Topical Ruxolitinib Lichen Planus

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-30

Study Completion Date

2020-08-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lichen Planus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Topical INCB018424

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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INCB018424

INCB018424 Cream

Group Type EXPERIMENTAL

INCB018424

Intervention Type DRUG

INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP.

Interventions

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INCB018424

INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP.

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No