A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo

Summary

The purpose of this study will be to examine the efficacy, safety, and tolerability of ruxolitinib cream in subjects with vitiligo.

Timeline

Start

2017-06-07

Primary completion

2018-09-12

Completion

2021-09-08

Outcome

Met primary endpoint

registry analysis (superiority test); Vehicle Twice Daily (BID) vs Ruxolitinib Cream 1.5% BID; p = 0.0001; Odds Ratio (OR) 24.66 NCT03099304 ↗

paper F-VASI50 at week 24 was reached by significantly more patients given ruxolitinib cream PMID 32653055 ↗

release “The primary endpoint was met in the randomized Phase 2 trial of ruxolitinib cream in patients with vitiligo” incyte.com ↗

Publications

• Howell MD, Kuo FI, Rumberger B, Boarder E, Sun K, Butler K, Harris JE, Grimes P, Rosmarin D. Baseline Levels of Circulating Inflammatory Biomarkers Stratify Patients with Vitiligo Who Significantly Repigment after Treatment with Ruxolitinib Cream. JID Innov. 2023 Sep 13;3(6):100230. doi: 10.1016/j.xjidi.2023.100230. eCollection 2023 Nov.
• Rosmarin D, Pandya AG, Lebwohl M, Grimes P, Hamzavi I, Gottlieb AB, Butler K, Kuo F, Sun K, Ji T, Howell MD, Harris JE. Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial. Lancet. 2020 Jul 11;396(10244):110-120. doi: 10.1016/S0140-6736(20)30609-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ruxolitinib	Small molecule	0.15 %	Topical
Subject	Ruxolitinib	Small molecule	0.5 %	Topical
Subject	Ruxolitinib	Small molecule	1 %	Topical
Subject	Ruxolitinib	Small molecule	1.5 %	Topical

Indications