A Dose Ranging Study of the Effect 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:	NCT00778700

Purpose

The study will be a double-blind, randomized, vehicle-controlled study with application of INCB018424 phosphate cream or vehicle in patients with stable plaque psoriasis. Application will be QD for 12 weeks without occlusive dressings. There will be 4 treatments of 50 subjects each.

Condition	Intervention	Phase
Plaque Psoriasis	Drug: INCB018424 Phosphate Cream Drug: 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, Randomized, Vehicle-Controlled Dose Ranging Study of the Effect of INCB018424 Phosphate Cream When Applied to Patients With Plaque Psoriasis

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:

To evaluate the safety and tolerability of 3 different strengths of INCB018424 cream formulation compared with placebo when applied once daily to patients with plaque psoriasis. [ Time Frame: End of Study ] [ Designated as safety issue: No ]
Change in total lesion score of all psoriatic lesions [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the pharmacokinetics of 3 different dose strengths of INCB018424 cream formulation when applied once daily to patients with plaque psoriasis. [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	October 2008
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Active Drug - 0.5 percent phosphate cream	Drug: INCB018424 Phosphate Cream 0.5, 1.0 and 1.5% phosphate cream
2: Experimental Active Drug - 1.0 percent phosphate cream	Drug: INCB018424 Phosphate Cream 0.5, 1.0 and 1.5% phosphate cream
3: Experimental Active Drug - 1.5 percent phosphate cream	Drug: INCB018424 Phosphate Cream 0.5, 1.0 and 1.5% phosphate cream
4: Placebo Comparator Vehicle containing placebo cream	Drug: Placebo Cream Cream with no active drug

Eligibility

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

Criteria

Inclusion Criteria:

Plaque psoriasis involving up to 2 to 20% Body Surface Area

Exclusion Criteria:

Lesions solely involving intertriginious areas, the scalp or the face
Systemic therapy for their psoriasis
Pustular psoriasis or erythroderma
Currently on other topical agents or UVB therapy within 2 weeks of the first dose of study medication
Started or discontinued therapy within 2 months of Screening with agents that can exacerbate psoriasis
Receiving systemic triazole antifungals except fluconazole

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778700

Show 28 Study Locations

Sponsors and Collaborators

Incyte Corporation

Investigators

Study Director:

Monica Luchi, M.D.

Incyte Corporation

More Information

No publications provided

Responsible Party:	Incyte Corporation ( Pam Murphy, VP Communications & IR )
Study ID Numbers:	INCB 18424-203
Study First Received:	October 21, 2008
Last Updated:	April 27, 2009
ClinicalTrials.gov Identifier:	NCT00778700 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on May 07, 2009