Long-Term Safety Period (Weeks 8 to 52) Withdrawal by Subject	0	0	0	12	8	26	34
Long-Term Safety Period (Weeks 8 to 52) Reason not Specified	0	0	0	1	1	1	0

Baseline Characteristics

TRuE AD2 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis

Baseline characteristics by cohort

Measure	VC Period: Vehicle Cream BID n=124 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=248 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=246 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	Total n=618 Participants Total of all reporting groups
Age, Continuous	38.9 years STANDARD_DEVIATION 18.90 • n=5 Participants	35.8 years STANDARD_DEVIATION 18.45 • n=7 Participants	35.9 years STANDARD_DEVIATION 18.01 • n=5 Participants	36.4 years STANDARD_DEVIATION 18.38 • n=4 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	150 Participants n=7 Participants	150 Participants n=5 Participants	380 Participants n=4 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	98 Participants n=7 Participants	96 Participants n=5 Participants	238 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	17 Participants n=5 Participants	31 Participants n=7 Participants	30 Participants n=5 Participants	78 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	107 Participants n=5 Participants	217 Participants n=7 Participants	216 Participants n=5 Participants	540 Participants n=4 Participants
Race/Ethnicity, Customized Race · White/Caucasian	85 Participants n=5 Participants	174 Participants n=7 Participants	178 Participants n=5 Participants	437 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black/African-American	32 Participants n=5 Participants	63 Participants n=7 Participants	57 Participants n=5 Participants	152 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	2 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	14 Participants n=4 Participants
Race/Ethnicity, Customized Race · American-Indian/Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Race · Native Hawaiian/Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other	3 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Body Mass Index	27.75 Kilograms per square metre (kg/m^2) STANDARD_DEVIATION 6.737 • n=5 Participants	27.60 Kilograms per square metre (kg/m^2) STANDARD_DEVIATION 7.091 • n=7 Participants	28.01 Kilograms per square metre (kg/m^2) STANDARD_DEVIATION 7.495 • n=5 Participants	27.80 Kilograms per square metre (kg/m^2) STANDARD_DEVIATION 7.177 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline to Week 8

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=118 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=231 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=228 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8	7.6 percentage of participants Interval 3.5 to 14.0	39.0 percentage of participants Interval 32.6 to 45.6	51.3 percentage of participants Interval 44.6 to 58.0	—

SECONDARY outcome

Timeframe: Baseline to Week 8

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded.

EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) 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) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 and the severity strata 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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=118 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=231 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=228 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Week 8	14.4 percentage of participants Interval 8.6 to 22.1	51.5 percentage of participants Interval 44.9 to 58.1	61.8 percentage of participants Interval 55.2 to 68.2	—

SECONDARY outcome

Timeframe: Baseline to Week 8

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed included participants in the ITT population with a Baseline Itch NRS score ≥ 4.

The Itch NRS is a daily participant-reported measure (24-hour recall), of the worst level of itch intensity using a diary. 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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=80 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=157 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=146 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8	16.3 percentage of participants	42.7 percentage of participants	50.7 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline to Week 8

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed included participants in the ITT population with a Baseline score ≥ 6.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=110 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=213 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=211 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
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 at Week 8	19.1 percentage of participants	20.7 percentage of participants	25.6 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline to Week 8

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed included participants in the ITT population with a Baseline score ≥ 6.

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. Each item asks the participant to rate the severity of the participant's sleep impairment.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=111 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=215 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=212 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
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 at Week 8	13.5 percentage of participants	20.0 percentage of participants	23.1 percentage of participants	—

SECONDARY outcome

Timeframe: From date of randomization up to Week 8

Population: Safety population included all randomized participants who applied at least 1 application of ruxolitinib cream or vehicle cream.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=124 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=248 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=246 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (SAE) TEAE	31.5 percentage of participants	29.0 percentage of participants	23.6 percentage of participants	—
VC Period: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (SAE) Treatment Emergent SAE	0.0 percentage of participants	1.2 percentage of participants	0.4 percentage of participants	—

SECONDARY outcome

Timeframe: From first dose date in LTS Period (Week 8) until last follow-up visit (up to 52 weeks)

Population: LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=53 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=52 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=204 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID n=221 Participants Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
LTS Period: Percentage of Participants With at Least One TEAE and Treatment Emergent SAE TEAE	58.5 percentage of participants	65.4 percentage of participants	66.2 percentage of participants	54.3 percentage of participants
LTS Period: Percentage of Participants With at Least One TEAE and Treatment Emergent SAE Treatment Emergent SAE	3.8 percentage of participants	0.0 percentage of participants	2.5 percentage of participants	1.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Weeks 2 and 4

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=118 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=231 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=228 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Percentage of Participants Who Achieved an IGA-TS at Weeks 2 and 4 Week 2	4.2 percentage of participants	17.3 percentage of participants	25.0 percentage of participants	—
VC Period: Percentage of Participants Who Achieved an IGA-TS at Weeks 2 and 4 Week 4	5.9 percentage of participants	35.5 percentage of participants	43.4 percentage of participants	—

SECONDARY outcome

Timeframe: Weeks 2, 4 and 8

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=118 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=231 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=228 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Percentage of Participants Achieving an IGA of 0 or 1 Week 2	9.3 percentage of participants	24.2 percentage of participants	34.6 percentage of participants	—
VC Period: Percentage of Participants Achieving an IGA of 0 or 1 Week 4	16.9 percentage of participants	45.9 percentage of participants	52.6 percentage of participants	—
VC Period: Percentage of Participants Achieving an IGA of 0 or 1 Week 8	16.1 percentage of participants	51.1 percentage of participants	62.3 percentage of participants	—

