A Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Participants With Plaque Psoriasis

NCT ID: NCT00778700

Last Updated: 2022-02-09

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

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-28

Study Completion Date

2009-06-26

Brief Summary

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The study was double-blind, randomized, vehicle-controlled study with application of Ruxolitinib phosphate cream or vehicle cream in participants with stable plaque psoriasis applied once daily for 12 weeks without occlusive dressings. There were 4 treatment groups anticipated to have 50 participants in each.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vehicle Cream

Vehicle cream, applied topically, once daily from Day 1 to Week 12.

Group Type PLACEBO_COMPARATOR

Placebo Cream

Intervention Type OTHER

Cream with no active drug

Ruxolitinib Phosphate 0.5% Cream

Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.

Group Type EXPERIMENTAL

Ruxolitinib Phosphate

Intervention Type DRUG

Ruxolitinib phosphate cream

Ruxolitinib Phosphate 1.0% Cream

Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.

Group Type EXPERIMENTAL

Ruxolitinib Phosphate

Intervention Type DRUG

Ruxolitinib phosphate cream

Ruxolitinib Phosphate 1.5% Cream

Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.

Group Type EXPERIMENTAL

Ruxolitinib Phosphate

Intervention Type DRUG

Ruxolitinib phosphate cream

Interventions

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Placebo Cream

Cream with no active drug

Intervention Type OTHER

Ruxolitinib Phosphate

Ruxolitinib phosphate cream

Intervention Type DRUG

Other Intervention Names

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INCB018424

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Lesions solely involving intertriginous areas, the scalp or the face
* Systemic therapy for their psoriasis
* Pustular psoriasis or erythroderma
* Currently on other topical agents or Ultraviolet B (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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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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Monica Luchi, M.D.

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

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Hot Springs, Arkansas, United States

Site Status

Los Angeles, California, United States

Site Status

San Diego, California, United States

Site Status

Santa Monica, California, United States

Site Status

Vallejo, California, United States

Site Status

New Haven, Connecticut, United States

Site Status

Miami, Florida, United States

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Ormond Beach, Florida, United States

Site Status

Naperville, Illinois, United States

Site Status

Wheaton, Illinois, United States

Site Status

Evansville, Indiana, United States

Site Status

South Bend, Indiana, United States

Site Status

Boston, Massachusetts, United States

Site Status

Clinton Township, Michigan, United States

Site Status

Fridley, Minnesota, United States

Site Status

St Louis, Missouri, United States

Site Status

Albuquerque, New Mexico, United States

Site Status

Rochester, New York, United States

Site Status

Norman, Oklahoma, United States

Site Status

Simpsonville, South Carolina, United States

Site Status

Austin, Texas, United States

Site Status

College Station, Texas, United States

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Dallas, Texas, United States

Site Status

Houston, Texas, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Norfolk, Virginia, United States

Site Status

Walla Walla, Washington, United States

Site Status

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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INCB 18424-203

Identifier Type: -

Identifier Source: org_study_id

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