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
1 other identifier
interventional
199
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2008
Shorter than P25 for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2008
CompletedFirst Posted
Study publicly available on registry
October 23, 2008
CompletedStudy Start
First participant enrolled
October 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2009
CompletedResults Posted
Study results publicly available
February 9, 2022
CompletedFebruary 9, 2022
January 1, 2022
8 months
October 21, 2008
October 20, 2021
January 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (17)
Absolute Change From Baseline in the Individual Lesion Scores for Lesion Thickness
From Baseline (Day 1) to Day 84
Absolute Change From Baseline in the Individual Lesion Scores for Lesion Erythema
From Baseline (Day 1) to Day 84
Absolute Change From Baseline in the Individual Lesion Scores for Lesion Scaling
From Baseline (Day 1) to Day 84
Percent Change From Baseline in the Individual Lesion Scores of Lesion Thickness
From Baseline (Day 1) to Day 84
Percent Change From Baseline in the Individual Lesion Scores of Lesion Erythema
From Baseline (Day 1) to Day 84
- +12 more secondary outcomes
Study Arms (4)
Vehicle Cream
PLACEBO COMPARATORVehicle cream, applied topically, once daily from Day 1 to Week 12.
Ruxolitinib Phosphate 0.5% Cream
EXPERIMENTALRuxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
Ruxolitinib Phosphate 1.0% Cream
EXPERIMENTALRuxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
Ruxolitinib Phosphate 1.5% Cream
EXPERIMENTALRuxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
Interventions
Ruxolitinib phosphate cream
Eligibility Criteria
You may qualify if:
- Plaque psoriasis involving up to 2 to 20% Body Surface Area
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Unknown Facility
Hot Springs, Arkansas, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Santa Monica, California, United States
Unknown Facility
Vallejo, California, United States
Unknown Facility
New Haven, Connecticut, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Ormond Beach, Florida, United States
Unknown Facility
Naperville, Illinois, United States
Unknown Facility
Wheaton, Illinois, United States
Unknown Facility
Evansville, Indiana, United States
Unknown Facility
South Bend, Indiana, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Clinton Township, Michigan, United States
Unknown Facility
Fridley, Minnesota, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Norman, Oklahoma, United States
Unknown Facility
Simpsonville, South Carolina, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
College Station, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Walla Walla, Washington, United States
Unknown Facility
Madison, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Incyte Organization
Study Officials
- STUDY DIRECTOR
Monica Luchi, M.D.
Incyte Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2008
First Posted
October 23, 2008
Study Start
October 28, 2008
Primary Completion
June 26, 2009
Study Completion
June 26, 2009
Last Updated
February 9, 2022
Results First Posted
February 9, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, 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.
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