- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03697460
Topical Ruxolitinib Lichen Planus
INCB018424 in the Treatment of Cutaneous Lichen Planus
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- Mayo Clinic in Arizona
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Subjects must be able to understand and comply with the requirements of the study and communicate with the investigator.
Subjects must give written, signed, and dated informed consent before any study related activity is performed.
When appropriate, a legal representative will sign the informed consent according to local laws and regulation
Both men and women must be at least 18 years of age at the time of screening
Subjects must have clinical and histological features of LP
LP must involve between 2 and 20% of the BSA
Subjects must have a minimum of 10 lesions of LP
Subjects must have treatment naive cutaneous LP or treatment refractory disease, as defined by failure of at least one established treatment for LP
Failure of prior therapy Topical treatment Systemic immunosuppressant Oral metronidazole Oral sulfasalazine Oral retinoid
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: INCB018424
INCB018424 Cream
|
INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Modified Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS)
Time Frame: week 0, week 4
|
mCAILS summation score as measured by Erythema (0-8), Scaling (0-8) Plaque elevation (0-8) Hyper/hypopigmentation (0-8) Size (0-18), Total score ranging from 0-50 with higher score indicating higher severity
|
week 0, week 4
|
Change in Total Body Lesion Count
Time Frame: week 0, week 4
|
The number of total body lesions.
|
week 0, week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pruritus Numerical Rating Scale
Time Frame: week 0, week 4
|
Pruritus Numerical Rating Scale as measured by they question "How severe has your itching been over the last 24 hours?"
Ranging from 0 = none, to 10 = severe.
The higher the score the more severe.
|
week 0, week 4
|
Change in Overall Quality of Life Skindex-16 Score
Time Frame: week 0, week 4
|
Skindex-16 score as measured by 16 questions, 3 subscales: Symptoms, Emotional, Functional.
Score ranges for each question (0-6).
Total score ranging from 0-96 with higher score indicating worse quality of life
|
week 0, week 4
|
Number of Subjects With Greater Than or Equal to 50% Improvement in Physician Global Assessment Score
Time Frame: week 0, week 4
|
PGA score as measured by Grade 0 (clear: no evidence of disease (100% improvement)) to Grade 6 (Worse, disease is worse than at baseline evaluation by (≥25%) or more).
Higher score equals worse disease
|
week 0, week 4
|
Body Surface Area (BSA) Affected by Cutaneous Lichen Planus
Time Frame: week 0, week 4
|
BSA as measured as the percentage of the body affected by Cutaneous Lichen Planus.
Ranging from 0-100% of the body.
|
week 0, week 4
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-005406
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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