Topical Ruxolitinib Lichen Planus

Phase 2 Completed 12 enrolled Aaron R. Mangold

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2018-08-30
Primary completion: 2020-06-25
Completion: 2020-08-25

Outcome

Met primary endpoint

paper Total lesion count decreased by a median of 50 lesions (interquartile range 25, 723; P < 0.001). PMID 35131254 ↗

paper modified Composite Assessment of Index Lesion Severity scores decreased by a mean difference of 7.6 (standard deviation 8.8, P = 0.016) PMID 35131254 ↗

Publications

Brumfiel CM, Patel MH, Severson KJ, Zhang N, Li X, Quillen JK, Zunich SM, Branch EL, Nelson SA, Pittelkow MR, Mangold AR. Ruxolitinib Cream in the Treatment of Cutaneous Lichen Planus: A Prospective, Open-Label Study. J Invest Dermatol. 2022 Aug;142(8):2109-2116.e4. doi: 10.1016/j.jid.2022.01.015. Epub 2022 Feb 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ruxolitinib	Small molecule	1.5 %	Topical