SECONDARY outcome

Timeframe: Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

Population: LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=50 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=49 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=187 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID n=203 Participants Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 Week 8	26.0 percentage of participants	10.2 percentage of participants	57.5 percentage of participants	65.5 percentage of participants
LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 Week 12	59.6 percentage of participants	45.8 percentage of participants	59.6 percentage of participants	73.0 percentage of participants
LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 Week 16	59.6 percentage of participants	59.6 percentage of participants	68.9 percentage of participants	74.1 percentage of participants
LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 Week 20	69.0 percentage of participants	58.7 percentage of participants	71.1 percentage of participants	74.5 percentage of participants
LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 Week 24	61.0 percentage of participants	67.4 percentage of participants	70.4 percentage of participants	72.4 percentage of participants
LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 Week 28	67.6 percentage of participants	67.4 percentage of participants	74.1 percentage of participants	72.0 percentage of participants
LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 Week 32	77.1 percentage of participants	72.7 percentage of participants	74.2 percentage of participants	73.8 percentage of participants
LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 Week 36	81.3 percentage of participants	69.8 percentage of participants	73.3 percentage of participants	79.3 percentage of participants
LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 Week 40	77.1 percentage of participants	66.7 percentage of participants	76.0 percentage of participants	79.3 percentage of participants
LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 Week 44	74.3 percentage of participants	70.5 percentage of participants	75.2 percentage of participants	80.1 percentage of participants
LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 Week 48	79.4 percentage of participants	69.8 percentage of participants	75.2 percentage of participants	75.9 percentage of participants
LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 Week 52	79.4 percentage of participants	74.4 percentage of participants	76.7 percentage of participants	80.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Weeks 2 and 4

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed includes participants in the ITT population with a Baseline Itch NRS score ≥ 4.

The Itch NRS is a daily participant-reported measure (24-hour recall), of the worst level of itch intensity using a diary. 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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=80 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=157 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=146 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch NRS Score From Baseline to Weeks 2 and 4 Week 2	5.0 percentage of participants	27.4 percentage of participants	32.2 percentage of participants	—
VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch NRS Score From Baseline to Weeks 2 and 4 Week 4	12.5 percentage of participants	38.2 percentage of participants	45.2 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline to Weeks 2, 4 and 8

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded.

EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) 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) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 and the severity strata 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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=118 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=231 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=228 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Percentage of Participants Who Achieved EASI50 Week 2	16.1 percentage of participants	45.5 percentage of participants	53.5 percentage of participants	—
VC Period: Percentage of Participants Who Achieved EASI50 Week 4	28.8 percentage of participants	69.7 percentage of participants	71.9 percentage of participants	—
VC Period: Percentage of Participants Who Achieved EASI50 Week 8	33.9 percentage of participants	75.8 percentage of participants	79.8 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline to Weeks 2 and 4

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded.

EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) 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) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 and the severity strata 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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=118 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=231 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=228 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Percentage of Participants Who Achieved EASI75 at Weeks 2 and 4 Week 2	4.2 percentage of participants	25.5 percentage of participants	31.6 percentage of participants	—
VC Period: Percentage of Participants Who Achieved EASI75 at Weeks 2 and 4 Week 4	10.2 percentage of participants	42.0 percentage of participants	50.4 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline to Weeks 2, 4 and 8

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded.

EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) 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) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 and the severity strata 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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=118 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=231 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=228 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Percentage of Participants Who Achieved EASI90 Week 2	0.8 percentage of participants	10.8 percentage of participants	15.8 percentage of participants	—
VC Period: Percentage of Participants Who Achieved EASI90 Week 4	2.5 percentage of participants	25.5 percentage of participants	32.5 percentage of participants	—
VC Period: Percentage of Participants Who Achieved EASI90 Week 8	4.2 percentage of participants	35.1 percentage of participants	43.4 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4 and 8

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) 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) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 and the severity strata 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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=118 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=231 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=228 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Percent Change From Baseline in EASI Score Percent Change From Baseline at Week 2	-13.95 percent change Standard Error 4.02	-45.86 percent change Standard Error 2.84	-49.08 percent change Standard Error 2.86	—
VC Period: Percent Change From Baseline in EASI Score Percent Change From Baseline at Week 4	-20.45 percent change Standard Error 3.62	-65.00 percent change Standard Error 2.50	-66.35 percent change Standard Error 2.51	—
VC Period: Percent Change From Baseline in EASI Score Percent Change From Baseline at Week 8	-28.84 percent change Standard Error 3.57	-73.37 percent change Standard Error 2.50	-74.84 percent change Standard Error 2.46	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4 and 8

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=118 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=231 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=228 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score Percent Change From Baseline at Week 2	-13.87 percent change Standard Deviation 24.816	-39.62 percent change Standard Deviation 28.061	-45.22 percent change Standard Deviation 28.461	—
VC Period: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score Percent Change From Baseline at Week 4	-21.79 percent change Standard Deviation 30.083	-54.85 percent change Standard Deviation 29.803	-58.76 percent change Standard Deviation 29.580	—
VC Period: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score Percent Change From Baseline at Week 8	-23.63 percent change Standard Deviation 33.918	-63.71 percent change Standard Deviation 28.494	-67.39 percent change Standard Deviation 29.098	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4 and 8

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

The Itch NRS is a daily participant-reported measure (24-hour recall), of the worst level of itch intensity using a diary. 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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=118 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=231 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=228 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Change From Baseline in Itch NRS Score Change From Baseline at Week 2	-0.69 score on a scale Standard Error 0.21	-2.21 score on a scale Standard Error 0.15	-2.43 score on a scale Standard Error 0.15	—
VC Period: Change From Baseline in Itch NRS Score Change From Baseline at Week 4	-1.03 score on a scale Standard Error 0.23	-2.82 score on a scale Standard Error 0.17	-3.00 score on a scale Standard Error 0.17	—
VC Period: Change From Baseline in Itch NRS Score Change From Baseline at Week 8	-1.39 score on a scale Standard Error 0.25	-3.28 score on a scale Standard Error 0.18	-3.09 score on a scale Standard Error 0.17	—

SECONDARY outcome

Timeframe: Up to Week 8

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. 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.

The Itch NRS is a daily participant-reported measure (24-hour recall), of the worst level of itch intensity using a diary. 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. Kaplan-Meier estimation method was used for analyses.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=118 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=231 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=228 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2, 3, or 4 Points ≥ 2-Point Improvement in Itch NRS Score	20.0 days Interval 13.0 to 24.0	5.0 days Interval 4.0 to 6.0	4.0 days Interval 4.0 to 5.0	—
VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2, 3, or 4 Points ≥ 3-Point Improvement in Itch NRS Score	44.0 days Interval 25.0 to The upper limit of 95% CI was not estimable	8.0 days Interval 6.0 to 13.0	8.0 days Interval 6.0 to 11.0	—
VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2, 3, or 4 Points ≥ 4-Point Improvement in Itch NRS Score	NA days The median and 95% CI were not estimable because they were not achieved	16 days Interval 12.0 to 22.0	14 days Interval 10.0 to 18.0	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4 and 8

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

The Skin Pain NRS is a daily patient-reported measure (24-hour recall), of the worst level of pain intensity from 0 (no pain) to 10 (worst imaginable pain) using a diary. 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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=118 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=231 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=228 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Change From Baseline in Skin Pain NRS Score Change From Baseline at Week 2	-0.53 score on a scale Standard Deviation 1.677	-1.78 score on a scale Standard Deviation 2.145	-1.73 score on a scale Standard Deviation 2.125	—
VC Period: Change From Baseline in Skin Pain NRS Score Change From Baseline at Week 4	-0.93 score on a scale Standard Deviation 1.964	-2.28 score on a scale Standard Deviation 2.449	-2.27 score on a scale Standard Deviation 2.262	—
VC Period: Change From Baseline in Skin Pain NRS Score Change From Baseline at Week 8	-1.35 score on a scale Standard Deviation 2.540	-2.45 score on a scale Standard Deviation 2.575	-2.37 score on a scale Standard Deviation 2.428	—

SECONDARY outcome

Timeframe: Weeks 2 and 4

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed included participants in the ITT population with a Baseline score ≥ 6.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=110 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=213 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=211 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score at Weeks 2 and 4 Week 2	10.0 percentage of participants	14.6 percentage of participants	18.0 percentage of participants	—
VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score at Weeks 2 and 4 Week 4	12.7 percentage of participants	16.9 percentage of participants	18.0 percentage of participants	—

SECONDARY outcome

Timeframe: Weeks 2 and 4

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed included participants in the ITT population with a Baseline score ≥ 6.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=111 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=215 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=212 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
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 at Weeks 2 and 4 Week 2	7.2 percentage of participants	10.7 percentage of participants	13.2 percentage of participants	—
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 at Weeks 2 and 4 Week 4	9.0 percentage of participants	13.0 percentage of participants	19.8 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4 and 8

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=118 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=231 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=228 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score Change From Baseline at Week 4	-2.02 score on a scale Standard Error 0.50	-2.32 score on a scale Standard Error 0.35	-2.88 score on a scale Standard Error 0.35	—
VC Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score Change From Baseline at Week 8	-2.60 score on a scale Standard Error 0.60	-3.30 score on a scale Standard Error 0.42	-3.40 score on a scale Standard Error 0.41	—
VC Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score Change From Baseline at Week 2	-1.32 score on a scale Standard Error 0.46	-1.92 score on a scale Standard Error 0.33	-2.30 score on a scale Standard Error 0.33	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4 and 8

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=118 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=231 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=228 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score Change From Baseline at Week 2	-0.80 score on a scale Standard Error 0.44	-1.87 score on a scale Standard Error 0.31	-2.00 score on a scale Standard Error 0.31	—
VC Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score Change From Baseline at Week 4	-1.37 score on a scale Standard Error 0.49	-2.13 score on a scale Standard Error 0.35	-2.91 score on a scale Standard Error 0.35	—
VC Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score Change From Baseline at Week 8	-2.08 score on a scale Standard Error 0.55	-3.26 score on a scale Standard Error 0.39	-3.31 score on a scale Standard Error 0.38	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, and 52

Population: LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=50 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=49 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=187 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID n=203 Participants Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score Change From Baseline at Week 12	-1.73 score on a scale Standard Deviation 4.019	-2.04 score on a scale Standard Deviation 6.282	-0.32 score on a scale Standard Deviation 4.724	-0.04 score on a scale Standard Deviation 3.914
LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score Change From Baseline at Week 24	-0.47 score on a scale Standard Deviation 4.695	-1.04 score on a scale Standard Deviation 5.969	-0.11 score on a scale Standard Deviation 5.136	0.22 score on a scale Standard Deviation 4.868
LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score Change From Baseline at Week 52	-1.48 score on a scale Standard Deviation 5.304	-2.33 score on a scale Standard Deviation 6.582	-0.24 score on a scale Standard Deviation 5.660	-0.69 score on a scale Standard Deviation 5.483

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, and 52

Population: LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=50 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=49 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=187 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID n=203 Participants Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score Change From Baseline at Week 12	-2.00 score on a scale Standard Deviation 4.973	-1.80 score on a scale Standard Deviation 5.588	-0.37 score on a scale Standard Deviation 4.621	-0.32 score on a scale Standard Deviation 4.466
LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score Change From Baseline at Week 24	-0.97 score on a scale Standard Deviation 6.188	-1.87 score on a scale Standard Deviation 5.691	-0.03 score on a scale Standard Deviation 4.688	0.06 score on a scale Standard Deviation 5.376
LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score Change From Baseline at Week 52	-1.39 score on a scale Standard Deviation 7.198	-2.88 score on a scale Standard Deviation 7.235	-0.36 score on a scale Standard Deviation 6.049	-0.42 score on a scale Standard Deviation 5.950

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4 and 8

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

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. Use 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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=118 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=231 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=228 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Change From Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA) Change From Baseline at Week 2	-0.48 % BSA Standard Deviation 3.008	-2.92 % BSA Standard Deviation 3.944	-3.99 % BSA Standard Deviation 4.636	—
VC Period: Change From Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA) Change From Baseline at Week 4	-1.62 % BSA Standard Deviation 3.338	-4.77 % BSA Standard Deviation 4.711	-5.45 % BSA Standard Deviation 5.223	—
VC Period: Change From Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA) Change From Baseline at Week 8	-2.13 % BSA Standard Deviation 4.671	-6.00 % BSA Standard Deviation 4.845	-6.61 % BSA Standard Deviation 5.479	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Population: LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

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. Use 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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=50 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=49 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=187 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID n=203 Participants Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA Change From Baseline at Week 12	-3.89 % BSA Standard Deviation 5.530	-4.71 % BSA Standard Deviation 4.980	-6.61 % BSA Standard Deviation 4.395	-7.69 % BSA Standard Deviation 5.106
LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA Change From Baseline at Week 16	-4.41 % BSA Standard Deviation 5.553	-5.47 % BSA Standard Deviation 5.289	-6.77 % BSA Standard Deviation 5.270	-7.80 % BSA Standard Deviation 5.096
LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA Change From Baseline at Week 20	-4.88 % BSA Standard Deviation 5.210	-6.27 % BSA Standard Deviation 6.193	-7.48 % BSA Standard Deviation 4.900	-8.05 % BSA Standard Deviation 4.920
LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA Change From Baseline at Week 24	-4.70 % BSA Standard Deviation 4.775	-6.37 % BSA Standard Deviation 5.817	-7.49 % BSA Standard Deviation 4.988	-8.00 % BSA Standard Deviation 5.071
LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA Change From Baseline at Week 28	-4.59 % BSA Standard Deviation 4.677	-6.21 % BSA Standard Deviation 6.597	-7.48 % BSA Standard Deviation 4.827	-8.07 % BSA Standard Deviation 5.099
LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA Change From Baseline at Week 32	-5.10 % BSA Standard Deviation 5.203	-6.79 % BSA Standard Deviation 5.960	-7.69 % BSA Standard Deviation 4.891	-7.89 % BSA Standard Deviation 5.004
LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA Change From Baseline at Week 36	-4.65 % BSA Standard Deviation 5.266	-6.16 % BSA Standard Deviation 6.045	-7.79 % BSA Standard Deviation 4.856	-8.38 % BSA Standard Deviation 5.119
LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA Change From Baseline at Week 40	-4.59 % BSA Standard Deviation 5.196	-6.42 % BSA Standard Deviation 5.887	-7.83 % BSA Standard Deviation 4.976	-8.44 % BSA Standard Deviation 5.090
LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA Change From Baseline at Week 44	-5.18 % BSA Standard Deviation 4.901	-6.56 % BSA Standard Deviation 6.200	-7.92 % BSA Standard Deviation 5.082	-8.43 % BSA Standard Deviation 5.122
LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA Change From Baseline at Week 48	-5.30 % BSA Standard Deviation 5.130	-6.61 % BSA Standard Deviation 5.897	-7.64 % BSA Standard Deviation 5.380	-8.33 % BSA Standard Deviation 5.204
LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA Change From Baseline at Week 52	-5.12 % BSA Standard Deviation 5.114	-6.83 % BSA Standard Deviation 5.837	-7.92 % BSA Standard Deviation 4.823	-8.42 % BSA Standard Deviation 4.973

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4 and 8

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=118 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=231 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=228 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score Change From Baseline at Week 2	-2.06 score on a scale Standard Deviation 5.371	-8.21 score on a scale Standard Deviation 6.694	-8.86 score on a scale Standard Deviation 6.807	—
VC Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score Change From Baseline at Week 4	-4.01 score on a scale Standard Deviation 6.125	-9.59 score on a scale Standard Deviation 6.883	-9.97 score on a scale Standard Deviation 6.839	—
VC Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score Change From Baseline at Week 8	-4.18 score on a scale Standard Deviation 6.574	-10.34 score on a scale Standard Deviation 6.835	-10.08 score on a scale Standard Deviation 7.167	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24 and 52

Population: LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=50 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=49 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=187 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID n=203 Participants Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
LTS Period: Change From Baseline in POEM Score Change From Baseline at Week 12	-5.65 score on a scale Standard Deviation 7.460	-6.04 score on a scale Standard Deviation 7.269	-9.72 score on a scale Standard Deviation 6.571	-10.58 score on a scale Standard Deviation 6.883
LTS Period: Change From Baseline in POEM Score Change From Baseline at Week 24	-4.03 score on a scale Standard Deviation 7.006	-5.71 score on a scale Standard Deviation 6.567	-10.30 score on a scale Standard Deviation 6.675	-10.58 score on a scale Standard Deviation 6.848
LTS Period: Change From Baseline in POEM Score Change From Baseline at Week 52	-6.15 score on a scale Standard Deviation 7.304	-6.28 score on a scale Standard Deviation 7.340	-10.29 score on a scale Standard Deviation 6.187	-10.65 score on a scale Standard Deviation 6.699

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, and 8

Population: ITT population included all participants who were randomized to the study. Participants in the ITT population with age \>= 16 were included. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=105 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=194 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=202 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Score Change From Baseline at Week 2	-0.91 score on a scale Standard Deviation 4.679	-5.40 score on a scale Standard Deviation 5.874	-5.14 score on a scale Standard Deviation 5.394	—
VC Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Score Change From Baseline at Week 4	-3.00 score on a scale Standard Deviation 4.962	-6.62 score on a scale Standard Deviation 5.966	-6.16 score on a scale Standard Deviation 5.771	—
VC Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Score Change From Baseline at Week 8	-3.30 score on a scale Standard Deviation 5.353	-7.18 score on a scale Standard Deviation 6.004	-6.41 score on a scale Standard Deviation 5.731	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, and 52

