Atopic Dermatitis
Conditions
Keywords
Atopic dermatitis, pruritus, eczema, topical therapy, JAK inhibitor
Brief summary
The purpose of this study is to assess the efficacy of ruxolitinib cream in adolescents and adults with atopic dermatitis (AD).
Interventions
DRUGRuxolitinib cream
Ruxolitinib 0.75% or 1.5% cream.
DRUGVehicle cream
Ruxolitinib matching vehicle cream.
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adolescents aged ≥ 12 to 17 years, inclusive, and men and women aged ≥ 18 years. * Participants diagnosed with atopic dermatitis (AD) as defined by the Hanifin and Rajka criteria. * AD duration of at least 2 years. * Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at Screening and Baseline (VC Period) and 0 to 4 at Week 8 (LTS Period). * Participants with percentage body surface area (%BSA) (excluding scalp) of AD involvement of 3% to 20% at Screening and Baseline (VC Period) and 0% to 20% at Week 8 (LTS Period). * Participants who agree to discontinue all agents used to treat AD from Screening through the final follow-up visit. * Participants who have at least 1 target lesion that measures approximately 10 cm\^2 or more at Screening and Baseline. Lesion must be representative of the participant's disease state and not be located on the hands, feet, or genitalia. * Willingness to avoid pregnancy or fathering of children.
Exclusion criteria
* Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to Baseline. * Concurrent conditions and history of other diseases: * Immunocompromised. * Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Baseline. * Active acute bacterial, fungal, or viral skin infection within 1 week before Baseline. * Any other concomitant skin disorder, pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety. * Presence of AD lesions only on the hands or feet without prior history of involvement of other classical areas of involvement such as the face or the folds. * Other types of eczema. * Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. * Use of any of the following treatments within the indicated washout period before Baseline: * 5 half-lives or 12 weeks, whichever is longer - biologic agents (e.g. dupilumab). * 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (e.g. mycophenolate or tacrolimus). * 2 weeks - immunizations and sedating antihistamines, unless on long-term stable regimen (nonsedating antihistamines are permitted). * 1 week - use of other topical treatments for AD (other than bland emollients). Diluted sodium hypochlorite bleach baths are allowed as long as they do not exceed 2 baths per week and their frequency remains the same throughout the study. * Participants who have previously received Janus kinase (JAK) inhibitors, systemic or topical. * Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 2 weeks prior to Baseline and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the participant's AD. * Positive serology test results at screening for human immunodeficiency virus (HIV) antibody. * Liver function tests: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 × upper limit of normal (ULN); alkaline phosphatase and/or bilirubin \> 1.5 × ULN (isolated bilirubin \> 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%). * Pregnant or lactating participants, or those considering pregnancy. * History of alcoholism or drug addiction within 1 year before screening or current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to comply with the administration schedule and study assessments. * Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before Baseline with another investigational medication or current enrollment in another investigational drug protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8 | Baseline to Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8 | Baseline to Week 8 | 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. |
| 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 | Baseline to Week 8 | 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. |
| 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 | Baseline to Week 8 | 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. |
| VC Period: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (SAE) | From date of randomization up to Week 8 | 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. |
| LTS Period: Percentage of Participants With at Least One TEAE and Treatment Emergent SAE | From first dose date in LTS Period (Week 8) until last follow-up visit (up to 52 weeks) | 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. |
| VC Period: Percentage of Participants Who Achieved an IGA-TS at Weeks 2 and 4 | Baseline to Weeks 2 and 4 | 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. |
| VC Period: Percentage of Participants Achieving an IGA of 0 or 1 | Weeks 2, 4 and 8 | 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. |
| LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | 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. |
| VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch NRS Score From Baseline to Weeks 2 and 4 | Baseline to Weeks 2 and 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. |
| VC Period: Percentage of Participants Who Achieved EASI50 | Baseline to Weeks 2, 4 and 8 | 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. |
| VC Period: Percentage of Participants Who Achieved EASI75 at Weeks 2 and 4 | Baseline to Weeks 2 and 4 | 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. |
| VC Period: Percentage of Participants Who Achieved EASI90 | Baseline to Weeks 2, 4 and 8 | 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. |
| LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score | Baseline, Weeks 12, 24, and 52 | 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. |
| VC Period: Percent Change From Baseline in EASI Score | Baseline, Weeks 2, 4 and 8 | 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. |
| VC Period: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score | Baseline, Weeks 2, 4 and 8 | 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. |
| VC Period: Change From Baseline in Itch NRS Score | Baseline, Weeks 2, 4 and 8 | 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. |
| VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2, 3, or 4 Points | Up to Week 8 | 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. |
| VC Period: Change From Baseline in Skin Pain NRS Score | Baseline, Weeks 2, 4 and 8 | 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. |
| 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 | Weeks 2 and 4 | 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. |
| 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 | Weeks 2 and 4 | 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. |
| VC Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score | Baseline, Weeks 2, 4 and 8 | 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. |
| VC Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score | Baseline, Weeks 2, 4 and 8 | 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. |
| LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score | Baseline, Weeks 12, 24, and 52 | 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. |
| VC Period: Change From Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA) | Baseline, Weeks 2, 4 and 8 | 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. |
| LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Baseline, Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | 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. |
| VC Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score | Baseline, Weeks 2, 4 and 8 | 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. |
| LTS Period: Change From Baseline in POEM Score | Baseline, Weeks 12, 24 and 52 | 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. |
| VC Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Baseline, Weeks 2, 4, and 8 | 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. |
| LTS Period: Change From Baseline in DLQI Score | Baseline, Weeks 12, 24, and 52 | 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. |
| VC Period: Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score | Baseline, Weeks 2, 4, and 8 | 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. |
| LTS Period: Change From Baseline in CDLQI Score | Baseline, Weeks 12, 24, and 52 | 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. |
| VC Period: Mean Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, and 8 | 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. |
| VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | 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. |
| VC Period: Percentage of Participants With a Score of Either 1 or 2 on the PGIC at Weeks 2, 4, and 8 | 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. |
| VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Week 8 | Baseline to Week 8 | 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. |
| VC Period: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Version 2.0 (v2.0) | Baseline, Weeks 2, 4, and 8 | 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. |
| LTS Period: Change From Baseline in WPAI-SHP v2.0 | Baseline, Weeks 12, 24, 36, and 52 | 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. |
| VC Period: Trough Plasma Concentrations of Ruxolitinib | Pre-dose at Weeks 2, 4 and 8 | Plasma samples were collected just before the morning application of study drug during each specified time point. |
| LTS Period: Trough Plasma Concentrations of Ruxolitinib | Pre-dose at Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | Plasma samples were collected just before the morning application of study drug during each specified time point. |
| VC Period: Change From Baseline in EuroQuality of Life Five Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) Score | Baseline, Weeks 2, 4 and 8 | 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. |
Countries
Bulgaria, Canada, Czechia, Germany, Poland, Spain, United States
Participant flow
Recruitment details
A total of 618 participants were enrolled at 65 investigative sites in North America and Europe from December 20, 2018 to November 09, 2020.
