Psoriasis
Conditions
Brief summary
The study was double-blind, randomized, vehicle-controlled study with application of Ruxolitinib phosphate cream or vehicle cream in participants with stable plaque psoriasis applied once daily for 12 weeks without occlusive dressings. There were 4 treatment groups anticipated to have 50 participants in each.
Interventions
OTHERPlacebo Cream
Cream with no active drug
Ruxolitinib phosphate cream
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Plaque psoriasis involving up to 2 to 20% Body Surface Area
Exclusion criteria
* Lesions solely involving intertriginous areas, the scalp or the face * Systemic therapy for their psoriasis * Pustular psoriasis or erythroderma * Currently on other topical agents or Ultraviolet B (UVB) therapy within 2 weeks of the first dose of study medication * Started or discontinued therapy within 2 months of Screening with agents that can exacerbate psoriasis * Receiving systemic triazole antifungals except fluconazole
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in Total Lesion Score for All Treatable Psoriatic Lesions to Day 84 | From Baseline (Day 1) to Day 84 | Total Lesion Score is calculated as the sum of component scores for erythema (E), scaling (S), and thickness (T) of the study-treated lesions taken together. Each component consists of ratings of 0=none, 1=mild, 2=moderate, 3=marked, and 4=severe such that total lesion score can vary in value from 0 to 12. A negative change from Baseline indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in the Individual Lesion Scores for Lesion Erythema | From Baseline (Day 1) to Day 84 | Lesion erythema was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative change from Baseline indicates improvement. |
| Absolute Change From Baseline in the Individual Lesion Scores for Lesion Scaling | From Baseline (Day 1) to Day 84 | Lesion scaling was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative change from Baseline indicates improvement. |
| Percent Change From Baseline in the Individual Lesion Scores of Lesion Thickness | From Baseline (Day 1) to Day 84 | Lesion thickness was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative percent change from Baseline indicates improvement in lesion. |
| Percent Change From Baseline in the Individual Lesion Scores of Lesion Erythema | From Baseline (Day 1) to Day 84 | Lesion erythema was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative percent change from Baseline indicates improvement in lesion. |
| Percent Change From Baseline in the Individual Lesion Scores of Lesion Scaling | From Baseline (Day 1) to Day 84 | Lesion scaling was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative percent change from Baseline indicates improvement in lesion. |
| Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Thickness at Day 84 | Day 84 | Lesion thickness was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. Participants with individual lesion scores 0 (none) and 1 (mild) are reported in this outcome measure. |
| Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Erythema at Day 84 | Day 84 | The individual lesion scores were calculated individually for thickness, erythema, and scaling. Lesion erythema was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. Participants with individual lesion scores 0 (none) and 1 (mild) are reported in this outcome measure. The LOCF method was used for analysis. |
| Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Scaling at Day 84 | Day 84 | The individual lesion scores were calculated individually for thickness, erythema, and scaling. Lesion scaling was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. Participants with individual lesion scores 0 (none) and 1 (mild) are reported in this outcome measure. The LOCF method was used for analysis. |
| Absolute Change From Baseline in the Individual Lesion Scores for Lesion Thickness | From Baseline (Day 1) to Day 84 | Lesion thickness was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative change from Baseline indicates improvement. |
| Absolute Change From Baseline in the Physician's Global Assessment (PGA) Score | Baseline (Day 1) to Day 84 | The overall disease activity in the participants, a measure of the overall quality (erythema, scaling, and thickness) and extent (BSA) of plaques, was measured using the PGA. The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a 6-point scale ranging from 0 to 5 where 0 is 'Clear' (no evidence of disease) and 5 is 'very Severe' lesion. A negative change from Baseline indicates improvement. The ANCOVA method was used for analyses. |
| Percent Change From Baseline in the PGA Score | Baseline (Day 1) to Day 84 | The overall disease activity in the participants, a measure of the overall quality (erythema, scaling, and thickness) and extent (BSA) of plaques, was measured using the PGA. The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a 6-point scale ranging from 0 to 5 where 0 indicates 'Clear' (no evidence of disease) and 5 indicates 'very Severe' lesion. A negative percent change indicates improvement. The ANCOVA method was used for analyses. |
| Percentage of Participants Achieving Clear (Score=0) and Almost Clear (Score=1) on the PGA | Day 84 | The overall disease activity in the participants, a measure of the overall quality (erythema, scaling, and thickness) and extent (BSA) of plaques, was measured using the PGA. The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a 6-point scale ranging from 0 to 5 where 0 indicates 'Clear' (no evidence of disease) and 5 indicates 'very Severe' lesion. Participants with individual lesion scores 0 (clear) and 1 (almost clear) are reported in this outcome measure. |
| Absolute Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score | Baseline (Day 1) to Day 84 | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring \[lower extremities, trunk (including stomach, chest, back), upper extremities, head\]; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by scale 0 (none) to 4 (severe). Final PASI is the sum of severity score for each area multiplied coverage for each section multiplied by area score weight of section (lower extremities: 0.4, trunk: 0.3, upper extremities: 0.2, head: 0.1). A negative change from baseline indicates improvement. The ANCOVA method was used for analyses. |
| Percent Change From Baseline in the PASI Score | Baseline (Day 1) to Day 84 | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring \[lower extremities, trunk (including stomach, chest, back), upper extremities, head\]; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by scale 0 (none) to 4 (severe). Final PASI is the sum of severity score for each area multiplied by coverage for each section multiplied by area score weight of section (lower extremities: 0.4, trunk: 0.3, upper extremities: 0.2, head: 0.1). A percent negative change from baseline indicates improvement in disease. The ANCOVA method was used for analyses. |
| Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Baseline (Day 1) and Days 15, 28, 56, 84, and 112 | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring \[lower extremities, trunk (including stomach, chest, back), upper extremities, head\]; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by scale 0 (none) to 4 (severe). Final PASI is the sum of severity score for each area\* multiplied by coverage for each section\* multiplied by area score weight of section (lower extremities: 0.4, trunk: 0.3, upper extremities: 0.2, head: 0.1). A negative percent change from Baseline indicates improvement. Data for Day 84 was imputed using the LOCF method. |
| Trough Plasma Concentrations [Minimum Concentration at Steady-state (Css,Min)] of Ruxolitinib Phosphate Prior to Study Drug Application at Steady State | Pre-application on Days 1, 15, 28, 56, and 84 | — |
| Absolute Change From Baseline in the Percent Treatable Body Surface Area (BSA) | Baseline (Day 1) to Day 84 | The lesion areas were estimated based on the Rule of Nines method for the entire skin surface; psoriatic disease activity and the percent BSA were calculated for the treatable areas (i.e., areas that excluded the scalp, face, and intertriginous areas). The BSA is calculated as follows: BSA (m\^²)=(\[Height(cm) x Weight(kg)\]/3600 )\^½. A negative change from Baseline indicates improvement. |
Countries
United States
Participant flow
Recruitment details
A total of 199 participants were enrolled at 27 sites in the United States from 28 October 2008 to 26 June 2009.
Pre-assignment details
220 participants with stable plaque psoriasis were enrolled in the study, 199 of whom received randomized study drug and were analyzed in this study. 21 subjects did not receive study drug and were therefore excluded from the ITT and Safety analysis sets. The participants were randomized in 1:1:1:1 ratio to receive vehicle cream or Ruxolitinib phosphate 0.5% cream or Ruxolitinib phosphate 1.0% cream or Ruxolitinib phosphate 1.5% cream.
Participants by arm
| Arm | Count |
|---|---|
| Vehicle Vehicle cream, applied topically, once daily from Day 1 to Week 12. | 50 |
| Ruxolitinib Phosphate 0.5% Cream Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12. | 51 |
| Ruxolitinib Phosphate 1.0% Cream Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12. | 49 |
| Ruxolitinib Phosphate 1.5% Cream Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12. | 49 |
| Total | 199 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 6 | 1 | 3 | 5 |
| Overall Study | Lost to Follow-up | 3 | 1 | 0 | 1 |
| Overall Study | Other | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 0 | 0 |
| Overall Study | Reason not Specified | 2 | 0 | 1 | 3 |
| Overall Study | Subject Withdrew Consent | 6 | 4 | 1 | 4 |
Baseline characteristics
| Characteristic | Vehicle | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream | Total |
|---|---|---|---|---|---|
| Age, Continuous | 42.3 years STANDARD_DEVIATION 10.94 | 45.4 years STANDARD_DEVIATION 10.91 | 44.9 years STANDARD_DEVIATION 13.03 | 43.6 years STANDARD_DEVIATION 12.8 | 44.0 years STANDARD_DEVIATION 11.92 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 6 Participants | 8 Participants | 3 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 45 Participants | 41 Participants | 46 Participants | 173 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 3 Participants | 1 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized White or Caucasian Native | 45 Participants | 46 Participants | 46 Participants | 48 Participants | 185 Participants |
| Sex: Female, Male Female | 17 Participants | 20 Participants | 24 Participants | 23 Participants | 84 Participants |
| Sex: Female, Male Male | 33 Participants | 31 Participants | 25 Participants | 26 Participants | 115 Participants |
| Total Lesion Score | 7.2 score on a scale | 7.1 score on a scale | 6.7 score on a scale | 7.1 score on a scale | 7.0 score on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 51 | 0 / 49 | 0 / 49 | 0 / 199 |
| other Total, other adverse events | 11 / 50 | 11 / 51 | 16 / 49 | 18 / 49 | 56 / 199 |
| serious Total, serious adverse events | 1 / 50 | 2 / 51 | 0 / 49 | 3 / 49 | 6 / 199 |
Outcome results
Primary
Absolute Change From Baseline in Total Lesion Score for All Treatable Psoriatic Lesions to Day 84
Total Lesion Score is calculated as the sum of component scores for erythema (E), scaling (S), and thickness (T) of the study-treated lesions taken together. Each component consists of ratings of 0=none, 1=mild, 2=moderate, 3=marked, and 4=severe such that total lesion score can vary in value from 0 to 12. A negative change from Baseline indicates improvement.
Time frame: From Baseline (Day 1) to Day 84
Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Cream | Absolute Change From Baseline in Total Lesion Score for All Treatable Psoriatic Lesions to Day 84 | -1.07 score on a scale | Standard Error 0.29 |
| Ruxolitinib Phosphate 0.5% Cream | Absolute Change From Baseline in Total Lesion Score for All Treatable Psoriatic Lesions to Day 84 | -2.25 score on a scale | Standard Error 0.284 |
| Ruxolitinib Phosphate 1.0% Cream | Absolute Change From Baseline in Total Lesion Score for All Treatable Psoriatic Lesions to Day 84 | -2.47 score on a scale | Standard Error 0.285 |
| Ruxolitinib Phosphate 1.5% Cream | Absolute Change From Baseline in Total Lesion Score for All Treatable Psoriatic Lesions to Day 84 | -2.27 score on a scale | Standard Error 0.287 |
p-value: 0.004190% CI: [-1.85, -0.51]ANCOVA
p-value: 0.000790% CI: [-2.08, -0.73]ANCOVA
p-value: 0.003590% CI: [-1.88, -0.53]ANCOVA
Secondary
Absolute Change From Baseline in the Individual Lesion Scores for Lesion Erythema
Lesion erythema was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative change from Baseline indicates improvement.
Time frame: From Baseline (Day 1) to Day 84
Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Cream | Absolute Change From Baseline in the Individual Lesion Scores for Lesion Erythema | -0.45 score on a scale | Standard Deviation 0.711 |
| Ruxolitinib Phosphate 0.5% Cream | Absolute Change From Baseline in the Individual Lesion Scores for Lesion Erythema | -0.59 score on a scale | Standard Deviation 0.757 |
| Ruxolitinib Phosphate 1.0% Cream | Absolute Change From Baseline in the Individual Lesion Scores for Lesion Erythema | -0.72 score on a scale | Standard Deviation 0.889 |
| Ruxolitinib Phosphate 1.5% Cream | Absolute Change From Baseline in the Individual Lesion Scores for Lesion Erythema | -0.64 score on a scale | Standard Deviation 0.872 |
Secondary
Absolute Change From Baseline in the Individual Lesion Scores for Lesion Scaling
Lesion scaling was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative change from Baseline indicates improvement.
Time frame: From Baseline (Day 1) to Day 84
Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Cream | Absolute Change From Baseline in the Individual Lesion Scores for Lesion Scaling | -0.46 score on a scale | Standard Deviation 0.972 |
| Ruxolitinib Phosphate 0.5% Cream | Absolute Change From Baseline in the Individual Lesion Scores for Lesion Scaling | -0.91 score on a scale | Standard Deviation 0.741 |
| Ruxolitinib Phosphate 1.0% Cream | Absolute Change From Baseline in the Individual Lesion Scores for Lesion Scaling | -0.87 score on a scale | Standard Deviation 0.991 |
| Ruxolitinib Phosphate 1.5% Cream | Absolute Change From Baseline in the Individual Lesion Scores for Lesion Scaling | -0.85 score on a scale | Standard Deviation 0.961 |
Secondary
Absolute Change From Baseline in the Individual Lesion Scores for Lesion Thickness
Lesion thickness was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative change from Baseline indicates improvement.
