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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT00617994
First received: January 21, 2008
Last updated: March 13, 2012
Last verified: March 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:


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 ]

Enrollment: 25
Study Start Date: August 2007
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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
Experimental: B
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
Experimental: C
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617994

Locations
United States, Minnesota
Fridley, Minnesota, United States, 55432
United States, New York
Rochester, New York, United States, 14623
United States, Texas
Austin, Texas, United States, 78759
College Station, Texas, United States, 77840
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: William Williams, MD Incyte Corporation
  More Information

No publications provided

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT00617994     History of Changes
Other Study ID Numbers: INCB 18424-202
Study First Received: January 21, 2008
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Incyte Corporation:
psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 26, 2014