Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (TRuE AD1) - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis
Sponsor
Incyte Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT03745638
Collaborator
(none)
631
79
7
23.4
8
0.3
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the efficacy and safety of twice daily ruxolitinib cream in adolescents and adults with Atopic Dermatitis (AD).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
631 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Double-Blind, Randomized, 8-Week, Vehicle-Controlled Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Adolescents and Adults With Atopic Dermatitis
Actual Study Start Date
:
Dec 20, 2018
Actual Primary Completion Date
:
Dec 23, 2019
Actual Study Completion Date
:
Dec 1, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: VC Period: Vehicle Cream BID Participants received vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 to Week 8 during the Vehicle Control (VC) Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
Drug: Vehicle Cream
Matching vehicle cream applied topically to the affected area as a thin film twice daily.
|
| Experimental: VC Period: Ruxolitinib 0.75% Cream BID Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
Drug: Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Other Names:
|
| Experimental: VC Period: Ruxolitinib 1.5% Cream BID Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
Drug: Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Other Names:
|
| Experimental: LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the Long-term Safety (LTS) Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
Drug: Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Other Names:
|
| Experimental: LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
Drug: Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Other Names:
|
| Experimental: LTS Period: Ruxolitinib 0.75% Cream Arm description: Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
Drug: Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Other Names:
|
| Experimental: LTS Period: Ruxolitinib 1.5% Cream Arm description: Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
Drug: Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) [Baseline to Week 8]
EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.
- VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch Numerical Rating Scale (NRS) Score [Baseline to Week 8]
The Itch NRS is a daily participant-reported measure (24-hour recall), using a diary, of the worst level of itch intensity. Participants were asked to rate the itching severity because of their AD in the daily diary by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours.
- 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 [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. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance. Each item asks the participant to rate the severity of the participant's sleep disturbance.
- VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep-Related Impairment (8a - 24-Hour Recall) [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 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 first dose 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 0 (clear skin) to 4 (severe disease) scale. The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥ 2 grade improvement from Baseline.
- VC Period: Percentage of Participants Achieving IGA Scores 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. IGA score signifies 0 (clear skin) and 1 (almost clear skin).
- LTS Period: Percentage of Participants Achieving IGA Scores 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 0 (clear skin) to 4 (severe disease) scale. The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. IGA score signifies 0 (clear skin) and 1 (almost clear skin).
- 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), using a diary, of the worst level of itch intensity. Participants are asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours.
- VC Period: Percentage of Participants Achieving EASI50 [Weeks 2, 4 and 8]
EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI50 responder was defined as a participant achieving 50% or greater improvement from Baseline in EASI score.
- VC Period: Percentage of Participants Achieving EASI75 [Weeks 2 and 4]
EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.
- VC Period: Percentage of Participants Achieving EASI90 [Weeks 2, 4 and 8]
EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI90 responder was defined as a participant achieving 90% or greater improvement from Baseline in EASI score.
- VC Period: Percent Change From Baseline in EASI Score [Baseline, Weeks 2, 4 and 8]
EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. A negative change from Baseline indicates improvement.
- 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), using a diary, of the worst level of itch intensity. Participants are asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. A negative change from Baseline indicates improvement.
- 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), using a diary, of the worst level of itch intensity. Participants were asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. Kaplan-Meier estimation method was used for analyses.
- 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), using a diary, of the worst level of pain intensity from 0 (no pain) to 10 (worst imaginable pain). Participants will be asked, "Rate the pain severity from your atopic dermatitis skin changes by selecting a number that best describes your worst level of pain in the past 24 hours." A negative change from Baseline indicates improvement.
- VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score [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 [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-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.
- 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. Used the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1*BSA head and neck + 0.3*BSA trunk + 0.2* BSA upper limbs + 0.4*BSA lower limbs. A negative change from Baseline indicates improvement.
- 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. Used the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1*BSA head and neck + 0.3*BSA trunk + 0.2* BSA upper limbs + 0.4*BSA lower limbs. A negative change from Baseline indicates improvement.
- 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 (clear or almost clear) to 28 (very severe eczema). High scores are indicative of more severe disease and poor quality of life. A negative change from Baseline indicates improvement.
- 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: 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.
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
and Older
Sexes Eligible for Study:
All
Accepts 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 [Vehicle Controlled (VC) Period] and 0 to 4 at Week 8 [Long-Term Safety (LTS) Period].
-
Participants with percentage of 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 (eg. dupilumab).
-
4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg. 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cahaba Dermatology | Birmingham | Alabama | United States | 35244 |
| 2 | Elite Clinical Studies | Phoenix | Arizona | United States | 85018 |
| 3 | First OC Dermatology | Fountain Valley | California | United States | 92708 |
| 4 | Dermatology Research Associates | Los Angeles | California | United States | 90045 |
| 5 | Dermatology Specialists Inc | Oceanside | California | United States | 92056 |
| 6 | Integrated Research Group Inc. | Riverside | California | United States | 92506 |
| 7 | Advanced Rx Clinical Research | Westminster | California | United States | 92683 |
| 8 | Clearlyderm Boca Raton - BTC - PPDS | Boca Raton | Florida | United States | 33433 |
| 9 | Olympian Clinical Research | Largo | Florida | United States | 33770 |
| 10 | Acevedo Clinical Research | Miami | Florida | United States | 33142 |
| 11 | Well Pharma Medical Research Corporation | Miami | Florida | United States | 33143 |
| 12 | AdvancedPharma CR LLC | Miami | Florida | United States | 33147 |
| 13 | University of South Florida | Tampa | Florida | United States | 33613 |
| 14 | ForCare Clinical Research | Tampa | Florida | United States | 33624 |
| 15 | Metabolic Research Institute Inc | West Palm Beach | Florida | United States | 33401 |
| 16 | Aeroallergy Research Lab Of Savannah | Savannah | Georgia | United States | 31406 |
| 17 | Clinical Research Atlanta - ERN-PPDS | Stockbridge | Georgia | United States | 30281 |
| 18 | Sneeze Wheeze and Itch Associates LLC | Normal | Illinois | United States | 61761 |
| 19 | Dawes Fretzin Clinical Research Group LLC | Indianapolis | Indiana | United States | 46256 |
| 20 | DS Research | New Albany | Indiana | United States | 47150 |
| 21 | Kansas City Dermatology P.A. | Overland Park | Kansas | United States | 66215 |
| 22 | Skin Sciences, PLLC | Louisville | Kentucky | United States | 40217 |
| 23 | Michael W Simon MD | Nicholasville | Kentucky | United States | 40356 |
| 24 | DermAssociates | Rockville | Maryland | United States | 20850 |
| 25 | Henry Ford Medical Center | Detroit | Michigan | United States | 48202 |
| 26 | JDR Dermatology Research | Las Vegas | Nevada | United States | 89148 |
| 27 | Forest Hills Dermatology Group | Forest Hills | New York | United States | 11375 |
| 28 | Sadick Dermatology | New York | New York | United States | 10075 |
| 29 | Wake Research Associates, LLC | Raleigh | North Carolina | United States | 27612 |
| 30 | Ohio Pediatric Research Assn Inc | Huber Heights | Ohio | United States | 45424 |
| 31 | Central Sooner Research | Norman | Oklahoma | United States | 73071 |
| 32 | Cyn3rgy Research - Clinedge - PPDS | Gresham | Oregon | United States | 97030 |
| 33 | Clinical Research Institute Of Southern Oregon - Crisor | Medford | Oregon | United States | 97504 |
| 34 | Oregon Medical Research Center PC | Portland | Oregon | United States | 97223 |
| 35 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
| 36 | Synexus Clinical Research Us Inc. Greer | Greer | South Carolina | United States | 29651 |
| 37 | Alliance for Multispecialty Research, LLC | Knoxville | Tennessee | United States | 37920 |
| 38 | Family Medicine Associates Of Texas | Carrollton | Texas | United States | 75010 |
| 39 | Progressive Clinical Research PA | San Antonio | Texas | United States | 78213 |
| 40 | Jordan Valley Medical Center | West Jordan | Utah | United States | 84088 |
| 41 | PI Coor Clinical Research LLC | Burke | Virginia | United States | 22015 |
| 42 | West End Dermatology | Henrico | Virginia | United States | 23233 |
| 43 | Lynderm Research Inc | Markham | Ontario | Canada | L3P 1X2 |
| 44 | York Dermatology Center | Richmond Hill | Ontario | Canada | L4C 9M7 |
| 45 | K. Papp Clinical Research | Waterloo | Ontario | Canada | N2J 1C4 |
| 46 | Windsor Clinical Research Inc. | Windsor | Ontario | Canada | N8W 5L7 |
| 47 | XLR8 Medical Research | Windsor | Ontario | Canada | N8X 3V6 |
| 48 | Siena Medical Reserch Corporation | Westmount | Quebec | Canada | H3Z 2S6 |
| 49 | CHRU de Brest - Hopital Morvan | Brest | France | 29609 | |
| 50 | Le Bateau Blanc - Imm. A | Martigues | France | 13500 | |
| 51 | Hôpital L'archet 2 | Nice | France | 06202 | |
| 52 | Centre Hospitalier Lyon Sud | Pierre-Bénite | France | 69495 | |
| 53 | Hôpital Charles Nicolle | Rouen | France | 76031 | |
| 54 | Elben Klinken Stade - Buxtehude | Buxtehude | Niedersachsen | Germany | 21614 |
| 55 | Universitätsklinikum Bonn | Bonn | Nordrhein-Westfalen | Germany | 53105 |
| 56 | Universitätsklinikum Carl Gustav Carus an der TU Dresden | Dresden | Sachsen | Germany | 01307 |
| 57 | Universitatsklinikum Schleswig-Holstein | Lübeck | Schleswig-Holstein | Germany | 23538 |
| 58 | Universitätsklinikum Frankfurt | Frankfurt am Main | Germany | 60590 | |
| 59 | Synexus (DRS) - Synexus Magyarország Kft. Budapest | Budapest | Hungary | 1036 | |
| 60 | Synexus Affiliate - Synexus Magyarorszag Kft. Debrecen | Debrecen | Hungary | 4025 | |
| 61 | Synexus (DRS) - Synexus Magyarország Kft. Gyula | Gyula | Hungary | 5700 | |
| 62 | Pécsi Tudományegyetem | Pécs | Hungary | 7632 | |
| 63 | Allergo-Derm Bakos Kft. | Szolnok | Hungary | 5000 | |
| 64 | Synexus (DRS) - Synexus Magyarország Kft. Zalaegerszeg | Zalaegerszeg | Hungary | 8900 | |
| 65 | Fondazione Policlinico Universitario A Gemelli | Roma | Italy | 168 | |
| 66 | Synexus - Wroclaw | Wroclaw | Dolnoslaskie | Poland | 50-381 |
| 67 | Centrum Medyczne ADAMAR | Wroclaw | Dolnoslaskie | Poland | 53-658 |
| 68 | ETG Zgierz | Zgierz | Lódzkie | Poland | 95-100 |
| 69 | Klinika Ambroziak | Warsaw | Mazowieckie | Poland | 02-953 |
| 70 | Synexus - Gdansk | Gdansk | Pomorskie | Poland | 80-382 |
| 71 | Laser Clinic S.C. | Szczecin | Zachodniopomorskie | Poland | 70-332 |
| 72 | Synexus - Katowice | Katowice | Poland | 40-040 | |
| 73 | Centrum Medyczne Krakow - PRATIA - PPDS | Krakow | Poland | 30-510 | |
| 74 | ETG Lublin | Lublin | Poland | 20-412 | |
| 75 | Synexus Polska Sp. z o.o. Oddzial w Poznaniu | Poznan | Poland | 60-702 | |
| 76 | Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o | Tarnow | Poland | 33-100 | |
| 77 | ETG Warszawa | Warsaw | Poland | 02-777 | |
| 78 | Medycyna Kliniczna Marzena Waszczak-Jeka | Warszawa | Poland | 00-874 | |
| 79 | Royalderm | Warszawa | Poland | 02-962 |
Sponsors and Collaborators
- Incyte Corporation
Investigators
- Study Director: Michael E. Kuligowski, MD, PhD, MBA, Incyte Corporation
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT03745638
Other Study ID Numbers:
- INCB 18424-303
- 2018-003712-45
First Posted:
Nov 19, 2018
Last Update Posted:
Dec 17, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Incyte Corporation
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | A total of 631 participants took part in the study at 78 sites, 48 in North America and 30 in Europe from December 20, 2018 to December 01, 2020. |
|---|---|
| Pre-assignment Detail | Participants who completed Week 8 assessments of the Vehicle Control (VC) Period with no safety concerns continued in the 44-week Long Term Safety (LTS) Period. Participants who were on active treatment during the VC Period continued with the same treatment regimen in the LTS Period and those who applied vehicle cream during the VC Period were equally randomized into 1 of the 2 active treatment groups: ruxolitinib 0.75%, ruxolitinib 1.5% cream during the LTS Period. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID | LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID | LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID | LTS Period: Ruxolitinib 0.75% Cream | LTS Period: Ruxolitinib 1.5% Cream |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
| Period Title: Vehicle Control Period (Day 1 to Week 8) | |||||||
| STARTED | 126 | 252 | 253 | 0 | 0 | 0 | 0 |
| COMPLETED | 95 | 222 | 225 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 31 | 30 | 28 | 0 | 0 | 0 | 0 |
| Period Title: Vehicle Control Period (Day 1 to Week 8) | |||||||
| STARTED | 0 | 0 | 0 | 48 | 47 | 222 | 225 |
| COMPLETED | 0 | 0 | 0 | 37 | 38 | 176 | 174 |
| NOT COMPLETED | 0 | 0 | 0 | 11 | 9 | 46 | 51 |
Baseline Characteristics
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Total of all reporting groups |
| Overall Participants | 126 | 252 | 253 | 631 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
35.2
(18.11)
|
36.8
(19.06)
|
33.7
(17.15)
|
35.2
(18.15)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
79
62.7%
|
154
61.1%
|
158
62.5%
|
391
62%
|
| Male |
47
37.3%
|
98
38.9%
|
95
37.5%
|
240
38%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
21
16.7%
|
30
11.9%
|
37
14.6%
|
88
13.9%
|
| Not Hispanic or Latino |
104
82.5%
|
218
86.5%
|
212
83.8%
|
534
84.6%
|
| Unknown or Not Reported |
1
0.8%
|
4
1.6%
|
4
1.6%
|
9
1.4%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
2
0.8%
|
0
0%
|
2
0.3%
|
| Asian |
8
6.3%
|
10
4%
|
14
5.5%
|
32
5.1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
3
1.2%
|
0
0%
|
3
0.5%
|
| Black or African American |
29
23%
|
55
21.8%
|
56
22.1%
|
140
22.2%
|
| White |
85
67.5%
|
173
68.7%
|
177
70%
|
435
68.9%
|
| Other |
4
3.2%
|
9
3.6%
|
6
2.4%
|
19
3%
|
| Body Mass Index (BMI) (Kilograms per square metre (kg/m^2)) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Kilograms per square metre (kg/m^2)] |
26.92
(6.245)
|
27.33
(6.745)
|
27.47
(8.077)
|
27.30
(7.212)
|
Outcome Measures
| Title | Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8 |
|---|---|
| Description | The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥ 2 grade improvement from Baseline. |
| Time Frame | Baseline to Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 126 | 252 | 253 |
| Number (95% Confidence Interval) [percentage of participants] |
15.1
12%
|
50.0
19.8%
|
53.8
21.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference. | |
| Method | Exact Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 6.38 | |
| Confidence Interval |
(2-Sided) 95% 3.556 to 11.923 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference. | |
| Method | Exact Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 7.50 | |
| Confidence Interval |
(2-Sided) 95% 4.178 to 14.040 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) |
|---|---|
| Description | EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score. |
| Time Frame | Baseline to Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 126 | 252 | 253 |
| Number (95% Confidence Interval) [percentage of participants] |
24.6
19.5%
|
56.0
22.2%
|
62.1
24.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference. | |
| Method | Exact Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 4.04 | |
| Confidence Interval |
(2-Sided) 95% 2.441 to 6.808 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference. | |
| Method | Exact Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 5.22 | |
| Confidence Interval |
(2-Sided) 95% 3.145 to 8.831 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch Numerical Rating Scale (NRS) Score |
|---|---|
| Description | The Itch NRS is a daily participant-reported measure (24-hour recall), using a diary, of the worst level of itch intensity. Participants were asked to rate the itching severity because of their AD in the daily diary by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours. |
| Time Frame | Baseline to Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. Number analyzed included participants in the ITT population with a Baseline Itch NRS score ≥ 4. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 78 | 156 | 161 |
| Number [percentage of participants] |
15.4
12.2%
|
40.4
16%
|
52.2
20.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0002 |
| Comments | The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference. | |
| Method | Exact Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 3.66 | |
| Confidence Interval |
(2-Sided) 95% 1.773 to 8.083 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference. | |