Pre-assignment details
Participants who completed Week 8 assessments of the Vehicle Control (VC) Period with no safety concerns continued in the 44-week Long Term Safety (LTS) Period. Participants who were on active treatment during the VC Period continued with the same treatment regimen in the LTS Period and those who applied vehicle cream during the VC Period were equally randomized into 1 of the 2 active treatment groups: ruxolitinib 0.75%, ruxolitinib 1.5% cream during the LTS Period.
Participants by arm
| Arm | Count |
|---|---|
| VC Period: Vehicle Cream BID 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. | 124 |
| 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. | 248 |
| 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. | 246 |
| Total | 618 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| 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) | Reason not Specified | 0 | 0 | 0 | 1 | 1 | 1 | 0 |
| Long-Term Safety Period (Weeks 8 to 52) | Withdrawal by Subject | 0 | 0 | 0 | 12 | 8 | 26 | 34 |
| 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) | Reason not Specified | 1 | 2 | 2 | 0 | 0 | 0 | 0 |
| Vehicle Control Period (Day 1 to Week 8) | Withdrawal by Subject | 11 | 21 | 15 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID | Total |
|---|---|---|---|---|
| Age, Continuous | 38.9 years STANDARD_DEVIATION 18.9 | 35.8 years STANDARD_DEVIATION 18.45 | 35.9 years STANDARD_DEVIATION 18.01 | 36.4 years STANDARD_DEVIATION 18.38 |
| Body Mass Index | 27.75 Kilograms per square metre (kg/m^2) STANDARD_DEVIATION 6.737 | 27.60 Kilograms per square metre (kg/m^2) STANDARD_DEVIATION 7.091 | 28.01 Kilograms per square metre (kg/m^2) STANDARD_DEVIATION 7.495 | 27.80 Kilograms per square metre (kg/m^2) STANDARD_DEVIATION 7.177 |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 17 Participants | 31 Participants | 30 Participants | 78 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 107 Participants | 217 Participants | 216 Participants | 540 Participants |
| Race/Ethnicity, Customized Race American-Indian/Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 2 Participants | 6 Participants | 6 Participants | 14 Participants |
| Race/Ethnicity, Customized Race Black/African-American | 32 Participants | 63 Participants | 57 Participants | 152 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian/Pacific Islander | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Other | 3 Participants | 5 Participants | 4 Participants | 12 Participants |
| Race/Ethnicity, Customized Race White/Caucasian | 85 Participants | 174 Participants | 178 Participants | 437 Participants |
| Sex: Female, Male Female | 80 Participants | 150 Participants | 150 Participants | 380 Participants |
| Sex: Female, Male Male | 44 Participants | 98 Participants | 96 Participants | 238 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 124 | 0 / 301 | 0 / 298 |
| other Total, other adverse events | 9 / 124 | 49 / 301 | 51 / 298 |
| serious Total, serious adverse events | 0 / 124 | 8 / 301 | 4 / 298 |
Outcome results
Primary
VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8
The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥ 2 grade improvement from Baseline.
Time frame: Baseline to Week 8
Population: ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VC Period: Vehicle Cream BID | VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8 | 7.6 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8 | 39.0 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8 | 51.3 percentage of participants |
p-value: <0.000195% CI: [4.125, 21.202]Exact Logistic Regression
p-value: <0.000195% CI: [7.354, 38.061]Exact Logistic Regression
Secondary
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. 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VC Period: Vehicle Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 12 | -3.89 % BSA | Standard Deviation 5.53 |
| VC Period: Vehicle Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 24 | -4.70 % BSA | Standard Deviation 4.775 |
| VC Period: Vehicle Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 40 | -4.59 % BSA | Standard Deviation 5.196 |
| VC Period: Vehicle Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 16 | -4.41 % BSA | Standard Deviation 5.553 |
| VC Period: Vehicle Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 36 | -4.65 % BSA | Standard Deviation 5.266 |
| VC Period: Vehicle Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 28 | -4.59 % BSA | Standard Deviation 4.677 |
| VC Period: Vehicle Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 20 | -4.88 % BSA | Standard Deviation 5.21 |
| VC Period: Vehicle Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 52 | -5.12 % BSA | Standard Deviation 5.114 |
| VC Period: Vehicle Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 48 | -5.30 % BSA | Standard Deviation 5.13 |
| VC Period: Vehicle Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 32 | -5.10 % BSA | Standard Deviation 5.203 |
| VC Period: Vehicle Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 44 | -5.18 % BSA | Standard Deviation 4.901 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 32 | -6.79 % BSA | Standard Deviation 5.96 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 44 | -6.56 % BSA | Standard Deviation 6.2 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 36 | -6.16 % BSA | Standard Deviation 6.045 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 40 | -6.42 % BSA | Standard Deviation 5.887 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 20 | -6.27 % BSA | Standard Deviation 6.193 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 52 | -6.83 % BSA | Standard Deviation 5.837 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 24 | -6.37 % BSA | Standard Deviation 5.817 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 48 | -6.61 % BSA | Standard Deviation 5.897 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 28 | -6.21 % BSA | Standard Deviation 6.597 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 16 | -5.47 % BSA | Standard Deviation 5.289 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 12 | -4.71 % BSA | Standard Deviation 4.98 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 48 | -7.64 % BSA | Standard Deviation 5.38 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 12 | -6.61 % BSA | Standard Deviation 4.395 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 16 | -6.77 % BSA | Standard Deviation 5.27 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 20 | -7.48 % BSA | Standard Deviation 4.9 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 24 | -7.49 % BSA | Standard Deviation 4.988 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 28 | -7.48 % BSA | Standard Deviation 4.827 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 32 | -7.69 % BSA | Standard Deviation 4.891 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 36 | -7.79 % BSA | Standard Deviation 4.856 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 40 | -7.83 % BSA | Standard Deviation 4.976 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 44 | -7.92 % BSA | Standard Deviation 5.082 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 52 | -7.92 % BSA | Standard Deviation 4.823 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 32 | -7.89 % BSA | Standard Deviation 5.004 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 52 | -8.42 % BSA | Standard Deviation 4.973 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 44 | -8.43 % BSA | Standard Deviation 5.122 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 28 | -8.07 % BSA | Standard Deviation 5.099 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 24 | -8.00 % BSA | Standard Deviation 5.071 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 20 | -8.05 % BSA | Standard Deviation 4.92 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 48 | -8.33 % BSA | Standard Deviation 5.204 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 16 | -7.80 % BSA | Standard Deviation 5.096 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 12 | -7.69 % BSA | Standard Deviation 5.106 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 40 | -8.44 % BSA | Standard Deviation 5.09 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA | Change From Baseline at Week 36 | -8.38 % BSA | Standard Deviation 5.119 |
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VC Period: Vehicle Cream BID | LTS Period: Change From Baseline in CDLQI Score | Change From Baseline at Week 12 | -7.50 score on a scale | Standard Deviation 2.121 |
| VC Period: Vehicle Cream BID | LTS Period: Change From Baseline in CDLQI Score | Change From Baseline at Week 52 | -8.00 score on a scale | Standard Deviation 1.414 |
| VC Period: Vehicle Cream BID | LTS Period: Change From Baseline in CDLQI Score | Change From Baseline at Week 24 | -8.50 score on a scale | Standard Deviation 2.121 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in CDLQI Score | Change From Baseline at Week 12 | -4.88 score on a scale | Standard Deviation 5.436 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in CDLQI Score | Change From Baseline at Week 52 | -6.38 score on a scale | Standard Deviation 9.023 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in CDLQI Score | Change From Baseline at Week 24 | -4.88 score on a scale | Standard Deviation 4.549 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in CDLQI Score | Change From Baseline at Week 24 | -5.72 score on a scale | Standard Deviation 6.066 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in CDLQI Score | Change From Baseline at Week 12 | -5.54 score on a scale | Standard Deviation 5.153 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in CDLQI Score | Change From Baseline at Week 52 | -5.35 score on a scale | Standard Deviation 4.902 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in CDLQI Score | Change From Baseline at Week 12 | -5.57 score on a scale | Standard Deviation 5.482 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in CDLQI Score | Change From Baseline at Week 52 | -6.57 score on a scale | Standard Deviation 5.983 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in CDLQI Score | Change From Baseline at Week 24 | -5.68 score on a scale | Standard Deviation 7.326 |
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VC Period: Vehicle Cream BID | LTS Period: Change From Baseline in DLQI Score | Change From Baseline at Week 12 | -2.09 score on a scale | Standard Deviation 3.611 |
| VC Period: Vehicle Cream BID | LTS Period: Change From Baseline in DLQI Score | Change From Baseline at Week 52 | -3.09 score on a scale | Standard Deviation 3.753 |
| VC Period: Vehicle Cream BID | LTS Period: Change From Baseline in DLQI Score | Change From Baseline at Week 24 | -1.22 score on a scale | Standard Deviation 3.293 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in DLQI Score | Change From Baseline at Week 12 | -2.79 score on a scale | Standard Deviation 5.542 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in DLQI Score | Change From Baseline at Week 52 | -3.20 score on a scale | Standard Deviation 4.234 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in DLQI Score | Change From Baseline at Week 24 | -3.08 score on a scale | Standard Deviation 3.759 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in DLQI Score | Change From Baseline at Week 24 | -7.17 score on a scale | Standard Deviation 6.152 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in DLQI Score | Change From Baseline at Week 12 | -7.07 score on a scale | Standard Deviation 5.931 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in DLQI Score | Change From Baseline at Week 52 | -7.49 score on a scale | Standard Deviation 5.776 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in DLQI Score | Change From Baseline at Week 12 | -7.06 score on a scale | Standard Deviation 6.044 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in DLQI Score | Change From Baseline at Week 52 | -7.28 score on a scale | Standard Deviation 6.196 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in DLQI Score | Change From Baseline at Week 24 | -7.01 score on a scale | Standard Deviation 5.754 |
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VC Period: Vehicle Cream BID | LTS Period: Change From Baseline in POEM Score | Change From Baseline at Week 12 | -5.65 score on a scale | Standard Deviation 7.46 |
| VC Period: Vehicle Cream BID | LTS Period: Change From Baseline in POEM Score | Change From Baseline at Week 52 | -6.15 score on a scale | Standard Deviation 7.304 |
| VC Period: Vehicle Cream BID | LTS Period: Change From Baseline in POEM Score | Change From Baseline at Week 24 | -4.03 score on a scale | Standard Deviation 7.006 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in POEM Score | Change From Baseline at Week 12 | -6.04 score on a scale | Standard Deviation 7.269 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in POEM Score | Change From Baseline at Week 52 | -6.28 score on a scale | Standard Deviation 7.34 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in POEM Score | Change From Baseline at Week 24 | -5.71 score on a scale | Standard Deviation 6.567 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in POEM Score | Change From Baseline at Week 24 | -10.30 score on a scale | Standard Deviation 6.675 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in POEM Score | Change From Baseline at Week 12 | -9.72 score on a scale | Standard Deviation 6.571 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in POEM Score | Change From Baseline at Week 52 | -10.29 score on a scale | Standard Deviation 6.187 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in POEM Score | Change From Baseline at Week 12 | -10.58 score on a scale | Standard Deviation 6.883 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in POEM Score | Change From Baseline at Week 52 | -10.65 score on a scale | Standard Deviation 6.699 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in POEM Score | Change From Baseline at Week 24 | -10.58 score on a scale | Standard Deviation 6.848 |
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score | Change From Baseline at Week 24 | -1.87 score on a scale | Standard Deviation 5.691 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score | Change From Baseline at Week 12 | -1.80 score on a scale | Standard Deviation 5.588 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score | Change From Baseline at Week 52 | -2.88 score on a scale | Standard Deviation 7.235 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score | Change From Baseline at Week 52 | -0.36 score on a scale | Standard Deviation 6.049 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score | Change From Baseline at Week 12 | -0.37 score on a scale | Standard Deviation 4.621 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score | Change From Baseline at Week 24 | -0.03 score on a scale | Standard Deviation 4.688 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score | Change From Baseline at Week 24 | 0.06 score on a scale | Standard Deviation 5.376 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score | Change From Baseline at Week 12 | -0.32 score on a scale | Standard Deviation 4.466 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score | Change From Baseline at Week 52 | -0.42 score on a scale | Standard Deviation 5.95 |
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score | Change From Baseline at Week 12 | -2.04 score on a scale | Standard Deviation 6.282 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score | Change From Baseline at Week 52 | -2.33 score on a scale | Standard Deviation 6.582 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score | Change From Baseline at Week 24 | -1.04 score on a scale | Standard Deviation 5.969 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score | Change From Baseline at Week 24 | -0.11 score on a scale | Standard Deviation 5.136 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score | Change From Baseline at Week 12 | -0.32 score on a scale | Standard Deviation 4.724 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score | Change From Baseline at Week 52 | -0.24 score on a scale | Standard Deviation 5.66 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score | Change From Baseline at Week 12 | -0.04 score on a scale | Standard Deviation 3.914 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score | Change From Baseline at Week 52 | -0.69 score on a scale | Standard Deviation 5.483 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score | Change From Baseline at Week 24 | 0.22 score on a scale | Standard Deviation 4.868 |
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 33.07 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -25.22 score on a scale | Standard Deviation 25.009 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | 3.60 score on a scale | Standard Deviation 24.186 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -13.50 score on a scale | Standard Deviation 29.784 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -13.78 score on a scale | Standard Deviation 19.69 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -16.47 score on a scale | Standard Deviation 18.007 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -15.27 score on a scale | Standard Deviation 30.36 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -11.43 score on a scale | Standard Deviation 21.432 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -14.88 score on a scale | Standard Deviation 20.044 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -10.72 score on a scale | Standard Deviation 23.285 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -0.81 score on a scale | Standard Deviation 17.257 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -13.85 score on a scale | Standard Deviation 17.578 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -11.74 score on a scale | Standard Deviation 22.736 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -11.35 score on a scale | Standard Deviation 22.947 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -15.24 score on a scale | Standard Deviation 20.15 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -5.44 score on a scale | Standard Deviation 27.625 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -10.17 score on a scale | Standard Deviation 27.793 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -18.79 score on a scale | Standard Deviation 21.232 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -20.00 score on a scale | Standard Deviation 25.312 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -17.40 score on a scale | Standard Deviation 23.123 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -17.83 score on a scale | Standard Deviation 27.226 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -23.43 score on a scale | Standard Deviation 25.748 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -17.70 score on a scale | Standard Deviation 23.161 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -22.95 score on a scale | Standard Deviation 24.656 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -0.17 score on a scale | Standard Deviation 24.581 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -0.38 score on a scale | Standard Deviation 23.511 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -21.17 score on a scale | Standard Deviation 25.287 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -0.02 score on a scale | Standard Deviation 20.41 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | 0.50 score on a scale | Standard Deviation 28.348 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -19.87 score on a scale | Standard Deviation 21.572 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -19.74 score on a scale | Standard Deviation 23.719 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -22.42 score on a scale | Standard Deviation 25.547 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -18.62 score on a scale | Standard Deviation 28.397 |
| LTS Period: Ruxolitinib 1.5% Cream BID | 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 | -22.02 score on a scale | Standard Deviation 19.652 |
| LTS Period: Ruxolitinib 1.5% Cream BID | 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 | -16.20 score on a scale | Standard Deviation 32.591 |
| LTS Period: Ruxolitinib 1.5% Cream BID | 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 | -21.92 score on a scale | Standard Deviation 26.378 |
| LTS Period: Ruxolitinib 1.5% Cream BID | 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 | -22.32 score on a scale | Standard Deviation 26.481 |
| LTS Period: Ruxolitinib 1.5% Cream BID | 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 | -25.34 score on a scale | Standard Deviation 26.927 |
| LTS Period: Ruxolitinib 1.5% Cream BID | 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 | -23.93 score on a scale | Standard Deviation 27.743 |
| LTS Period: Ruxolitinib 1.5% Cream BID | 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 | 3.48 score on a scale | Standard Deviation 16.47 |
| LTS Period: Ruxolitinib 1.5% Cream BID | 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 | 5.13 score on a scale | Standard Deviation 24.419 |
| LTS Period: Ruxolitinib 1.5% Cream BID | 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 | 3.37 score on a scale | Standard Deviation 20.967 |
| LTS Period: Ruxolitinib 1.5% Cream BID | 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 | 6.36 score on a scale | Standard Deviation 21.806 |
| LTS Period: Ruxolitinib 1.5% Cream BID | 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 | -21.84 score on a scale | Standard Deviation 27.812 |
| LTS Period: Ruxolitinib 1.5% Cream BID | 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 | -22.56 score on a scale | Standard Deviation 22.433 |
| LTS Period: Ruxolitinib 1.5% Cream BID | 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 | -24.61 score on a scale | Standard Deviation 20.359 |
| LTS Period: Ruxolitinib 1.5% Cream BID | 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 | -21.86 score on a scale | Standard Deviation 25.836 |
| LTS Period: Ruxolitinib 1.5% Cream BID | 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 | -17.91 score on a scale | Standard Deviation 24.692 |
| LTS Period: Ruxolitinib 1.5% Cream BID | 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 | -19.31 score on a scale | Standard Deviation 26.893 |
Secondary
LTS Period: Percentage of Participants Achieving an IGA 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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VC Period: Vehicle Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 44 | 74.3 percentage of participants |
| VC Period: Vehicle Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 52 | 79.4 percentage of participants |
| VC Period: Vehicle Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 36 | 81.3 percentage of participants |
| VC Period: Vehicle Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 8 | 26.0 percentage of participants |
| VC Period: Vehicle Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 40 | 77.1 percentage of participants |
| VC Period: Vehicle Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 16 | 59.6 percentage of participants |
| VC Period: Vehicle Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 20 | 69.0 percentage of participants |
| VC Period: Vehicle Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 12 | 59.6 percentage of participants |
| VC Period: Vehicle Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 48 | 79.4 percentage of participants |
| VC Period: Vehicle Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 24 | 61.0 percentage of participants |
| VC Period: Vehicle Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 28 | 67.6 percentage of participants |
| VC Period: Vehicle Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 32 | 77.1 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 12 | 45.8 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 32 | 72.7 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 20 | 58.7 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 40 | 66.7 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 44 | 70.5 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 36 | 69.8 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 8 | 10.2 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 28 | 67.4 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 24 | 67.4 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 16 | 59.6 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 52 | 74.4 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 48 | 69.8 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 36 | 73.3 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 8 | 57.5 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 12 | 59.6 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 16 | 68.9 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 20 | 71.1 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 24 | 70.4 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 28 | 74.1 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 32 | 74.2 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 40 | 76.0 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 44 | 75.2 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 48 | 75.2 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 52 | 76.7 percentage of participants |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 28 | 72.0 percentage of participants |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 24 | 72.4 percentage of participants |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 8 | 65.5 percentage of participants |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 44 | 80.1 percentage of participants |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 20 | 74.5 percentage of participants |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 16 | 74.1 percentage of participants |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 52 | 80.1 percentage of participants |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 48 | 75.9 percentage of participants |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 36 | 79.3 percentage of participants |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 32 | 73.8 percentage of participants |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 12 | 73.0 percentage of participants |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 40 | 79.3 percentage of participants |
Secondary
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)
Population: LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VC Period: Vehicle Cream BID | LTS Period: Percentage of Participants With at Least One TEAE and Treatment Emergent SAE | TEAE | 58.5 percentage of participants |
| VC Period: Vehicle Cream BID | LTS Period: Percentage of Participants With at Least One TEAE and Treatment Emergent SAE | Treatment Emergent SAE | 3.8 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Percentage of Participants With at Least One TEAE and Treatment Emergent SAE | Treatment Emergent SAE | 0.0 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Percentage of Participants With at Least One TEAE and Treatment Emergent SAE | TEAE | 65.4 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants With at Least One TEAE and Treatment Emergent SAE | TEAE | 66.2 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants With at Least One TEAE and Treatment Emergent SAE | Treatment Emergent SAE | 2.5 percentage of participants |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants With at Least One TEAE and Treatment Emergent SAE | TEAE | 54.3 percentage of participants |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Percentage of Participants With at Least One TEAE and Treatment Emergent SAE | Treatment Emergent SAE | 1.4 percentage of participants |
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VC Period: Vehicle Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 52 | 12.9 nM | Standard Deviation 21.8 |
| VC Period: Vehicle Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 28 | 20.4 nM | Standard Deviation 39.9 |
| VC Period: Vehicle Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 24 | 11.7 nM | Standard Deviation 26 |
| VC Period: Vehicle Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 48 | 16.8 nM | Standard Deviation 38.6 |
| VC Period: Vehicle Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 44 | 15.9 nM | Standard Deviation 31.9 |
| VC Period: Vehicle Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 16 | 12.3 nM | Standard Deviation 22.8 |
| VC Period: Vehicle Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 12 | 13.8 nM | Standard Deviation 22.7 |
| VC Period: Vehicle Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 40 | 12.6 nM | Standard Deviation 36.7 |
| VC Period: Vehicle Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 36 | 11.4 nM | Standard Deviation 23.7 |
| VC Period: Vehicle Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 20 | 18.8 nM | Standard Deviation 41 |
| VC Period: Vehicle Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 32 | 14.6 nM | Standard Deviation 30.6 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 20 | 25.3 nM | Standard Deviation 43.9 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 12 | 23.9 nM | Standard Deviation 55.2 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 16 | 16.1 nM | Standard Deviation 27.7 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 24 | 27.6 nM | Standard Deviation 62.4 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 28 | 17.6 nM | Standard Deviation 32.2 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 32 | 26.4 nM | Standard Deviation 51.3 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 36 | 29.9 nM | Standard Deviation 52.8 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 40 | 32.8 nM | Standard Deviation 59.4 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 44 | 23.0 nM | Standard Deviation 33.7 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 48 | 35.7 nM | Standard Deviation 64.5 |
