Phase III TRuE-V trial of Opzelura shows improvements in nonsegmental vitiligo.- Incyte

Building on the previously announced positive topline results from the TRuE-V program, findings from the Week 24 analysis showed treatment with 1.5% ruxolitinib cream twice daily (BID) resulted in greater improvement to vehicle for the primary and all key secondary endpoints in both the TRuE-V1 and TRuE-V2 studies.

Results were consistent across both studies. At Week 24, 29.9% of patients applying ruxolitinib cream achieved at least 75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75), the primary endpoint. More than 51% of patients applying ruxolitinib cream achieved at least 50% improvement from baseline in F-VASI (F-VASI50), and more than 15% of patients applying ruxolitinib cream achieved at least 90% improvement from baseline in F-VASI (F-VASI90), key secondary endpoints.

Additional key secondary endpoints were met, including a significantly greater proportion of patients achieving at least 50% improvement from baseline in total body Vitiligo Area Scoring Index (T-VASI50) and a Vitiligo Noticeability Scale (VNS) response with application of ruxolitinib cream compared to vehicle, and a significant improvement on percentage change from baseline in facial body surface area (F-BSA) with application of ruxolitinib cream compared to vehicle. These data will be presented as a late-breaking oral presentation (Abstract #D3T01.2A) at the European Academy of Dermatology and Venereology (EADV) 30th Congress, held virtually from September 29-October 2, 2021.