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

VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep-Related Impairment (8a - 24-Hour Recall)

The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. Each item asks the participant to rate the severity of the participant's sleep impairment.

Time frame: Baseline to Week 8

VC Period: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (SAE)

An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or an important medical event may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. A TEAE or treatment emergent SAE is any AE or SAE either reported for first time or worsening of a pre-existing event after first dose of study drug.

Time frame: From first dose up to Week 8

LTS Period: Percentage of Participants With at Least One TEAE and Treatment Emergent SAE

An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or an important medical event may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. A TEAE or treatment emergent SAE is any AE or SAE either reported for first time or worsening of a pre-existing event after first dose of study drug.

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

VC Period: Percentage of Participants Who Achieved an IGA-TS at Weeks 2 and 4

The IGA is an overall eczema severity rating on a 0 (clear skin) to 4 (severe disease) scale. The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥ 2 grade improvement from Baseline.

Time frame: Baseline to Weeks 2 and 4

VC Period: Percentage of Participants Achieving IGA Scores of 0 or 1

The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. IGA score signifies 0 (clear skin) and 1 (almost clear skin).

Time frame: Weeks 2, 4 and 8

LTS Period: Percentage of Participants Achieving IGA Scores of 0 or 1

The IGA is an overall eczema severity rating on a 0 (clear skin) to 4 (severe disease) scale. The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. IGA score signifies 0 (clear skin) and 1 (almost clear skin).

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

VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch NRS Score From Baseline to Weeks 2 and 4

The Itch NRS is a daily participant-reported measure (24-hour recall), using a diary, of the worst level of itch intensity. Participants are asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours.

Time frame: Baseline to Weeks 2 and 4

VC Period: Percentage of Participants Achieving EASI50

EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI50 responder was defined as a participant achieving 50% or greater improvement from Baseline in EASI score.

Time frame: Weeks 2, 4 and 8

VC Period: Percentage of Participants Achieving EASI75

EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.

Time frame: Weeks 2 and 4

VC Period: Percentage of Participants Achieving EASI90

EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI90 responder was defined as a participant achieving 90% or greater improvement from Baseline in EASI score.

Time frame: Weeks 2, 4 and 8

VC Period: Percent Change From Baseline in EASI Score

EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. A negative change from Baseline indicates improvement.

Time frame: Baseline, Weeks 2, 4 and 8

VC Period: Percent Change From Baseline In SCORing Atopic Dermatitis (SCORAD) Score

The SCORAD is a tool to assess extent and severity of eczema. To determine the extent, the rule of nines or handprint method is used to assess eczema affected area (A). To determine disease severity (B) it evaluates 6 clinical characteristics: 1. redness, 2. swelling, 3. oozing/crusting, 4. scratch marks, 5. lichenification, and 6. dryness on a 4-point scale of 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), added to give B with maximum score of 18. Subjective symptoms (C) of itch and sleeplessness are assessed using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), added to give C with maximum score of 20. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combined using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. A negative change from Baseline indicates improvement.

Time frame: Baseline, Weeks 2, 4 and 8

VC Period: Change From Baseline in Itch NRS Score

The Itch NRS is a daily participant-reported measure (24-hour recall), using a diary, of the worst level of itch intensity. Participants are asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. A negative change from Baseline indicates improvement.

Time frame: Baseline, Weeks 2, 4, and 8

VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2, 3, or 4 Points

The Itch NRS is a daily participant-reported measure (24-hour recall), using a diary, of the worst level of itch intensity. Participants were asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. Kaplan-Meier estimation method was used for analyses.

Time frame: Up to Week 8

VC Period: Change From Baseline in Skin Pain NRS Score

The Skin Pain NRS is a daily patient-reported measure (24-hour recall), using a diary, of the worst level of pain intensity from 0 (no pain) to 10 (worst imaginable pain). Participants will be asked, "Rate the pain severity from your atopic dermatitis skin changes by selecting a number that best describes your worst level of pain in the past 24 hours." A negative change from Baseline indicates improvement.

Time frame: Baseline, Weeks 2, 4, and 8

VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score

The PROMIS Short Form - Sleep Disturbance (8b) questionnaire assesses participant's self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This questionnaire is completed in the morning by the participant where each item asks the participant to rate the severity of the participant's sleep disturbance. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance.

Time frame: Weeks 2 and 4

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

The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment.

Time frame: Weeks 2 and 4

VC Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score

The PROMIS Short Form - Sleep Disturbance (8b) questionnaire assesses participant's self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This questionnaire is completed in the morning by the participant where each item asks the participant to rate the severity of the participant's sleep disturbance. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance. A negative change from Baseline indicates improvement.

Time frame: Baseline, Weeks 2, 4, and 8

VC Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score

The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. A negative change from Baseline indicates improvement.

Time frame: Baseline, Weeks 2, 4, and 8

LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score

The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. A negative change from Baseline indicates improvement.

Time frame: Baseline, Weeks 12, 24, and 52

LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score

The PROMIS Short Form - Sleep Disturbance (8b) questionnaire assesses participant's self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This questionnaire is completed in the morning by the participant where each item asks the participant to rate the severity of the participant's sleep disturbance. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance. A negative change from Baseline indicates improvement.

Time frame: Baseline, Weeks 12, 24, and 52

VC Period: Change From Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA)

Body surface area affected by AD was assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region was assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage was reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Used the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1\*BSA head and neck + 0.3\*BSA trunk + 0.2\* BSA upper limbs + 0.4\*BSA lower limbs. A negative change from Baseline indicates improvement.

Time frame: Baseline, Weeks 2, 4 and 8

LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA

Body surface area affected by AD was assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region was assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage was reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Used the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1\*BSA head and neck + 0.3\*BSA trunk + 0.2\* BSA upper limbs + 0.4\*BSA lower limbs. A negative change from Baseline indicates improvement.

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

VC Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score

The POEM is a 7-question quality-of-life assessment that asks how many days the participant has been bothered by various aspects of their skin condition during the past 7 days. It assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (clear or almost clear) to 28 (very severe eczema). High scores are indicative of more severe disease and poor quality of life. A negative change from Baseline indicates improvement.

Time frame: Baseline, Weeks 2, 4, and 8

LTS Period: Change From Baseline in POEM Score

The POEM is a 7-question quality-of-life assessment that asks how many days the participant has been bothered by various aspects of their skin condition during the past 7 days. It assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life. A negative change from Baseline indicates improvement.

Time frame: Baseline, Weeks 12, 24, and 52

VC Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Score

The DLQI is a simple, 10 question (Q) validated quality-of-life questionnaire to measure how much the skin problem has affected the participant. It covers 6 domains including symptoms and feelings (Q1 and Q2), daily activities (Q3 and Q4), leisure (Q5 and Q6), work and school (Q7), personal relationships (Q8 and Q9), and treatment(Q10). The recall Period of this scale is over the last week. Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. Scores range from 0 ("no impact on participant's life") to 30 ("extremely large effect on participant's life"), and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant's life.

Time frame: Baseline, Weeks 2, 4, and 8

LTS Period: Change From Baseline in DLQI Score

The DLQI is a simple, 10 question (Q) validated quality-of-life questionnaire to measure how much the skin problem has affected the participant. It covers 6 domains including symptoms and feelings (Q1 and Q2), daily activities (Q3 and Q4), leisure (Q5 and Q6), work and school (Q7), personal relationships (Q8 and Q9), and treatment(Q10). The recall Period of this scale is over the last week. Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. Scores range from 0 ("no impact on participant's life") to 30 ("extremely large effect on participant's life"), and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant's life.

Time frame: Baseline, Weeks 12, 24, and 52

VC Period: Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score

CDLQI is the youth/children's version of the DLQI. The CDLQI is a simple 10 question (Q) validated quality-of-life questionnaire. It covers 6 domains including symptoms and feelings (Q1 and Q2), leisure (Q4, Q5, and Q6), school or holidays (Q7), personal relationships (Q3 and Q8), sleep (Q9) and treatment (Q10). Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. The total DLQI score is calculated by adding the score of each question resulting in a maximum score of 30 (extremely large effect on participant's life) and a minimum score of 0 (no impact on participant's life) and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant's life.

Time frame: Baseline, Weeks 2, 4, and 8

LTS Period: Change From Baseline in CDLQI Score

CDLQI is the youth/children's version of the DLQI. The CDLQI is a simple 10 question (Q) validated quality-of-life questionnaire. It covers 6 domains including symptoms and feelings (Q1 and Q2), leisure (Q4, Q5, and Q6), school or holidays (Q7), personal relationships (Q3 and Q8), sleep (Q9) and treatment (Q10). Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. The total DLQI score is calculated by adding the score of each question resulting in a maximum score of 30 (extremely large effect on participant's life) and a minimum score of 0 (no impact on participant's life) and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant's life.

Time frame: Baseline, Weeks 12, 24, and 52

VC Period: Mean Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, and 8

The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. It is a 7-point scale where participants rate the questions as: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The lower score indicates improvement.

Time frame: Weeks 2, 4, and 8

VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8

The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. It is a 7-point scale where participants rate the questions as: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The lower score indicates improvement.

Time frame: Weeks 2, 4, and 8

VC Period: Percentage of Participants With a Score of Either 1 or 2 on the PGIC at Weeks 2, 4, and 8

The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. It is a 7-point scale where participants rate the questions as: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The lower score indicates improvement.

Time frame: Weeks 2, 4, and 8

VC Period: Change From Baseline in EuroQuality of Life Five Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) Score

EQ-5D-5L questionnaire has 2 parts: EQ-5D-5L descriptive system \& EQ-VAS. EQ-5D is a validated, self-administered, generic utility questionnaire wherein participants rate their current health state based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. 5L indicates that for each dimension, there are 5 levels:1=no problems,2=slight problems,3=moderate problems,4=severe problems, and 5=extreme problems. EQ-5D-5L score is assessed using VAS that ranges from 0 to 100 millimetres (mm), where 0 indicates "worst health you can imagine" and 100 indicates "best health you can imagine". The participant was asked to indicate his/her health state over past 7 days in each of the 5 dimensions. Digits for the 5 dimensions can be combined into a 5-digit number that describes the participant's health state. In the EQ-VAS, participants had to record their health state on a scale ranging from 0 to 100. A positive change from Baseline indicates improvement.

Time frame: Baseline, Weeks 2, 4, and 8

VC Period: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Version 2.0 (v2.0)

The WPAI-SHP is a 6-item participant questionnaire developed to measure the effect of overall health and specific symptoms on productivity at work and regular activities outside of it in the past 7 days. The WPAI-SHP consists of 6 questions as follows: 1=currently employed; 2=hours missed due to AD; 3=hours missed other reasons; 4=hours actually worked; 5=degree AD affected productivity while working; 6=degree AD affected regular activities and the computed percentage, range for each sub scale is from 0 to 100, with higher values indicating greater impairment and less productivity. A negative change from Baseline indicates improvement.

Time frame: Baseline, Weeks 2, 4, and 8

LTS Period: Change From Baseline in WPAI-SHP v2.0

The WPAI-SHP is a 6-item participant questionnaire developed to measure the effect of overall health and specific symptoms on productivity at work and regular activities outside of it in the past 7 days. The WPAI-SHP consists of 6 questions as follows: 1=currently employed; 2=hours missed due to AD; 3=hours missed other reasons; 4=hours actually worked; 5=degree AD affected productivity while working; 6=degree AD affected regular activities and the computed percentage, range for each sub scale is from 0 to 100, with higher values indicating greater impairment and less productivity. A negative change from Baseline indicates improvement.

Time frame: Baseline, Weeks 12, 24, 36, and 52

VC Period: Trough Plasma Concentrations of Ruxolitinib

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

Time frame: Pre-dose at Weeks 2, 4 and 8

LTS Period: Trough Plasma Concentrations of Ruxolitinib

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

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