Time frame: From Baseline (Day 1) to Day 84
Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Cream | Absolute Change From Baseline in the Individual Lesion Scores for Lesion Thickness | -0.45 score on a scale | Standard Deviation 0.775 |
| Ruxolitinib Phosphate 0.5% Cream | Absolute Change From Baseline in the Individual Lesion Scores for Lesion Thickness | -0.71 score on a scale | Standard Deviation 0.677 |
| Ruxolitinib Phosphate 1.0% Cream | Absolute Change From Baseline in the Individual Lesion Scores for Lesion Thickness | 0.84 score on a scale | Standard Deviation 0.898 |
| Ruxolitinib Phosphate 1.5% Cream | Absolute Change From Baseline in the Individual Lesion Scores for Lesion Thickness | -0.90 score on a scale | Standard Deviation 0.778 |
Secondary
Absolute Change From Baseline in the Percent Treatable Body Surface Area (BSA)
The lesion areas were estimated based on the Rule of Nines method for the entire skin surface; psoriatic disease activity and the percent BSA were calculated for the treatable areas (i.e., areas that excluded the scalp, face, and intertriginous areas). The BSA is calculated as follows: BSA (m\^²)=(\[Height(cm) x Weight(kg)\]/3600 )\^½. A negative change from Baseline indicates improvement.
Time frame: Baseline (Day 1) to Day 84
Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Cream | Absolute Change From Baseline in the Percent Treatable Body Surface Area (BSA) | -0.36 Percent treatable BSA | Standard Deviation 2.26 |
| Ruxolitinib Phosphate 0.5% Cream | Absolute Change From Baseline in the Percent Treatable Body Surface Area (BSA) | -1.63 Percent treatable BSA | Standard Deviation 3.746 |
| Ruxolitinib Phosphate 1.0% Cream | Absolute Change From Baseline in the Percent Treatable Body Surface Area (BSA) | -2.41 Percent treatable BSA | Standard Deviation 4.276 |
| Ruxolitinib Phosphate 1.5% Cream | Absolute Change From Baseline in the Percent Treatable Body Surface Area (BSA) | -1.94 Percent treatable BSA | Standard Deviation 3.545 |
Secondary
Absolute Change From Baseline in the Physician's Global Assessment (PGA) Score
The overall disease activity in the participants, a measure of the overall quality (erythema, scaling, and thickness) and extent (BSA) of plaques, was measured using the PGA. The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a 6-point scale ranging from 0 to 5 where 0 is 'Clear' (no evidence of disease) and 5 is 'very Severe' lesion. A negative change from Baseline indicates improvement. The ANCOVA method was used for analyses.
Time frame: Baseline (Day 1) to Day 84
Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Cream | Absolute Change From Baseline in the Physician's Global Assessment (PGA) Score | -0.34 score on a scale | Standard Deviation 0.76 |
| Ruxolitinib Phosphate 0.5% Cream | Absolute Change From Baseline in the Physician's Global Assessment (PGA) Score | -0.73 score on a scale | Standard Deviation 0.836 |
| Ruxolitinib Phosphate 1.0% Cream | Absolute Change From Baseline in the Physician's Global Assessment (PGA) Score | -0.92 score on a scale | Standard Deviation 1.077 |
| Ruxolitinib Phosphate 1.5% Cream | Absolute Change From Baseline in the Physician's Global Assessment (PGA) Score | -0.79 score on a scale | Standard Deviation 0.922 |
Secondary
Absolute Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring \[lower extremities, trunk (including stomach, chest, back), upper extremities, head\]; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by scale 0 (none) to 4 (severe). Final PASI is the sum of severity score for each area multiplied coverage for each section multiplied by area score weight of section (lower extremities: 0.4, trunk: 0.3, upper extremities: 0.2, head: 0.1). A negative change from baseline indicates improvement. The ANCOVA method was used for analyses.
Time frame: Baseline (Day 1) to Day 84
Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Cream | Absolute Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score | -1.49 score on a scale | Standard Deviation 2.999 |
| Ruxolitinib Phosphate 0.5% Cream | Absolute Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score | -3.47 score on a scale | Standard Deviation 3.951 |
| Ruxolitinib Phosphate 1.0% Cream | Absolute Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score | -3.48 score on a scale | Standard Deviation 4.204 |
| Ruxolitinib Phosphate 1.5% Cream | Absolute Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score | -2.93 score on a scale | Standard Deviation 3.599 |
Secondary
Percentage of Participants Achieving Clear (Score=0) and Almost Clear (Score=1) on the PGA
The overall disease activity in the participants, a measure of the overall quality (erythema, scaling, and thickness) and extent (BSA) of plaques, was measured using the PGA. The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a 6-point scale ranging from 0 to 5 where 0 indicates 'Clear' (no evidence of disease) and 5 indicates 'very Severe' lesion. Participants with individual lesion scores 0 (clear) and 1 (almost clear) are reported in this outcome measure.
Time frame: Day 84
Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle Cream | Percentage of Participants Achieving Clear (Score=0) and Almost Clear (Score=1) on the PGA | 4.3 percentage of participants |
| Ruxolitinib Phosphate 0.5% Cream | Percentage of Participants Achieving Clear (Score=0) and Almost Clear (Score=1) on the PGA | 12.2 percentage of participants |
| Ruxolitinib Phosphate 1.0% Cream | Percentage of Participants Achieving Clear (Score=0) and Almost Clear (Score=1) on the PGA | 32.7 percentage of participants |
| Ruxolitinib Phosphate 1.5% Cream | Percentage of Participants Achieving Clear (Score=0) and Almost Clear (Score=1) on the PGA | 12.5 percentage of participants |
Secondary
Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Erythema at Day 84
The individual lesion scores were calculated individually for thickness, erythema, and scaling. Lesion erythema was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. Participants with individual lesion scores 0 (none) and 1 (mild) are reported in this outcome measure. The LOCF method was used for analysis.
Time frame: Day 84
Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle Cream | Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Erythema at Day 84 | 19.1 percentage of participants |
| Ruxolitinib Phosphate 0.5% Cream | Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Erythema at Day 84 | 34.7 percentage of participants |
| Ruxolitinib Phosphate 1.0% Cream | Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Erythema at Day 84 | 46.9 percentage of participants |
| Ruxolitinib Phosphate 1.5% Cream | Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Erythema at Day 84 | 33.3 percentage of participants |
Secondary
Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Scaling at Day 84
The individual lesion scores were calculated individually for thickness, erythema, and scaling. Lesion scaling was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. Participants with individual lesion scores 0 (none) and 1 (mild) are reported in this outcome measure. The LOCF method was used for analysis.
Time frame: Day 84
Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle Cream | Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Scaling at Day 84 | 42.6 percentage of participants |
| Ruxolitinib Phosphate 0.5% Cream | Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Scaling at Day 84 | 61.2 percentage of participants |
| Ruxolitinib Phosphate 1.0% Cream | Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Scaling at Day 84 | 63.3 percentage of participants |
| Ruxolitinib Phosphate 1.5% Cream | Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Scaling at Day 84 | 50.0 percentage of participants |
Secondary
Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Thickness at Day 84
Lesion thickness was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. Participants with individual lesion scores 0 (none) and 1 (mild) are reported in this outcome measure.
Time frame: Day 84
Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle Cream | Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Thickness at Day 84 | 25.5 percentage of participants |
| Ruxolitinib Phosphate 0.5% Cream | Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Thickness at Day 84 | 55.1 percentage of participants |
| Ruxolitinib Phosphate 1.0% Cream | Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Thickness at Day 84 | 55.1 percentage of participants |
| Ruxolitinib Phosphate 1.5% Cream | Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Thickness at Day 84 | 50.0 percentage of participants |
Secondary
Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring \[lower extremities, trunk (including stomach, chest, back), upper extremities, head\]; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by scale 0 (none) to 4 (severe). Final PASI is the sum of severity score for each area\* multiplied by coverage for each section\* multiplied by area score weight of section (lower extremities: 0.4, trunk: 0.3, upper extremities: 0.2, head: 0.1). A negative percent change from Baseline indicates improvement. Data for Day 84 was imputed using the LOCF method.
Time frame: Baseline (Day 1) and Days 15, 28, 56, 84, and 112
Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number analyzed are the participants with percent treatable BSA of at least 10%.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 75% Reduction on Day 112 | 0.0 percentage of participants |
| Vehicle Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 50% Reduction on Day 15 | 0.0 percentage of participants |
| Vehicle Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 75% Reduction on Day 15 | 0.0 percentage of participants |
| Vehicle Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 90% Reduction on Day 112 | 0.0 percentage of participants |
| Vehicle Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 75% Reduction on Day 84 | 0.0 percentage of participants |
| Vehicle Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 75% Reduction on Day 56 | 0.0 percentage of participants |
| Vehicle Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 75% Reduction on Day 28 | 0.0 percentage of participants |
| Vehicle Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 90% Reduction on Day 84 | 0.0 percentage of participants |
| Vehicle Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 50% Reduction on Day 56 | 16.7 percentage of participants |
| Vehicle Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 90% Reduction on Day 56 | 0.0 percentage of participants |
| Vehicle Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 90% Reduction on Day 28 | 0.0 percentage of participants |
| Vehicle Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 50% Reduction on Day 84 | 18.8 percentage of participants |
| Vehicle Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 50% Reduction on Day 28 | 0.0 percentage of participants |
| Vehicle Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 90% Reduction on Day 15 | 0.0 percentage of participants |
| Vehicle Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 50% Reduction on Day 112 | 17.6 percentage of participants |
| Ruxolitinib Phosphate 0.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 75% Reduction on Day 84 | 30.0 percentage of participants |
| Ruxolitinib Phosphate 0.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 50% Reduction on Day 15 | 0.0 percentage of participants |
| Ruxolitinib Phosphate 0.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 50% Reduction on Day 28 | 11.1 percentage of participants |
| Ruxolitinib Phosphate 0.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 50% Reduction on Day 56 | 50.0 percentage of participants |
| Ruxolitinib Phosphate 0.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 50% Reduction on Day 84 | 60.0 percentage of participants |
| Ruxolitinib Phosphate 0.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 50% Reduction on Day 112 | 66.7 percentage of participants |
| Ruxolitinib Phosphate 0.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 75% Reduction on Day 15 | 0.0 percentage of participants |
| Ruxolitinib Phosphate 0.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 75% Reduction on Day 28 | 0.0 percentage of participants |
| Ruxolitinib Phosphate 0.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 75% Reduction on Day 56 | 25.0 percentage of participants |
| Ruxolitinib Phosphate 0.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 75% Reduction on Day 112 | 33.3 percentage of participants |
| Ruxolitinib Phosphate 0.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 90% Reduction on Day 15 | 0.0 percentage of participants |
| Ruxolitinib Phosphate 0.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 90% Reduction on Day 28 | 0.0 percentage of participants |
| Ruxolitinib Phosphate 0.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 90% Reduction on Day 56 | 0.0 percentage of participants |
| Ruxolitinib Phosphate 0.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 90% Reduction on Day 84 | 0.0 percentage of participants |
| Ruxolitinib Phosphate 0.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 90% Reduction on Day 112 | 0.0 percentage of participants |
| Ruxolitinib Phosphate 1.0% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 75% Reduction on Day 15 | 5.0 percentage of participants |
| Ruxolitinib Phosphate 1.0% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 75% Reduction on Day 84 | 15.0 percentage of participants |
| Ruxolitinib Phosphate 1.0% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 50% Reduction on Day 112 | 31.6 percentage of participants |
| Ruxolitinib Phosphate 1.0% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 50% Reduction on Day 15 | 20.0 percentage of participants |
| Ruxolitinib Phosphate 1.0% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 75% Reduction on Day 112 | 15.8 percentage of participants |
| Ruxolitinib Phosphate 1.0% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 90% Reduction on Day 112 | 15.8 percentage of participants |
| Ruxolitinib Phosphate 1.0% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 90% Reduction on Day 15 | 0.0 percentage of participants |
| Ruxolitinib Phosphate 1.0% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 90% Reduction on Day 28 | 0.0 percentage of participants |
| Ruxolitinib Phosphate 1.0% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 50% Reduction on Day 56 | 21.1 percentage of participants |
| Ruxolitinib Phosphate 1.0% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 90% Reduction on Day 56 | 5.3 percentage of participants |
| Ruxolitinib Phosphate 1.0% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 50% Reduction on Day 84 | 45.0 percentage of participants |
| Ruxolitinib Phosphate 1.0% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 90% Reduction on Day 84 | 15.0 percentage of participants |
| Ruxolitinib Phosphate 1.0% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 75% Reduction on Day 28 | 5.6 percentage of participants |
| Ruxolitinib Phosphate 1.0% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 50% Reduction on Day 28 | 33.3 percentage of participants |
| Ruxolitinib Phosphate 1.0% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 75% Reduction on Day 56 | 10.5 percentage of participants |
| Ruxolitinib Phosphate 1.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 50% Reduction on Day 112 | 17.6 percentage of participants |
| Ruxolitinib Phosphate 1.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 50% Reduction on Day 15 | 18.8 percentage of participants |
| Ruxolitinib Phosphate 1.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 75% Reduction on Day 84 | 12.5 percentage of participants |
| Ruxolitinib Phosphate 1.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 75% Reduction on Day 28 | 0.0 percentage of participants |
| Ruxolitinib Phosphate 1.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 90% Reduction on Day 56 | 7.7 percentage of participants |
| Ruxolitinib Phosphate 1.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 50% Reduction on Day 28 | 25.0 percentage of participants |
| Ruxolitinib Phosphate 1.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 75% Reduction on Day 112 | 11.8 percentage of participants |
| Ruxolitinib Phosphate 1.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 50% Reduction on Day 84 | 37.5 percentage of participants |
| Ruxolitinib Phosphate 1.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 75% Reduction on Day 15 | 0.0 percentage of participants |
| Ruxolitinib Phosphate 1.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 75% Reduction on Day 56 | 7.7 percentage of participants |
| Ruxolitinib Phosphate 1.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 90% Reduction on Day 15 | 0.0 percentage of participants |
| Ruxolitinib Phosphate 1.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 50% Reduction on Day 56 | 38.5 percentage of participants |
| Ruxolitinib Phosphate 1.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 90% Reduction on Day 112 | 5.9 percentage of participants |
| Ruxolitinib Phosphate 1.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 90% Reduction on Day 84 | 6.3 percentage of participants |
| Ruxolitinib Phosphate 1.5% Cream | Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point | Achieved 90% Reduction on Day 28 | 0.0 percentage of participants |
Secondary
Percent Change From Baseline in the Individual Lesion Scores of Lesion Erythema
Lesion erythema was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative percent change from Baseline indicates improvement in lesion.
Time frame: From Baseline (Day 1) to Day 84
Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Cream | Percent Change From Baseline in the Individual Lesion Scores of Lesion Erythema | -15.40 percent change | Standard Deviation 22.146 |
| Ruxolitinib Phosphate 0.5% Cream | Percent Change From Baseline in the Individual Lesion Scores of Lesion Erythema | -22.53 percent change | Standard Deviation 27.702 |
| Ruxolitinib Phosphate 1.0% Cream | Percent Change From Baseline in the Individual Lesion Scores of Lesion Erythema | -30.74 percent change | Standard Deviation 39.404 |
| Ruxolitinib Phosphate 1.5% Cream | Percent Change From Baseline in the Individual Lesion Scores of Lesion Erythema | -23.93 percent change | Standard Deviation 35.828 |
Secondary
Percent Change From Baseline in the Individual Lesion Scores of Lesion Scaling
Lesion scaling was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative percent change from Baseline indicates improvement in lesion.
Time frame: From Baseline (Day 1) to Day 84
Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Cream | Percent Change From Baseline in the Individual Lesion Scores of Lesion Scaling | -17.68 percent change | Standard Deviation 38.175 |
| Ruxolitinib Phosphate 0.5% Cream | Percent Change From Baseline in the Individual Lesion Scores of Lesion Scaling | -37.13 percent change | Standard Deviation 28.05 |
| Ruxolitinib Phosphate 1.0% Cream | Percent Change From Baseline in the Individual Lesion Scores of Lesion Scaling | -35.38 percent change | Standard Deviation 44.14 |
| Ruxolitinib Phosphate 1.5% Cream | Percent Change From Baseline in the Individual Lesion Scores of Lesion Scaling | -36.11 percent change | Standard Deviation 41.286 |
Secondary
Percent Change From Baseline in the Individual Lesion Scores of Lesion Thickness
Lesion thickness was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative percent change from Baseline indicates improvement in lesion.
