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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00617994
Recruitment Status : Completed
First Posted : February 18, 2008
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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Brief Summary:
This will be an open label study of ruxolitinib topical cream applied to 2 - 20% BSA in patients with active, stable plaque psoriasis.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Ruxolitinib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Safety, Tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD) and Preliminary Efficacy Study of Ruxolitinib When Applied to Patients With Plaque Psoriasis Involving 2 - 20% Body Surface Area (BSA).
Study Start Date : August 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a small percent BSA.
 Drug: Ruxolitinib
Ruxolitinib 1.5% cream BID for 28 days
Other Name: INCB018424
Experimental: Group B
Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 1.
 Drug: Ruxolitinib
Ruxolitinib 1.5% cream BID for 28 days
Other Name: INCB018424
Experimental: Group C
Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 2.
 Drug: Ruxolitinib
Ruxolitinib 1.5% cream BID for 28 days
Other Name: INCB018424


Outcome Measures
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Primary Outcome Measures :
  1. 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 ruxolitinib plasma concentrations. [ Time Frame: End of Study ]

Secondary Outcome Measures :
  1. Pharmacodynamics and preliminary efficacy [ Time Frame: End of Study ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00617994


Locations
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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
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Study Director: William Williams, MD Incyte Corporation
More Information
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT00617994    
Other Study ID Numbers: INCB 18424-202
First Posted: February 18, 2008    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Keywords provided by Incyte Corporation:
psoriasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases