Atopic Dermatitis
Conditions
Keywords
Atopic dermatitis, eczema, pruritus, Janus kinase (JAK) inhibitors
Brief summary
The purpose of this study is to establish the efficacy of each strength of ruxolitinib cream once daily (QD) or twice daily (BID) in participants with atopic dermatitis as compared with vehicle cream BID.
Interventions
Ruxolitinib 1.5% cream QD
Ruxolitinib 1.5% cream BID
DRUGTriamcinolone 0.1% Cream BID
Triamcinolone 0.1% cream BID
DRUGVehicle Cream BID
Vehicle cream BID
DRUGRuxolitinib 0.15% Cream QD
Ruxolitinib 0.15% cream QD
DRUGRuxolitinib 0.5% Cream QD
Ruxolitinib 0.5% cream QD
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Participants diagnosed with atopic dermatitis (AD) as defined by the Hanifin and Rajka criteria. * Participants with a history of AD for at least 2 years. * Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at screening and baseline. * Participants with body surface area (BSA) of AD involvement, excluding the face and intertriginous areas, of 3% to 20% at screening and baseline. * Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.
Exclusion criteria
* Participants with evidence of active acute or chronic infections. * Use of topical treatments for AD (other than bland emollients) within 2 weeks of baseline. * Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine) within 4 weeks or 5 half-lives of baseline (whichever is longer). * Participants with other dermatologic disease besides AD whose presence or treatments could complicate the assessment of disease (eg, psoriasis). * Participants with a history of other diseases besides dermatologic disorders (eg, other autoimmune diseases) taking treatments that could complicate assessments. * Participants with cytopenias at screening, defined as: * Leukocytes \< 3.0 × 10\^9/L. * Neutrophils \< lower limit of normal. * Hemoglobin \< 10 g/dL. * Lymphocytes \< 0.8 × 10\^9/L * Platelets \< 100 × 10\^9/L. * Participants with severely impaired liver function (Child-Pugh Class C) or end-stage renal disease (ESRD) on dialysis or at least 1 of the following: * Serum creatinine \> 1.5 mg/dL. * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 × upper limit of normal. * Participants taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit (topical agents with limited systemic availability are permitted). * Participants who have previously received Janus kinase (JAK) inhibitors, systemic or topical (e.g., ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID | Baseline and Week 4 | EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. 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. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD/BID Cream Compared With Participants Treated With Triamcinolone 0.1% Cream BID Followed by Vehicle | Baseline and Week 4 | EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. 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. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement. |
| Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8 | Baseline, Week 2 and 8 | EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. 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. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement. |
| Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8 | Week 2, 4 and 8 | The categorical variable EASI-50 will be equal to 1 for percentage improvement from baseline in EASI score of 50% or greater and will be equal to 0 for percentage improvement of less than 50%. This definition is introduced for the purpose of identifying participants who respond to the treatment (1 = responder, 0 = non-responder). |
| Percentage Change From Baseline in EASI Score at Week 4 | Baseline and Week 4 | EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. 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. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement. |
| Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD Compared With Participants Treated With Vehicle Cream BID | Baseline and Week 4 | EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. 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. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement. |
| Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8 | Week 2, 4 and 8 | IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). An IGA responder was defined as a participant achieving an IGA score of 0 to 1 and an IGA score improvement at least 2 from baseline. |
| Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Baseline, Week 2, 4 and 8 | The Itch NRS is a once-per-24 hours (daily) participant-reported measure of itch intensity 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. The categorical NRS is defined as 0 = None, 1 to 3 = Mild, 4 to 6 = Moderate, and 7 to 10 = Severe. |
| Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | Up to Week 24 | AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4.Data are reported for Grade 3 and higher severity for this outcome measure. |
| Time to Achieve EASI-50 | From Baseline to Week 8 | Time to EASI-50 is defined as the interval between the time of randomization and the time of achieving at least 50% improvement in EASI score. |
Countries
Canada, United States
Participant flow
Recruitment details
A total of 307 participants were randomized and 306 were treated at 50 study centers in the United States and Canada from 9 January 2017 to 12 March 2018.
Pre-assignment details
307 participants randomized to 6 treatment groups (ruxolitinib cream 1.5% BID, or QD, 0.5% or 0.15% QD, vehicle BID, & TAC 0.1% BID). Participants applied blinded study drug for 8 weeks, TAC 0.1% BID for 4 weeks followed by vehicle BID for 4 weeks in DB period. After DB period, participants who met criteria (compliant with the protocol and no safety concerns) offered OL treatment with ruxolitinib 1.5% BID for 4 weeks. Out of 261 participants who completed DB Period, 252 entered the OL Period.
Participants by arm
| Arm | Count |
|---|---|
| Double Blind (DB): Vehicle BID Participants applied vehicle cream twice daily (BID) for 8 weeks DB period. | 52 |
| DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period. | 51 |
| DB: Ruxolitinib 0.15% Once Daily (QD) Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period. | 51 |
| DB : Ruxolitinib 0.5% QD Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period. | 51 |
| DB : Ruxolitinib 1.5% QD Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period. | 52 |
| DB : Ruxolitinib 1.5% Cream Twice Daily (BID) Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period. | 50 |
| Total | 307 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double Blind (DB) Period | Adverse Event | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Double Blind (DB) Period | Lack of Efficacy | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Double Blind (DB) Period | Lost to Follow-up | 0 | 3 | 2 | 5 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Double Blind (DB) Period | Other | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Double Blind (DB) Period | Physician Decision | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Double Blind (DB) Period | Pregnancy | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Double Blind (DB) Period | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Double Blind (DB) Period | Randomized but not treated | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Double Blind (DB) Period | Withdrawal by Subject | 7 | 5 | 1 | 2 | 4 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Open Label (OL) Period | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 2 | 1 | 0 | 1 | 1 |
| Open Label (OL) Period | Reason not specified | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Open Label (OL) Period | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 0 | 1 | 2 |
Baseline characteristics
| Characteristic | DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID | Total | DB : Ruxolitinib 1.5% Cream Twice Daily (BID) | DB : Ruxolitinib 1.5% QD | Double Blind (DB): Vehicle BID | DB : Ruxolitinib 0.5% QD | DB: Ruxolitinib 0.15% Once Daily (QD) |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 38.5 years STANDARD_DEVIATION 16.19 | 38.1 years STANDARD_DEVIATION 14.82 | 39.0 years STANDARD_DEVIATION 15.72 | 39.1 years STANDARD_DEVIATION 14.54 | 34.8 years STANDARD_DEVIATION 15.04 | 38.6 years STANDARD_DEVIATION 13.73 | 38.4 years STANDARD_DEVIATION 13.83 |
| Race/Ethnicity, Customized Asian | 8 Participants | 41 Participants | 2 Participants | 10 Participants | 8 Participants | 8 Participants | 5 Participants |
| Race/Ethnicity, Customized Black/African-American | 13 Participants | 85 Participants | 13 Participants | 17 Participants | 15 Participants | 10 Participants | 17 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 8 Participants | 20 Participants | 3 Participants | 1 Participants | 3 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 43 Participants | 285 Participants | 47 Participants | 51 Participants | 47 Participants | 48 Participants | 49 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 8 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White/Caucasian | 28 Participants | 172 Participants | 33 Participants | 24 Participants | 27 Participants | 33 Participants | 27 Participants |
| Sex: Female, Male Female | 28 Participants | 168 Participants | 24 Participants | 31 Participants | 32 Participants | 27 Participants | 26 Participants |
| Sex: Female, Male Male | 23 Participants | 139 Participants | 26 Participants | 21 Participants | 20 Participants | 24 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 51 | 0 / 51 | 0 / 51 | 0 / 51 | 0 / 259 |
| other Total, other adverse events | 10 / 52 | 3 / 51 | 6 / 51 | 2 / 51 | 6 / 51 | 23 / 259 |
| serious Total, serious adverse events | 0 / 52 | 1 / 51 | 0 / 51 | 0 / 51 | 0 / 51 | 0 / 259 |
Outcome results
Primary
Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. 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. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Time frame: Baseline and Week 4
Population: Participants from Intent to treat (ITT) population, all participants who are randomized to vehicle BID or ruxolitinib 1.5% BID, with available data were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DB: Vehicle BID | Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID | -11.90 percent change | Standard Error 6.65 |
| DB: Ruxolitinib 1.5% BID | Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID | -71.57 percent change | Standard Error 6.42 |
p-value: <0.000195% CI: [-77.85, -41.47]MMRM
Secondary
Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8
The Itch NRS is a once-per-24 hours (daily) participant-reported measure of itch intensity 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. The categorical NRS is defined as 0 = None, 1 to 3 = Mild, 4 to 6 = Moderate, and 7 to 10 = Severe.
Time frame: Baseline, Week 2, 4 and 8
Population: ITT Population included all participants who are randomized to the study. Overall number of participants analyzed are participants with data available for analysis at specified time-point and 'n' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB: Vehicle BID | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Baseline | 6.0 score on scale | Standard Deviation 2.11 |
| DB: Vehicle BID | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Change from Baseline at Week 8 | -1.2 score on scale | Standard Deviation 2.13 |
| DB: Vehicle BID | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Change from Baseline at Week 4 | -1.0 score on scale | Standard Deviation 1.79 |
| DB: Vehicle BID | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Change from Baseline at Week 2 | -0.7 score on scale | Standard Deviation 1.46 |
| DB: Ruxolitinib 1.5% BID | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Change from Baseline at Week 8 | -2.2 score on scale | Standard Deviation 1.86 |
| DB: Ruxolitinib 1.5% BID | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Change from Baseline at Week 2 | -2.2 score on scale | Standard Deviation 1.75 |
| DB: Ruxolitinib 1.5% BID | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Baseline | 5.2 score on scale | Standard Deviation 2.22 |
| DB: Ruxolitinib 1.5% BID | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Change from Baseline at Week 4 | -2.5 score on scale | Standard Deviation 1.94 |
| DB: Ruxolitinib 0.5% QD | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Baseline | 6.1 score on scale | Standard Deviation 2.23 |
| DB: Ruxolitinib 0.5% QD | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Change from Baseline at Week 8 | -3.0 score on scale | Standard Deviation 2.49 |
| DB: Ruxolitinib 0.5% QD | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Change from Baseline at Week 2 | -1.9 score on scale | Standard Deviation 1.97 |
| DB: Ruxolitinib 0.5% QD | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Change from Baseline at Week 4 | -2.3 score on scale | Standard Deviation 2.08 |
| DB: Ruxolitinib 1.5% QD | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Change from Baseline at Week 8 | -2.9 score on scale | Standard Deviation 2.41 |
| DB: Ruxolitinib 1.5% QD | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Change from Baseline at Week 2 | -2.5 score on scale | Standard Deviation 2.23 |
| DB: Ruxolitinib 1.5% QD | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Change from Baseline at Week 4 | -2.6 score on scale | Standard Deviation 2.22 |
| DB: Ruxolitinib 1.5% QD | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Baseline | 6.2 score on scale | Standard Deviation 1.71 |
| DB: Ruxolitinib 1.5% BID | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Change from Baseline at Week 4 | -3.3 score on scale | Standard Deviation 2.24 |
| DB: Ruxolitinib 1.5% BID | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Baseline | 6.2 score on scale | Standard Deviation 2.14 |
| DB: Ruxolitinib 1.5% BID | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Change from Baseline at Week 8 | -3.8 score on scale | Standard Deviation 2.39 |
| DB: Ruxolitinib 1.5% BID | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Change from Baseline at Week 2 | -3.1 score on scale | Standard Deviation 2.14 |
| DB: Ruxolitinib 1.5% BID | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Change from Baseline at Week 8 | -4.2 score on scale | Standard Deviation 2.91 |
| DB: Ruxolitinib 1.5% BID | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Baseline | 5.9 score on scale | Standard Deviation 2.25 |
| DB: Ruxolitinib 1.5% BID | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Change from Baseline at Week 2 | -3.7 score on scale | Standard Deviation 2.56 |
| DB: Ruxolitinib 1.5% BID | Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 | Change from Baseline at Week 4 | -4.0 score on scale | Standard Deviation 2.89 |
Secondary
Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. 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. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Time frame: Baseline, Week 2 and 8
Population: ITT Population included all participants who are randomized to Vehicle BID, TAC 0.1% BID/Vehicle Cream BID, Ruxolitinib 0.15%, 0.5%, 1.5%, 1.5% QD/BID in the DB Period. The overall number of participants analyzed are participants with data available for analysis for this Outcome Measure and n signifies number of participants with data available at specific timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| DB: Vehicle BID | Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8 | Week 2 | -4.84 percent change | Standard Error 5.34 |
| DB: Vehicle BID | Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8 | Week 8 | -21.86 percent change | Standard Error 7.09 |
| DB: Ruxolitinib 1.5% BID | Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8 | Week 2 | -39.94 percent change | Standard Error 5.29 |
| DB: Ruxolitinib 1.5% BID | Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8 | Week 8 | -58.02 percent change | Standard Error 6.94 |
| DB: Ruxolitinib 0.5% QD | Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8 | Week 2 | -29.96 percent change | Standard Error 5.23 |
| DB: Ruxolitinib 0.5% QD | Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8 | Week 8 | -50.24 percent change | Standard Error 6.82 |
| DB: Ruxolitinib 1.5% QD | Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8 | Week 2 | -45.88 percent change | Standard Error 5.41 |
| DB: Ruxolitinib 1.5% QD | Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8 | Week 8 | -58.37 percent change | Standard Error 6.93 |
| DB: Ruxolitinib 1.5% BID | Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8 | Week 2 | -49.88 percent change | Standard Error 5.18 |
| DB: Ruxolitinib 1.5% BID | Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8 | Week 8 | -67.05 percent change | Standard Error 6.72 |
| DB: Ruxolitinib 1.5% BID | Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8 | Week 2 | -52.68 percent change | Standard Error 5.29 |
| DB: Ruxolitinib 1.5% BID | Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8 | Week 8 | -79.01 percent change | Standard Error 6.83 |
Comparison: Week 2p-value: 0.000995% CI: [-39.84, -10.41]MMRM
Comparison: Week 2p-value: <0.000195% CI: [-62.64, -33.06]MMRM
Comparison: Week 2p-value: <0.000195% CI: [-56, -26.08]MMRM
Comparison: Week 2p-value: <0.000195% CI: [-59.69, -30.4]MMRM
Comparison: Week 2p-value: 0.180695% CI: [-4.66, 24.63]MMRM
Comparison: Week 2p-value: 0.433395% CI: [-20.82, 8.95]MMRM
Comparison: Week 2p-value: 0.180595% CI: [-24.51, 4.63]MMRM
Comparison: Week 2p-value: 0.089595% CI: [-27.45, 1.98]MMRM
Comparison: Week 8p-value: 0.004295% CI: [-47.74, -9.02]MMRM
Comparison: Week 8p-value: 0.000395% CI: [-56.03, -17.01]MMRM
Comparison: Week 8p-value: <0.0001MMRM
Comparison: Week 8p-value: <0.000195% CI: [-76.53, -37.77]MMRM
Comparison: Week 8p-value: 0.424395% CI: [-11.37, 26.93]MMRM
Comparison: Week 8p-value: 0.971595% CI: [-19.65, 18.95]MMRM
Comparison: Week 8p-value: 0.350795% CI: [-28.05, 9.99]MMRM
Comparison: Week 8p-value: 0.03295% CI: [-40.15, -1.82]MMRM
Secondary
Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD/BID Cream Compared With Participants Treated With Triamcinolone 0.1% Cream BID Followed by Vehicle
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. 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. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Time frame: Baseline and Week 4
Population: Participants from ITT population, all participants who are randomized to TAC 0.1% BID followed by vehicle BID and ruxolitinib 0.15% or 0.5% or 1.5% QD/BID in the DB Period, with available data were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DB: Vehicle BID | Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD/BID Cream Compared With Participants Treated With Triamcinolone 0.1% Cream BID Followed by Vehicle | -59.54 percent change | Standard Error 6.53 |
| DB: Ruxolitinib 1.5% BID | Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD/BID Cream Compared With Participants Treated With Triamcinolone 0.1% Cream BID Followed by Vehicle | -44.92 percent change | Standard Error 6.47 |
| DB: Ruxolitinib 0.5% QD | Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD/BID Cream Compared With Participants Treated With Triamcinolone 0.1% Cream BID Followed by Vehicle | -52.80 percent change | Standard Error 6.52 |
| DB: Ruxolitinib 1.5% QD | Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD/BID Cream Compared With Participants Treated With Triamcinolone 0.1% Cream BID Followed by Vehicle | -66.72 percent change | Standard Error 6.36 |
| DB: Ruxolitinib 1.5% BID | Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD/BID Cream Compared With Participants Treated With Triamcinolone 0.1% Cream BID Followed by Vehicle | -71.57 percent change | Standard Error 6.42 |
Comparison: Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 0.15% QDp-value: 0.112795% CI: [-3.47, 32.73]MMRM
Comparison: Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 0.5% QDp-value: 0.465995% CI: [-11.44, 24.92]MMRM
Comparison: Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 1.5% QDp-value: 0.43295% CI: [-25.13, 10.77]MMRM
p-value: 0.190395% CI: [-30.05, 6]MMRM
Secondary
Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD Compared With Participants Treated With Vehicle Cream BID
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. 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. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Time frame: Baseline and Week 4
Population: Participants from Intent to treat (ITT) population, all participants who are randomized to vehicle BID and ruxolitinib 0.15% or 0.5% or 1.5% QD in the DB Period, with available data were included in the analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DB: Vehicle BID | Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD Compared With Participants Treated With Vehicle Cream BID | -11.90 percent change | Standard Error 6.65 |
| DB: Ruxolitinib 1.5% BID | Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD Compared With Participants Treated With Vehicle Cream BID | -44.92 percent change | Standard Error 6.47 |
| DB: Ruxolitinib 0.5% QD | Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD Compared With Participants Treated With Vehicle Cream BID | -52.80 percent change | Standard Error 6.52 |
| DB: Ruxolitinib 1.5% QD | Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD Compared With Participants Treated With Vehicle Cream BID | -66.72 percent change | Standard Error 6.36 |
Comparison: DB: Vehicle BID, Ruxolitinib 0.15% QDp-value: 0.000495% CI: [-51.27, -14.76]MMRM
p-value: <0.000195% CI: [-59.23, -22.57]MMRM
p-value: <0.000195% CI: [-72.93, -36.7]MMRM
Secondary
Number of Participants With At Least One Adverse Event (AEs) and as Per Severity
AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4.Data are reported for Grade 3 and higher severity for this outcome measure.
