Open Label, Safety and Efficacy Study of Topical Investigational Drug to Treat Patients With Psoriasis - Full Text View

Sponsor:	Incyte Corporation
Information provided by:	Incyte Corporation
ClinicalTrials.gov Identifier:	NCT00617994

Purpose

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
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).

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:

Safety and tolerability will be assessed by signs and symptoms of adverse experiences, measuring VS and ECGs, clinical laboratory blood and urine samples. The PK endpoints are planned to determine the INCB018424 plasma concentrations. [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacodynamics and preliminary efficacy [ Time Frame: End of Study ] [ Designated as safety issue: No ]

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
A: Experimental Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a small percent BSA.	Drug: INCB018424 INCB018424 1.5% cream BID for 28 days
B: Experimental Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 1.	Drug: INCB018424 INCB018424 1.5% cream BID for 28 days
C: Experimental Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 2.	Drug: INCB018424 INCB018424 1.5% cream BID for 28 days

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Lesions solely involving the palms of the hands, the soles of the feet, the intertriginious areas, the scalp or the face
Pustular psoriasis or erythroderma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617994

Locations

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

Sponsors and Collaborators

Incyte Corporation

Investigators

Study Director:

William Williams, MD

Incyte Corporation

More Information

No publications provided

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

Keywords provided by Incyte Corporation:

psoriasis

Additional relevant MeSH terms:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 05, 2009