Time frame: From Baseline (Day 1) to Day 84
Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Cream | Percent Change From Baseline in the Individual Lesion Scores of Lesion Thickness | -17.37 percent change | Standard Deviation 31.075 |
| Ruxolitinib Phosphate 0.5% Cream | Percent Change From Baseline in the Individual Lesion Scores of Lesion Thickness | -30.95 percent change | Standard Deviation 27.851 |
| Ruxolitinib Phosphate 1.0% Cream | Percent Change From Baseline in the Individual Lesion Scores of Lesion Thickness | -36.56 percent change | Standard Deviation 38.447 |
| Ruxolitinib Phosphate 1.5% Cream | Percent Change From Baseline in the Individual Lesion Scores of Lesion Thickness | -36.80 percent change | Standard Deviation 33.016 |
Secondary
Percent Change From Baseline in the PASI Score
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring \[lower extremities, trunk (including stomach, chest, back), upper extremities, head\]; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by scale 0 (none) to 4 (severe). Final PASI is the sum of severity score for each area multiplied by coverage for each section multiplied by area score weight of section (lower extremities: 0.4, trunk: 0.3, upper extremities: 0.2, head: 0.1). A percent negative change from baseline indicates improvement in disease. The ANCOVA method was used for analyses.
Time frame: Baseline (Day 1) to Day 84
Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Cream | Percent Change From Baseline in the PASI Score | -18.45 percent change | Standard Deviation 29.907 |
| Ruxolitinib Phosphate 0.5% Cream | Percent Change From Baseline in the PASI Score | -34.19 percent change | Standard Deviation 40.532 |
| Ruxolitinib Phosphate 1.0% Cream | Percent Change From Baseline in the PASI Score | -39.97 percent change | Standard Deviation 38.215 |
| Ruxolitinib Phosphate 1.5% Cream | Percent Change From Baseline in the PASI Score | -32.81 percent change | Standard Deviation 38.995 |
Secondary
Percent Change From Baseline in the PGA Score
The overall disease activity in the participants, a measure of the overall quality (erythema, scaling, and thickness) and extent (BSA) of plaques, was measured using the PGA. The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a 6-point scale ranging from 0 to 5 where 0 indicates 'Clear' (no evidence of disease) and 5 indicates 'very Severe' lesion. A negative percent change indicates improvement. The ANCOVA method was used for analyses.
Time frame: Baseline (Day 1) to Day 84
Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Cream | Percent Change From Baseline in the PGA Score | -9.09 percent change from baseline | Standard Deviation 23.624 |
| Ruxolitinib Phosphate 0.5% Cream | Percent Change From Baseline in the PGA Score | -22.10 percent change from baseline | Standard Deviation 24.626 |
| Ruxolitinib Phosphate 1.0% Cream | Percent Change From Baseline in the PGA Score | -29.69 percent change from baseline | Standard Deviation 34.344 |
| Ruxolitinib Phosphate 1.5% Cream | Percent Change From Baseline in the PGA Score | -23.33 percent change from baseline | Standard Deviation 26.485 |
Secondary
Trough Plasma Concentrations [Minimum Concentration at Steady-state (Css,Min)] of Ruxolitinib Phosphate Prior to Study Drug Application at Steady State
Time frame: Pre-application on Days 1, 15, 28, 56, and 84
Population: All participants who used at least one application of study medication, and provided at least one plasma sample were considered potentially evaluable for the pharmacokinetic (PK)/ pharmacodynamic (PD) population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Cream | Trough Plasma Concentrations [Minimum Concentration at Steady-state (Css,Min)] of Ruxolitinib Phosphate Prior to Study Drug Application at Steady State | 9.19 nanomolar (nM) | Standard Deviation 11.77 |
| Ruxolitinib Phosphate 0.5% Cream | Trough Plasma Concentrations [Minimum Concentration at Steady-state (Css,Min)] of Ruxolitinib Phosphate Prior to Study Drug Application at Steady State | 16.99 nanomolar (nM) | Standard Deviation 19.05 |
| Ruxolitinib Phosphate 1.0% Cream | Trough Plasma Concentrations [Minimum Concentration at Steady-state (Css,Min)] of Ruxolitinib Phosphate Prior to Study Drug Application at Steady State | 19.97 nanomolar (nM) | Standard Deviation 25.13 |