A Phase 2 interventional study of Placebo Cream and Ruxolitinib Phosphate in Psoriasis, sponsored by Incyte Corporation. Completed at 28 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-02-09.
Sponsored by Incyte Corporation · Phase 2, Interventional, and Treatment
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.
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Exclusion Criteria:
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
Other: Placebo Cream
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
Drug: Ruxolitinib Phosphate
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
Drug: Ruxolitinib Phosphate
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
Drug: Ruxolitinib Phosphate
Cream with no active drug
Ruxolitinib phosphate cream
Also known as: INCB018424
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
A total of 199 participants were enrolled at 27 sites in the United States from 28 October 2008 to 26 June 2009.
| Milestone | Vehicle Cream | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream |
|---|---|---|---|---|
| Started | 50 | 51 | 49 | 49 |
| Completed | 32 | 44 | 43 | 36 |
| Not completed | 18 | 7 | 6 | 13 |
| Withdrew: Adverse event | 6 | 1 | 3 | 5 |
| Withdrew: Protocol violation | 1 | 1 | 0 | 0 |
| Withdrew: Subject withdrew consent | 6 | 4 | 1 | 4 |
| Withdrew: Lost to follow-up | 3 | 1 | 0 | 1 |
| Withdrew: Reason not specified | 2 | 0 | 1 | 3 |
| Withdrew: Other | 0 | 0 | 1 | 0 |
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.
| score on a scale | Vehicle Cream | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream |
|---|---|---|---|---|
| Absolute Change From Baseline in Total Lesion Score for All Treatable Psoriatic Lesions to Day 84 | -1.07 ± 0.290 | -2.25 ± 0.284 | -2.47 ± 0.285 | -2.27 ± 0.287 |
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.
| score on a scale | Vehicle Cream | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream |
|---|---|---|---|---|
| Absolute Change From Baseline in the Individual Lesion Scores for Lesion Thickness | -0.45 ± 0.775 | -0.71 ± 0.677 | 0.84 ± 0.898 | -0.90 ± 0.778 |
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.
| score on a scale | Vehicle Cream | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream |
|---|---|---|---|---|
| Absolute Change From Baseline in the Individual Lesion Scores for Lesion Erythema | -0.45 ± 0.711 | -0.59 ± 0.757 | -0.72 ± 0.889 | -0.64 ± 0.872 |
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.
| score on a scale | Vehicle Cream | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream |
|---|---|---|---|---|
| Absolute Change From Baseline in the Individual Lesion Scores for Lesion Scaling | -0.46 ± 0.972 | -0.91 ± 0.741 | -0.87 ± 0.991 | -0.85 ± 0.961 |
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 | Vehicle Cream | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream |
|---|---|---|---|---|
| Percent Change From Baseline in the Individual Lesion Scores of Lesion Thickness | -17.37 ± 31.075 | -30.95 ± 27.851 | -36.56 ± 38.447 | -36.80 ± 33.016 |
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 | Vehicle Cream | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream |
|---|---|---|---|---|
| Percent Change From Baseline in the Individual Lesion Scores of Lesion Erythema | -15.40 ± 22.146 | -22.53 ± 27.702 | -30.74 ± 39.404 | -23.93 ± 35.828 |
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.
| percent change | Vehicle Cream | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream |
|---|---|---|---|---|
| Percent Change From Baseline in the Individual Lesion Scores of Lesion Scaling | -17.68 ± 38.175 | -37.13 ± 28.050 | -35.38 ± 44.140 | -36.11 ± 41.286 |
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 | Vehicle Cream | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream |
|---|---|---|---|---|
| Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Thickness at Day 84 | 25.5 | 55.1 | 55.1 | 50.0 |
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 | Vehicle Cream | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream |
|---|---|---|---|---|
| Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Erythema at Day 84 | 19.1 | 34.7 | 46.9 | 33.3 |
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.
| percentage of participants | Vehicle Cream | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream |
|---|---|---|---|---|
| Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Scaling at Day 84 | 42.6 | 61.2 | 63.3 | 50.0 |
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.
| Percent treatable BSA | Vehicle Cream | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream |
|---|---|---|---|---|
| Absolute Change From Baseline in the Percent Treatable Body Surface Area (BSA) | -0.36 ± 2.260 | -1.63 ± 3.746 | -2.41 ± 4.276 | -1.94 ± 3.545 |
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.
| score on a scale | Vehicle Cream | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream |
|---|---|---|---|---|
| Absolute Change From Baseline in the Physician's Global Assessment (PGA) Score | -0.34 ± 0.760 | -0.73 ± 0.836 | -0.92 ± 1.077 | -0.79 ± 0.922 |
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.
| percent change from baseline | Vehicle Cream | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream |
|---|---|---|---|---|
| Percent Change From Baseline in the PGA Score | -9.09 ± 23.624 | -22.10 ± 24.626 | -29.69 ± 34.344 | -23.33 ± 26.485 |
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.
| percentage of participants | Vehicle Cream | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream |
|---|---|---|---|---|
| Percentage of Participants Achieving Clear (Score=0) and Almost Clear (Score=1) on the PGA | 4.3 | 12.2 | 32.7 | 12.5 |
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.
| score on a scale | Vehicle Cream | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream |
|---|---|---|---|---|
| Absolute Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score | -1.49 ± 2.999 | -3.47 ± 3.951 | -3.48 ± 4.204 | -2.93 ± 3.599 |
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.
| percent change | Vehicle Cream | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream |
|---|---|---|---|---|
| Percent Change From Baseline in the PASI Score | -18.45 ± 29.907 | -34.19 ± 40.532 | -39.97 ± 38.215 | -32.81 ± 38.995 |
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.
| percentage of participants | Vehicle Cream | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream |
|---|---|---|---|---|
| Achieved 50% Reduction on Day 15 | 0.0 | 0.0 | 20.0 | 18.8 |
| Achieved 50% Reduction on Day 28 | 0.0 | 11.1 | 33.3 | 25.0 |
| Achieved 50% Reduction on Day 56 | 16.7 | 50.0 | 21.1 | 38.5 |
| Achieved 50% Reduction on Day 84 | 18.8 | 60.0 | 45.0 | 37.5 |
| Achieved 50% Reduction on Day 112 | 17.6 | 66.7 | 31.6 | 17.6 |
| Achieved 75% Reduction on Day 15 | 0.0 | 0.0 | 5.0 | 0.0 |
| Achieved 75% Reduction on Day 28 | 0.0 | 0.0 | 5.6 | 0.0 |
| Achieved 75% Reduction on Day 56 | 0.0 | 25.0 | 10.5 | 7.7 |
| Achieved 75% Reduction on Day 84 | 0.0 | 30.0 | 15.0 | 12.5 |
| Achieved 75% Reduction on Day 112 | 0.0 | 33.3 | 15.8 | 11.8 |
| Achieved 90% Reduction on Day 15 | 0.0 | 0.0 | 0.0 | 0.0 |
| Achieved 90% Reduction on Day 28 | 0.0 | 0.0 | 0.0 | 0.0 |
| Achieved 90% Reduction on Day 56 | 0.0 | 0.0 | 5.3 | 7.7 |
| Achieved 90% Reduction on Day 84 | 0.0 | 0.0 | 15.0 | 6.3 |
| Achieved 90% Reduction on Day 112 | 0.0 | 0.0 | 15.8 | 5.9 |
| nanomolar (nM) | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream |
|---|---|---|---|
| Trough Plasma Concentrations [Minimum Concentration at Steady-state (Css,Min)] of Ruxolitinib Phosphate Prior to Study Drug Application at Steady State | 9.19 ± 11.77 | 16.99 ± 19.05 | 19.97 ± 25.13 |
Collected over From first dose up to 28 days after last dose of study drug (Up to 16 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vehicle Cream | 0/50 (0%) | 1/50 (2%) | 11/50 (22%) |
| Ruxolitinib Phosphate 0.5% Cream | 0/51 (0%) | 2/51 (3.9%) | 11/51 (21.6%) |
| Ruxolitinib Phosphate 1.0% Cream | 0/49 (0%) | 0/49 (0%) | 16/49 (32.7%) |
| Ruxolitinib Phosphate 1.5% Cream | 0/49 (0%) | 3/49 (6.1%) | 18/49 (36.7%) |
| Total | 0/199 (0%) | 6/199 (3%) | 56/199 (28.1%) |
| Event | Vehicle Cream | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream | Total |
|---|---|---|---|---|---|
| CholelithiasisHepatobiliary disorders | 0/50 | 0/51 | 0/49 | 1/49 | 1/199 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 0/50 | 0/51 | 0/49 | 1/49 | 1/199 |
| Procedural painInjury, poisoning and procedural complications | 0/50 | 0/51 | 0/49 | 1/49 | 1/199 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/50 | 0/51 | 0/49 | 1/49 | 1/199 |
| Cerebrovascular accidentNervous system disorders | 1/50 | 0/51 | 0/49 | 0/49 | 1/199 |
| Coronary artery occlusionCardiac disorders | 0/50 | 1/51 | 0/49 | 0/49 | 1/199 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 0/50 | 1/51 | 0/49 | 0/49 | 1/199 |
| Event | Vehicle Cream | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream | Total |
|---|---|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 3/50 | 6/51 | 1/49 | 3/49 | 13/199 |
| Application site irritationGeneral disorders | 3/50 | 1/51 | 2/49 | 5/49 | 11/199 |
| NasopharyngitisInfections and infestations | 1/50 | 2/51 | 3/49 | 5/49 | 11/199 |
| Application site pruritusGeneral disorders | 4/50 | 2/51 | 2/49 | 2/49 | 10/199 |
| Electrocardiogram QT interval abnormalInvestigations | 0/50 | 0/51 | 2/49 | 3/49 | 5/199 |
| GastroenteritisInfections and infestations | 1/50 | 0/51 | 0/49 | 3/49 | 4/199 |
| HeadacheNervous system disorders | 0/50 | 0/51 | 3/49 | 1/49 | 4/199 |
| InfluenzaInfections and infestations | 2/50 | 0/51 | 3/49 | 1/49 | 6/199 |
| SinusitisInfections and infestations | 1/50 | 1/51 | 3/49 | 2/49 | 7/199 |
| Back painMusculoskeletal and connective tissue disorders | 0/50 | 3/51 | 1/49 | 1/49 | 5/199 |
Safety population included all participants who were enrolled and used at least one application of study drug.
| Age, Continuous(years) | Vehicle | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream | Total |
|---|---|---|---|---|---|
| Mean | 42.3 ± 10.94 | 45.4 ± 10.91 | 44.9 ± 13.03 | 43.6 ± 12.80 | 44.0 ± 11.92 |
| Sex: Female, Male(Participants) | Vehicle | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream | Total |
|---|---|---|---|---|---|
| Female | 17 | 20 | 24 | 23 | 84 |
| Male | 33 | 31 | 25 | 26 | 115 |
| Ethnicity (NIH/OMB)(Participants) | Vehicle | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 9 | 6 | 8 | 3 | 26 |
| Not Hispanic or Latino | 41 | 45 | 41 | 46 | 173 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Vehicle | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream | Total |
|---|---|---|---|---|---|
| White or Caucasian Native | 45 | 46 | 46 | 48 | 185 |
| Black or African American | 2 | 2 | 1 | 1 | 6 |
| Asian | 1 | 0 | 1 | 0 | 2 |
| Other | 2 | 3 | 1 | 0 | 6 |
| Total Lesion Score(score on a scale) | Vehicle | Ruxolitinib Phosphate 0.5% Cream | Ruxolitinib Phosphate 1.0% Cream | Ruxolitinib Phosphate 1.5% Cream | Total |
|---|---|---|---|---|---|
| Mean | 7.2 (5 to 11) | 7.1 (5 to 10) | 6.7 (5 to 11) | 7.1 (5 to 12) | 7.0 (5 to 12) |
Plan to share: Yes — Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Supporting information: Study protocol, Sap
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