A Study of INCB018424 Phosphate Cream When Applied to Patients With Plaque Psoriasis - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	January 8, 2009
Last Updated Date	January 26, 2009
Start Date ^†	May 2007
Current Primary Outcome Measures ^† (submitted: January 11, 2009)	The safety, tolerability (assessed by local irritation, adverse experiences, vital signs, ECGs, and clinical labs) and pharmacokinetics (plasma concentrations) of INCB018424 cream formulations when applied once or twice daily to patients. [ Time Frame: End of study ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00820950 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^† (submitted: January 11, 2009)	Efficacy endpoints will include: Change in target lesion scores including total score and each component analyzed separately. Change in target lesion area [ Time Frame: End of Study ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^†	Same as current

Descriptive Information
Brief Title ^†	A Study of INCB018424 Phosphate Cream When Applied to Patients With Plaque Psoriasis
Official Title ^†	A Double-Blind, Vehicle-Controlled, Rising Dose, Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy Study of INCB018424 Phosphate Cream When Applied to Patients With Plaque Psoriasis
Brief Summary	The study is comprised of two parts. The first portion of this study will be a double-blind, Sponsor-unblinded, vehicle-controlled study with application of INCB018424 or vehicle to paired lesions at least 15 cm apart in patients with active but stable plaque psoriasis. Part 2 of the study is a double-blind, sponsor unblinded, comparison of INCB018424 with two FDA approved products in patients with active but stable plaque psoriasis.
Detailed Description
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^†	Plaque Psoriasis
Intervention ^†	Drug: INCB018424 phosphate cream Drug: Vehicle (placebo) cream
Study Arms / Comparison Groups	Experimental: INCB018424 phosphate cream 0.5% Experimental: INCB018424 phosphate cream 1.0% Experimental: INCB018424 phosphate cream 1.5% Placebo Comparator: Vehicle Cream
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 ^†	Completed
Enrollment ^†	29
Completion Date
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^†	Inclusion Criteria: Body Mass Index (BMI) of 17 to 40 kg/m2 Subjects must have two comparable psoriatic lesions measuring between 9 and 100 cm2 and these target lesions must be similar in size to each other, and separated by at least 15 cm. Exclusion Criteria: Subjects with lesions solely involving the palms of the hands or soles of the feet or intertriginous areas, the scalp or the face. Subjects with pustular psoriasis or erythroderma. Subjects currently on other topical agents or UVB therapy within 2 weeks of the first dose of study medication. Subjects receiving PUVA within 4 weeks of the first dose of study medication. Subjects receiving systemic retinoids, etanercept, adalimumab or efalizumab or oral immunosuppressives within 3 months prior to the first dose of study medication. Subjects receiving any other biological therapy (infliximab, alefacept, abatacept, etc) within 3 months of the first dose of study medication.
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00820950
Responsible Party	Pamela Murphy, VP, Communications & IR, Incyte Corporation
Secondary IDs ^††
Study Sponsor ^†	Incyte Corporation
Collaborators ^††
Investigators ^†
Information Provided By	Incyte Corporation
Verification Date	January 2009
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.