Clinical trial NCT00778700: A Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Participants With Plaque Psoriasis
Official title: A Double-Blind, Randomized, Vehicle-Controlled Dose Ranging Study of the Effect of INCB018424 Phosphate Cream When Applied to Patients With Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2008-10-23
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Absolute Change From Baseline in Total Lesion Score for All Treatable Psoriatic Lesions to Day 84
timeFrame: From Baseline (Day 1) to Day 84
Secondary outcomes:
measure: Absolute Change From Baseline in the Individual Lesion Scores for Lesion Thickness
timeFrame: From Baseline (Day 1) to Day 84
measure: Absolute Change From Baseline in the Individual Lesion Scores for Lesion Erythema
timeFrame: From Baseline (Day 1) to Day 84
measure: Absolute Change From Baseline in the Individual Lesion Scores for Lesion Scaling
timeFrame: From Baseline (Day 1) to Day 84
measure: Percent Change From Baseline in the Individual Lesion Scores of Lesion Thickness
timeFrame: From Baseline (Day 1) to Day 84
measure: Percent Change From Baseline in the Individual Lesion Scores of Lesion Erythema
timeFrame: From Baseline (Day 1) to Day 84
measure: Percent Change From Baseline in the Individual Lesion Scores of Lesion Scaling
timeFrame: From Baseline (Day 1) to Day 84
measure: Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Thickness at Day 84
timeFrame: Day 84
measure: Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Erythema at Day 84
timeFrame: Day 84
measure: Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Scaling at Day 84
timeFrame: Day 84
measure: Absolute Change From Baseline in the Percent Treatable Body Surface Area (BSA)
timeFrame: Baseline (Day 1) to Day 84
measure: Absolute Change From Baseline in the Physician's Global Assessment (PGA) Score
timeFrame: Baseline (Day 1) to Day 84
measure: Percent Change From Baseline in the PGA Score
timeFrame: Baseline (Day 1) to Day 84
measure: Percentage of Participants Achieving Clear (Score=0) and Almost Clear (Score=1) on the PGA
timeFrame: Day 84
measure: Absolute Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score
timeFrame: Baseline (Day 1) to Day 84
measure: Percent Change From Baseline in the PASI Score
timeFrame: Baseline (Day 1) to Day 84
measure: Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point
timeFrame: Baseline (Day 1) and Days 15, 28, 56, 84, and 112
measure: Trough Plasma Concentrations [Minimum Concentration at Steady-state (Css,Min)] of Ruxolitinib Phosphate Prior to Study Drug Application at Steady State
timeFrame: Pre-application on Days 1, 15, 28, 56, and 84
Other outcomes:
Locations:
city: Hot Springs
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Vallejo
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Miami
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Naperville
country: United States
state: Illinois
city: Wheaton
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Boston
country: United States
state: Massachusetts
city: Clinton Township
country: United States
state: Michigan
city: Fridley
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Albuquerque
country: United States
state: New Mexico
city: Rochester
country: United States
state: New York
city: Norman
country: United States
state: Oklahoma
city: Simpsonville
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: College Station
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Walla Walla
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Incyte Corporation
name: Monica Luchi, M.D.
role: STUDY_DIRECTOR
References: