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Completed

NCT Number: NCT03697460

Topical Ruxolitinib Lichen Planus

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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Key information

Conditions

Lichen Planus Lichenoid Eruptions Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INCB018424

Drug

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

Primary outcomes

  1. Change in Modified Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS)

    Time frame: week 0, week 4

    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

  2. Change in Total Body Lesion Count

    Time frame: week 0, week 4

    The number of total body lesions.

Secondary outcomes

  1. Change in Pruritus Numerical Rating Scale

    Time frame: week 0, week 4

    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.

  2. Change in Overall Quality of Life Skindex-16 Score

    Time frame: week 0, week 4

    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

  3. Number of Subjects With Greater Than or Equal to 50% Improvement in Physician Global Assessment Score

    Time frame: week 0, week 4

    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

  4. Body Surface Area (BSA) Affected by Cutaneous Lichen Planus

    Time frame: week 0, week 4

    BSA as measured as the percentage of the body affected by Cutaneous Lichen Planus. Ranging from 0-100% of the body.

Sponsors and collaborators

Lead sponsor

Aaron R. Mangold

Other

Registry information

Official study title

INCB018424 in the Treatment of Cutaneous Lichen Planus

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 5, 2018
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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