| Method | Exact Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 6.01 | |
| Confidence Interval |
(2-Sided) 95% 2.931 to 13.220 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form - Sleep Disturbance (8b - 24-Hour Recall) Score |
|---|---|
| Description | The PROMIS Short Form - Sleep Disturbance (8b) questionnaire assesses participant's self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance. Each item asks the participant to rate the severity of the participant's sleep disturbance. |
| Time Frame | Baseline to Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. Number analyzed included participants in the ITT population with a Baseline score ≥ 6. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 116 | 233 | 238 |
| Number [percentage of participants] |
9.5
7.5%
|
21.0
8.3%
|
22.3
8.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0081 |
| Comments | The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference. | |
| Method | Exact Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.56 | |
| Confidence Interval |
(2-Sided) 95% 1.242 to 5.723 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0039 |
| Comments | The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference. | |
| Method | Exact Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.74 | |
| Confidence Interval |
(2-Sided) 95% 1.334 to 6.083 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep-Related Impairment (8a - 24-Hour Recall) |
|---|---|
| Description | The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. Each item asks the participant to rate the severity of the participant's sleep impairment. |
| Time Frame | Baseline to Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. Number analyzed included participants in the ITT population with a Baseline score ≥ 6. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 114 | 233 | 245 |
| Number [percentage of participants] |
13.2
10.5%
|
20.2
8%
|
21.6
8.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1421 |
| Comments | The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference. | |
| Method | Exact Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.67 | |
| Confidence Interval |
(2-Sided) 95% 0.862 to 3.391 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0746 |
| Comments | The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference. | |
| Method | Exact Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.82 | |
| Confidence Interval |
(2-Sided) 95% 0.949 to 3.665 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | VC Period: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (SAE) |
|---|---|
| Description | An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or an important medical event may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. A TEAE or treatment emergent SAE is any AE or SAE either reported for first time or worsening of a pre-existing event after first dose of study drug. |
| Time Frame | From first dose up to Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all randomized participants who applied at least 1 application of ruxolitinib cream or vehicle cream. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 126 | 252 | 253 |
| TEAE |
34.9
27.7%
|
29.0
11.5%
|
29.2
11.5%
|
| Treatment Emergent SAE |
1.6
1.3%
|
0.4
0.2%
|
0.8
0.3%
|
| Title | LTS Period: Percentage of Participants With at Least One TEAE and Treatment Emergent SAE |
|---|---|
| Description | An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or an important medical event may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. A TEAE or treatment emergent SAE is any AE or SAE either reported for first time or worsening of a pre-existing event after first dose of study drug. |
| Time Frame | From first dose date in LTS Period (Week 8) until last follow-up visit (up to 52 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. |
| Arm/Group Title | LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID | LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID | LTS Period: Ruxolitinib 0.75% Cream | LTS Period: Ruxolitinib 1.5% Cream |
|---|---|---|---|---|
| Arm/Group Description | Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
| Measure Participants | 48 | 47 | 222 | 225 |
| TEAE |
47.9
38%
|
48.9
19.4%
|
54.5
21.5%
|
53.3
8.4%
|
| Treatment Emergent SAE |
6.3
5%
|
2.1
0.8%
|
2.3
0.9%
|
1.3
0.2%
|
| Title | VC Period: Percentage of Participants Who Achieved an IGA-TS at Weeks 2 and 4 |
|---|---|
| Description | The IGA is an overall eczema severity rating on a 0 (clear skin) to 4 (severe disease) scale. The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥ 2 grade improvement from Baseline. |
| Time Frame | Baseline to Weeks 2 and 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 126 | 252 | 253 |
| Week 2 |
3.2
2.5%
|
22.2
8.8%
|
27.3
10.8%
|
| Week 4 |
6.3
5%
|
42.5
16.9%
|
46.6
18.4%
|
| Title | VC Period: Percentage of Participants Achieving IGA Scores of 0 or 1 |
|---|---|
| Description | The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. IGA score signifies 0 (clear skin) and 1 (almost clear skin). |
| Time Frame | Weeks 2, 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. |
| Measure Participants | 126 | 252 | 253 |
| Week 2 |
6.3
5%
|
32.5
12.9%
|
34.8
13.8%
|
| Week 4 |
15.1
12%
|
53.2
21.1%
|
54.9
21.7%
|
| Week 8 |
23.8
18.9%
|
58.7
23.3%
|
62.8
24.8%
|
| Title | LTS Period: Percentage of Participants Achieving IGA Scores of 0 or 1 |
|---|---|
| Description | The IGA is an overall eczema severity rating on a 0 (clear skin) to 4 (severe disease) scale. The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. IGA score signifies 0 (clear skin) and 1 (almost clear skin). |
| Time Frame | Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID | LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID | LTS Period: Ruxolitinib 0.75% Cream | LTS Period: Ruxolitinib 1.5% Cream |
|---|---|---|---|---|
| Arm/Group Description | Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
| Measure Participants | 48 | 47 | 222 | 225 |
| Week 8 |
18.8
14.9%
|
38.3
15.2%
|
65.3
25.8%
|
68.4
10.8%
|
| Week 12 |
55.6
44.1%
|
65.2
25.9%
|
62.7
24.8%
|
66.5
10.5%
|
| Week 16 |
60.5
48%
|
62.2
24.7%
|
66.5
26.3%
|
68.9
10.9%
|
| Week 20 |
63.6
50.5%
|
67.4
26.7%
|
62.4
24.7%
|
73.5
11.6%
|
| Week 24 |
71.4
56.7%
|
78.6
31.2%
|
67.0
26.5%
|
76.7
12.2%
|
| Week 28 |
64.9
51.5%
|
74.4
29.5%
|
67.3
26.6%
|
77.3
12.3%
|
| Week 32 |
77.1
61.2%
|
81.4
32.3%
|
71.5
28.3%
|
75.9
12%
|
| Week 36 |
73.5
58.3%
|
82.1
32.6%
|
74.5
29.4%
|
71.7
11.4%
|
| Week 40 |
81.3
64.5%
|
79.5
31.5%
|
73.5
29.1%
|
75.5
12%
|
| Week 44 |
84.8
67.3%
|
86.5
34.3%
|
74.3
29.4%
|
76.2
12.1%
|
| Week 48 |
72.2
57.3%
|
76.3
30.3%
|
74.3
29.4%
|
73.8
11.7%
|
| Week 52 |
76.3
60.6%
|
73.7
29.2%
|
76.9
30.4%
|
75.4
11.9%
|
| Title | VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch NRS Score From Baseline to Weeks 2 and 4 |
|---|---|
| Description | The Itch NRS is a daily participant-reported measure (24-hour recall), using a diary, of the worst level of itch intensity. Participants are asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. |
| Time Frame | Baseline to Weeks 2 and 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. Number analyzed includes participants in the ITT population with a Baseline Itch NRS score ≥ 4. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 78 | 156 | 161 |
| Week 2 |
5.1
4%
|
26.3
10.4%
|
33.5
13.2%
|
| Week 4 |
11.5
9.1%
|
38.5
15.3%
|
51.6
20.4%
|
| Title | VC Period: Percentage of Participants Achieving EASI50 |
|---|---|
| Description | EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI50 responder was defined as a participant achieving 50% or greater improvement from Baseline in EASI score. |
| Time Frame | Weeks 2, 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 126 | 252 | 253 |
| Week 2 |
19.8
15.7%
|
53.2
21.1%
|
62.5
24.7%
|
| Week 4 |
27.8
22.1%
|
68.7
27.3%
|
75.5
29.8%
|
| Week 8 |
43.7
34.7%
|
69.4
27.5%
|
77.9
30.8%
|
| Title | VC Period: Percentage of Participants Achieving EASI75 |
|---|---|
| Description | EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score. |
| Time Frame | Weeks 2 and 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 126 | 252 | 253 |
| Week 2 |
5.6
4.4%
|
30.2
12%
|
36.0
14.2%
|
| Week 4 |
14.3
11.3%
|
51.6
20.5%
|
58.5
23.1%
|
| Title | VC Period: Percentage of Participants Achieving EASI90 |
|---|---|
| Description | EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI90 responder was defined as a participant achieving 90% or greater improvement from Baseline in EASI score. |
| Time Frame | Weeks 2, 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 126 | 252 | 253 |
| Week 2 |
2.4
1.9%
|
12.7
5%
|
19.8
7.8%
|
| Week 4 |
4.0
3.2%
|
30.6
12.1%
|
36.4
14.4%
|
| Week 8 |
9.5
7.5%
|
38.1
15.1%
|
44.3
17.5%
|
| Title | VC Period: Percent Change From Baseline in EASI Score |
|---|---|
| Description | EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. A negative change from Baseline indicates improvement. |
| Time Frame | Baseline, Weeks 2, 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 126 | 252 | 253 |
| Percent Change From Baseline at Week 2 |
-16.34
(3.42)
|
-51.82
(2.36)
|
-56.62
(2.35)
|
| Percent Change From Baseline at Week 4 |
-23.03
(3.90)
|
-68.04
(2.66)
|
-71.08
(2.64)
|
| Percent Change From Baseline at Week 8 |
-37.88
(3.72)
|
-71.01
(2.52)
|
-77.40
(2.49)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Percent change from Baseline in EASI score at Week 2 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -35.48 | |
| Confidence Interval |
(2-Sided) 95% -43.64 to -27.32 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.16 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Percent change from Baseline in EASI score at Week 2 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Method of Mean Difference] |
| Estimated Value | -40.29 | |
| Confidence Interval |
(2-Sided) 95% -48.44 to -32.13 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.15 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Percent change from Baseline in EASI score at Week 4 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -45.01 | |
| Confidence Interval |
(2-Sided) 95% -54.28 to -35.74 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.72 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Percent change from Baseline in EASI score at Week 4 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -48.05 | |
| Confidence Interval |
(2-Sided) 95% -57.30 to -38.79 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.71 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Percent change from Baseline in EASI score at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method | Mixed-Model with Repeated Measures | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -33.13 | |
| Confidence Interval |
(2-Sided) 95% -41.95 to -24.30 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.49 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Percent change from Baseline in EASI score at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -39.52 | |
| Confidence Interval |
(2-Sided) 95% -48.32 to -30.72 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.48 |
|
| Estimation Comments | ||
| Title | VC Period: Percent Change From Baseline In SCORing Atopic Dermatitis (SCORAD) Score |
|---|---|
| Description | The SCORAD is a tool to assess extent and severity of eczema. To determine the extent, the rule of nines or handprint method is used to assess eczema affected area (A). To determine disease severity (B) it evaluates 6 clinical characteristics: 1. redness, 2. swelling, 3. oozing/crusting, 4. scratch marks, 5. lichenification, and 6. dryness on a 4-point scale of 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), added to give B with maximum score of 18. Subjective symptoms (C) of itch and sleeplessness are assessed using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), added to give C with maximum score of 20. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combined using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. A negative change from Baseline indicates improvement. |
| Time Frame | Baseline, Weeks 2, 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 126 | 252 | 253 |
| Percent Change From Baseline at Week 2 |
-16.67
(34.152)
|
-43.96
(28.548)
|
-49.32
(31.878)
|
| Percent Change From Baseline at Week 4 |
-27.68
(34.518)
|
-57.80
(28.635)
|
-61.33
(30.113)
|
| Percent Change From Baseline at Week 8 |
-37.00
(36.392)
|
-62.14
(31.108)
|
-67.24
(28.711)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Percent change from Baseline in SCORAD score at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -25.3 | |
| Confidence Interval |
(2-Sided) 95% -32.62 to -17.95 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.74 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Percent change from Baseline in SCORAD score at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -30.4 | |
| Confidence Interval |
(2-Sided) 95% -37.68 to -23.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.72 |
|
| Estimation Comments | ||
| Title | VC Period: Change From Baseline in Itch NRS Score |
|---|---|
| Description | The Itch NRS is a daily participant-reported measure (24-hour recall), using a diary, of the worst level of itch intensity. Participants are asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. A negative change from Baseline indicates improvement. |
| Time Frame | Baseline, Weeks 2, 4, and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 126 | 252 | 253 |
| Change From Baseline at Week 2 |
-0.89
(0.20)
|
-2.28
(0.14)
|
-2.53
(0.13)
|
| Change From Baseline at Week 4 |
-1.08
(0.23)
|
-2.79
(0.16)
|
-3.16
(0.15)
|
| Change From Baseline at Week 8 |
-1.54
(0.25)
|
-3.14
(0.17)
|
-3.53
(0.16)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Change from Baseline in Itch NRS score at Week 2 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -1.39 | |
| Confidence Interval |
(2-Sided) 95% -1.87 to -0.91 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.24 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Change from Baseline in Itch NRS score at Week 2 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -1.64 | |
| Confidence Interval |
(2-Sided) 95% -2.11 to -1.16 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.24 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Change from Baseline in Itch NRS score at Week 4 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -1.70 | |
| Confidence Interval |
(2-Sided) 95% -2.25 to -1.15 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Change from Baseline in Itch NRS score at Week 4 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -2.08 | |
| Confidence Interval |
(2-Sided) 95% -2.63 to -1.53 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Change from Baseline in Itch NRS score at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -1.60 | |
| Confidence Interval |
(2-Sided) 95% -2.20 to -1.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.30 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Change from Baseline in Itch NRS score at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -1.99 | |
| Confidence Interval |
(2-Sided) 95% -2.58 to -1.40 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.30 |
|
| Estimation Comments | ||
| Title | VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2, 3, or 4 Points |
|---|---|
| Description | The Itch NRS is a daily participant-reported measure (24-hour recall), using a diary, of the worst level of itch intensity. Participants were asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. Kaplan-Meier estimation method was used for analyses. |
| Time Frame | Up to Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. Number analyzed included participants in the ITT population with a Baseline Itch NRS score ≥ 2, ≥ 3 or ≥ 4 and a daily Itch NRS assessment during the VC Period. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 126 | 252 | 253 |
| ≥ 2-Point Improvement in Itch NRS Score |
15.0
|
4.0
|
3.0
|
| ≥ 3-Point Improvement in Itch NRS Score |
27.0
|
8.0
|
6.0
|
| ≥ 4-Point Improvement in Itch NRS Score |
NA
|
14.0
|
13.0
|
| Title | VC Period: Change From Baseline in Skin Pain NRS Score |
|---|---|
| Description | The Skin Pain NRS is a daily patient-reported measure (24-hour recall), using a diary, of the worst level of pain intensity from 0 (no pain) to 10 (worst imaginable pain). Participants will be asked, "Rate the pain severity from your atopic dermatitis skin changes by selecting a number that best describes your worst level of pain in the past 24 hours." A negative change from Baseline indicates improvement. |
| Time Frame | Baseline, Weeks 2, 4, and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 126 | 252 | 253 |
| Change From Baseline at Week 2 |
-0.70
(1.746)
|
-1.90
(1.950)
|
-2.07
(2.164)
|
| Change From Baseline at Week 4 |
-0.84
(2.307)
|
-2.36
(2.217)
|
-2.72
(2.513)
|
| Change From Baseline at Week 8 |
-1.16
(2.610)
|
-2.55
(2.360)
|
-2.84
(2.743)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Change from Baseline in Skin Pain NRS score at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -1.2 | |
| Confidence Interval |
(2-Sided) 95% -1.74 to -0.74 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.25 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Change from Baseline in Skin Pain NRS score at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -1.6 | |
| Confidence Interval |
(2-Sided) 95% -2.11 to -1.13 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.25 |
|
| Estimation Comments | ||
| Title | VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score |
|---|---|
| Description | The PROMIS Short Form - Sleep Disturbance (8b) questionnaire assesses participant's self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This questionnaire is completed in the morning by the participant where each item asks the participant to rate the severity of the participant's sleep disturbance. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance. |
| Time Frame | Weeks 2 and 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. Number analyzed included participants in the ITT population with a Baseline score ≥ 6. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 116 | 233 | 238 |
| Week 2 |
5.2
4.1%
|
13.7
5.4%
|
14.7
5.8%
|
| Week 4 |
6.9
5.5%
|
19.3
7.7%
|
21.0
8.3%
|
| Title | VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score |
|---|---|
| Description | The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. |
| Time Frame | Weeks 2 and 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. Number analyzed included participants in the ITT population with a Baseline score ≥ 6. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 114 | 233 | 245 |
| Week 2 |
8.8
7%
|
16.3
6.5%
|
13.5
5.3%
|
| Week 4 |
13.2
10.5%
|
20.6
8.2%
|
19.2
7.6%
|
| Title | VC Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score |
|---|---|
