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This is a study of itacitinib in patients with chronic plaque psoriasis. This study will evaluate safety and efficacy parameters of itacitinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 mg QD Itacitinib | Experimental |
| |
| 100 mg QD Placebo | Experimental |
| |
| 200 mg QD Itacitinib | Experimental |
| |
| 200 mg QD Placebo | Experimental |
| |
| 200 mg BID Itacitinib | Experimental |
| |
| 200 mg BID Placebo | Experimental |
| |
| 600 mg once a day Itacitinib | Experimental |
| |
| 600 mg once a day Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itacitinib | Drug | Itacitinib administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of itacitinib as measured by changes in frequency and severity of adverse events, ECGs, physical examination, vital signs, and clinical laboratory evaluations. | Approximately two months. | |
| The mean percent change from baseline in static Physician's Global Assessment (sPGA) on the day 28 visit. | Approximately 28 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving static Physician's Global Assessment (sPGA) of 1 or 2 at each scheduled visit. | Day 1, Day 8, Day 15, Day 28 and Day 56 (approximately two months). | |
| Preliminary Pharmacokinetic (PK) collections. | Plasma concentrations of itacitinib will be used to estimate peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor Sandor, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hot Springs | Arkansas | United States | ||||
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| ID | Term |
|---|---|
| C000718170 | itacitinib |
| C000603457 | INCB039110 |
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|
|
| Placebo | Drug | Placebo administered orally |
|
| Following 15 days of therapy. |
| Los Angeles |
| California |
| United States |
| Clinton | Minnesota | United States |
| Fridley | Minnesota | United States |
| Rochester | New York | United States |
| Moncton | New Brunswick | Canada |
| Windsor | Ontario | Canada |
| Montreal | Quebec | Canada |
| Québec | Canada |