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

NCT00617994 | Completed Phase 2 Results

• 1 other identifier: INCB 18424-202
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

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.

Conditions

Psoriasis

Keywords

psoriasis

Outcome Measures

Primary Outcomes (4)

• Number of Treatment of Emergent Adverse Events

  Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment

  Approximately 3 months

• Pharmacokinetics Parameter : Skin Flux of INCB018424

  The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study.

  Days 1, 4, 8, 15, 22, and 28-30

• Pharmacokinetics Parameter: Bioavailability of INCB018424

  The INCB018424 bioavailability was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study.

  Approximately one month: Days 1, 4, 8, 15, 22, and 28

• Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424

  All observed INCB018424 plasma concentrations from Days 8, 15, 22, and 28 were averaged to obtain an overall mean exposure for each subject. Samples were taken pre-dose and approximately one hour post-dose.

  Approximately one month: Days 1, 4, 8, 15, 22, and 28

Secondary Outcomes (3)

• Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline

  Approximately 2 months (Days 1, 8, 15, 22, 28 and up to an additional 28 day Follow-Up)

• Mean Change in Psoriatic Lesion Area

  Days 1 and 28

• Mean Change in Physicians Global Assessment Score

  Approximately 2 months: Days 1, 8, 15, 22, 28 and follow-up approximately one month later

Study Arms (3)

Group A

EXPERIMENTAL

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

Drug: Ruxolitinib

Group B

EXPERIMENTAL

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

Drug: Ruxolitinib

Group C

EXPERIMENTAL

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

Drug: Ruxolitinib

Interventions

Ruxolitinib DRUG

Ruxolitinib 1.5% cream BID for 28 days

Also known as: INCB018424

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have psoriatic lesions measuring protocol specific BSA

You may not qualify if:

• 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

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (4)

Unknown Facility

Fridley, Minnesota, 55432, United States

Location

Unknown Facility

Rochester, New York, 14623, United States

Location

Unknown Facility

Austin, Texas, 78759, United States

Location

Unknown Facility

College Station, Texas, 77840, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Incyte Corporation Call Center (US)
• Organization: Incyte

medinfo@incyte.com

1.855.463.3463

Study Officials

• William Williams, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2008
• First Posted: February 18, 2008
• Study Start: August 31, 2007
• Primary Completion: April 30, 2009
• Study Completion: May 31, 2009
• Last Updated: February 8, 2022
• Results First Posted: February 8, 2022

Record last verified: 2022-02

Locations

US (4)