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This will be an open label study of ruxolitinib topical cream applied to 2 - 20% BSA in patients with active, stable plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a small percent BSA. |
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| Group B | Experimental | Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 1. |
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| Group C | Experimental | Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib | Drug | Ruxolitinib 1.5% cream BID for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment of Emergent Adverse Events | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment | Approximately 3 months |
| Pharmacokinetics Parameter : Skin Flux of INCB018424 | The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study. | Days 1, 4, 8, 15, 22, and 28-30 |
| Pharmacokinetics Parameter: Bioavailability of INCB018424 | The INCB018424 bioavailability was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study. | Approximately one month: Days 1, 4, 8, 15, 22, and 28 |
| Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424 | All observed INCB018424 plasma concentrations from Days 8, 15, 22, and 28 were averaged to obtain an overall mean exposure for each subject. Samples were taken pre-dose and approximately one hour post-dose. | Approximately one month: Days 1, 4, 8, 15, 22, and 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Changes in total lesion scores were compared to baseline score. Lesions were compared between active treated areas INCB018424 and control areas of the same subject (within-subject comparisons) using one sample t-test. Total lesion score was calculated as the sum of the scores for Thickness (T), erythema (E), and scaling (S) for the target and control lesions. All individual scores use a 5-point scale ranging from 0 (none) to 4 (severe) with increasing score reflecting increased lesion severity. These ratings are then added to create a total score ranging from 0 to 12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Williams, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fridley | Minnesota | 55432 | United States | |||
A total of 25 participants with active but stable plaque psoriasis were enrolled in the dose-escalation study.
The study was conducted at 6 study centers in the United States from 08 November 2007 to 13 April 2009. This study is completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A | 2% to 7% of BSA treated BID with INCB018424 1.5% cream |
| FG001 | Cohort B | 8% to 13% of BSA treated BID with INCB018424 1.5% cream |
| FG002 | Cohort C | 14% to 20% of BSA treated QD with INCB018424 1.5% cream |
| FG003 | Cohort D | 14% to 20% of BSA treated BID with INCB018424 1.0% cream |
| FG004 | Cohort E | 14% to 20% of BSA treated BID with INCB018424 1.5% cream |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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ITT: The intent-to-treat (ITT) population included all enrolled participants who applied INCB018424 cream at least once and had a predose and at least one post-dose lesion assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A | 2% to 7% of BSA treated BID with INCB018424 1.5% cream |
| BG001 | Cohort B | 8% to 13% of BSA treated BID with INCB018424 1.5% cream |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Treatment of Emergent Adverse Events | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment | Posted | Count of Participants | Participants | Approximately 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A | 2 to 7% of BSA treated BID with INCB018424 1.5% cream | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Schizophrenia, paranoid type | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Incyte Corporation Call Center (US) | Incyte | 1.855.463.3463 | medinfo@incyte.com |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
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| Approximately 2 months (Days 1, 8, 15, 22, 28 and up to an additional 28 day Follow-Up) |
| Mean Change in Psoriatic Lesion Area | The target and control lesion areas were determined in an objective manner on Day 1 and Day 28 based on a tracing of the perimeter of the lesions on transparency film and measurement of the area. | Days 1 and 28 |
| Mean Change in Physicians Global Assessment Score | The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a scale that ranged from 0 (clear) to 6 (most severe) in whole-unit increments. Note that, for analysis purposes, the scale was adjusted to range from 1 (clear) to 7 (most severe) to allow for the evaluation of mean scores. | Approximately 2 months: Days 1, 8, 15, 22, 28 and follow-up approximately one month later |
| Rochester |
| New York |
| 14623 |
| United States |
| Austin | Texas | 78759 | United States |
| College Station | Texas | 77840 | United States |
| BG002 | Cohort C | 14% to 20% of BSA treated QD with INCB018424 1.5% cream |
| BG003 | Cohort D | 14% to 20% of BSA treated BID with INCB018424 1.0% cream |
| BG004 | Cohort E | 14% to 20% of BSA treated BID with INCB018424 1.5% cream |
| BG005 | Total | Total of all reporting groups |
| Years |
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| Sex/Gender, Customized | Number | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| OG003 | Cohort D | 14% to 20% of BSA treated BID with INCB018424 1.0% cream |
| OG004 | Cohort E | 14% to 20% of BSA treated BID with INCB018424 1.5% cream |
|
|
| Primary | Pharmacokinetics Parameter : Skin Flux of INCB018424 | The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study. | Posted | Mean | Standard Deviation | ng/cm^2/h | Days 1, 4, 8, 15, 22, and 28-30 |
|
|
|
| Primary | Pharmacokinetics Parameter: Bioavailability of INCB018424 | The INCB018424 bioavailability was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study. | Posted | Mean | Standard Deviation | percentage | Approximately one month: Days 1, 4, 8, 15, 22, and 28 |
|
|
|
| Secondary | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Changes in total lesion scores were compared to baseline score. Lesions were compared between active treated areas INCB018424 and control areas of the same subject (within-subject comparisons) using one sample t-test. Total lesion score was calculated as the sum of the scores for Thickness (T), erythema (E), and scaling (S) for the target and control lesions. All individual scores use a 5-point scale ranging from 0 (none) to 4 (severe) with increasing score reflecting increased lesion severity. These ratings are then added to create a total score ranging from 0 to 12. | Posted | Mean | 95% Confidence Interval | Change in Total Score | Approximately 2 months (Days 1, 8, 15, 22, 28 and up to an additional 28 day Follow-Up) |
|
|
|
| Secondary | Mean Change in Psoriatic Lesion Area | The target and control lesion areas were determined in an objective manner on Day 1 and Day 28 based on a tracing of the perimeter of the lesions on transparency film and measurement of the area. | Posted | Mean | Standard Deviation | cm^2 | Days 1 and 28 |
|
|
|
| Secondary | Mean Change in Physicians Global Assessment Score | The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a scale that ranged from 0 (clear) to 6 (most severe) in whole-unit increments. Note that, for analysis purposes, the scale was adjusted to range from 1 (clear) to 7 (most severe) to allow for the evaluation of mean scores. | Posted | Mean | Standard Deviation | Score | Approximately 2 months: Days 1, 8, 15, 22, 28 and follow-up approximately one month later |
|
|
|
| Primary | Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424 | All observed INCB018424 plasma concentrations from Days 8, 15, 22, and 28 were averaged to obtain an overall mean exposure for each subject. Samples were taken pre-dose and approximately one hour post-dose. | Posted | Mean | Standard Deviation | nM | Approximately one month: Days 1, 4, 8, 15, 22, and 28 |
|
|
|
| 5 |
| 0 |
| 5 |
| 2 |
| 5 |
| EG001 | Cohort B | 8 to 13% of BSA treated BID with INCB018424 1.5% cream BID | 0 | 5 | 0 | 5 | 4 | 5 |
| EG002 | Cohort C | 14 to 20% of BSA treated QD with INCB018424 1.5% cream QD | 0 | 5 | 1 | 5 | 2 | 5 |
| EG003 | Cohort D | 14-20% of BSA with INCB018424 1.0% cream BID | 0 | 5 | 0 | 5 | 1 | 5 |
| EG004 | Cohort E | 14 to 20% of BSA treated BID with INCB018424 1.5% cream BID | 0 | 5 | 0 | 5 | 2 | 5 |
| EG005 | Total | Total | 0 | 25 | 1 | 25 | 11 | 25 |
| Application site irritation | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Reticulocytosis | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
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| Scratch | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA 10.1 | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
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| Tension headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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Clinical Study Agreement
| Day 15 |
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| Day 22 |
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| Day 28 |
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| Follow-up |
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| Day 1 |
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| Day 8 |
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| Day 15 |
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| Day 22 |
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| Day 28 |
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| Follow-up |
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