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

NCT ID: NCT00617994

Last Updated: 2022-02-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-05-31

Brief Summary

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

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a small percent BSA.

Group Type EXPERIMENTAL

Ruxolitinib

Intervention Type DRUG

Ruxolitinib 1.5% cream BID for 28 days

Group B

Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 1.

Group Type EXPERIMENTAL

Ruxolitinib

Intervention Type DRUG

Ruxolitinib 1.5% cream BID for 28 days

Group C

Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 2.

Group Type EXPERIMENTAL

Ruxolitinib

Intervention Type DRUG

Ruxolitinib 1.5% cream BID for 28 days

Interventions

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Ruxolitinib

Ruxolitinib 1.5% cream BID for 28 days

Intervention Type DRUG

Other Intervention Names

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INCB018424

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Incyte Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Williams, MD

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

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Fridley, Minnesota, United States

Site Status

Rochester, New York, United States

Site Status

Austin, Texas, United States

Site Status

College Station, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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INCB 18424-202

Identifier Type: -

Identifier Source: org_study_id

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