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

• ClinicalTrials.gov Identifier: NCT00778700
• Recruitment Status: Completed
• First Posted: October 23, 2008
• Results First Posted: February 9, 2022
• Last Update Posted: February 9, 2022
• Sponsor: Incyte Corporation
• Information provided by (Responsible Party): Incyte Corporation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Psoriasis	Other: Placebo Cream; Drug: Ruxolitinib Phosphate	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 199 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: October 28, 2008
• Actual Primary Completion Date: June 26, 2009
• Actual Study Completion Date: June 26, 2009

Arms and Interventions

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 Name: 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 Name: 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 Name: INCB018424

Outcome Measures

Primary Outcome Measures :

1. Absolute Change From Baseline in Total Lesion Score for All Treatable Psoriatic Lesions to Day 84 [ Time Frame: From Baseline (Day 1) 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.

Secondary Outcome Measures :

1. Absolute Change From Baseline in the Individual Lesion Scores for Lesion Thickness [ Time Frame: From Baseline (Day 1) to 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. A negative change from Baseline indicates improvement.
2. Absolute Change From Baseline in the Individual Lesion Scores for Lesion Erythema [ Time Frame: From Baseline (Day 1) to Day 84 ]
   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.
3. Absolute Change From Baseline in the Individual Lesion Scores for Lesion Scaling [ Time Frame: From Baseline (Day 1) to Day 84 ]
   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.
4. Percent Change From Baseline in the Individual Lesion Scores of Lesion Thickness [ Time Frame: From Baseline (Day 1) to 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. A negative percent change from Baseline indicates improvement in lesion.
5. Percent Change From Baseline in the Individual Lesion Scores of Lesion Erythema [ Time Frame: From Baseline (Day 1) to Day 84 ]
   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.
6. Percent Change From Baseline in the Individual Lesion Scores of Lesion Scaling [ Time Frame: From Baseline (Day 1) to Day 84 ]
   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.
7. Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Thickness at Day 84 [ Time Frame: 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.
8. Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Erythema at Day 84 [ Time Frame: 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.
9. Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Scaling at Day 84 [ Time Frame: 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.
10. Absolute Change From Baseline in the Percent Treatable Body Surface Area (BSA) [ Time Frame: Baseline (Day 1) to Day 84 ]
    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.
11. Absolute Change From Baseline in the Physician's Global Assessment (PGA) Score [ Time Frame: Baseline (Day 1) to Day 84 ]
    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.
12. Percent Change From Baseline in the PGA Score [ Time Frame: Baseline (Day 1) to Day 84 ]
    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.
13. Percentage of Participants Achieving Clear (Score=0) and Almost Clear (Score=1) on the PGA [ Time Frame: Day 84 ]
    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.
14. Absolute Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score [ Time Frame: Baseline (Day 1) to Day 84 ]
    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.
15. Percent Change From Baseline in the PASI Score [ Time Frame: Baseline (Day 1) to Day 84 ]
    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.
16. Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point [ Time Frame: Baseline (Day 1) and Days 15, 28, 56, 84, and 112 ]
    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.
17. Trough Plasma Concentrations [Minimum Concentration at Steady-state (Css,Min)] of Ruxolitinib Phosphate Prior to Study Drug Application at Steady State [ Time Frame: Pre-application on Days 1, 15, 28, 56, and 84 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Arkansas

Hot Springs, Arkansas, United States

United States, California

Los Angeles, California, United States

San Diego, California, United States

Santa Monica, California, United States

Vallejo, California, United States

United States, Connecticut

New Haven, Connecticut, United States

United States, Florida

Miami, Florida, United States

Ormond Beach, Florida, United States

United States, Illinois

Naperville, Illinois, United States

Wheaton, Illinois, United States

United States, Indiana

Evansville, Indiana, United States

South Bend, Indiana, United States

United States, Massachusetts

Boston, Massachusetts, United States

United States, Michigan

Clinton Township, Michigan, United States

United States, Minnesota

Fridley, Minnesota, United States

United States, Missouri

Saint Louis, Missouri, United States

United States, New Mexico

Albuquerque, New Mexico, United States

United States, New York

Rochester, New York, United States

United States, Oklahoma

Norman, Oklahoma, United States

United States, South Carolina

Simpsonville, South Carolina, United States

United States, Texas

Austin, Texas, United States

College Station, Texas, United States

Dallas, Texas, United States

Houston, Texas, United States

United States, Utah

Salt Lake City, Utah, United States

United States, Virginia

Norfolk, Virginia, United States

United States, Washington

Walla Walla, Washington, United States

United States, Wisconsin

Madison, Wisconsin, United States

Sponsors and Collaborators

Incyte Corporation

Investigators

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

More Information

• Responsible Party: Incyte Corporation
• ClinicalTrials.gov Identifier: NCT00778700
• Other Study ID Numbers: INCB 18424-203
• First Posted: October 23, 2008
• Results First Posted: February 9, 2022
• Last Update Posted: February 9, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• 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.
• URL: https://www.incyte.com/our-company/compliance-and-transparency

• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases