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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00778700
• Other study ID #: INCB 18424-203
• Status: Completed
• Phase: Phase 2
• Start date: October 28, 2008
• Est. completion date: June 26, 2009

Study information

• Verified date: January 2022
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: June 26, 2009
• Est. primary completion date: June 26, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Other:
• Placebo Cream
Cream with no active drug

Drug:
• Ruxolitinib Phosphate
Ruxolitinib phosphate cream

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change From Baseline in Total Lesion Score for All Treatable Psoriatic Lesions to Day 84	Total Lesion Score is calculated as the sum of component scores for erythema (E), scaling (S), and thickness (T) of the study-treated lesions taken together. Each component consists of ratings of 0=none, 1=mild, 2=moderate, 3=marked, and 4=severe such that total lesion score can vary in value from 0 to 12. A negative change from Baseline indicates improvement.	From Baseline (Day 1) to Day 84
Secondary	Absolute Change From Baseline in the Individual Lesion Scores for Lesion Thickness	Lesion thickness was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative change from Baseline indicates improvement.	From Baseline (Day 1) to Day 84
Secondary	Absolute Change From Baseline in the Individual Lesion Scores for Lesion Erythema	Lesion erythema was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative change from Baseline indicates improvement.	From Baseline (Day 1) to Day 84
Secondary	Absolute Change From Baseline in the Individual Lesion Scores for Lesion Scaling	Lesion scaling was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative change from Baseline indicates improvement.	From Baseline (Day 1) to Day 84
Secondary	Percent Change From Baseline in the Individual Lesion Scores of Lesion Thickness	Lesion thickness was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative percent change from Baseline indicates improvement in lesion.	From Baseline (Day 1) to Day 84
Secondary	Percent Change From Baseline in the Individual Lesion Scores of Lesion Erythema	Lesion erythema was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative percent change from Baseline indicates improvement in lesion.	From Baseline (Day 1) to Day 84
Secondary	Percent Change From Baseline in the Individual Lesion Scores of Lesion Scaling	Lesion scaling was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative percent change from Baseline indicates improvement in lesion.	From Baseline (Day 1) to Day 84
Secondary	Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Thickness at Day 84	Lesion thickness was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. Participants with individual lesion scores 0 (none) and 1 (mild) are reported in this outcome measure.	Day 84
Secondary	Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Erythema at Day 84	The individual lesion scores were calculated individually for thickness, erythema, and scaling. Lesion erythema was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. Participants with individual lesion scores 0 (none) and 1 (mild) are reported in this outcome measure. The LOCF method was used for analysis.	Day 84
Secondary	Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Scaling at Day 84	The individual lesion scores were calculated individually for thickness, erythema, and scaling. Lesion scaling was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. Participants with individual lesion scores 0 (none) and 1 (mild) are reported in this outcome measure. The LOCF method was used for analysis.	Day 84
Secondary	Absolute Change From Baseline in the Percent Treatable Body Surface Area (BSA)	The lesion areas were estimated based on the Rule of Nines method for the entire skin surface; psoriatic disease activity and the percent BSA were calculated for the treatable areas (i.e., areas that excluded the scalp, face, and intertriginous areas). The BSA is calculated as follows: BSA (m^²)=([Height(cm) x Weight(kg)]/3600 )^½. A negative change from Baseline indicates improvement.	Baseline (Day 1) to Day 84
Secondary	Absolute Change From Baseline in the Physician's Global Assessment (PGA) Score	The overall disease activity in the participants, a measure of the overall quality (erythema, scaling, and thickness) and extent (BSA) of plaques, was measured using the PGA. The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a 6-point scale ranging from 0 to 5 where 0 is 'Clear' (no evidence of disease) and 5 is 'very Severe' lesion. A negative change from Baseline indicates improvement. The ANCOVA method was used for analyses.	Baseline (Day 1) to Day 84
Secondary	Percent Change From Baseline in the PGA Score	The overall disease activity in the participants, a measure of the overall quality (erythema, scaling, and thickness) and extent (BSA) of plaques, was measured using the PGA. The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a 6-point scale ranging from 0 to 5 where 0 indicates 'Clear' (no evidence of disease) and 5 indicates 'very Severe' lesion. A negative percent change indicates improvement. The ANCOVA method was used for analyses.	Baseline (Day 1) to Day 84
Secondary	Percentage of Participants Achieving Clear (Score=0) and Almost Clear (Score=1) on the PGA	The overall disease activity in the participants, a measure of the overall quality (erythema, scaling, and thickness) and extent (BSA) of plaques, was measured using the PGA. The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a 6-point scale ranging from 0 to 5 where 0 indicates 'Clear' (no evidence of disease) and 5 indicates 'very Severe' lesion. Participants with individual lesion scores 0 (clear) and 1 (almost clear) are reported in this outcome measure.	Day 84
Secondary	Absolute Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score	PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring [lower extremities, trunk (including stomach, chest, back), upper extremities, head]; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by scale 0 (none) to 4 (severe). Final PASI is the sum of severity score for each area multiplied coverage for each section multiplied by area score weight of section (lower extremities: 0.4, trunk: 0.3, upper extremities: 0.2, head: 0.1). A negative change from baseline indicates improvement. The ANCOVA method was used for analyses.	Baseline (Day 1) to Day 84
Secondary	Percent Change From Baseline in the PASI Score	PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring [lower extremities, trunk (including stomach, chest, back), upper extremities, head]; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by scale 0 (none) to 4 (severe). Final PASI is the sum of severity score for each area multiplied by coverage for each section multiplied by area score weight of section (lower extremities: 0.4, trunk: 0.3, upper extremities: 0.2, head: 0.1). A percent negative change from baseline indicates improvement in disease. The ANCOVA method was used for analyses.	Baseline (Day 1) to Day 84
Secondary	Percentage of Participants With Treatable Percent BSA =10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point	PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring [lower extremities, trunk (including stomach, chest, back), upper extremities, head]; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by scale 0 (none) to 4 (severe). Final PASI is the sum of severity score for each area* multiplied by coverage for each section* multiplied by area score weight of section (lower extremities: 0.4, trunk: 0.3, upper extremities: 0.2, head: 0.1). A negative percent change from Baseline indicates improvement. Data for Day 84 was imputed using the LOCF method.	Baseline (Day 1) and Days 15, 28, 56, 84, and 112
Secondary	Trough Plasma Concentrations [Minimum Concentration at Steady-state (Css,Min)] of Ruxolitinib Phosphate Prior to Study Drug Application at Steady State		Pre-application on Days 1, 15, 28, 56, and 84