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

A Double-Blind, Randomized, Vehicle-Controlled Dose Ranging Study of the Effect of INCB018424 Phosphate Cream When Applied to Patients With Plaque Psoriasis

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Other: Placebo Cream; Drug: Ruxolitinib Phosphate

• Study Type: Interventional
• Enrollment (Actual): 199
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Hot Springs, Arkansas, United States
  • California
    • Los Angeles, California, United States
    • San Diego, California, United States
    • Santa Monica, California, United States
    • Vallejo, California, United States
  • Connecticut
    • New Haven, Connecticut, United States
  • Florida
    • Miami, Florida, United States
    • Ormond Beach, Florida, United States
  • Illinois
    • Naperville, Illinois, United States
    • Wheaton, Illinois, United States
  • Indiana
    • Evansville, Indiana, United States
    • South Bend, Indiana, United States
  • Massachusetts
    • Boston, Massachusetts, United States
  • Michigan
    • Clinton Township, Michigan, United States
  • Minnesota
    • Fridley, Minnesota, United States
  • Missouri
    • Saint Louis, Missouri, United States
  • New Mexico
    • Albuquerque, New Mexico, United States
  • New York
    • Rochester, New York, United States
  • Oklahoma
    • Norman, Oklahoma, United States
  • South Carolina
    • Simpsonville, South Carolina, United States
  • Texas
    • Austin, Texas, United States
    • College Station, Texas, United States
    • Dallas, Texas, United States
    • Houston, Texas, United States
  • Utah
    • Salt Lake City, Utah, United States
  • Virginia
    • Norfolk, Virginia, United States
  • Washington
    • Walla Walla, Washington, United States
  • Wisconsin
    • Madison, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Vehicle Cream; Vehicle cream, applied topically, once daily from Day 1 to Week 12.	Other: Placebo Cream; Cream with no active drug
EXPERIMENTAL: Ruxolitinib Phosphate 0.5% Cream; Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.	Drug: Ruxolitinib Phosphate; Ruxolitinib phosphate cream; Other Names: INCB018424
EXPERIMENTAL: Ruxolitinib Phosphate 1.0% Cream; Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.	Drug: Ruxolitinib Phosphate; Ruxolitinib phosphate cream; Other Names: INCB018424
EXPERIMENTAL: Ruxolitinib Phosphate 1.5% Cream; Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.	Drug: Ruxolitinib Phosphate; Ruxolitinib phosphate cream; Other Names: INCB018424

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Monica Luchi, M.D., Incyte Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 28, 2008
• Primary Completion (ACTUAL): June 26, 2009
• Study Completion (ACTUAL): June 26, 2009

Study Registration Dates

• First Submitted: October 21, 2008
• First Submitted That Met QC Criteria: October 21, 2008
• First Posted (ESTIMATE): October 23, 2008

Study Record Updates

• Last Update Posted (ACTUAL): February 9, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: INCB 18424-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
• IPD Sharing Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• IPD Sharing Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No