Topical Ruxolitinib Lichen Planus

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of INCB018424 PHOSPHATE CREAM in cutaneous LP as assessed by the change in Physician Global Assessment (PGA), Body Surface Area (BSA), Index Treatment and Control Lesion by Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (CAILS) score, Pruritus Numerical Rating Scale (NRS), and Skindex-16. To predict responses through the identification of unique biomarkers of LP at week 0 and utilizing RNA sequencing on responsive and non-responsive tissue at week 4.

Detailed Description
-----------------
This is a single center, exploratory, open-label, single-arm design study of 12 patients. Treatment naïve and treatment refractory patients with LP will be treated with INCB018424 PHOSPHATE CREAM. Patients who are non-responders, to physician choice standard of care, will undergo a washout period and will be enrolled in the study. The study consists of 3 epochs: screening/washout period (of at least 1 week and up to 4 weeks), treatment epoch (of 8 weeks from screen/washout), and follow up epoch (of 4 weeks). The screening and washout period will allow for treatment naïve/ new diagnosis LP to undergo evaluation and diagnosis and for treatment refractory to undergo a washout. The total duration of the study will be 13-16 weeks.

Official Title
-----------------
INCB018424 in the Treatment of Cutaneous Lichen Planus

Conditions
-----------------
Lichen Planus

Intervention / Treatment
-----------------
* Drug: INCB018424


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Topical INCB018424
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INCB018424<br>INCB018424 Cream | Drug: INCB018424<br>* INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP.<br>|

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) | 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 | 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 | 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 | 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 | 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 | 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 |