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To characterize the efficacy, safety and tolerability of SNA-120 at 2 doses versus placebo when administered topically for the treatment of pruritus associated with psoriasis vulgaris (PV) and PV itself.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SNA-120 (0.05% ) | Active Comparator | Pegcantratinib Ointment |
|
| SNA-120 (0.5%) | Active Comparator | Pegcantratinib Ointment |
|
| Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNA-120 | Drug | Pegcantratinib ointment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Itch Numeric Rating Scale scores (I-NRS) | The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching | week 1 |
| Change in Itch Numeric Rating Scale scores (I-NRS) | The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching | week 2 |
| Change in Itch Numeric Rating Scale scores (I-NRS) | The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching | week 4 |
| Change in Itch Numeric Rating Scale scores (I-NRS) | The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching | week 6 |
| Change in Itch Numeric Rating Scale scores (I-NRS) | The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching | week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects (≥ 1 grade change) on IGA scale | Investigator Global Assessment | week 12 |
| Proportion of subjects (≥ 2 grade change) on IGA scale | Investigator Global Assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by incidence and severity of adverse events | up to 12 weeks | |
| Safety measured by change in clinical laboratory results from baseline | urinalysis lab assessments | up to 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 025 | Scottsdale | Arizona | 85255 | United States | ||
| Sienna 022 |
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| Vehicle |
| Drug |
Placebo ointment to mimic Pegcantratinib ointment |
|
| week 12 |
| Proportion of subjects categorized as a "0" or "1" on IGA scale and minimum improvement of 2 categories | Investigator Global Assessment | baseline and week 12 |
| Change in PASI-50 | Percentage of subjects with 50% reductions in Psoriasis Area and Severity Index | baseline and week 12 |
| Safety measured by change in clinical laboratory results from baseline | biochemistry lab assessments | up to 12 weeks |
| Safety measured by change in clinical laboratory results from baseline | hematology lab assessments | up to 12 weeks |
| Safety measured by change in blood pressure from baseline | systolic/diastolic blood pressure (BP in mmHg) | up to 12 weeks |
| Safety measured by change in pulse from baseline | Pulse (beats per minute [bpm]) | up to 12 weeks |
| Safety measured by number of abnormal physical examination changes | Any abnormal physical examination changes from baseline and week 12 | baseline and week 12 |
| Safety measured by PR/PQ intervals measured by 12-lead ECG | week 2 |
| Safety measured by PR/PQ intervals measured by 12-lead ECG | week 8 |
| Safety measured by PR/PQ intervals measured by 12-lead ECG | week 12 |
| Safety measured by QRS duration measured by 12-lead ECG | week 2 |
| Safety measured by QRS duration measured by 12-lead ECG | week 8 |
| Safety measured by QRS duration measured by 12-lead ECG | week 12 |
| Safety measured by QT interval measure by 12-lead ECG | week 2 |
| Safety measured by QT interval measure by 12-lead ECG | week 8 |
| Safety measured by QT interval measure by 12-lead ECG | week 12 |
| Fort Smith |
| Arkansas |
| 72916 |
| United States |
| Site 028 | Fountain Valley | California | 92708 | United States |
| Sienna 009 | Fremont | California | 94538 | United States |
| Sienna 008 | San Diego | California | 92123 | United States |
| Sienna 020 | Santa Monica | California | 90404 | United States |
| Sienna 015 | Denver | Colorado | 80220 | United States |
| Sienna 005 | Farmington | Connecticut | 06032 | United States |
| Site 030 | Shelton | Connecticut | 06484 | United States |
| Site 026 | Doral | Florida | 33122 | United States |
| Sienna 019 | Largo | Florida | 33770 | United States |
| Sienna 017 | North Miami Beach | Florida | 33162 | United States |
| Sienna 024 | Ocala | Florida | 34471 | United States |
| Site 027 | West Palm Beach | Florida | 33406 | United States |
| Site 029 | Macon | Georgia | 31217 | United States |
| Sienna 010 | New Albany | Indiana | 47150 | United States |
| Sienna 011 | Plainfield | Indiana | 46168 | United States |
| Sienna 023 | Louisville | Kentucky | 40202 | United States |
| Site 038 | Metairie | Louisiana | 70006 | United States |
| Site 032 | Rockville | Maryland | 20850 | United States |
| Site 039 | Clarkston | Michigan | 48346 | United States |
| Sienna 002 | Fridley | Minnesota | 55432 | United States |
| Sienna 001 | St Louis | Missouri | 63117 | United States |
| Sienna 004 | East Windsor | New Jersey | 08520 | United States |
| Sienna 013 | Albuquerque | New Mexico | 87106 | United States |
| Site 037 | Rochester | New York | 14623 | United States |
| Sienna 016 | High Point | North Carolina | 27626 | United States |
| Sienna 006 | Winston-Salem | North Carolina | 27104 | United States |
| Site 041 | Norman | Oklahoma | 73071 | United States |
| Sienna 003 | Portland | Oregon | 97223 | United States |
| Site 031 | Pittsburgh | Pennsylvania | 15213 | United States |
| Site 035 | Murfreesboro | Tennessee | 37130 | United States |
| Sienna 012 | Austin | Texas | 78759 | United States |
| Sienna 021 | Dallas | Texas | 75246 | United States |
| Sienna 018 | Houston | Texas | 77030 | United States |
| Site 034 | Pflugerville | Texas | 78660 | United States |
| Sienna 007 | Murray | Utah | 84107 | United States |
| Sienna 014 | Norfolk | Virginia | 23502 | United States |
| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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