| Description | The PROMIS Short Form - Sleep Disturbance (8b) questionnaire assesses participant's self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This questionnaire is completed in the morning by the participant where each item asks the participant to rate the severity of the participant's sleep disturbance. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance. A negative change from Baseline indicates improvement. |
| Time Frame | Baseline, Weeks 2, 4, and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 126 | 252 | 253 |
| Change From Baseline at Week 2 |
-0.18
(0.45)
|
-1.72
(0.31)
|
-2.49
(0.30)
|
| Change From Baseline at Week 4 |
-0.25
(0.50)
|
-2.58
(0.34)
|
-3.10
(0.33)
|
| Change From Baseline at Week 8 |
-0.43
(0.59)
|
-2.97
(0.39)
|
-3.62
(0.39)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0049 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -1.53 | |
| Confidence Interval |
(2-Sided) 95% -2.60 to -0.47 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.54 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -2.31 | |
| Confidence Interval |
(2-Sided) 95% -3.37 to -1.25 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.54 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -2.33 | |
| Confidence Interval |
(2-Sided) 95% -3.52 to -1.15 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.60 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -2.85 | |
| Confidence Interval |
(2-Sided) 95% -4.03 to -1.67 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.60 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0004 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -2.54 | |
| Confidence Interval |
(2-Sided) 95% -3.93 to -1.14 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.71 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -3.18 | |
| Confidence Interval |
(2-Sided) 95% -4.57 to -1.79 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.71 |
|
| Estimation Comments | ||
| Title | VC Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score |
|---|---|
| Description | The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. A negative change from Baseline indicates improvement. |
| Time Frame | Baseline, Weeks 2, 4, and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 126 | 252 | 253 |
| Change From Baseline at Week 2 |
-0.58
(0.49)
|
-1.76
(0.33)
|
-2.25
(0.33)
|
| Change From Baseline at Week 4 |
-1.06
(0.55)
|
-2.71
(0.37)
|
-2.97
(0.36)
|
| Change From Baseline at Week 8 |
-1.22
(0.62)
|
-3.34
(0.41)
|
-3.52
(0.40)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0487 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -1.18 | |
| Confidence Interval |
(2-Sided) 95% -2.35 to -0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.60 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0049 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -1.68 | |
| Confidence Interval |
(2-Sided) 95% -2.84 to -0.51 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.59 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0128 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -1.64 | |
| Confidence Interval |
(2-Sided) 95% -2.94 to -0.35 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.66 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0037 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -1.91 | |
| Confidence Interval |
(2-Sided) 95% -3.20 to -0.62 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.66 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0048 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -2.11 | |
| Confidence Interval |
(2-Sided) 95% -3.58 to -0.65 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.75 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0020 |
| Comments | ||
| Method | Mixed-Model with Repeated Measures | |
| Comments | The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -2.30 | |
| Confidence Interval |
(2-Sided) 95% -3.75 to -0.84 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.74 |
|
| Estimation Comments | ||
| Title | LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score |
|---|---|
| Description | The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. A negative change from Baseline indicates improvement. |
| Time Frame | Baseline, Weeks 12, 24, and 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID | LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID | LTS Period: Ruxolitinib 0.75% Cream | LTS Period: Ruxolitinib 1.5% Cream |
|---|---|---|---|---|
| Arm/Group Description | Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
| Measure Participants | 48 | 47 | 222 | 225 |
| Change From Baseline at Week 12 |
-1.51
(4.739)
|
-2.22
(7.305)
|
-0.39
(3.984)
|
-0.39
(3.907)
|
| Change From Baseline at Week 24 |
-0.54
(5.211)
|
-2.66
(7.268)
|
0.11
(4.929)
|
0.02
(5.584)
|
| Change From Baseline at Week 52 |
-0.97
(5.085)
|
-2.81
(7.005)
|
-0.37
(5.775)
|
-0.54
(5.511)
|
| Title | LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score |
|---|---|
| Description | The PROMIS Short Form - Sleep Disturbance (8b) questionnaire assesses participant's self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This questionnaire is completed in the morning by the participant where each item asks the participant to rate the severity of the participant's sleep disturbance. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance. A negative change from Baseline indicates improvement. |
| Time Frame | Baseline, Weeks 12, 24, and 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID | LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID | LTS Period: Ruxolitinib 0.75% Cream | LTS Period: Ruxolitinib 1.5% Cream |
|---|---|---|---|---|
| Arm/Group Description | Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
| Measure Participants | 48 | 47 | 222 | 225 |
| Change From Baseline at Week 12 |
-1.93
(5.284)
|
-2.67
(7.160)
|
-0.67
(4.575)
|
-0.66
(3.865)
|
| Change From Baseline at Week 24 |
-1.22
(5.681)
|
-3.15
(8.242)
|
0.02
(5.536)
|
0.51
(5.563)
|
| Change From Baseline at Week 52 |
-1.95
(4.876)
|
-3.31
(7.082)
|
-0.27
(6.506)
|
-0.07
(5.918)
|
| Title | VC Period: Change From Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA) |
|---|---|
| Description | Body surface area affected by AD was assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region was assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage was reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Used the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1*BSA head and neck + 0.3*BSA trunk + 0.2* BSA upper limbs + 0.4*BSA lower limbs. A negative change from Baseline indicates improvement. |
| Time Frame | Baseline, Weeks 2, 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 126 | 252 | 253 |
| Change From Baseline at Week 2 |
-0.43
(5.559)
|
-3.69
(4.230)
|
-3.76
(4.238)
|
| Change From Baseline at Week 4 |
-1.56
(4.088)
|
-5.29
(4.969)
|
-5.25
(5.190)
|
| Change From Baseline at Week 8 |
-2.51
(4.722)
|
-6.30
(5.378)
|
-6.54
(4.967)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Change from Baseline in %BSA at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -3.1 | |
| Confidence Interval |
(2-Sided) 95% -4.07 to -2.18 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.48 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Change from Baseline in %BSA at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -3.7 | |
| Confidence Interval |
(2-Sided) 95% -4.67 to -2.79 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.48 |
|
| Estimation Comments | ||
| Title | LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA |
|---|---|
| Description | Body surface area affected by AD was assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region was assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage was reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Used the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1*BSA head and neck + 0.3*BSA trunk + 0.2* BSA upper limbs + 0.4*BSA lower limbs. A negative change from Baseline indicates improvement. |
| Time Frame | Baseline, Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID | LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID | LTS Period: Ruxolitinib 0.75% Cream | LTS Period: Ruxolitinib 1.5% Cream |
|---|---|---|---|---|
| Arm/Group Description | Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
| Measure Participants | 48 | 47 | 222 | 225 |
| Change From Baseline at Week 12 |
-4.23
(4.849)
|
-2.84
(4.907)
|
-6.84
(4.852)
|
-6.96
(4.989)
|
| Change From Baseline at Week 16 |
-4.96
(5.194)
|
-2.98
(5.429)
|
-7.36
(4.875)
|
-7.26
(5.080)
|
| Change From Baseline at Week 20 |
-4.78
(5.095)
|
-3.75
(5.321)
|
-7.69
(4.901)
|
-7.49
(5.012)
|
| Change From Baseline at Week 24 |
-5.32
(4.964)
|
-3.85
(5.223)
|
-7.64
(4.998)
|
-7.64
(4.737)
|
| Change From Baseline at Week 28 |
-4.56
(5.486)
|
-4.43
(4.995)
|
-7.66
(5.029)
|
-7.62
(4.913)
|
| Change From Baseline at Week 32 |
-5.17
(4.472)
|
-4.53
(5.399)
|
-7.80
(5.011)
|
-7.61
(5.261)
|
| Change From Baseline at Week 36 |
-5.21
(4.972)
|
-4.39
(5.509)
|
-8.18
(5.111)
|
-7.97
(5.010)
|
| Change From Baseline at Week 40 |
-4.67
(5.519)
|
-4.75
(5.337)
|
-8.07
(4.899)
|
-8.11
(4.997)
|
| Change From Baseline at Week 44 |
-5.28
(5.173)
|
-4.56
(5.609)
|
-8.14
(4.789)
|
-8.02
(4.939)
|
| Change From Baseline at Week 48 |
-5.65
(5.128)
|
-4.58
(5.696)
|
-8.39
(5.023)
|
-7.96
(4.993)
|
| Change From Baseline at Week 52 |
-5.72
(5.481)
|
-4.93
(5.771)
|
-8.58
(5.013)
|
-8.14
(4.906)
|
| Title | VC Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score |
|---|---|
| Description | The POEM is a 7-question quality-of-life assessment that asks how many days the participant has been bothered by various aspects of their skin condition during the past 7 days. It assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (clear or almost clear) to 28 (very severe eczema). High scores are indicative of more severe disease and poor quality of life. A negative change from Baseline indicates improvement. |
| Time Frame | Baseline, Weeks 2, 4, and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 126 | 252 | 253 |
| Change From Baseline at Week 2 |
-2.25
(5.779)
|
-9.47
(7.212)
|
-10.60
(6.670)
|
| Change From Baseline at Week 4 |
-3.38
(6.685)
|
-10.12
(7.380)
|
-11.53
(6.891)
|
| Change From Baseline at Week 8 |
-4.30
(7.044)
|
-10.60
(7.262)
|
-11.82
(6.931)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Change from Baseline in POEM score at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -5.1 | |
| Confidence Interval |
(2-Sided) 95% -6.43 to -3.80 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.67 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Change from Baseline in POEM score at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -6.3 | |
| Confidence Interval |
(2-Sided) 95% -7.62 to -5.00 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.67 |
|
| Estimation Comments | ||
| Title | LTS Period: Change From Baseline in POEM Score |
|---|---|
| Description | The POEM is a 7-question quality-of-life assessment that asks how many days the participant has been bothered by various aspects of their skin condition during the past 7 days. It assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life. A negative change from Baseline indicates improvement. |
| Time Frame | Baseline, Weeks 12, 24, and 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID | LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID | LTS Period: Ruxolitinib 0.75% Cream | LTS Period: Ruxolitinib 1.5% Cream |
|---|---|---|---|---|
| Arm/Group Description | Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
| Measure Participants | 48 | 47 | 222 | 225 |
| Change From Baseline at Week 12 |
-5.95
(6.607)
|
-6.89
(9.730)
|
-10.74
(6.653)
|
-11.38
(6.710)
|
| Change From Baseline at Week 24 |
-4.46
(6.185)
|
-7.26
(9.189)
|
-10.46
(6.655)
|
-11.44
(6.689)
|
| Change From Baseline at Week 52 |
-4.61
(6.868)
|
-7.00
(8.752)
|
-10.51
(7.396)
|
-10.61
(7.057)
|
| Title | VC Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Score |
|---|---|
| Description | The DLQI is a simple, 10 question (Q) validated quality-of-life questionnaire to measure how much the skin problem has affected the participant. It covers 6 domains including symptoms and feelings (Q1 and Q2), daily activities (Q3 and Q4), leisure (Q5 and Q6), work and school (Q7), personal relationships (Q8 and Q9), and treatment(Q10). The recall Period of this scale is over the last week. Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. Scores range from 0 ("no impact on participant's life") to 30 ("extremely large effect on participant's life"), and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant's life. |
| Time Frame | Baseline, Weeks 2, 4, and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. Participants in the ITT population with age >= 16 were included. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 107 | 215 | 223 |
| Change From Baseline at Week 2 |
-1.54
(4.618)
|
-6.18
(5.740)
|
-6.90
(5.980)
|
| Change From Baseline at Week 4 |
-2.50
(6.101)
|
-6.88
(5.867)
|
-7.15
(6.565)
|
| Change From Baseline at Week 8 |
-2.83
(6.722)
|
-7.28
(5.907)
|
-7.72
(6.152)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Change from Baseline in total DLQI score at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -3.8 | |
| Confidence Interval |
(2-Sided) 95% -4.85 to -2.68 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.55 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Change from Baseline in total DLQI score at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -4.5 | |
| Confidence Interval |
(2-Sided) 95% -5.56 to -3.42 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.55 |
|
| Estimation Comments | ||
| Title | LTS Period: Change From Baseline in DLQI Score |
|---|---|
| Description | The DLQI is a simple, 10 question (Q) validated quality-of-life questionnaire to measure how much the skin problem has affected the participant. It covers 6 domains including symptoms and feelings (Q1 and Q2), daily activities (Q3 and Q4), leisure (Q5 and Q6), work and school (Q7), personal relationships (Q8 and Q9), and treatment(Q10). The recall Period of this scale is over the last week. Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. Scores range from 0 ("no impact on participant's life") to 30 ("extremely large effect on participant's life"), and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant's life. |
| Time Frame | Baseline, Weeks 12, 24, and 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Participants in the LTS evaluable population with age >= 16 were included. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID | LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID | LTS Period: Ruxolitinib 0.75% Cream | LTS Period: Ruxolitinib 1.5% Cream |
|---|---|---|---|---|
| Arm/Group Description | Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
| Measure Participants | 40 | 38 | 189 | 200 |
| Change From Baseline at Week 12 |
-3.65
(5.602)
|
-4.53
(6.246)
|
-7.67
(5.855)
|
-7.79
(6.240)
|
| Change From Baseline at Week 24 |
-3.21
(4.814)
|
-5.32
(6.304)
|
-7.87
(6.080)
|
-7.75
(6.277)
|
| Change From Baseline at Week 52 |
-3.35
(5.438)
|
-4.81
(6.720)
|
-7.95
(6.589)
|
-7.70
(6.443)
|
| Title | VC Period: Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score |
|---|---|
| Description | CDLQI is the youth/children's version of the DLQI. The CDLQI is a simple 10 question (Q) validated quality-of-life questionnaire. It covers 6 domains including symptoms and feelings (Q1 and Q2), leisure (Q4, Q5, and Q6), school or holidays (Q7), personal relationships (Q3 and Q8), sleep (Q9) and treatment (Q10). Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. The total DLQI score is calculated by adding the score of each question resulting in a maximum score of 30 (extremely large effect on participant's life) and a minimum score of 0 (no impact on participant's life) and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant's life. |
| Time Frame | Baseline, Weeks 2, 4, and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. Participants in the ITT population with age < 16 were included. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 19 | 37 | 30 |
| Change From Baseline at Week 2 |
-1.06
(3.733)
|
-5.06
(6.937)
|
-6.76
(6.306)
|
| Change From Baseline at Week 4 |
-2.47
(6.530)
|
-4.35
(8.683)
|
-6.90
(5.101)
|
| Change From Baseline at Week 8 |
-2.31
(5.618)
|
-5.88
(7.524)
|
-7.61
(6.142)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Change from Baseline in total CDLQI score at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0018 |
| Comments | ||
| Method | ANCOVA | |
| Comments | P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -3.3 | |
| Confidence Interval |
(2-Sided) 95% -5.29 to -1.26 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.01 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Change from Baseline in total CDLQI score at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0378 |
| Comments | ||
| Method | ANCOVA | |
| Comments | P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -2.3 | |
| Confidence Interval |
(2-Sided) 95% -4.43 to -0.13 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.08 |
|
| Estimation Comments | ||
| Title | LTS Period: Change From Baseline in CDLQI Score |
|---|---|
| Description | CDLQI is the youth/children's version of the DLQI. The CDLQI is a simple 10 question (Q) validated quality-of-life questionnaire. It covers 6 domains including symptoms and feelings (Q1 and Q2), leisure (Q4, Q5, and Q6), school or holidays (Q7), personal relationships (Q3 and Q8), sleep (Q9) and treatment (Q10). Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. The total DLQI score is calculated by adding the score of each question resulting in a maximum score of 30 (extremely large effect on participant's life) and a minimum score of 0 (no impact on participant's life) and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant's life. |
| Time Frame | Baseline, Weeks 12, 24, and 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Participants in the LTS evaluable population with age < 16 were included. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID | LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID | LTS Period: Ruxolitinib 0.75% Cream | LTS Period: Ruxolitinib 1.5% Cream |
|---|---|---|---|---|
| Arm/Group Description | Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
| Measure Participants | 8 | 9 | 33 | 25 |
| Change From Baseline at Week 12 |
-4.00
(5.477)
|
-1.13
(8.097)
|
-5.83
(7.661)
|
-8.86
(5.532)
|
| Change From Baseline at Week 24 |
-2.71
(5.155)
|
-2.00
(3.780)
|
-6.72
(7.640)
|
-9.42
(7.214)
|
| Change From Baseline at Week 52 |
-4.33
(8.359)
|
-0.43
(4.928)
|
-6.70
(7.766)
|
-9.71
(6.262)
|
| Title | VC Period: Mean Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, and 8 |
|---|---|
| Description | The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. It is a 7-point scale where participants rate the questions as: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The lower score indicates improvement. |