| VC Period: Ruxolitinib 0.75% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 52 | 35.7 nM | Standard Deviation 65.2 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 32 | 14.0 nM | Standard Deviation 23.2 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 52 | 17.7 nM | Standard Deviation 33.9 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 36 | 15.0 nM | Standard Deviation 28.4 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 12 | 14.3 nM | Standard Deviation 26.9 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 44 | 14.8 nM | Standard Deviation 28.8 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 24 | 18.5 nM | Standard Deviation 49.8 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 16 | 15.1 nM | Standard Deviation 28.3 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 20 | 13.6 nM | Standard Deviation 20.5 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 48 | 23.4 nM | Standard Deviation 58.1 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 28 | 16.1 nM | Standard Deviation 36.1 |
| VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 40 | 20.0 nM | Standard Deviation 51.1 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 28 | 20.8 nM | Standard Deviation 39.8 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 32 | 25.9 nM | Standard Deviation 67.8 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 16 | 23.9 nM | Standard Deviation 45.9 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 36 | 22.0 nM | Standard Deviation 40.1 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 40 | 26.3 nM | Standard Deviation 59.4 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 12 | 22.6 nM | Standard Deviation 46.6 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 52 | 23.3 nM | Standard Deviation 48.1 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 20 | 26.8 nM | Standard Deviation 55.9 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 24 | 25.7 nM | Standard Deviation 56.9 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 44 | 24.1 nM | Standard Deviation 40.9 |
| LTS Period: Ruxolitinib 1.5% Cream BID | LTS Period: Trough Plasma Concentrations of Ruxolitinib | Week 48 | 26.3 nM | Standard Deviation 54.3 |
Secondary
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. 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA) | Change From Baseline at Week 4 | -4.77 % BSA | Standard Deviation 4.711 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA) | Change From Baseline at Week 2 | -2.92 % BSA | Standard Deviation 3.944 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA) | Change From Baseline at Week 8 | -6.00 % BSA | Standard Deviation 4.845 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA) | Change From Baseline at Week 2 | -3.99 % BSA | Standard Deviation 4.636 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA) | Change From Baseline at Week 8 | -6.61 % BSA | Standard Deviation 5.479 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA) | Change From Baseline at Week 4 | -5.45 % BSA | Standard Deviation 5.223 |
Comparison: Change from Baseline in %BSA at Week 8p-value: <0.000195% CI: [-4.84, -2.97]ANCOVA
Comparison: Change from Baseline in %BSA at Week 8p-value: <0.000195% CI: [-5.47, -3.63]ANCOVA
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 7.5 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score | Change From Baseline at Week 4 | -4.82 score on a scale | Standard Deviation 4.934 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score | Change From Baseline at Week 2 | -3.45 score on a scale | Standard Deviation 4.57 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score | Change From Baseline at Week 8 | -4.56 score on a scale | Standard Deviation 5.061 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score | Change From Baseline at Week 2 | -3.58 score on a scale | Standard Deviation 4.032 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score | Change From Baseline at Week 8 | -4.12 score on a scale | Standard Deviation 6.418 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score | Change From Baseline at Week 4 | -4.52 score on a scale | Standard Deviation 5.221 |
Comparison: Change from Baseline in total CDLQI score at Week 8p-value: 0.009995% CI: [-7.24, -1.03]ANCOVA
Comparison: Change from Baseline in total CDLQI score at Week 8p-value: 0.054295% CI: [-6.3, 0.06]ANCOVA
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Change From Baseline at Week 4 | -6.62 score on a scale | Standard Deviation 5.966 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Change From Baseline at Week 2 | -5.40 score on a scale | Standard Deviation 5.874 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Change From Baseline at Week 8 | -7.18 score on a scale | Standard Deviation 6.004 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Change From Baseline at Week 2 | -5.14 score on a scale | Standard Deviation 5.394 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Change From Baseline at Week 8 | -6.41 score on a scale | Standard Deviation 5.731 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Change From Baseline at Week 4 | -6.16 score on a scale | Standard Deviation 5.771 |
Comparison: Change from Baseline in total DLQI score at Week 8p-value: <0.000195% CI: [-4.19, -2.32]ANCOVA
Comparison: Change from Baseline in total DLQI score at Week 8p-value: <0.000195% CI: [-3.67, -1.83]ANCOVA
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | 6.38 score on a scale | Standard Deviation 17.512 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | 6.16 score on a scale | Standard Deviation 14.409 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | 7.16 score on a scale | Standard Deviation 18.245 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | 6.98 score on a scale | Standard Deviation 15.956 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | 8.36 score on a scale | Standard Deviation 16.767 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | 8.55 score on a scale | Standard Deviation 17.244 |
Comparison: Change from Baseline in EQ VAS score at Week 8p-value: 0.01595% CI: [0.85, 7.86]ANCOVA
Comparison: Change from Baseline in EQ VAS score at Week 8p-value: 0.004495% CI: [1.59, 8.54]ANCOVA
Secondary
VC Period: Change From Baseline in Itch NRS Score
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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in Itch NRS Score | Change From Baseline at Week 4 | -2.82 score on a scale | Standard Error 0.17 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in Itch NRS Score | Change From Baseline at Week 2 | -2.21 score on a scale | Standard Error 0.15 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in Itch NRS Score | Change From Baseline at Week 8 | -3.28 score on a scale | Standard Error 0.18 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in Itch NRS Score | Change From Baseline at Week 2 | -2.43 score on a scale | Standard Error 0.15 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in Itch NRS Score | Change From Baseline at Week 8 | -3.09 score on a scale | Standard Error 0.17 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in Itch NRS Score | Change From Baseline at Week 4 | -3.00 score on a scale | Standard Error 0.17 |
Comparison: Change from Baseline in Itch NRS score at Week 2p-value: <0.000195% CI: [-2.02, -1.01]Mixed-Model with Repeated Measures
Comparison: Change from Baseline in Itch NRS score at Week 2p-value: <0.000195% CI: [-2.24, -1.24]Mixed-Model with Repeated Measures
Comparison: Change from Baseline in Itch NRS score at Week 4p-value: <0.000195% CI: [-2.36, -1.23]Mixed-Model with Repeated Measures
Comparison: Change from Baseline in Itch NRS score at Week 4p-value: <0.000195% CI: [-2.53, -1.4]Mixed-Model with Repeated Measures
Comparison: Change from Baseline in Itch NRS score at Week 8p-value: <0.000195% CI: [-2.49, -1.29]Mixed-Model with Repeated Measures
Comparison: Change from Baseline in Itch NRS score at Week 8p-value: <0.000195% CI: [-2.3, -1.1]Mixed-Model with Repeated Measures
Secondary
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 (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 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score | Change From Baseline at Week 4 | -9.59 score on a scale | Standard Deviation 6.883 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score | Change From Baseline at Week 2 | -8.21 score on a scale | Standard Deviation 6.694 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score | Change From Baseline at Week 8 | -10.34 score on a scale | Standard Deviation 6.835 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score | Change From Baseline at Week 2 | -8.86 score on a scale | Standard Deviation 6.807 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score | Change From Baseline at Week 8 | -10.08 score on a scale | Standard Deviation 7.167 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score | Change From Baseline at Week 4 | -9.97 score on a scale | Standard Deviation 6.839 |
Comparison: Change from Baseline in POEM score at Week 8p-value: <0.000195% CI: [-7.38, -4.86]ANCOVA
Comparison: Change from Baseline in POEM score at Week 8p-value: <0.000195% CI: [-7.17, -4.67]ANCOVA
Secondary
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
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| VC Period: Vehicle Cream BID | 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 0.5 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 0.6 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score | Change From Baseline at Week 4 | -2.32 score on a scale | Standard Error 0.35 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score | Change From Baseline at Week 2 | -1.92 score on a scale | Standard Error 0.33 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score | Change From Baseline at Week 8 | -3.30 score on a scale | Standard Error 0.42 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score | Change From Baseline at Week 2 | -2.30 score on a scale | Standard Error 0.33 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score | Change From Baseline at Week 8 | -3.40 score on a scale | Standard Error 0.41 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score | Change From Baseline at Week 4 | -2.88 score on a scale | Standard Error 0.35 |
