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

January 12, 2022 updated by: Incyte Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
199

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From Baseline (Day 1) to Day 84

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
From Baseline (Day 1) to Day 84
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.
From Baseline (Day 1) to Day 84
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.
From Baseline (Day 1) to Day 84
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.
From Baseline (Day 1) to Day 84
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.
From Baseline (Day 1) to Day 84
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.
From Baseline (Day 1) to Day 84
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.
Day 84
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.
Day 84
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.
Day 84
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.
Baseline (Day 1) to Day 84
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.
Baseline (Day 1) to Day 84
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.
Baseline (Day 1) to Day 84
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.
Day 84
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.
Baseline (Day 1) to Day 84
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.
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
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.
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
Time Frame: Pre-application on Days 1, 15, 28, 56, and 84
Pre-application on Days 1, 15, 28, 56, and 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Incyte Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Monica Luchi, M.D., Incyte Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 26, 2009

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 26, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2008

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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