Press release
Incyte Announces Full Results From Phase 3 TRuE-V Program Evaluating Ruxolitinib Cream (Opzelura™) in Patients With Vitiligo
- Treatment with ruxolitinib cream (Opzelura™) resulted in facial repigmentation at Week 24, characterized by a significant proportion of patients achieving
About this update from Incyte Corporation
[{"type":"text","content":"\n- Treatment with ruxolitinib cream (Opzelura™) resulted in facial repigmentation at Week 24, characterized by a significant proportion of patients achieving ≥75% improvement from baseline in the facial Vitiligo Area Scoring Index\n\n- A significantly greater proportion of patients treated with ruxolitinib cream also achieved ≥50% improvement from baseline in total body Vitiligo Area Scoring Index (T-VASI50)\n\n- Results will be presented in a late-breaking oral presentation at the European Academy of Dermatology and Venereology (EADV) 30th Congress\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) today announced the full 24-week results from its pivotal Phase 3 TRuE-V clinical trial program investigating ruxolitinib cream (Opzelura™), a topical JAK inhibitor, in adolescent and adult patients (age ≥12 years) with nonsegmental vitiligo. These data will be presented today 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.\n\nBuilding 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, which were consistent across both studies, showed:\n\n\nAt Week 24, 29.9% of patients applying ruxolitinib cream achieved ≥75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75), the primary endpoint.\n\n\nMore than 51% of patients applying ruxolitinib cream achieved ≥50% improvement from baseline in F-VASI (F-VASI50), and more than 15% of patients applying ruxolitinib cream achieved ≥90% improvement from baseline in F-VASI (F-VASI90), key secondary endpoints.\n\n\nAdditional key secondary endpoints were met, including a significantly greater proportion of patients achieving ≥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 vehic...