Comparison: Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2p-value: 0.290395% CI: [-1.71, 0.51]Mixed-Model with Repeated Measures
Comparison: Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2p-value: 0.083795% CI: [-2.09, 0.13]Mixed-Model with Repeated Measures
Comparison: Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4p-value: 0.627295% CI: [-1.5, 0.91]Mixed-Model with Repeated Measures
Comparison: Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4p-value: 0.160995% CI: [-2.07, 0.34]Mixed-Model with Repeated Measures
Comparison: Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8p-value: 0.336295% CI: [-2.13, 0.73]Mixed-Model with Repeated Measures
Comparison: Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8p-value: 0.26995% CI: [-2.23, 0.62]Mixed-Model with Repeated Measures
Secondary
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
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score | Change From Baseline at Week 4 | -2.13 score on a scale | Standard Error 0.35 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score | Change From Baseline at Week 2 | -1.87 score on a scale | Standard Error 0.31 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score | Change From Baseline at Week 8 | -3.26 score on a scale | Standard Error 0.39 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score | Change From Baseline at Week 2 | -2.00 score on a scale | Standard Error 0.31 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score | Change From Baseline at Week 8 | -3.31 score on a scale | Standard Error 0.38 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score | Change From Baseline at Week 4 | -2.91 score on a scale | Standard Error 0.35 |
Comparison: Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2p-value: 0.048295% CI: [-2.13, -0.01]Mixed-Model with Repeated Measures
Comparison: Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2p-value: 0.027195% CI: [-2.26, -0.14]Mixed-Model with Repeated Measures
Comparison: Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4p-value: 0.209195% CI: [-1.94, 0.42]Mixed-Model with Repeated Measures
Comparison: Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4p-value: 0.011195% CI: [-2.71, -0.35]Mixed-Model with Repeated Measures
Comparison: Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8p-value: 0.080295% CI: [-2.51, 0.14]Mixed-Model with Repeated Measures
Comparison: Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8p-value: 0.066695% CI: [-2.56, 0.09]Mixed-Model with Repeated Measures
Secondary
VC Period: Change From Baseline in Skin Pain NRS Score
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | VC Period: Change From Baseline in Skin Pain NRS Score | Change From Baseline at Week 8 | -1.35 score on a scale | Standard Deviation 2.54 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in Skin Pain NRS Score | Change From Baseline at Week 4 | -2.28 score on a scale | Standard Deviation 2.449 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in Skin Pain NRS Score | Change From Baseline at Week 2 | -1.78 score on a scale | Standard Deviation 2.145 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Change From Baseline in Skin Pain NRS Score | Change From Baseline at Week 8 | -2.45 score on a scale | Standard Deviation 2.575 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in Skin Pain NRS Score | Change From Baseline at Week 2 | -1.73 score on a scale | Standard Deviation 2.125 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in Skin Pain NRS Score | Change From Baseline at Week 8 | -2.37 score on a scale | Standard Deviation 2.428 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Change From Baseline in Skin Pain NRS Score | Change From Baseline at Week 4 | -2.27 score on a scale | Standard Deviation 2.262 |
Comparison: Change from Baseline in Skin Pain NRS score at Week 8p-value: <0.000195% CI: [-1.94, -0.97]ANCOVA
Comparison: Change from Baseline in Skin Pain NRS score at Week 8p-value: <0.000195% CI: [-1.72, -0.76]ANCOVA
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 25.5 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | 3.50 score on a scale | Standard Deviation 24.76 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | 0.64 score on a scale | Standard Deviation 19.19 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -0.15 score on a scale | Standard Deviation 22.299 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -12.76 score on a scale | Standard Deviation 21.371 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -15.25 score on a scale | Standard Deviation 22.648 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -18.83 score on a scale | Standard Deviation 23.365 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -12.58 score on a scale | Standard Deviation 24.67 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -15.14 score on a scale | Standard Deviation 25.543 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -17.00 score on a scale | Standard Deviation 25.916 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -12.79 score on a scale | Standard Deviation 23.462 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -17.24 score on a scale | Standard Deviation 24.715 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | -19.66 score on a scale | Standard Deviation 25.157 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -13.24 score on a scale | Standard Deviation 19.958 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -18.70 score on a scale | Standard Deviation 23.55 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -13.65 score on a scale | Standard Deviation 22.476 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | 3.51 score on a scale | Standard Deviation 18.479 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | 2.53 score on a scale | Standard Deviation 17.803 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -16.68 score on a scale | Standard Deviation 23.295 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -17.32 score on a scale | Standard Deviation 19.013 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | 4.31 score on a scale | Standard Deviation 19.679 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -11.10 score on a scale | Standard Deviation 23.717 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -18.10 score on a scale | Standard Deviation 19.832 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -18.60 score on a scale | Standard Deviation 25.557 |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | -16.19 score on a scale | Standard Deviation 22.037 |
Comparison: Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8p-value: 0.14295% CI: [-13.12, 1.89]ANCOVA
Comparison: Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8p-value: 0.037595% CI: [-15.51, -0.47]ANCOVA
Comparison: Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8p-value: 0.001295% CI: [-14.48, -3.63]ANCOVA
Comparison: Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8p-value: 0.009595% CI: [-12.58, -1.77]ANCOVA
Comparison: Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8p-value: <0.000195% CI: [-22.69, -7.73]ANCOVA
Comparison: Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8p-value: 0.00195% CI: [-20.1, -5.18]ANCOVA
Comparison: Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8p-value: <0.000195% CI: [-16.18, -7.95]ANCOVA
Comparison: Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8p-value: <0.000195% CI: [-14.53, -6.37]ANCOVA
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 1.38 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Mean Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, and 8 | Week 4 | 1.95 score on a scale | Standard Deviation 0.98 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Mean Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, and 8 | Week 2 | 2.19 score on a scale | Standard Deviation 1.019 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Mean Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, and 8 | Week 8 | 1.73 score on a scale | Standard Deviation 0.906 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Mean Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, and 8 | Week 2 | 1.95 score on a scale | Standard Deviation 0.98 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Mean Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, and 8 | Week 8 | 1.70 score on a scale | Standard Deviation 0.909 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Mean Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, and 8 | Week 4 | 1.71 score on a scale | Standard Deviation 0.852 |
Secondary
VC Period: Percentage of Participants Achieving an IGA 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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VC Period: Vehicle Cream BID | VC Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 4 | 16.9 percentage of participants |
| VC Period: Vehicle Cream BID | VC Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 2 | 9.3 percentage of participants |
| VC Period: Vehicle Cream BID | VC Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 8 | 16.1 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 4 | 45.9 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 2 | 24.2 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 8 | 51.1 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 2 | 34.6 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 8 | 62.3 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants Achieving an IGA of 0 or 1 | Week 4 | 52.6 percentage of participants |
Secondary
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 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥ 2 grade improvement from Baseline.
