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

Sponsored by:	Incyte Corporation
Information provided by:	Incyte Corporation
ClinicalTrials.gov Identifier:	NCT00820950

Purpose

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.

Condition	Intervention	Phase
Plaque Psoriasis	Drug: INCB018424 phosphate cream Drug: Vehicle (placebo) cream	Phase II

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	29
Study Start Date:	May 2007
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental INCB018424 phosphate cream 0.5%	Drug: INCB018424 phosphate cream INCB018424 phosphate cream 0.5%, 1.0% and 1.5%
2: Experimental INCB018424 phosphate cream 1.0%	Drug: INCB018424 phosphate cream INCB018424 phosphate cream 0.5%, 1.0% and 1.5%
3: Experimental INCB018424 phosphate cream 1.5%	Drug: INCB018424 phosphate cream INCB018424 phosphate cream 0.5%, 1.0% and 1.5%
4: Placebo Comparator Vehicle Cream	Drug: Vehicle (placebo) cream Vehicle (placebo) cream

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820950

Locations

United States, California

Vallejo, California, United States
United States, Massachusetts

Boston, Massachusetts, United States
United States, New York

Rochester, New York, United States

Stony Brook, New York, United States
United States, Oregon

Portland, Oregon, United States
United States, Pennsylvania

Philadelphia, Pennsylvania, United States

Sponsors and Collaborators

Incyte Corporation

More Information

Responsible Party:	Incyte Corporation ( Pamela Murphy, VP, Communications & IR )
Study ID Numbers:	INCB 18424-201
Study First Received:	January 8, 2009
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00820950
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on January 16, 2009