Population: 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. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=47 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=41 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=157 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID n=180 Participants Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
LTS Period: Change From Baseline in DLQI Score Change From Baseline at Week 12	-2.09 score on a scale Standard Deviation 3.611	-2.79 score on a scale Standard Deviation 5.542	-7.07 score on a scale Standard Deviation 5.931	-7.06 score on a scale Standard Deviation 6.044
LTS Period: Change From Baseline in DLQI Score Change From Baseline at Week 24	-1.22 score on a scale Standard Deviation 3.293	-3.08 score on a scale Standard Deviation 3.759	-7.17 score on a scale Standard Deviation 6.152	-7.01 score on a scale Standard Deviation 5.754
LTS Period: Change From Baseline in DLQI Score Change From Baseline at Week 52	-3.09 score on a scale Standard Deviation 3.753	-3.20 score on a scale Standard Deviation 4.234	-7.49 score on a scale Standard Deviation 5.776	-7.28 score on a scale Standard Deviation 6.196

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, and 8

Population: ITT population included all participants who were randomized to the study. Participants in the ITT population with age \< 16 were included. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=13 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=37 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=26 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score Change From Baseline at Week 2	-1.67 score on a scale Standard Deviation 5.416	-3.45 score on a scale Standard Deviation 4.570	-3.58 score on a scale Standard Deviation 4.032	—
VC Period: Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score Change From Baseline at Week 4	-3.10 score on a scale Standard Deviation 6.488	-4.82 score on a scale Standard Deviation 4.934	-4.52 score on a scale Standard Deviation 5.221	—
VC Period: Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score Change From Baseline at Week 8	-2.36 score on a scale Standard Deviation 7.500	-4.56 score on a scale Standard Deviation 5.061	-4.12 score on a scale Standard Deviation 6.418	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, and 52

Population: 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. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=3 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=8 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=30 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID n=23 Participants Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
LTS Period: Change From Baseline in CDLQI Score Change From Baseline at Week 12	-7.50 score on a scale Standard Deviation 2.121	-4.88 score on a scale Standard Deviation 5.436	-5.54 score on a scale Standard Deviation 5.153	-5.57 score on a scale Standard Deviation 5.482
LTS Period: Change From Baseline in CDLQI Score Change From Baseline at Week 24	-8.50 score on a scale Standard Deviation 2.121	-4.88 score on a scale Standard Deviation 4.549	-5.72 score on a scale Standard Deviation 6.066	-5.68 score on a scale Standard Deviation 7.326
LTS Period: Change From Baseline in CDLQI Score Change From Baseline at Week 52	-8.00 score on a scale Standard Deviation 1.414	-6.38 score on a scale Standard Deviation 9.023	-5.35 score on a scale Standard Deviation 4.902	-6.57 score on a scale Standard Deviation 5.983

SECONDARY outcome

Timeframe: Weeks 2, 4 and 8

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=118 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=231 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=228 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Mean Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, and 8 Week 2	3.32 score on a scale Standard Deviation 1.268	2.19 score on a scale Standard Deviation 1.019	1.95 score on a scale Standard Deviation 0.980	—
VC Period: Mean Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, and 8 Week 4	2.99 score on a scale Standard Deviation 1.259	1.95 score on a scale Standard Deviation 0.980	1.71 score on a scale Standard Deviation 0.852	—
VC Period: Mean Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, and 8 Week 8	2.93 score on a scale Standard Deviation 1.380	1.73 score on a scale Standard Deviation 0.906	1.70 score on a scale Standard Deviation 0.909	—

SECONDARY outcome

Timeframe: Weeks 2, 4 and 8

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=118 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=231 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=228 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 Week 8 - Much Worse: 6	3.0 percentage of participants	0.0 percentage of participants	0.5 percentage of participants	—
VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 Week 2 - Very Much Improved: 1	4.6 percentage of participants	32.1 percentage of participants	41.0 percentage of participants	—
VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 Week 2 - Much Improved: 2	20.2 percentage of participants	27.1 percentage of participants	30.9 percentage of participants	—
VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 Week 2 - Minimally Improved: 3	38.5 percentage of participants	32.1 percentage of participants	20.7 percentage of participants	—
VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 Week 2 - No Change: 4	21.1 percentage of participants	7.8 percentage of participants	6.5 percentage of participants	—
VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 Week 2 - Minimally Worse: 5	7.3 percentage of participants	0.5 percentage of participants	0.9 percentage of participants	—
VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 Week 2 - Much Worse: 6	7.3 percentage of participants	0.5 percentage of participants	0.0 percentage of participants	—
VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 Week 2 - Very Much Worse: 7	0.9 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 Week 4 - Very Much Improved: 1	10.0 percentage of participants	41.9 percentage of participants	49.1 percentage of participants	—
VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 Week 4 - Much Improved: 2	29.0 percentage of participants	28.6 percentage of participants	35.2 percentage of participants	—
VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 Week 4 - Minimally Improved: 3	29.0 percentage of participants	22.1 percentage of participants	12.0 percentage of participants	—
VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 Week 4 - No Change: 4	20.0 percentage of participants	6.9 percentage of participants	2.8 percentage of participants	—
VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 Week 4 - Minimally Worse: 5	8.0 percentage of participants	0.5 percentage of participants	0.9 percentage of participants	—
VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 Week 4 - Much Worse: 6	4.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 Week 4 - Very Much Worse: 7	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 Week 8 - Very Much Improved: 1	16.8 percentage of participants	52.7 percentage of participants	51.6 percentage of participants	—
VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 Week 8 - Much Improved: 2	24.8 percentage of participants	26.1 percentage of participants	32.6 percentage of participants	—
VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 Week 8 - Minimally Improved: 3	23.8 percentage of participants	16.3 percentage of participants	12.1 percentage of participants	—
VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 Week 8 - No Change: 4	22.8 percentage of participants	4.9 percentage of participants	1.9 percentage of participants	—
VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 Week 8 - Minimally Worse: 5	7.9 percentage of participants	0.0 percentage of participants	1.4 percentage of participants	—
VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 Week 8 - Very Much Worse: 7	1.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Weeks 2, 4 and 8

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=118 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=231 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=228 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Percentage of Participants With a Score of Either 1 or 2 on the PGIC at Weeks 2, 4, and 8 Week 2	24.8 percentage of participants Interval 17.0 to 34.0	59.2 percentage of participants Interval 52.3 to 65.8	71.9 percentage of participants Interval 65.4 to 77.8	—
VC Period: Percentage of Participants With a Score of Either 1 or 2 on the PGIC at Weeks 2, 4, and 8 Week 4	39.0 percentage of participants Interval 29.4 to 49.3	70.5 percentage of participants Interval 64.0 to 76.5	84.3 percentage of participants Interval 78.7 to 88.8	—
VC Period: Percentage of Participants With a Score of Either 1 or 2 on the PGIC at Weeks 2, 4, and 8 Week 8	41.6 percentage of participants Interval 31.9 to 51.8	78.8 percentage of participants Interval 72.5 to 84.2	84.2 percentage of participants Interval 78.6 to 88.8	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4 and 8

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=118 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=231 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=228 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Change From Baseline in EuroQuality of Life Five Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) Score Change From Baseline at Week 2	1.43 score on a scale Standard Deviation 13.975	6.16 score on a scale Standard Deviation 14.409	6.98 score on a scale Standard Deviation 15.956	—
VC Period: Change From Baseline in EuroQuality of Life Five Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) Score Change From Baseline at Week 4	3.31 score on a scale Standard Deviation 15.061	6.38 score on a scale Standard Deviation 17.512	8.55 score on a scale Standard Deviation 17.244	—
VC Period: Change From Baseline in EuroQuality of Life Five Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) Score Change From Baseline at Week 8	2.97 score on a scale Standard Deviation 15.946	7.16 score on a scale Standard Deviation 18.245	8.36 score on a scale Standard Deviation 16.767	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, and 8

Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=118 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=231 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=228 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Version 2.0 (v2.0) Percent Activity Impairment Due to AD: Change From Baseline at Week 8	-9.50 score on a scale Standard Deviation 25.361	-19.66 score on a scale Standard Deviation 25.157	-18.60 score on a scale Standard Deviation 25.557	—
VC Period: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Version 2.0 (v2.0) Percent Work Time Missed Due to AD: Change From Baseline at Week 2	4.77 score on a scale Standard Deviation 23.348	0.64 score on a scale Standard Deviation 19.190	2.53 score on a scale Standard Deviation 17.803	—
VC Period: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Version 2.0 (v2.0) Percent Work Time Missed Due to AD: Change From Baseline at Week 4	3.22 score on a scale Standard Deviation 22.497	-0.15 score on a scale Standard Deviation 22.299	4.31 score on a scale Standard Deviation 19.679	—
VC Period: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Version 2.0 (v2.0) Percent Work Time Missed Due to AD: Change From Baseline at Week 8	10.03 score on a scale Standard Deviation 24.477	3.50 score on a scale Standard Deviation 24.760	3.51 score on a scale Standard Deviation 18.479	—
VC Period: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Version 2.0 (v2.0) Percent Impairment While Working Due to AD: Change From Baseline at Week 2	-4.49 score on a scale Standard Deviation 25.500	-12.76 score on a scale Standard Deviation 21.371	-13.24 score on a scale Standard Deviation 19.958	—
VC Period: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Version 2.0 (v2.0) Percent Impairment While Working Due to AD: Change From Baseline at Week 4	-12.05 score on a scale Standard Deviation 24.514	-15.25 score on a scale Standard Deviation 22.648	-18.10 score on a scale Standard Deviation 19.832	—
VC Period: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Version 2.0 (v2.0) Percent Impairment While Working Due to AD: Change From Baseline at Week 8	-10.93 score on a scale Standard Deviation 25.618	-18.83 score on a scale Standard Deviation 23.365	-17.32 score on a scale Standard Deviation 19.013	—
VC Period: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Version 2.0 (v2.0) Percent Overall Work Impairment Due to AD: Change From Baseline at Week 2	-2.78 score on a scale Standard Deviation 31.057	-12.58 score on a scale Standard Deviation 24.670	-11.10 score on a scale Standard Deviation 23.717	—
VC Period: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Version 2.0 (v2.0) Percent Overall Work Impairment Due to AD: Change From Baseline at Week 4	-10.41 score on a scale Standard Deviation 26.627	-15.14 score on a scale Standard Deviation 25.543	-16.19 score on a scale Standard Deviation 22.037	—
VC Period: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Version 2.0 (v2.0) Percent Overall Work Impairment Due to AD: Change From Baseline at Week 8	-2.06 score on a scale Standard Deviation 29.625	-17.00 score on a scale Standard Deviation 25.916	-13.65 score on a scale Standard Deviation 22.476	—
VC Period: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Version 2.0 (v2.0) Percent Activity Impairment Due to AD: Change From Baseline at Week 2	-4.63 score on a scale Standard Deviation 21.243	-12.79 score on a scale Standard Deviation 23.462	-16.68 score on a scale Standard Deviation 23.295	—
VC Period: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Version 2.0 (v2.0) Percent Activity Impairment Due to AD: Change From Baseline at Week 4	-8.38 score on a scale Standard Deviation 20.981	-17.24 score on a scale Standard Deviation 24.715	-18.70 score on a scale Standard Deviation 23.550	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 36, and 52

Population: LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.

