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

This study is currently recruiting participants.
Verified by Incyte Corporation, February 2008

Sponsored by: Incyte Corporation
Information provided by: Incyte Corporation
ClinicalTrials.gov Identifier: NCT00617994
  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
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  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




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