Time frame: Baseline to 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VC Period: Vehicle Cream BID | VC Period: Percentage of Participants Who Achieved an IGA-TS at Weeks 2 and 4 | Week 2 | 4.2 percentage of participants |
| VC Period: Vehicle Cream BID | VC Period: Percentage of Participants Who Achieved an IGA-TS at Weeks 2 and 4 | Week 4 | 5.9 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants Who Achieved an IGA-TS at Weeks 2 and 4 | Week 2 | 17.3 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants Who Achieved an IGA-TS at Weeks 2 and 4 | Week 4 | 35.5 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants Who Achieved an IGA-TS at Weeks 2 and 4 | Week 2 | 25.0 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants Who Achieved an IGA-TS at Weeks 2 and 4 | Week 4 | 43.4 percentage of participants |
Secondary
VC Period: Percentage of Participants Who Achieved EASI50
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VC Period: Vehicle Cream BID | VC Period: Percentage of Participants Who Achieved EASI50 | Week 4 | 28.8 percentage of participants |
| VC Period: Vehicle Cream BID | VC Period: Percentage of Participants Who Achieved EASI50 | Week 2 | 16.1 percentage of participants |
| VC Period: Vehicle Cream BID | VC Period: Percentage of Participants Who Achieved EASI50 | Week 8 | 33.9 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants Who Achieved EASI50 | Week 4 | 69.7 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants Who Achieved EASI50 | Week 2 | 45.5 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants Who Achieved EASI50 | Week 8 | 75.8 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants Who Achieved EASI50 | Week 2 | 53.5 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants Who Achieved EASI50 | Week 8 | 79.8 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants Who Achieved EASI50 | Week 4 | 71.9 percentage of participants |
Secondary
VC Period: Percentage of Participants Who Achieved EASI75 at Weeks 2 and 4
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VC Period: Vehicle Cream BID | VC Period: Percentage of Participants Who Achieved EASI75 at Weeks 2 and 4 | Week 2 | 4.2 percentage of participants |
| VC Period: Vehicle Cream BID | VC Period: Percentage of Participants Who Achieved EASI75 at Weeks 2 and 4 | Week 4 | 10.2 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants Who Achieved EASI75 at Weeks 2 and 4 | Week 2 | 25.5 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants Who Achieved EASI75 at Weeks 2 and 4 | Week 4 | 42.0 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants Who Achieved EASI75 at Weeks 2 and 4 | Week 4 | 50.4 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants Who Achieved EASI75 at Weeks 2 and 4 | Week 2 | 31.6 percentage of participants |
Secondary
VC Period: Percentage of Participants Who Achieved EASI90
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VC Period: Vehicle Cream BID | VC Period: Percentage of Participants Who Achieved EASI90 | Week 4 | 2.5 percentage of participants |
| VC Period: Vehicle Cream BID | VC Period: Percentage of Participants Who Achieved EASI90 | Week 2 | 0.8 percentage of participants |
| VC Period: Vehicle Cream BID | VC Period: Percentage of Participants Who Achieved EASI90 | Week 8 | 4.2 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants Who Achieved EASI90 | Week 4 | 25.5 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants Who Achieved EASI90 | Week 2 | 10.8 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants Who Achieved EASI90 | Week 8 | 35.1 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants Who Achieved EASI90 | Week 2 | 15.8 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants Who Achieved EASI90 | Week 8 | 43.4 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants Who Achieved EASI90 | Week 4 | 32.5 percentage of participants |
Secondary
VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Week 8
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VC Period: Vehicle Cream BID | VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Week 8 | 14.4 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Week 8 | 51.5 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Week 8 | 61.8 percentage of participants |
p-value: <0.000195% CI: [3.723, 13.184]Exact Logistic Regression
p-value: <0.000195% CI: [5.775, 20.732]Exact Logistic Regression
Secondary
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), 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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch NRS Score From Baseline to Weeks 2 and 4 | Week 2 | 27.4 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch NRS Score From Baseline to Weeks 2 and 4 | Week 4 | 38.2 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch NRS Score From Baseline to Weeks 2 and 4 | Week 2 | 32.2 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch NRS Score From Baseline to Weeks 2 and 4 | Week 4 | 45.2 percentage of participants |
Secondary
VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8 | 42.7 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8 | 50.7 percentage of participants |
p-value: <0.000195% CI: [2.045, 9.036]Exact Logistic Regression
p-value: <0.000195% CI: [2.833, 12.657]Exact Logistic Regression
Secondary
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
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: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | 20.7 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | 25.6 percentage of participants |
p-value: 0.855395% CI: [0.598, 2.094]Exact Logistic Regression
p-value: 0.235995% CI: [0.805, 2.741]Exact Logistic Regression
Secondary
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
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | 14.6 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | 16.9 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | 18.0 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | 18.0 percentage of participants |
Secondary
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
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | 20.0 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | 23.1 percentage of participants |
p-value: 0.178495% CI: [0.827, 3.342]Exact Logistic Regression
p-value: 0.047295% CI: [1.007, 4]Exact Logistic Regression
Secondary
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
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | 10.7 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 | 13.0 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | 13.2 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 | 19.8 percentage of participants |
Secondary
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With a Score of Either 1 or 2 on the PGIC at Weeks 2, 4, and 8 | Week 8 | 78.8 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With a Score of Either 1 or 2 on the PGIC at Weeks 2, 4, and 8 | Week 2 | 59.2 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With a Score of Either 1 or 2 on the PGIC at Weeks 2, 4, and 8 | Week 4 | 70.5 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With a Score of Either 1 or 2 on the PGIC at Weeks 2, 4, and 8 | Week 4 | 84.3 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With a Score of Either 1 or 2 on the PGIC at Weeks 2, 4, and 8 | Week 2 | 71.9 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With a Score of Either 1 or 2 on the PGIC at Weeks 2, 4, and 8 | Week 8 | 84.2 percentage of participants |
Comparison: Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8p-value: <0.000195% CI: [2.987, 9.049]Exact Logistic Regression
Comparison: Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8p-value: <0.000195% CI: [4.23, 13.415]Exact Logistic Regression
Secondary
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 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (SAE) | TEAE | 29.0 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (SAE) | Treatment Emergent SAE | 1.2 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (SAE) | TEAE | 23.6 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (SAE) | Treatment Emergent SAE | 0.4 percentage of participants |
Secondary
