Press release
Incyte Announces Positive 52-Week Results From a Randomized Phase 2 Study of Ruxolitinib Cream in Patients With Vitiligo
- Data presented at EADV demonstrate continued improvement in repigmentation of vitiligo lesions upon longer treatment duration with ruxolitinib cream
About this update from Incyte Corporation
[{"type":"text","content":"\n- Data presented at EADV demonstrate continued improvement in repigmentation of vitiligo lesions upon longer treatment duration with ruxolitinib cream\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) today announces positive 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.\n\n\nAs previously announced, the study met its primary endpoint, demonstrating that significantly more patients treated with ruxolitinib cream for 24 weeks achieved a ≥50 percent improvement from baseline in the facial vitiligo area severity index (F-VASI50) score compared to patients treated with a vehicle control (non-medicated cream).\n\n\nUpdated results at week 52 show substantial improvements in total body repigmentation with ruxolitinib cream, measured by the proportion of patients achieving a ≥50 percent improvement from baseline in the total vitiligo area severity index (T-VASI50), a key secondary endpoint. In addition, after 52 weeks of treatment with ruxolitinib cream 1.5 percent administered twice daily (BID), 58 percent of patients achieved F-VASI50 and 51 percent of patients achieved a ≥75 percent improvement (F-VASI75). 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.\n\n\nThe 52-week results are being shared at the 28th European Academy of Dermatology and Venereology (EADV) congress in Madrid, Spain, during a late-breaking research session today, October 12, 2019, from 11:30 a.m. CEST to 11:45 a.m. CEST (Location: Hall 10 Dalí; Late Breaking News, Abstract #D3T01.1L).\n\n\n“We are very encouraged about the positive updated data presented at EADV, which demonstrate substantial facial and total body repigmentation of vitiligo lesions in patients treated with ruxolitinib cream, and continued improvements with longer duration of treatment,” said Jim Lee, M.D., Group Vice President, Inflammation & Autoimmunity, Incyte. “As we seek to offer a much-needed option for those patients impacted by this life-altering disease, we are excited that the pivotal Phase 3 studies evaluating ruxolitinib cream in patients with vitiligo are underway, with results expected in 2021.”\n\n\nKey 52-week results include...