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Sponsored by: |
Incyte Corporation |
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Information provided by: | Incyte Corporation |
ClinicalTrials.gov Identifier: | NCT00617994 |
This will be an open label study of INCB018424 topical cream applied to 2 - 20% BSA in patients with active, stable plaque psoriasis.
Condition | Intervention | Phase |
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Plaque Psoriasis |
Drug: INCB018424 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label, Safety, Tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD) and Preliminary Efficacy Study of INCB018424 When Applied to Patients With Plaque Psoriasis Involving 2 - 20% Body Surface Area (BSA). |
Enrollment: | 25 |
Study Start Date: | August 2007 |
Study Completion Date: | May 2009 |
Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a small percent BSA.
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Drug: INCB018424
INCB018424 1.5% cream BID for 28 days
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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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Drug: INCB018424
INCB018424 1.5% cream BID for 28 days
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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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Drug: INCB018424
INCB018424 1.5% cream BID for 28 days
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Minnesota | |
Fridley, Minnesota, United States, 55432 | |
United States, New York | |
Rochester, New York, United States, 14623 | |
United States, Texas | |
Austin, Texas, United States, 78759 | |
College Station, Texas, United States, 77840 |
Study Director: | William Williams, MD | Incyte Corporation |
Responsible Party: | Incyte Corporation ( Incyte Corporation ) |
Study ID Numbers: | INCB 18424-202 |
Study First Received: | January 21, 2008 |
Last Updated: | June 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00617994 History of Changes |
Health Authority: | United States: Food and Drug Administration |
psoriasis |
Skin Diseases Psoriasis Skin Diseases, Papulosquamous |
Skin Diseases Psoriasis Skin Diseases, Papulosquamous |