| Time Frame | Weeks 2, 4, and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 126 | 252 | 253 |
| Week 2 |
3.53
(1.500)
|
2.06
(0.937)
|
1.94
(0.911)
|
| Week 4 |
3.30
(1.434)
|
1.78
(0.903)
|
1.68
(0.843)
|
| Week 8 |
3.08
(1.489)
|
1.76
(0.913)
|
1.61
(0.914)
|
| Title | VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8 |
|---|---|
| Description | The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. It is a 7-point scale where participants rate the questions as: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The lower score indicates improvement. |
| Time Frame | Weeks 2, 4, and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 126 | 252 | 253 |
| Week 2 - Very Much Improved: 1 |
5.3
4.2%
|
31.4
12.5%
|
36.7
14.5%
|
| Week 2 - Much Improved: 2 |
18.6
14.8%
|
38.6
15.3%
|
40.1
15.8%
|
| Week 2 - Minimally Improved: 3 |
37.2
29.5%
|
25.0
9.9%
|
16.9
6.7%
|
| Week 2 - No Change: 4 |
13.3
10.6%
|
4.2
1.7%
|
5.5
2.2%
|
| Week 2 - Minimally Worse: 5 |
11.5
9.1%
|
0.4
0.2%
|
0.8
0.3%
|
| Week 2 - Much Worse: 6 |
10.6
8.4%
|
0.0
0%
|
0.0
0%
|
| Week 2 - Very Much Worse: 7 |
3.5
2.8%
|
0.4
0.2%
|
0.0
0%
|
| Week 4 - Very Much Improved: 1 |
6.7
5.3%
|
48.5
19.2%
|
51.7
20.4%
|
| Week 4 - Much Improved: 2 |
22.9
18.2%
|
29.5
11.7%
|
32.1
12.7%
|
| Week 4 - Minimally Improved: 3 |
38.1
30.2%
|
18.1
7.2%
|
13.3
5.3%
|
| Week 4 - No Change: 4 |
11.4
9%
|
3.0
1.2%
|
2.1
0.8%
|
| Week 4 - Minimally Worse: 5 |
11.4
9%
|
0.8
0.3%
|
0.8
0.3%
|
| Week 4 - Much Worse: 6 |
6.7
5.3%
|
0.0
0%
|
0.0
0%
|
| Week 4 - Very Much Worse: 7 |
2.9
2.3%
|
0.0
0%
|
0.0
0%
|
| Week 8 - Very Much Improved: 1 |
11.0
8.7%
|
48.4
19.2%
|
59.8
23.6%
|
| Week 8 - Much Improved: 2 |
30.0
23.8%
|
33.2
13.2%
|
25.8
10.2%
|
| Week 8 - Minimally Improved: 3 |
29.0
23%
|
14.8
5.9%
|
10.0
4%
|
| Week 8 - No Change: 4 |
12.0
9.5%
|
1.3
0.5%
|
2.2
0.9%
|
| Week 8 - Minimally Worse: 5 |
7.0
5.6%
|
2.2
0.9%
|
2.2
0.9%
|
| Week 8 - Much Worse: 6 |
10.0
7.9%
|
0.0
0%
|
0.0
0%
|
| Week 8 - Very Much Worse: 7 |
1.0
0.8%
|
0.0
0%
|
0.0
0%
|
| Title | VC Period: Percentage of Participants With a Score of Either 1 or 2 on the PGIC at Weeks 2, 4, and 8 |
|---|---|
| Description | The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. It is a 7-point scale where participants rate the questions as: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The lower score indicates improvement. |
| Time Frame | Weeks 2, 4, and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 126 | 252 | 253 |
| Week 2 |
23.9
19%
|
69.9
27.7%
|
76.8
30.4%
|
| Week 4 |
29.5
23.4%
|
78.1
31%
|
83.8
33.1%
|
| Week 8 |
41.0
32.5%
|
81.6
32.4%
|
85.6
33.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference. | |
| Method | Exact Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 6.28 | |
| Confidence Interval |
(2-Sided) 95% 3.632 to 11.018 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference. | |
| Method | Exact Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 8.39 | |
| Confidence Interval |
(2-Sided) 95% 4.755 to 15.083 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | VC Period: Change From Baseline in EuroQuality of Life Five Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) Score |
|---|---|
| Description | EQ-5D-5L questionnaire has 2 parts: EQ-5D-5L descriptive system & EQ-VAS. EQ-5D is a validated, self-administered, generic utility questionnaire wherein participants rate their current health state based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. 5L indicates that for each dimension, there are 5 levels:1=no problems,2=slight problems,3=moderate problems,4=severe problems, and 5=extreme problems. EQ-5D-5L score is assessed using VAS that ranges from 0 to 100 millimetres (mm), where 0 indicates "worst health you can imagine" and 100 indicates "best health you can imagine". The participant was asked to indicate his/her health state over past 7 days in each of the 5 dimensions. Digits for the 5 dimensions can be combined into a 5-digit number that describes the participant's health state. In the EQ-VAS, participants had to record their health state on a scale ranging from 0 to 100. A positive change from Baseline indicates improvement. |
| Time Frame | Baseline, Weeks 2, 4, and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 126 | 252 | 253 |
| Change From Baseline at Week 2 |
-0.94
(14.046)
|
6.93
(17.690)
|
8.21
(15.770)
|
| Change From Baseline at Week 4 |
1.76
(11.618)
|
8.73
(17.494)
|
7.10
(16.697)
|
| Change From Baseline at Week 8 |
1.74
(14.376)
|
9.12
(17.871)
|
7.98
(16.813)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Change from Baseline in EQ VAS score at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0037 |
| Comments | ||
| Method | ANCOVA | |
| Comments | P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 4.9 | |
| Confidence Interval |
(2-Sided) 95% 1.59 to 8.15 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.67 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Change from Baseline in EQ VAS score at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0006 |
| Comments | ||
| Method | ANCOVA | |
| Comments | P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 5.7 | |
| Confidence Interval |
(2-Sided) 95% 2.45 to 8.96 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.66 |
|
| Estimation Comments | ||
| Title | VC Period: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Version 2.0 (v2.0) |
|---|---|
| Description | The WPAI-SHP is a 6-item participant questionnaire developed to measure the effect of overall health and specific symptoms on productivity at work and regular activities outside of it in the past 7 days. The WPAI-SHP consists of 6 questions as follows: 1=currently employed; 2=hours missed due to AD; 3=hours missed other reasons; 4=hours actually worked; 5=degree AD affected productivity while working; 6=degree AD affected regular activities and the computed percentage, range for each sub scale is from 0 to 100, with higher values indicating greater impairment and less productivity. A negative change from Baseline indicates improvement. |
| Time Frame | Baseline, Weeks 2, 4, and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who were randomized to the study. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | VC Period: Vehicle Cream BID | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 126 | 252 | 253 |
| Percent Work Time Missed Due to AD: Change From Baseline at Week 2 |
4.45
(19.542)
|
-3.89
(24.223)
|
1.19
(14.954)
|
| Percent Work Time Missed Due to AD: Change From Baseline at Week 4 |
14.09
(30.660)
|
1.22
(23.898)
|
3.43
(17.242)
|
| Percent Work Time Missed Due to AD: Change From Baseline at Week 8 |
5.07
(23.253)
|
-0.26
(23.891)
|
6.23
(22.211)
|
| Percent Impairment While Working Due to AD: Change From Baseline at Week 2 |
-7.36
(22.630)
|
-15.00
(22.494)
|
-16.75
(20.951)
|
| Percent Impairment While Working Due to AD: Change From Baseline at Week 4 |
-9.56
(25.580)
|
-16.86
(22.417)
|
-19.43
(20.933)
|
| Percent Impairment While Working Due to AD: Change From Baseline at Week 8 |
-13.54
(28.019)
|
-19.43
(24.878)
|
-21.61
(22.071)
|
| Percent Overall Work Impairment Due to AD: Change From Baseline at Week 2 |
-5.27
(21.539)
|
-15.04
(27.812)
|
-15.49
(23.785)
|
| Percent Overall Work Impairment Due to AD: Change From Baseline at Week 4 |
-2.35
(27.602)
|
-13.82
(26.207)
|
-15.82
(25.545)
|
| Percent Overall Work Impairment Due to AD: Change From Baseline at Week 8 |
-9.01
(31.735)
|
-18.09
(27.718)
|
-15.54
(27.119)
|
| Percent Activity Impairment Due to AD: Change From Baseline at Week 2 |
-6.32
(23.434)
|
-16.58
(24.696)
|
-21.56
(24.695)
|
| Percent Activity Impairment Due to AD: Change From Baseline at Week 4 |
-10.09
(26.349)
|
-20.80
(24.107)
|
-23.53
(25.422)
|
| Percent Activity Impairment Due to AD: Change From Baseline at Week 8 |
-11.70
(28.992)
|
-21.30
(24.653)
|
-24.06
(26.682)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1417 |
| Comments | ||
| Method | ANCOVA | |
| Comments | P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -4.9 | |
| Confidence Interval |
(2-Sided) 95% -11.49 to 1.65 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.34 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6037 |
| Comments | ||
| Method | ANCOVA | |
| Comments | P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -1.7 | |
| Confidence Interval |
(2-Sided) 95% -8.19 to 4.77 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.29 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0003 |
| Comments | ||
| Method | ANCOVA | |
| Comments | P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -11.0 | |
| Confidence Interval |
(2-Sided) 95% -16.89 to -5.12 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.99 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -12.2 | |
| Confidence Interval |
(2-Sided) 95% -17.98 to -6.47 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.93 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -15.4 | |
| Confidence Interval |
(2-Sided) 95% -22.95 to -7.81 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.85 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0011 |
| Comments | ||
| Method | ANCOVA | |
| Comments | P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -12.4 | |
| Confidence Interval |
(2-Sided) 95% -19.85 to -5.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.77 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 0.75% Cream BID |
|---|---|---|
| Comments | Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -10.5 | |
| Confidence Interval |
