Topical Ruxolitinib Lichen Planus

• Status: Completed
• Trial end date: 2020-08-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aaron R. Mangold

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