Psoriasis
A Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Participants With Plaque Psoriasis
Incyte Study ID:
INCB 18424-203
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Study Complete
Clinical Study Purpose
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.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
Oct 2008 - Jun 2009
TYPE
Interventional
PHASE
Phase 2
SEX
Female & Male
AGE
18 - 75 Years
ACCEPTS HEALTHY VOLUNTEERS
No
Key Inclusion and Exclusion 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
Clinical Study Locations
Location
Status
Location
Miami, FL, US
Status
Active, not recruiting
Location
Naperville, IL, US
Status
Active, not recruiting
Location
Houston, TX, US
Status
Active, not recruiting
Location
Salt Lake City, UT, US
Status
Active, not recruiting
Location
Norman, OK, US
Status
Active, not recruiting
Location
Boston, MA, US
Status
Active, not recruiting
Protocol Summary
Incyte Study ID:
INCB 18424-203
Primary Purpose:
Treatment
Allocation:
Randomized
Study Design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Interventions:
Other
Enrollment:
199
Primary Outcome
Open
Absolute change from Baseline to Day 84 in total lesion score for all treatable psoriatic lesions.
Timeframe: Baseline and Day 84 (or early study termination visit)
Secondary Outcome
Open
Percentage of subjects achieving none (score=0) and mild (score=1) in each of the individual lesion scores at Day 84
Timeframe: Baseline and Day 84