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.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=50 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=49 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=187 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID n=203 Participants Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
LTS Period: Change From Baseline in WPAI-SHP v2.0 Percent Work Time Missed Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 12	-4.26 score on a scale Standard Deviation 24.958	-0.81 score on a scale Standard Deviation 17.257	-0.17 score on a scale Standard Deviation 24.581	3.48 score on a scale Standard Deviation 16.470
LTS Period: Change From Baseline in WPAI-SHP v2.0 Percent Work Time Missed Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 24	-2.06 score on a scale Standard Deviation 28.778	-11.35 score on a scale Standard Deviation 22.947	-0.38 score on a scale Standard Deviation 23.511	5.13 score on a scale Standard Deviation 24.419
LTS Period: Change From Baseline in WPAI-SHP v2.0 Percent Work Time Missed Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 36	-1.04 score on a scale Standard Deviation 23.312	-5.44 score on a scale Standard Deviation 27.625	-0.02 score on a scale Standard Deviation 20.410	3.37 score on a scale Standard Deviation 20.967
LTS Period: Change From Baseline in WPAI-SHP v2.0 Percent Work Time Missed Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 52	-2.29 score on a scale Standard Deviation 25.148	3.60 score on a scale Standard Deviation 24.186	0.50 score on a scale Standard Deviation 28.348	6.36 score on a scale Standard Deviation 21.806
LTS Period: Change From Baseline in WPAI-SHP v2.0 Percent Impairment While Working Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 12	-5.91 score on a scale Standard Deviation 10.075	-13.50 score on a scale Standard Deviation 29.784	-19.87 score on a scale Standard Deviation 21.572	-22.02 score on a scale Standard Deviation 19.652
LTS Period: Change From Baseline in WPAI-SHP v2.0 Percent Impairment While Working Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 24	-7.14 score on a scale Standard Deviation 22.835	-16.47 score on a scale Standard Deviation 18.007	-19.74 score on a scale Standard Deviation 23.719	-22.56 score on a scale Standard Deviation 22.433
LTS Period: Change From Baseline in WPAI-SHP v2.0 Percent Impairment While Working Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 36	-7.33 score on a scale Standard Deviation 15.337	-11.43 score on a scale Standard Deviation 21.432	-18.79 score on a scale Standard Deviation 21.232	-24.61 score on a scale Standard Deviation 20.359
LTS Period: Change From Baseline in WPAI-SHP v2.0 Percent Impairment While Working Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 52	-16.00 score on a scale Standard Deviation 24.129	-13.85 score on a scale Standard Deviation 17.578	-20.00 score on a scale Standard Deviation 25.312	-21.86 score on a scale Standard Deviation 25.836
LTS Period: Change From Baseline in WPAI-SHP v2.0 Percent Overall Work Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 12	-11.64 score on a scale Standard Deviation 20.194	-10.72 score on a scale Standard Deviation 23.285	-17.40 score on a scale Standard Deviation 23.123	-17.91 score on a scale Standard Deviation 24.692
LTS Period: Change From Baseline in WPAI-SHP v2.0 Percent Overall Work Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 24	-10.99 score on a scale Standard Deviation 33.070	-25.22 score on a scale Standard Deviation 25.009	-17.83 score on a scale Standard Deviation 27.226	-19.31 score on a scale Standard Deviation 26.893
LTS Period: Change From Baseline in WPAI-SHP v2.0 Percent Overall Work Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 36	-7.77 score on a scale Standard Deviation 25.443	-15.27 score on a scale Standard Deviation 30.360	-17.70 score on a scale Standard Deviation 23.161	-21.84 score on a scale Standard Deviation 27.812
LTS Period: Change From Baseline in WPAI-SHP v2.0 Percent Overall Work Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 52	-17.29 score on a scale Standard Deviation 33.754	-10.17 score on a scale Standard Deviation 27.793	-18.62 score on a scale Standard Deviation 28.397	-16.20 score on a scale Standard Deviation 32.591
LTS Period: Change From Baseline in WPAI-SHP v2.0 Percent Activity Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 12	-7.78 score on a scale Standard Deviation 24.016	-11.74 score on a scale Standard Deviation 22.736	-21.17 score on a scale Standard Deviation 25.287	-21.92 score on a scale Standard Deviation 26.378
LTS Period: Change From Baseline in WPAI-SHP v2.0 Percent Activity Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 24	-7.18 score on a scale Standard Deviation 26.552	-13.78 score on a scale Standard Deviation 19.690	-22.42 score on a scale Standard Deviation 25.547	-22.32 score on a scale Standard Deviation 26.481
LTS Period: Change From Baseline in WPAI-SHP v2.0 Percent Activity Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 36	-10.65 score on a scale Standard Deviation 23.655	-15.24 score on a scale Standard Deviation 20.150	-23.43 score on a scale Standard Deviation 25.748	-25.34 score on a scale Standard Deviation 26.927
LTS Period: Change From Baseline in WPAI-SHP v2.0 Percent Activity Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 52	-10.88 score on a scale Standard Deviation 28.001	-14.88 score on a scale Standard Deviation 20.044	-22.95 score on a scale Standard Deviation 24.656	-23.93 score on a scale Standard Deviation 27.743

SECONDARY outcome

Timeframe: Pre-dose at Weeks 2, 4 and 8

Population: The pharmacokinetic (PK) evaluable population included all participants who applied at least 1 application of ruxolitinib cream and provided at least 1 postdose plasma sample (1 PK measurement) that complies with the instruction in the Protocol. Number analyzed is the number of participants with data available for analyses at the specified time point.

Plasma samples were collected just before the morning application of study drug during each specified time point.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=236 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=238 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
VC Period: Trough Plasma Concentrations of Ruxolitinib Week 2	25.2 nanomole per litre (nM) Standard Deviation 37.4	38.5 nanomole per litre (nM) Standard Deviation 64.5	—	—
VC Period: Trough Plasma Concentrations of Ruxolitinib Week 4	22.6 nanomole per litre (nM) Standard Deviation 35.2	41.8 nanomole per litre (nM) Standard Deviation 83.6	—	—
VC Period: Trough Plasma Concentrations of Ruxolitinib Week 8	22.4 nanomole per litre (nM) Standard Deviation 36.1	36.1 nanomole per litre (nM) Standard Deviation 66.6	—	—

SECONDARY outcome

Timeframe: Pre-dose at Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Population: The PK evaluable population included all participants who applied at least 1 application of ruxolitinib cream and provided at least 1 postdose plasma sample (1 PK measurement) that complies with the instruction in the Protocol. Number analyzed is the number of participants with data available for analyses at the specified time point.

Plasma samples were collected just before the morning application of study drug during each specified time point.

