Topical Ruxolitinib Lichen Planus

Overview

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.

Full Title of Study: “INCB018424 in the Treatment of Cutaneous Lichen Planus”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 25, 2020

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.

Interventions

  • Drug: INCB018424
    • Topical cream

Arms, Groups and Cohorts

  • Experimental: INCB018424
    • INCB018424 Cream

Clinical Trial Outcome Measures

Primary Measures

  • modified Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS)
    • Time Frame: week 0 to week 4
    • Summation of: Erythema (0-8) Scaling (0-8) Plaque elevation (0-8) Hyper/hypopigmentation (0-8) Size (0-18) Summation Score: 0-50 higher score indicated higher severity
  • lesion count
    • Time Frame: week 0 to week 4
    • total lesion count

Secondary Measures

  • Pruritus Numerical Rating Scale
    • Time Frame: week 0 to week 4, week 0 to week 8, weeks 4 to 8, weeks 8 to 12
    • Worst itch in last 24 hours Score: 0-10 Higher score equals worse itch
  • Skindex-16
    • Time Frame: week 0 to week 4, week 0 to week 8, weeks 4 to 8, weeks 8 to 12
    • 16 questions 3 subscales: Symptoms, Emotional, Functional Score range for each question (0-6) Summation Score: 0-96 Higher score equals worse itch
  • Physician Global Assessment
    • Time Frame: week 0 to week 4, week 0 to week 8, weeks 4 to 8, weeks 8 to 12
    • Grade 0 to Grade 6 Higher score equals worse disease
  • Body Surface Area
    • Time Frame: week 0 to week 4, week 0 to week 8, weeks 4 to 8, weeks 8 to 12
    • 0-100%
  • modified CAILS
    • Time Frame: week 0 to week 8, weeks 4 to 8, weeks 8 to 12
    • Summation of: Erythema (0-8) Scaling (0-8) Plaque elevation (0-8) Hyper/hypopigmentation (0-8) Size (0-18) Summation Score: 0-50 higher score indicated higher severity
  • lesion count
    • Time Frame: week 0 to week 8, weeks 4 to 8, weeks 8 to 12
    • total lesion count

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aaron R. Mangold
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Aaron R. Mangold, Assistant Professor of Dermatology – Mayo Clinic
  • Overall Official(s)
    • Aaron R Mangold, Principal Investigator, Mayo Clinic

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