Time frame: Up to Week 24
Population: Safety Population in the DB treatment period included all enrolled participants who applied at least 1 dose of ruxolitinib cream, triamcinolone cream, or vehicle cream.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DB: Vehicle BID | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | At Least One AE | 17 Participants |
| DB: Vehicle BID | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | Grade 3 and Higher | 0 Participants |
| DB: Ruxolitinib 1.5% BID | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | At Least One AE | 17 Participants |
| DB: Ruxolitinib 1.5% BID | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | Grade 3 and Higher | 2 Participants |
| DB: Ruxolitinib 0.5% QD | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | At Least One AE | 19 Participants |
| DB: Ruxolitinib 0.5% QD | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | Grade 3 and Higher | 0 Participants |
| DB: Ruxolitinib 1.5% QD | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | At Least One AE | 11 Participants |
| DB: Ruxolitinib 1.5% QD | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | Grade 3 and Higher | 1 Participants |
| DB: Ruxolitinib 1.5% BID | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | Grade 3 and Higher | 0 Participants |
| DB: Ruxolitinib 1.5% BID | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | At Least One AE | 17 Participants |
| DB: Ruxolitinib 1.5% BID | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | At Least One AE | 12 Participants |
| DB: Ruxolitinib 1.5% BID | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | Grade 3 and Higher | 1 Participants |
| OL: Vehicle BID to Ruxolitinib 1.5% BID | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | Grade 3 and Higher | 0 Participants |
| OL: Vehicle BID to Ruxolitinib 1.5% BID | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | At Least One AE | 5 Participants |
| OL: TAC BID/Vehicle Cream BID to Ruxolitinib 1.5% BID | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | At Least One AE | 11 Participants |
| OL: TAC BID/Vehicle Cream BID to Ruxolitinib 1.5% BID | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | Grade 3 and Higher | 1 Participants |
| OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | At Least One AE | 11 Participants |
| OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | Grade 3 and Higher | 0 Participants |
| OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | At Least One AE | 8 Participants |
| OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | Grade 3 and Higher | 0 Participants |
| OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | Grade 3 and Higher | 0 Participants |
| OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | At Least One AE | 11 Participants |
| OL: Ruxolitinib 1.5% BID | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | Grade 3 and Higher | 0 Participants |
| OL: Ruxolitinib 1.5% BID | Number of Participants With At Least One Adverse Event (AEs) and as Per Severity | At Least One AE | 17 Participants |
Secondary
Percentage Change From Baseline in EASI Score at Week 4
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. 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. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Time frame: Baseline and Week 4
Population: ITT Population included all participants who are randomized to the study. Overall number of participants analyzed are participants with data available for analysis at Week 4.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB: Vehicle BID | Percentage Change From Baseline in EASI Score at Week 4 | -15.5 percent change | Standard Deviation 65.71 |
| DB: Ruxolitinib 1.5% BID | Percentage Change From Baseline in EASI Score at Week 4 | -59.8 percent change | Standard Deviation 35.71 |
| DB: Ruxolitinib 0.5% QD | Percentage Change From Baseline in EASI Score at Week 4 | -45.4 percent change | Standard Deviation 53.96 |
| DB: Ruxolitinib 1.5% QD | Percentage Change From Baseline in EASI Score at Week 4 | -52.2 percent change | Standard Deviation 48.32 |
| DB: Ruxolitinib 1.5% BID | Percentage Change From Baseline in EASI Score at Week 4 | -67.0 percent change | Standard Deviation 26.28 |
| DB: Ruxolitinib 1.5% BID | Percentage Change From Baseline in EASI Score at Week 4 | -71.6 percent change | Standard Deviation 25.27 |
Secondary
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8
IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). An IGA responder was defined as a participant achieving an IGA score of 0 to 1 and an IGA score improvement at least 2 from baseline.