Outcome measures

Measure	VC Period: Vehicle Cream BID n=50 Participants Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 0.75% Cream BID n=51 Participants Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	VC Period: Ruxolitinib 1.5% Cream BID n=198 Participants Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.	LTS Period: Ruxolitinib 1.5% Cream BID n=215 Participants Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
LTS Period: Trough Plasma Concentrations of Ruxolitinib Week 52	12.9 nM Standard Deviation 21.8	35.7 nM Standard Deviation 65.2	17.7 nM Standard Deviation 33.9	23.3 nM Standard Deviation 48.1
LTS Period: Trough Plasma Concentrations of Ruxolitinib Week 12	13.8 nM Standard Deviation 22.7	23.9 nM Standard Deviation 55.2	14.3 nM Standard Deviation 26.9	22.6 nM Standard Deviation 46.6
LTS Period: Trough Plasma Concentrations of Ruxolitinib Week 16	12.3 nM Standard Deviation 22.8	16.1 nM Standard Deviation 27.7	15.1 nM Standard Deviation 28.3	23.9 nM Standard Deviation 45.9
LTS Period: Trough Plasma Concentrations of Ruxolitinib Week 20	18.8 nM Standard Deviation 41.0	25.3 nM Standard Deviation 43.9	13.6 nM Standard Deviation 20.5	26.8 nM Standard Deviation 55.9
LTS Period: Trough Plasma Concentrations of Ruxolitinib Week 24	11.7 nM Standard Deviation 26.0	27.6 nM Standard Deviation 62.4	18.5 nM Standard Deviation 49.8	25.7 nM Standard Deviation 56.9
LTS Period: Trough Plasma Concentrations of Ruxolitinib Week 28	20.4 nM Standard Deviation 39.9	17.6 nM Standard Deviation 32.2	16.1 nM Standard Deviation 36.1	20.8 nM Standard Deviation 39.8
LTS Period: Trough Plasma Concentrations of Ruxolitinib Week 32	14.6 nM Standard Deviation 30.6	26.4 nM Standard Deviation 51.3	14.0 nM Standard Deviation 23.2	25.9 nM Standard Deviation 67.8
LTS Period: Trough Plasma Concentrations of Ruxolitinib Week 36	11.4 nM Standard Deviation 23.7	29.9 nM Standard Deviation 52.8	15.0 nM Standard Deviation 28.4	22.0 nM Standard Deviation 40.1
LTS Period: Trough Plasma Concentrations of Ruxolitinib Week 40	12.6 nM Standard Deviation 36.7	32.8 nM Standard Deviation 59.4	20.0 nM Standard Deviation 51.1	26.3 nM Standard Deviation 59.4
LTS Period: Trough Plasma Concentrations of Ruxolitinib Week 44	15.9 nM Standard Deviation 31.9	23.0 nM Standard Deviation 33.7	14.8 nM Standard Deviation 28.8	24.1 nM Standard Deviation 40.9
LTS Period: Trough Plasma Concentrations of Ruxolitinib Week 48	16.8 nM Standard Deviation 38.6	35.7 nM Standard Deviation 64.5	23.4 nM Standard Deviation 58.1	26.3 nM Standard Deviation 54.3

Adverse Events

Vehicle Cream BID

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Ruxolitinib 0.75% Cream BID

Serious events: 8 serious events

Other events: 49 other events

Deaths: 0 deaths

Ruxolitinib 1.5% Cream BID

Serious events: 4 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vehicle Cream BID n=124 participants at risk Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 52. Participants applied cream BID to areas identified at Baseline even if the areas improved.	Ruxolitinib 0.75% Cream BID n=301 participants at risk Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 52. Participants applied cream BID to areas identified at Baseline even if the areas improved.	Ruxolitinib 1.5% Cream BID n=298 participants at risk Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 52. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/124 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.33% 1/301 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.00% 0/298 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/124 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.33% 1/301 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.00% 0/298 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries
Cardiac disorders Arrhythmia	0.00% 0/124 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.00% 0/301 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.34% 1/298 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries
Cardiac disorders Myocardial infarction	0.00% 0/124 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.33% 1/301 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.00% 0/298 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries
Nervous system disorders Cerebrovascular accident	0.00% 0/124 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.33% 1/301 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.34% 1/298 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries
Infections and infestations Chronic tonsillitis	0.00% 0/124 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.00% 0/301 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.34% 1/298 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries
Infections and infestations Pneumonia	0.00% 0/124 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.33% 1/301 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.00% 0/298 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries
Infections and infestations Pyelonephritis	0.00% 0/124 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.33% 1/301 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.00% 0/298 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries
Infections and infestations Sepsis	0.00% 0/124 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.33% 1/301 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.00% 0/298 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries
Infections and infestations Tooth infection	0.00% 0/124 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.33% 1/301 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.00% 0/298 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries
Vascular disorders Deep vein thrombosis	0.00% 0/124 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.00% 0/301 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.34% 1/298 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/124 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.00% 0/301 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.34% 1/298 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/124 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.00% 0/301 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.34% 1/298 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries
Reproductive system and breast disorders Ovarian cyst ruptured	0.00% 0/124 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.33% 1/301 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.00% 0/298 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/124 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.33% 1/301 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.00% 0/298 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries

Other adverse events

Measure	Vehicle Cream BID n=124 participants at risk Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 52. Participants applied cream BID to areas identified at Baseline even if the areas improved.	Ruxolitinib 0.75% Cream BID n=301 participants at risk Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 52. Participants applied cream BID to areas identified at Baseline even if the areas improved.	Ruxolitinib 1.5% Cream BID n=298 participants at risk Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 52. Participants applied cream BID to areas identified at Baseline even if the areas improved.
General disorders Application site pain	6.5% 8/124 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.66% 2/301 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	0.67% 2/298 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries
Infections and infestations Nasopharyngitis	0.00% 0/124 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	9.3% 28/301 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	9.1% 27/298 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries
Infections and infestations Upper respiratory tract infection	0.81% 1/124 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	7.6% 23/301 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries	7.7% 23/298 • Up to 60 weeks For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

Email: medinfo@incyte.com

Results disclosure agreements

• Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
• Publication restrictions are in place

Restriction type: OTHER