(2-Sided) 95% -14.64 to -6.29 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.13 |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | VC Period: Vehicle Cream BID, VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Comments | Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -12.4 | |
| Confidence Interval |
(2-Sided) 95% -16.60 to -8.29 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.12 |
|
| Estimation Comments | ||
| Title | LTS Period: Change From Baseline in WPAI-SHP v2.0 |
|---|---|
| Description | The WPAI-SHP is a 6-item participant questionnaire developed to measure the effect of overall health and specific symptoms on productivity at work and regular activities outside of it in the past 7 days. The WPAI-SHP consists of 6 questions as follows: 1=currently employed; 2=hours missed due to AD; 3=hours missed other reasons; 4=hours actually worked; 5=degree AD affected productivity while working; 6=degree AD affected regular activities and the computed percentage, range for each sub scale is from 0 to 100, with higher values indicating greater impairment and less productivity. A negative change from Baseline indicates improvement. |
| Time Frame | Baseline, Weeks 12, 24, 36, and 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Number analyzed is the number of participants with data available for analyses at the specified time point. |
| Arm/Group Title | LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID | LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID | LTS Period: Ruxolitinib 0.75% Cream | LTS Period: Ruxolitinib 1.5% Cream |
|---|---|---|---|---|
| Arm/Group Description | Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
| Measure Participants | 48 | 47 | 222 | 225 |
| Percent Work Time Missed Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 12 |
-4.78
(18.023)
|
-2.02
(4.902)
|
-0.26
(27.118)
|
7.72
(22.067)
|
| Percent Work Time Missed Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 24 |
-0.39
(21.466)
|
4.77
(16.899)
|
-1.00
(28.511)
|
4.96
(18.942)
|
| Percent Work Time Missed Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 36 |
-3.92
(23.687)
|
-3.12
(6.143)
|
-0.32
(27.115)
|
8.93
(21.916)
|
| Percent Work Time Missed Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 52 |
-8.11
(18.718)
|
3.23
(26.008)
|
1.81
(26.094)
|
2.38
(16.245)
|
| Percent Impairment While Working Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 12 |
-11.50
(23.458)
|
-18.64
(28.668)
|
-20.21
(24.925)
|
-20.65
(21.844)
|
| Percent Impairment While Working Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 24 |
-8.42
(16.754)
|
-16.67
(28.697)
|
-23.51
(25.067)
|
-23.66
(24.396)
|
| Percent Impairment While Working Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 36 |
-3.13
(20.887)
|
-8.46
(33.378)
|
-23.15
(25.813)
|
-22.72
(23.185)
|
| Percent Impairment While Working Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 52 |
-10.00
(25.166)
|
-20.00
(27.634)
|
-23.42
(26.597)
|
-22.77
(24.109)
|
| Percent Overall Work Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 12 |
-12.18
(24.763)
|
-19.64
(28.842)
|
-18.21
(28.345)
|
-14.99
(28.777)
|
| Percent Overall Work Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 24 |
-7.46
(16.254)
|
-12.96
(34.336)
|
-20.26
(31.191)
|
-18.60
(28.284)
|
| Percent Overall Work Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 36 |
-5.70
(23.040)
|
-10.43
(33.034)
|
-20.52
(31.307)
|
-14.86
(29.482)
|
| Percent Overall Work Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 52 |
-16.36
(29.721)
|
-16.67
(40.350)
|
-19.42
(29.878)
|
-20.50
(26.949)
|
| Percent Activity Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 12 |
-12.20
(21.273)
|
-8.48
(26.244)
|
-21.50
(26.470)
|
-25.19
(26.314)
|
| Percent Activity Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 24 |
-11.46
(16.517)
|
-7.14
(25.113)
|
-22.83
(27.440)
|
-27.47
(25.943)
|
| Percent Activity Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 36 |
-6.39
(18.997)
|
-1.25
(27.845)
|
-24.48
(26.203)
|
-26.84
(27.493)
|
| Percent Activity Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 52 |
-11.05
(24.910)
|
-13.42
(25.392)
|
-22.91
(27.669)
|
-26.92
(28.042)
|
| Title | VC Period: Trough Plasma Concentrations of Ruxolitinib |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | VC Period: Ruxolitinib 0.75% Cream BID | VC Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Arm/Group Description | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. |
| Measure Participants | 236 | 241 |
| Week 2 |
26.8
(51.2)
|
33.4
(49.9)
|
| Week 4 |
25.1
(42.7)
|
34.7
(43.3)
|
| Week 8 |
24.0
(39.7)
|
33.3
(49.5)
|
| Title | LTS Period: Trough Plasma Concentrations of Ruxolitinib |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID | LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID | LTS Period: Ruxolitinib 0.75% Cream | LTS Period: Ruxolitinib 1.5% Cream |
|---|---|---|---|---|
| Arm/Group Description | Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. | Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence. |
| Measure Participants | 44 | 47 | 210 | 213 |
| Week 12 |
13.8
(21.3)
|
21.9
(34.4)
|
16.5
(28.1)
|
24.9
(45.4)
|
| Week 16 |
11.9
(18.8)
|
18.1
(34.6)
|
19.7
(58.8)
|
24.6
(51.0)
|
| Week 20 |
13.0
(22.2)
|
15.4
(32.0)
|
16.1
(31.2)
|
24.2
(46.1)
|
| Week 24 |
13.0
(22.1)
|
18.7
(31.6)
|
18.8
(42.4)
|
24.6
(51.8)
|
| Week 28 |
18.5
(36.9)
|
15.5
(24.6)
|
16.2
(31.2)
|
23.7
(45.3)
|
| Week 32 |
17.8
(27.3)
|
17.7
(33.3)
|
21.4
(59.8)
|
21.0
(35.3)
|
| Week 36 |
21.1
(54.8)
|
29.5
(84.0)
|
15.7
(30.5)
|
26.6
(51.2)
|
| Week 40 |
14.9
(25.3)
|
16.5
(31.0)
|
14.7
(27.6)
|
23.2
(64.1)
|
| Week 44 |
14.3
(23.7)
|
15.7
(32.6)
|
17.3
(33.5)
|
26.8
(58.6)
|
| Week 48 |
15.6
(26.8)
|
17.9
(56.0)
|
15.3
(30.3)
|
24.8
(55.3)
|
| Week 52 |
11.0
(17.9)
|
14.2
(27.5)
|
11.9
(20.5)
|
21.0
(55.7)
|
Adverse Events
| Time Frame | Up to 60 weeks | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries. | |||||
| Arm/Group Title | Vehicle Cream BID | Ruxolitinib 0.75% Cream BID | Ruxolitinib 1.5% Cream BID | |||
| Arm/Group Description | Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 52 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 52 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 52 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. | |||
All Cause Mortality |
||||||
| Vehicle Cream BID | Ruxolitinib 0.75% Cream BID | Ruxolitinib 1.5% Cream BID | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/126 (0%) | 0/300 (0%) | 0/300 (0%) | |||
Serious Adverse Events |
||||||
| Vehicle Cream BID | Ruxolitinib 0.75% Cream BID | Ruxolitinib 1.5% Cream BID | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/126 (1.6%) | 9/300 (3%) | 6/300 (2%) | |||
| Gastrointestinal disorders | ||||||
| Acute abdomen | 0/126 (0%) | 0/300 (0%) | 1/300 (0.3%) | |||
| Colitis | 0/126 (0%) | 0/300 (0%) | 1/300 (0.3%) | |||
| General disorders | ||||||
| Pyrexia | 0/126 (0%) | 0/300 (0%) | 1/300 (0.3%) | |||
| Serositis | 0/126 (0%) | 0/300 (0%) | 1/300 (0.3%) | |||
| Hepatobiliary disorders | ||||||
| Cholangitis | 0/126 (0%) | 0/300 (0%) | 1/300 (0.3%) | |||
| Cholelithiasis | 0/126 (0%) | 0/300 (0%) | 1/300 (0.3%) | |||
| Jaundice cholestatic | 0/126 (0%) | 0/300 (0%) | 1/300 (0.3%) | |||
| Infections and infestations | ||||||
| Bronchitis | 0/126 (0%) | 0/300 (0%) | 1/300 (0.3%) | |||
| Cholecystitis infective | 0/126 (0%) | 0/300 (0%) | 1/300 (0.3%) | |||
| Pneumonia | 0/126 (0%) | 2/300 (0.7%) | 1/300 (0.3%) | |||
| Injury, poisoning and procedural complications | ||||||
| Anaemia postoperative | 0/126 (0%) | 1/300 (0.3%) | 0/300 (0%) | |||
| Femur fracture | 0/126 (0%) | 1/300 (0.3%) | 0/300 (0%) | |||
| Humerus fracture | 0/126 (0%) | 1/300 (0.3%) | 0/300 (0%) | |||
| Pelvic fracture | 0/126 (0%) | 1/300 (0.3%) | 0/300 (0%) | |||
| Radius fracture | 0/126 (0%) | 1/300 (0.3%) | 0/300 (0%) | |||
| Rib fracture | 0/126 (0%) | 1/300 (0.3%) | 0/300 (0%) | |||
| Ulna fracture | 0/126 (0%) | 1/300 (0.3%) | 0/300 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Hypovolaemia | 0/126 (0%) | 0/300 (0%) | 1/300 (0.3%) | |||
| Type 2 diabetes mellitus | 0/126 (0%) | 1/300 (0.3%) | 0/300 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Nasal sinus cancer | 1/126 (0.8%) | 0/300 (0%) | 0/300 (0%) | |||
| Nervous system disorders | ||||||
| Central nervous system lesion | 0/126 (0%) | 1/300 (0.3%) | 0/300 (0%) | |||
| Dizziness | 0/126 (0%) | 0/300 (0%) | 1/300 (0.3%) | |||
| Psychiatric disorders | ||||||
| Substance-induced psychotic disorder | 0/126 (0%) | 1/300 (0.3%) | 0/300 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Dermatitis atopic | 1/126 (0.8%) | 0/300 (0%) | 0/300 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Vehicle Cream BID | Ruxolitinib 0.75% Cream BID | Ruxolitinib 1.5% Cream BID | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/126 (7.9%) | 52/300 (17.3%) | 70/300 (23.3%) | |||
| Infections and infestations | ||||||
| Nasopharyngitis | 2/126 (1.6%) | 18/300 (6%) | 31/300 (10.3%) | |||
| Upper respiratory tract infection | 4/126 (3.2%) | 27/300 (9%) | 36/300 (12%) | |||
| Nervous system disorders | ||||||
| Headache | 5/126 (4%) | 11/300 (3.7%) | 16/300 (5.3%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Incyte Corporation |
| Phone | 1-855-463-3463 |
| medinfo@incyte.com |
Responsible Party:
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT03745638
Other Study ID Numbers:
- INCB 18424-303
- 2018-003712-45
First Posted:
Nov 19, 2018
Last Update Posted:
Dec 17, 2021
Last Verified:
Nov 1, 2021