Incyte announced results from Phase 2 study of Ruxolitinib cream in vitiligo
Incyte announces 24-week results from its randomized, double-blind, dose-ranging, vehicle-controlled, Phase 2 study evaluating ruxolitinib cream, a nonsteroidal, anti-inflammatory, JAK inhibitor therapy, in adult patients with vitiligo. The study met its primary endpoint, demonstrating that significantly more patients treated with ruxolitinib cream for 24 weeks achieved a greater than or equal to 50% improvement from baseline in the facial vitiligo area severity index score compared to patients treated with a vehicle control. F-VASI50 response was most notably achieved with ruxolitinib cream 1.5% administered once daily and twice daily versus vehicle control. Ruxolitinib cream was generally well-tolerated at all dosage strengths. Over-activity of the JAK signaling pathway has been shown to drive inflammation involved in the pathogenesis and progression of vitiligo. These data on ruxolitinib cream, a JAK inhibitor, support the planned initiation of pivotal Phase 3 development later in 2019, for which preparations are already underway.