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 8 - Minimally Worse: 5 | 0.0 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 4 - Much Improved: 2 | 28.6 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 2 - Very Much Improved: 1 | 32.1 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 2 - Much Improved: 2 | 27.1 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 2 - Minimally Improved: 3 | 32.1 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 2 - No Change: 4 | 7.8 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 2 - Minimally Worse: 5 | 0.5 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 2 - Much Worse: 6 | 0.5 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 2 - Very Much Worse: 7 | 0.0 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 4 - Very Much Improved: 1 | 41.9 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 4 - Minimally Improved: 3 | 22.1 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 4 - No Change: 4 | 6.9 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 4 - Minimally Worse: 5 | 0.5 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 4 - Much Worse: 6 | 0.0 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | 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 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 8 - Very Much Improved: 1 | 52.7 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 8 - Much Improved: 2 | 26.1 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 8 - Minimally Improved: 3 | 16.3 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 8 - No Change: 4 | 4.9 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 8 - Much Worse: 6 | 0.0 percentage of participants |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 8 - Very Much Worse: 7 | 0.0 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 4 - Very Much Improved: 1 | 49.1 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 2 - Much Improved: 2 | 30.9 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 8 - Very Much Improved: 1 | 51.6 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 2 - Very Much Worse: 7 | 0.0 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 8 - Very Much Worse: 7 | 0.0 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 8 - Much Improved: 2 | 32.6 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 2 - Much Worse: 6 | 0.0 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 8 - Much Worse: 6 | 0.5 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 8 - Minimally Improved: 3 | 12.1 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 2 - Minimally Worse: 5 | 0.9 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 2 - Very Much Improved: 1 | 41.0 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 8 - No Change: 4 | 1.9 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 4 - No Change: 4 | 2.8 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 2 - No Change: 4 | 6.5 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 4 - Minimally Worse: 5 | 0.9 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 4 - Minimally Improved: 3 | 12.0 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 2 - Minimally Improved: 3 | 20.7 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 4 - Much Worse: 6 | 0.0 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 4 - Much Improved: 2 | 35.2 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 | Week 8 - Minimally Worse: 5 | 1.4 percentage of participants |
| VC Period: Ruxolitinib 1.5% Cream BID | 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 |
Secondary
VC Period: Percent Change From Baseline in EASI Score
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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| VC Period: Vehicle Cream BID | VC Period: Percent Change From Baseline in EASI Score | Percent Change From Baseline at Week 4 | -20.45 percent change | Standard Error 3.62 |
| VC Period: Vehicle Cream BID | VC Period: Percent Change From Baseline in EASI Score | Percent Change From Baseline at Week 2 | -13.95 percent change | Standard Error 4.02 |
| VC Period: Vehicle Cream BID | VC Period: Percent Change From Baseline in EASI Score | Percent Change From Baseline at Week 8 | -28.84 percent change | Standard Error 3.57 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percent Change From Baseline in EASI Score | Percent Change From Baseline at Week 4 | -65.00 percent change | Standard Error 2.5 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percent Change From Baseline in EASI Score | Percent Change From Baseline at Week 2 | -45.86 percent change | Standard Error 2.84 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percent Change From Baseline in EASI Score | Percent Change From Baseline at Week 8 | -73.37 percent change | Standard Error 2.5 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percent Change From Baseline in EASI Score | Percent Change From Baseline at Week 2 | -49.08 percent change | Standard Error 2.86 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percent Change From Baseline in EASI Score | Percent Change From Baseline at Week 8 | -74.84 percent change | Standard Error 2.46 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percent Change From Baseline in EASI Score | Percent Change From Baseline at Week 4 | -66.35 percent change | Standard Error 2.51 |
Comparison: Percent change from Baseline in EASI score at Week 2p-value: <0.000195% CI: [-41.57, -22.25]Mixed-Model with Repeated Measures
Comparison: Percent change from Baseline in EASI score at Week 2p-value: <0.000195% CI: [-44.81, -25.44]Mixed-Model with Repeated Measures
Comparison: Percent change from Baseline in EASI score at Week 4p-value: <0.000195% CI: [-53.19, -35.92]Mixed-Model with Repeated Measures
Comparison: Percent change from Baseline in EASI score at Week 4p-value: <0.000195% CI: [-54.55, -37.26]Mixed-Model with Repeated Measures
Comparison: Percent change from Baseline in EASI score at Week 8p-value: <0.000195% CI: [-53.08, -35.98]Mixed-Model with Repeated Measures
Comparison: Percent change from Baseline in EASI score at Week 8p-value: <0.000195% CI: [-54.51, -37.48]Mixed-Model with Repeated Measures
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score | Percent Change From Baseline at Week 4 | -54.85 percent change | Standard Deviation 29.803 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score | Percent Change From Baseline at Week 2 | -39.62 percent change | Standard Deviation 28.061 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score | Percent Change From Baseline at Week 8 | -63.71 percent change | Standard Deviation 28.494 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score | Percent Change From Baseline at Week 2 | -45.22 percent change | Standard Deviation 28.461 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score | Percent Change From Baseline at Week 8 | -67.39 percent change | Standard Deviation 29.098 |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score | Percent Change From Baseline at Week 4 | -58.76 percent change | Standard Deviation 29.58 |
Comparison: Percent change from Baseline in SCORAD score at Week 8p-value: <0.000195% CI: [-46.48, -32.38]ANCOVA
Comparison: Percent change from Baseline in SCORAD score at Week 8p-value: <0.000195% CI: [-50.51, -36.53]ANCOVA
Secondary
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), 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Vehicle Cream BID | 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 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2, 3, or 4 Points | ≥ 3-Point Improvement in Itch NRS Score | 8.0 days |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2, 3, or 4 Points | ≥ 2-Point Improvement in Itch NRS Score | 5.0 days |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2, 3, or 4 Points | ≥ 4-Point Improvement in Itch NRS Score | 16 days |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2, 3, or 4 Points | ≥ 2-Point Improvement in Itch NRS Score | 4.0 days |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2, 3, or 4 Points | ≥ 4-Point Improvement in Itch NRS Score | 14 days |
| VC Period: Ruxolitinib 1.5% Cream BID | VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2, 3, or 4 Points | ≥ 3-Point Improvement in Itch NRS Score | 8.0 days |
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VC Period: Vehicle Cream BID | VC Period: Trough Plasma Concentrations of Ruxolitinib | Week 2 | 25.2 nanomole per litre (nM) | Standard Deviation 37.4 |
| VC Period: Vehicle Cream BID | VC Period: Trough Plasma Concentrations of Ruxolitinib | Week 4 | 22.6 nanomole per litre (nM) | Standard Deviation 35.2 |
| VC Period: Vehicle Cream BID | VC Period: Trough Plasma Concentrations of Ruxolitinib | Week 8 | 22.4 nanomole per litre (nM) | Standard Deviation 36.1 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Trough Plasma Concentrations of Ruxolitinib | Week 2 | 38.5 nanomole per litre (nM) | Standard Deviation 64.5 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Trough Plasma Concentrations of Ruxolitinib | Week 4 | 41.8 nanomole per litre (nM) | Standard Deviation 83.6 |
| VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Trough Plasma Concentrations of Ruxolitinib | Week 8 | 36.1 nanomole per litre (nM) | Standard Deviation 66.6 |