Time frame: Week 2, 4 and 8
Population: ITT Population included all participants who are randomized to the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB: Vehicle BID | Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8 | Week 4 | 7.7 percentage of participants |
| DB: Vehicle BID | Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8 | Week 2 | 1.9 percentage of participants |
| DB: Vehicle BID | Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8 | Week 8 | 9.6 percentage of participants |
| DB: Ruxolitinib 1.5% BID | Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8 | Week 4 | 25.5 percentage of participants |
| DB: Ruxolitinib 1.5% BID | Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8 | Week 2 | 11.8 percentage of participants |
| DB: Ruxolitinib 1.5% BID | Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8 | Week 8 | 17.6 percentage of participants |
| DB: Ruxolitinib 0.5% QD | Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8 | Week 4 | 9.8 percentage of participants |
| DB: Ruxolitinib 0.5% QD | Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8 | Week 2 | 5.9 percentage of participants |
| DB: Ruxolitinib 0.5% QD | Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8 | Week 8 | 15.7 percentage of participants |
| DB: Ruxolitinib 1.5% QD | Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8 | Week 4 | 13.7 percentage of participants |
| DB: Ruxolitinib 1.5% QD | Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8 | Week 2 | 4.1 percentage of participants |
| DB: Ruxolitinib 1.5% QD | Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8 | Week 8 | 31.4 percentage of participants |
| DB: Ruxolitinib 1.5% BID | Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8 | Week 4 | 21.2 percentage of participants |
| DB: Ruxolitinib 1.5% BID | Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8 | Week 2 | 13.5 percentage of participants |
| DB: Ruxolitinib 1.5% BID | Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8 | Week 8 | 30.8 percentage of participants |
| DB: Ruxolitinib 1.5% BID | Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8 | Week 2 | 8.0 percentage of participants |
| DB: Ruxolitinib 1.5% BID | Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8 | Week 8 | 48.0 percentage of participants |
| DB: Ruxolitinib 1.5% BID | Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8 | Week 4 | 38.0 percentage of participants |
Secondary
Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8
The categorical variable EASI-50 will be equal to 1 for percentage improvement from baseline in EASI score of 50% or greater and will be equal to 0 for percentage improvement of less than 50%. This definition is introduced for the purpose of identifying participants who respond to the treatment (1 = responder, 0 = non-responder).
Time frame: Week 2, 4 and 8
Population: ITT Population included all participants who are randomized to the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB: Vehicle BID | Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8 | Week 4 | 23.1 percentage of participants |
| DB: Vehicle BID | Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8 | Week 2 | 13.5 percentage of participants |
| DB: Vehicle BID | Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8 | Week 8 | 26.9 percentage of participants |
| DB: Ruxolitinib 1.5% BID | Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8 | Week 4 | 66.7 percentage of participants |
| DB: Ruxolitinib 1.5% BID | Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8 | Week 2 | 43.1 percentage of participants |
| DB: Ruxolitinib 1.5% BID | Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8 | Week 8 | 60.8 percentage of participants |
| DB: Ruxolitinib 0.5% QD | Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8 | Week 4 | 52.9 percentage of participants |
| DB: Ruxolitinib 0.5% QD | Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8 | Week 2 | 31.4 percentage of participants |
| DB: Ruxolitinib 0.5% QD | Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8 | Week 8 | 54.9 percentage of participants |
| DB: Ruxolitinib 1.5% QD | Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8 | Week 4 | 58.8 percentage of participants |
| DB: Ruxolitinib 1.5% QD | Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8 | Week 2 | 57.1 percentage of participants |
| DB: Ruxolitinib 1.5% QD | Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8 | Week 8 | 62.7 percentage of participants |
| DB: Ruxolitinib 1.5% BID | Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8 | Week 4 | 73.1 percentage of participants |
| DB: Ruxolitinib 1.5% BID | Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8 | Week 2 | 50.0 percentage of participants |
| DB: Ruxolitinib 1.5% BID | Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8 | Week 8 | 69.2 percentage of participants |
| DB: Ruxolitinib 1.5% BID | Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8 | Week 2 | 52.0 percentage of participants |
| DB: Ruxolitinib 1.5% BID | Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8 | Week 8 | 76.0 percentage of participants |
| DB: Ruxolitinib 1.5% BID | Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8 | Week 4 | 78.0 percentage of participants |
Secondary
Time to Achieve EASI-50
Time to EASI-50 is defined as the interval between the time of randomization and the time of achieving at least 50% improvement in EASI score.
Time frame: From Baseline to Week 8
Population: ITT population included all participants who are randomized to the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DB: Vehicle BID | Time to Achieve EASI-50 | 4 week |
| DB: Ruxolitinib 1.5% BID | Time to Achieve EASI-50 | 2 week |
| DB: Ruxolitinib 0.5% QD | Time to Achieve EASI-50 | 4 week |
| DB: Ruxolitinib 1.5% QD | Time to Achieve EASI-50 | 2 week |
| DB: Ruxolitinib 1.5% BID | Time to Achieve EASI-50 | 2 week |
| DB: Ruxolitinib 1.5% BID | Time to Achieve EASI-50 | 2 week |