Topical Ruxolitinib Lichen Planus

Aaron R. Mangold

Status and phase: Completed; Phase 2

Conditions: Lichen Planus

Treatments: Drug: INCB018424

Study type: Interventional

Funder types: Other

Identifiers

NCT03697460

17-005406

Details and patient eligibility

About

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 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

INCB018424

Experimental group

Description:

INCB018424 Cream

Treatment:

Drug: INCB018424