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

Tracking Information

First Received Date ^ICMJE

January 21, 2008

Last Updated Date

June 9, 2009

Start Date ^ICMJE

August 2007

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00617994 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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).

Brief Summary

This will be an open label study of INCB018424 topical cream applied to 2 - 20% BSA in patients with active, stable plaque psoriasis.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Plaque Psoriasis

Intervention ^ICMJE

Drug: INCB018424

Study Arms / Comparison Groups

Experimental: Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a small percent BSA.
Experimental: Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 1.
Experimental: Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 2.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subjects must have psoriatic lesions measuring protocol specific BSA

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00617994

Responsible Party

Incyte Corporation, Incyte Corporation

Study ID Numbers ^ICMJE

INCB 18424-202

Study Sponsor ^ICMJE

Incyte Corporation

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

William Williams, MD

Incyte Corporation

Information Provided By

Incyte Corporation

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP