Incyte announces 52-week results from Phase 2 study of Ruxolitinib cream
Incyte announced 52-week results from its randomized, double-blind, dose-ranging, Phase 2 study evaluating ruxolitinib cream, a nonsteroidal, anti-inflammatory, JAK inhibitor therapy, in adult patients with vitiligo. As previously announced, 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. Updated results at week 52 show substantial improvements in total body repigmentation with ruxolitinib cream, measured by the proportion of patients achieving a greater than or equal to 50% improvement from baseline in the total vitiligo area severity index, a key secondary endpoint. In addition, after 52 weeks of treatment with ruxolitinib cream 1.5% administered twice daily, 58% of patients achieved F-VASI50 and 51% of patients achieved a greater than or equal to 75% improvement. F-VASI75 after 24 weeks is the primary outcome measure of both the TRuE-V1 and TRuE-V2 randomized Phase 3 trials that are already underway. Ruxolitinib cream was generally well-tolerated at all dosage strengths and no treatment-related serious adverse events were reported.