| 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. | 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. | Posted | | Least Squares Mean | Standard Error | score on a scale | | From Baseline (Day 1) to Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle Cream | Vehicle cream, applied topically, once daily from Day 1 to Week 12. | | OG001 | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12. | | OG002 | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12. | | OG003 | Ruxolitinib Phosphate 1.5% Cream | Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12. |
| | Units | Counts |
|---|
| Participants | - OG00047
- OG00149
- OG00249
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-1.07± 0.290
- OG001-2.25± 0.284
- OG002-2.47± 0.285
- OG003
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | The ANCOVA model included treatment as the main factor and Baseline score as the covariate. | 0.0041 | | Least Squares (LS) Mean Difference | -1.18 | Standard Error of the Mean | 0.406 | 2-Sided | 90 | -1.85 | -0.51 | | | | | Superiority | | | | | ANCOVA |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | From Baseline (Day 1) to Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle Cream | Vehicle cream, applied topically, once daily from Day 1 to Week 12. | | OG001 | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12. | | OG002 | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12. | | OG003 | Ruxolitinib Phosphate 1.5% Cream |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | From Baseline (Day 1) to Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle Cream | Vehicle cream, applied topically, once daily from Day 1 to Week 12. | | OG001 | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12. | | OG002 | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12. | | OG003 | Ruxolitinib Phosphate 1.5% Cream |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | From Baseline (Day 1) to Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle Cream | Vehicle cream, applied topically, once daily from Day 1 to Week 12. | | OG001 | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12. | | OG002 | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12. | | OG003 | Ruxolitinib Phosphate 1.5% Cream |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | percent change | | From Baseline (Day 1) to Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle Cream | Vehicle cream, applied topically, once daily from Day 1 to Week 12. | | OG001 | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12. | | OG002 | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12. | | OG003 | Ruxolitinib Phosphate 1.5% Cream |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | percent change | | From Baseline (Day 1) to Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle Cream | Vehicle cream, applied topically, once daily from Day 1 to Week 12. | | OG001 | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12. | | OG002 | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12. | | OG003 | Ruxolitinib Phosphate 1.5% Cream |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | percent change | | From Baseline (Day 1) to Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle Cream | Vehicle cream, applied topically, once daily from Day 1 to Week 12. | | OG001 | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12. | | OG002 | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12. | | OG003 | Ruxolitinib Phosphate 1.5% Cream |
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| 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. | 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. | Posted | | Number | | percentage of participants | | Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle Cream | Vehicle cream, applied topically, once daily from Day 1 to Week 12. | | OG001 | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12. | | OG002 | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12. | | OG003 | Ruxolitinib Phosphate 1.5% Cream | |
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| 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. | 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. | Posted | | Number | | percentage of participants | | Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle Cream | Vehicle cream, applied topically, once daily from Day 1 to Week 12. | | OG001 | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12. | | OG002 | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12. | | OG003 |
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| 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. | 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. | Posted | | Number | | percentage of participants | | Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle Cream | Vehicle cream, applied topically, once daily from Day 1 to Week 12. | | OG001 | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12. | | OG002 | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12. | | OG003 |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | Percent treatable BSA | | Baseline (Day 1) to Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle Cream | Vehicle cream, applied topically, once daily from Day 1 to Week 12. | | OG001 | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12. | | OG002 | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1) to Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle Cream | Vehicle cream, applied topically, once daily from Day 1 to Week 12. | | OG001 | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12. | | OG002 | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | percent change from baseline | | Baseline (Day 1) to Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle Cream | Vehicle cream, applied topically, once daily from Day 1 to Week 12. | | OG001 | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12. | | OG002 | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12. |
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| 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. | 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. | Posted | | Number | | percentage of participants | | Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle Cream | Vehicle cream, applied topically, once daily from Day 1 to Week 12. | | OG001 | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12. | | OG002 | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1) to Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle Cream | Vehicle cream, applied topically, once daily from Day 1 to Week 12. | | OG001 | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | percent change | | Baseline (Day 1) to Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle Cream | Vehicle cream, applied topically, once daily from Day 1 to Week 12. | | OG001 | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12. |
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| 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. | 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%. | Posted | | Number | | percentage of participants | | Baseline (Day 1) and Days 15, 28, 56, 84, and 112 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle Cream | Vehicle cream, applied topically, once daily from Day 1 to Week 12. | | OG001 | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12. |
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| Secondary | Trough Plasma Concentrations [Minimum Concentration at Steady-state (Css,Min)] of Ruxolitinib Phosphate Prior to Study Drug Application at Steady State | | 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. | Posted | | Mean | Standard Deviation | nanomolar (nM) | | Pre-application on Days 1, 15, 28, 56, and 84 | | | | ID | Title | Description |
|---|
| OG000 | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12. | | OG001 | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12. | | OG002 | Ruxolitinib Phosphate 1.5% Cream | Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12. |
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