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

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

MedlinePlus related topics:

Psoriasis

U.S. FDA Resources

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).

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 ]

Estimated Enrollment:	15
Study Start Date:	August 2007
Estimated Primary Completion Date:	August 2008 (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

Contacts


Contact: Robert Flores	302-498-6949	rflores@incyte.com

Locations


United States, Minnesota
		Recruiting
	Fridley, Minnesota, United States, 55432

United States, New York
		Recruiting
	Rochester, New York, United States, 14623

United States, Texas
		Recruiting
	Austin, Texas, United States, 78759
		Recruiting
	College Station, Texas, United States, 77840

Sponsors and Collaborators

Incyte Corporation

Investigators


Study Director:	William Williams, MD	Incyte Corporation

More Information

Responsible Party:	Incyte Corporation ( Incyte Corporation )
Study ID Numbers:	INCB 18424-202
First Received:	January 21, 2008
Last Updated:	February 6, 2008
ClinicalTrials.gov Identifier:	NCT00617994
Health Authority:	United States: Food and Drug Administration

Keywords provided by Incyte Corporation:

psoriasis

Study placed in the following topic categories:

Skin Diseases

Psoriasis

Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 30, 2008

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